Rank: #19 (Last year: #20) ¥1.04 Trillion ($6.91B)
Prior Fiscal: ¥922 Billion
Percentage Change: +12.4%
R&D Expenditure: ¥74.2B
Best FY24 Quarter: Q4 ¥263B
Latest Quarter: Q4 ¥263B
No. of Employees: 30,591
Global Headquarters: Tokyo, Japan

In February 2006, Terumo announced its intent to acquire MicroVention, a privately held medical device company focused on endovascular coils and related products to treat cerebral aneurysms. Since the close of that deal, the neurovascular-focused device organization has supported surgeons in the preservation and restoration of brain health from under the Terumo flag.

In September 2024, the company removed any perceived barriers between the two entities with a rebranding. MicroVention became Terumo Neuro. Its mission, however, would remain unchanged.

“This transformation reflects our growth as a company and Terumo’s confidence in our future. For 18 years, we have maintained independent branding as MicroVention, and now, as Terumo Neuro, we’re combining the best of MicroVention with the full strength and support of the Terumo family. Our culture, speed of innovation, focus on game-changing technologies, and close collaboration with physicians will remain unchanged,” stated Carsten Schroeder, president and CEO of Terumo Neuro at the time of the announcement.

Schroeder also emphasized that the company’s DNA remains rooted in innovation for ischemic stroke, hemorrhagic stroke, and access, while expanding into broader areas of neurovascular care.

In order to help accomplish this objective and further bolster technologies for other clinical areas—primarily cardiovascular disease treatment, chronic disease treatment, and digital technologies—Terumo established Terumo Ventures. Announced in August 2024, this initiative will result in an investment of $75 million over five years in early-stage companies. The goal is to enhance the company’s access to innovative technologies and business ideas from startups, promote open innovation, and pursue synergies with its internal R&D efforts.

Terumo Ventures is an aspect of the firm’s five-year growth strategy—GS26—rolled out in 2021, along with a 10-year vision for the organization. Terumo Ventures is also another aspect of that plan, “From Devices to Solutions,” a refocus on solving problems for its customers rather than simply producing products. The strategy is anchored by the 3Ds—Delivery, Digital, and Deviceuticals.

As part of the initiative, Terumo had been working to strengthen its innovation capabilities, including the introduction of the new director position in charge of innovation (started April 2024). The position centrally manages innovation-related functions across the company, such as R&D, intellectual property, clinical development, digital transformation, and venture investment, and facilitates cross-functional collaboration. Toshihiko Osada—formerly president of the Cardiac and Vascular Company and division president of Interventional Systems Division, Cardiac and Vascular Company—was announced as the first person to hold the new position.

To further this effort, on the final day of Terumo’s latest fiscal year, it was announced the company opened a new R&D center in Aliso Viejo, Calif. Named D-TECT (Discovery and Technology Center of Terumo), the mission for the center was to facilitate collaboration with local medical institutions, academia, and startups to reinforce Terumo’s global R&D capabilities.

“I am thrilled with the establishment of D-TECT, our latest initiative to expand Terumo’s Corporate R&D operations globally and to strengthen our ability to innovate,” said Dr. Shinji Omori, chief technology officer. “I firmly believe that the new center will play a pivotal role in generating new technologies that will drive the next growth of the Terumo Group through close collaboration with various stakeholders in the U.S.”

By establishing D-TECT as a satellite base of Terumo’s corporate R&D, the company will further accelerate its research and development activities in the U.S. The center will also play a key role in transferring the company’s core technologies, such as coating technology, metal materials and manufacturing technology, and evaluation technology, to other group companies in the U.S. In addition, it will explore new technologies emerging from local startups and academia, aiming to further deepen Terumo’s technological capabilities.

The location consists of two teams: one team is in charge of driving product development projects, and the other supports the R&D or manufacturing of the group companies. At opening, the center was established with a staff of about 10 researchers, including those seconded from the corporate R&D in Japan as well as locally hired researchers. The company planned to gradually expand the functionalities and scale of the center, with the goal of having a team of 30 researchers within five years.

While not a result of the new R&D center, Terumo did share information on a number of products and projects throughout the latest fiscal that had been in development.

May 2024 provided Terumo Cardiovascular with a 510(k) clearance of its CDI OneView Monitoring System. The platform provides visibility of key patient parameters during cardiopulmonary bypass surgery, critical to perfusion safety and improving patient outcomes. It measures or displays up to 22 key parameters, the newest of which are measured flow, cardiac index, regional cerebral oxygen saturation, oxygen extraction ratio, Area Under the DO2 Curve, and measured arterial oxygen saturation.

The next month, MicroVention (prior to its rebranding) launched the LVIS EVO Intraluminal Support Device in the U.S. for treatment of wide-neck intracranial aneurysms—the first of its kind in the country, according to the company. The technology became available in Europe in 2019, with over 12,000 units sold. It delivers enhanced visualization, optimized opening, and precise placement with drawn filled tube wire construction and advanced braid design. With enhanced visualization, LVIS EVO provides wall apposition confirmation. The entire stent body is visible under fluoroscopy. The optimized braid angle allows for improved device opening along the device’s entire length. With precise placement, LVIS EVO offers controlled delivery and development, as well as the ability to resheath the device up to 80% of the device length.

In the fall, Terumo BCT launched its Reveos Automated Blood Processing System in the U.S. to help blood centers meet blood and platelet supply needs while helping their staff work more efficiently. The technology is the first whole blood automation device available in the U.S. to process whole blood into three components—platelets, plasma, and red blood cell concentrates—in a single centrifugation cycle. This streamlined process helps maximize the yield of whole blood donations, addressing the ongoing challenges of platelet shortages and the need for more efficient blood processing methods.

Toward the end of 2024, Terumo Interventional Systems (TIS) made the R2P NaviCross peripheral support catheter commercially available in the U.S., further expanding the company’s radial-to-peripheral (R2P) portfolio. The catheter, launched in a 200-cm length, was designed for optimized performance in R2P procedures. Its double-braided, stainless-steel construction was engineered for superior trackability and torque control for lesion crossing in more complex procedures.

In January, the organization launched the Terumo Injection Filter Needle globally. Indicated for hypodermic and intravitreal injections, the needle features an integrated polyamide five-micrometer mesh filter to prevent particles from being injected. A specific hub design—in shape and material—was developed to enhance the connection between the needle and the syringe. The device was developed to extend the options for Terumo’s partners in the pharmaceutical industry working toward greater safety in injected drug delivery, particularly with respect to injections into sensitive areas such as the vitreous humor in the eye.

Several weeks before the end of the 2024 fiscal year, the firm received MDR approval for an expanded indication of its Ultimaster Nagomi and Ultimaster Tansei sirolimus-eluting coronary stent systems. This approval covered patients at high bleeding risk, including those eligible for dual antiplatelet therapy as short as one month.

All of these efforts intend to keep Terumo on its positive growth trajectory. Boasting back-to-back fiscal years of double-digit percentage increases, 2024 resulted in the organization topping the ¥1 trillion mark for the first time in its history. Specifically, the company enjoyed a 12.4% gain to tally ¥1.04 trillion.

Those sales spread across Terumo’s three companies—Cardiac and Vascular, Medical Care Solutions, and Blood and Cell Technologies (BCT). The first, Cardiac and Vascular, is the primary breadwinner for the organization. It mirrored the full firm’s year-over-year growth with a 12.4% rise. This resulted in a final total for the fiscal year of ¥624 billion. While all divisions within Cardiac and Vascular saw gains, the increases were primarily attributed to Terumo Interventional Systems and the Terumo Neuro divisions.

While Medical Care saw the lowest growth percentage of the three companies, it still enjoyed a respectable 6.9% elevation, which translated to a revenue take of ¥211 billion. Hospital Care Solutions sales in Japan drove a portion of the growth, but overseas (i.e., outside of Japan) gains were strong, seeing a 15.5% ballooning.

Terumo BCT celebrated the strongest increase at 19%, sending it over ¥200 billion for the fiscal. The quicker pace of growth in the plasma innovation business in North America and increased sales of the blood collection business in Europe and the U.S. were credited as the primary reasons for the improvement. Regions outside of Japan grew revenue by 20.3%.

¥921.86 Billion ($6.09 Billion)
Prior Fiscal: ¥820.21 Billion
Percentage Change: +12.4%
R&D Expenditure: ¥691M
Best FY23 Quarter: Q3 ¥239.08B
Latest Quarter: Q4 ¥238.91B
No. of Employees: 30,591

In December 2023, it was announced there would be changes occurring to Terumo’s leadership as of the start of its next fiscal (April 1, 2024). Shinjiro Sato would step down as CEO after serving in the role for approximately seven years. Coming to Terumo in June 2004, he also held titles including executive officer, senior executive officer, managing executive officer, and manager of business planning office. He would remain with the organization as a corporate advisor.

Stepping into his CEO shoes at the time of the fiscal changeover would be Hikaru Samejima, who was serving as president of the Medical Care Solutions business. Samejima joined Terumo in 2002 as a member of the Corporate Planning Department. While focused in the Cardiac and Vascular portion of the company, he served as president and division president before being promoted to president of the General Hospital Company.

Samejima took over at a time when the company reported record highs in revenue, operating profit, and net income. The 12.4% year-over-year growth translated into the ¥922 billion Terumo took in during its 2023 fiscal period. The gains were driven primarily by sales in the Americas and Europe, according to the company. It specifically pointed to increased demand for solutions out of the Interventional Systems (TIS) unit and blood centers business. Foreign exchange rates were also favorable.

The good fortune of increased revenue fell across all three segments. The Cardiac and Vascular Company, which is Terumo’s largest in terms of revenue, rose 15.6% to contribute ¥555.72 billion to the company’s coffers. TIS was again given credit for the gains, but the Neurovascular division was also indicated as another reason. All businesses within the Cardiac and Vascular Company achieved double-digit growth compared to fiscal 2022.

From Samejima’s former Terumo Company—Medical Care Solutions—the revenue gain was a bit more modest. The tally of ¥197.57 billion reflected 3% growth. Strong sales of infusion-related products and within the Pharmaceutical Solutions division were highlighted as the primary reasons for the revenue rise.

Blood and Cell Technologies (BCT) Company saw positive gains, which were attributed to an increase in sales of automated blood component collection products. The revenue ballooned by 14% compared to the previous fiscal to add ¥168.33 billion to the company’s total.

To ensure continued revenue elevation in the coming years, the firm dedicated significant effort to organic growth through a variety of product announcements.

A few weeks after the start of the ’23 fiscal on April 1, the company’s Thoracoflo device was first implanted within North America, noting its market debut in the region. The technology is used to treat patients with thoracoabdominal aortic disease using a less invasive surgical technique than traditional open surgical repair.

The following month, an indication expansion approval was granted for the RELAYPro Stent-Graft System by the U.S. FDA. The regulatory decision was with regard to the use of the innovation for the treatment of dissection and transection. The technology first gained U.S. FDA approval in 2021.

In June, MicroVention—a wholly owned subsidiary of Terumo—launched its ERIC Retrieval Device onto the U.S. marketplace. The device had gained the required clearance in March 2022. The device is a self-expanding, laser-cut clot retriever with multiple retrieval cages, located on a pusher wire delivery system. It is offered in three sizes that treat a wide vessel size range of 5.5 mm down to 1.5 mm and is compatible with MicroVention’s HEADWAY 17 and HEADWAY 21 microcatheters.

On the day of the U.S. Independence celebration, the Thoraflex Hybrid Frozen Elephant Trunk device gained the ability to be sold in Japan via an approval from the Japanese Pharmaceuticals and Medical Devices Agency. The Thoraflex Hybrid is a single-use medical device combining a Gelweave polyester graft with a nitinol self-expanding stent graft. It is indicated for the open surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta in cases of aneurysm and/or dissection.

August saw Terumo BCT secure U.S. FDA clearance for the Reveos Automated Whole Blood Processing System. According to the company, this was the first whole blood automation device available in the U.S. that processes whole blood into platelets and other components in a single centrifugation cycle.

In October, the company revealed its CE-marked Femoseal had arrived on the market in June 2023. In addition, in the same announcement, it noted CE-marked Angio-Seal VIP units would begin to show up in November 2023. Both CE marks were in compliance with the EU’s new MDR. The technologies are used to achieve femoral arterial hemostasis after percutaneous catheterization through the common femoral artery.

Also in November, Terumo India launched two products intended to assist with the management of liver cancer. With Occlusafe, Terumo’s balloon transcatheter arterial chemo-embolization device, patients benefit from more precise and targeted delivery of a chemotherapy drug to the tumor. The other offering, LifePearl, helps release the chemotherapeutic drug in a controlled and sustained manner at the targeted tumor site inside the liver.

Terumo India also addressed the need for insulin among those with diabetes. The launch of the organization’s Insulin Syringe provided a sterile delivery device for patients requiring regular injections.

Before the end of the calendar year, the firm released its AZUR HydroPack Peripheral Coil System. This offering is a soft, universal-shaped platinum and hydrogel coil designed to find and fill empty space within the vessel during embolotherapy. The system has a true 0.018” primary wind and is available in long lengths—ranging from 5cm to 60 cm—making it the longest gel core coil on the market at the time of launch. It allows for flexible sizing and can be deployed through 2.4Fr or 2.8Fr microcatheters in a single-coil platform.

Beyond the expansion of its own product portfolio, Terumo (specifically, its BCT Company) also shared insights on a pair of partnership arrangements it established throughout the 2023 fiscal period. The first team-up involved 908 Devices, which produces handheld and desktop devices for chemical and biochemical analysis. The goal of the collaboration was to enable online monitoring of critical process parameters in BCT’s Quantum Flex Cell Expansion System, an automated and functionally closed system purpose-built to meet the needs of cell therapy developers throughout their commercialization journey.

The other pairing brings BCT together with CiRA Foundation, a public interest organization for the transfer of induced pluripotent stem (iPS) cells to industry. By leveraging CiRA’s iPS cell knowledge and BCT’s enabling technologies and cell therapy manufacturing know-how, the companies sought to develop an automated and clinically relevant workflow for iPS cell-derived therapies.

During this same period, Terumo also ended a pair of previously established agreements. An arrangement dating back to April 2007 brought Terumo and Olympus together to create Olympus Terumo Biomaterials. The company is involved with the research and development, manufacturing, and sales of biomaterials such as ceramic artificial bones and regenerative medicine. It had been operating jointly under the direction of both firms until August 2023 when Olympus acquired all stocks to bring it into its exclusive fold as a wholly owned subsidiary.

Terumo also indicated a change to a partnership it had with Dexcom to distribute the latter’s continuous glucose monitoring (CGM) system within Japan. Dexcom adjusted its commercial strategy to directly perform sales and support activities for its CGM within the Asian country beginning April 2024. As such, it would no longer require Terumo’s support in that effort.

To help maintain the level of expansion the company was enjoying, there were also new facility announcements shared during the fiscal—actions taken to presumably ensure manufacturing could keep up with demand.

The first was declared in May 2023; Medical Care Solutions would gain a new manufacturing facility at the organization’s Kofu Factory located in Yamanashi, Japan. With an investment of ¥52.2 billion, the location would be used for Terumo’s contract development and manufacturing organization business, as well as products related to peritoneal dialysis. It is also expected the new facility would provide additional space to allow for the scale-up of production to meet future demands. Construction is expected to be completed during the 2025 fiscal.

Not exactly a new facility or expansion, Terumo announced the establishment of Terumo South Africa just before December 2023. Operating as a wholly owned subsidiary of Terumo Europe, the Johannesburg-based entity would serve as a direct contact for local partners and enable it to better serve the region.

“The opening of our new subsidiary in South Africa is a step forward in realizing our global Growth Strategy. We are dedicated to delivering exceptional value to our South African partners, customers, and the patients they serve,” explained Takuya Hosogai, president and CEO of Terumo Europe.

Valentine’s Day 2024 provided much love to Puerto Rico, the future home of another manufacturing site for Terumo. The $30 million investment would help bolster the manufacturing of the organization’s Angio-Seal Vascular Closure Device, which was experiencing growing demand. The 64,000-square-foot expansion was to be built adjacent to the existing site and is scheduled to be completed by the middle of 2025.

In addition, the existing, 22,000-square-foot building would also be renovated to support related production administration requirements.

¥820.21 Billion ($6.18 Billion)
Prior Fiscal: ¥703.3 Billion
Percentage Change: +16.6%
R&D Expenditure: ¥61.6B
Best FY22 Quarter: Q3 ¥214.6B
Latest Quarter: Q4 ¥202.2B
No. of Employees: 30,207

Terumo began a technology integration with data management company Glooko in March 2022 to deliver new diabetes data sharing solutions together worldwide. The integration aims to help people with diabetes transfer recorded data from the MEDISAFE WITH insulin patch pump into the Glooko platform, so they can visualize insulin dosage, food, and activities in graphs more easily. The integration also intends to realize personalized remote patient monitoring and patient care more effectively.

As a next step, both companies will work on a way to transfer recorded data from MEDISAFE WITH to the Glooko mobile app directly via near-field communication (NFC). MEDISAFE WITH, at the time, was the world’s first insulin patch pump with direct NFC connection to the Glooko mobile app. The app uses patients’ personal smartphones to share diabetes data with their diabetes team anytime, anywhere.

“We believe this is a valuable solution for both patients and healthcare providers especially under the post COVID-19 ‘new normal’ lifestyle,” Hikaru Samejima, president of Terumo’s General Hospital Company, said in a company press release announcing the partnership.

MEDISAFE WITH notched a CE mark in November 2020 and Glooko’s solutions are currently used in 31 countries to digitally connect diabetes patients and their healthcare professional teams.

“…people with diabetes will be able to make more informed decisions with their data, and collaborate with their health care team,” Glooko CEO Russ Johannesson said in the same press release. “That data includes insulin, glucose, diet, activity and blood pressure. Having the best connectivity is imperative for delivering world-class care…”

The Japanese company posted FY22 revenue of ¥820.2 billion ($6.18 billion), increasing just over 7% from the previous fiscal year’s total. Japanese revenue was somewhat flat—with a slight 0.6% rise—mainly due to strong revenue from Pharmaceutical Solutions and new products in the vascular graft division. This was despite a delayed recovery in medical demand from the COVID-19 pandemic. Overseas revenue performed quite admirably with a sharp incline of 23.3% year on year—mainly due to recovery of overall medical demand, despite some localized impacts caused by COVID-19 in China.

Terumo’s Cardiac and Vascular business posted ¥480.6 billion in sales in FY22, ballooning 21% over the year prior. According to the company’s financial report, revenue increased in Japan amid growth in new product sales like drug-eluting coronary stents and thoracic stent grafts, offsetting weaker demand from the impact of the resurgence of COVID-19 cases. Vascular graft division performance was solid due to several new product launches in the U.S.

The Terumo MicroVention neurovascular business achieved the first U.S. clinical case of its next-gen FRED X flow diverter last February. FRED X features a proprietary nano-polymer surface modification to reduce clot formation on the device surface. Its self-expanding, braided nitinol mesh helps redirect blood flow and promote aneurysm occlusion. According to Terumo, FRED X has both the smallest and largest flow diversion systems available in the United States.

The FDA granted breakthrough device status to Terumo’s RelayBranch thoracic stent-graft system last March. RelayBranch is implanted in patients with thoracic aortic arch pathologies needing treatment that includes coverage of the innominate and left common carotid arteries. The system is comprised of a main body graft deployed in the ascending aorta, with two anterograde tunnels that give way to a large cannulation window. Branch grafts are then deployed in these tunnels for the innominate artery and left common carotid artery.

FDA approval for the Thoraflex Hybrid Frozen Elephant Trunk (FET) device for complex aortic arch disease came a month later. The single-use device combines a Gelweave polyester graft with a Nitinol self-expanding stent graft and is indicated for open surgical repair or replacement of damaged or diseased aortic arch and descending aorta vessels with or without involvement of the ascending aorta in cases of aneurysm and/or dissection. Thoraflex Hybrid has had CE mark approval since 2012, with over 13,000 devices sold commercially around the world over the past decade. The first U.S. commercial implant of the device happened in July.

Terumo Medical Care Solutions—formerly named General Hospital Company and changed last April—revenue expanded 3.5% to ¥191.7. In the company’s primary Japan market, new adhesion barrier products and prefillable syringes of the Hospital Care division grew, making up for impacts from the resurgence of COVID-19 cases. Further, Pharmaceutical Solutions sales trended strongly across the globe.

August saw approval from Japan’s Ministry of Health, Labour and Welfare for the G-Lasta Subcutaneous Injection 3.6 mg BodyPod, a drug-device combination product co-developed with Kyowa Kirin. The product is used on the day of chemotherapy to reduce febrile neutropenia, so patients can skip the required outpatient visit on the day after chemo. G-Lasta launched in Japan in December.

Blood and Cell Technologies (BCT) accrued proceeds of ¥147.6 billion, skyrocketing 22.4% over the prior fiscal year. Japanese revenue declined somewhat due to weaker demand for blood bags. Overseas revenue swelled substantially, driven by recovery in blood transfusion demand in Asia and other regions, as well as strong demand for blood component collection systems in North America.

The company’s Rika plasma donation system earned FDA clearance last March. The automated technology includes safety features to minimize operator errors, ensure there’s never more than 200 milliliters of blood outside the donor’s body at one time, and collects plasma in 35 minutes or less. An advanced control system monitors the process and provides alerts and visual cues to guide the operator. Rika makes automatic adjustments during each collection to enable a seamless operating experience and the ability to spend more time with the donor.

Terumo BCT rolled out the Quantum Flex Cell Expansion System, a bioreactor platform to support process development through commercial manufacturing for the cell and gene therapy sector, in September. The automated and functionally closed cell expansion system can progress autologous and allogeneic applications, along with viral vector and exosome production, across various bioreactor sizes for process efficiencies in batch size. Hollow-fiber perfusion tech offers a cell culture environment where cells gain continuous access to fresh media, waste removal, and gas exchange, ensuring optimal conditions for expansion. Advanced software supports cGMP compliance, with user authentication, batch records, and fleet management features.

¥703.3 Billion ($5.77 Billion)
Prior Fiscal: ¥613.8 Billion
Percentage Change: +14.6%
R&D Expenditure: ¥519M
Best FY22 Quarter: Q4 ¥179.8B
Latest Quarter: Q4 (2022) ¥179.8B
No. of Employees: 28,294 (total)

The plotline seems hauntingly familiar: A deadly pandemic on the wane, a global supply chain on the fritz, political extremism on the rise, and hyperinflation on the move.

The year? 1921.

World War I had ended three years prior but planetary peace and harmony remained elusive amid growing social, political, and economic unrest. The Soviets toppled Georgia’s government as Ireland fought for its freedom from British rule and communism gained ground in China, Italy, Spain, and South Africa.

America’s economy was barely alive, having been felled by high unemployment (11.7%), a bear market (down 50%), and declining corporate profits. Europe’s fiscal health wasn’t much better—exorbitant war debts and hyperinflation sowed economic misery in both Austria and Germany, and a post-war shipbuilding slowdown effectively torpedoed Britain’s gross domestic product (it fell 22% in nine months).

Japan, meanwhile, was running short on thermometers. The country usually imported these instruments from Germany, the United Kingdom, and United States, but the war had severed the entire flow of goods and services. Further complicating matters was the financial instability of Japan’s only thermometer manufacturer, Takeuchi Terumo Works.

Realizing the critical need for domestic production, renowned physician/bacteriologist Baron Shibasaburo Kitasato and several scientists founded the Red Line Thermometers Corporation. Born on Sept. 17, 1921, the fledgling firm introduced its first clinical thermometer—Jintan Taionkei—to the Japanese market just five months later.

“Our goal in establishing the company is to manufacture and sell a wide variety of clinical and other thermometers and scientific instruments,” Red Line’s charter states. “Recently, we have realized that the development and spread of the concept of individuals taking care of their own health has led to increased demand for thermometers in Japan as well as in the developed nations of Europe and the United States, upon whom we have thus far depended to supply us with these items. But as the balance between supply and demand shifts, we are fast reaching a time when the present situation will reverse and there will be increased demand outside of Japan for products manufactured in Japan. This will inevitably lead to increased exports of our country’s products. Thus, we are supremely confident that our company’s future prospects are highly promising, that our profit will be great, and our business will thrive far into the future.”

Far, indeed. A century after its founding, Red Line Thermometers—a.k.a., Terumo Corporation (the name changed in 1974)—not only is thriving but driving therapeutic innovation as well.

In FY22 (year ended March 31, 2022), Terumo grew sales 14.6% to ¥703.3 billion. Gross profit ballooned 13.1% to ¥369.3 billion, and operating profit mushroomed 17.9% to ¥115.9 billion, according to company financial data.

Terumo’s stellar earnings in its most recent fiscal year was driven mainly by solid growth in its three business segments. Medical Care Solutions (formerly the General Hospital Company) proceeds benefitted from recovering demand for syringes and infusion-related products in Japan as well as higher sales of infusion and syringe pumps. Revenue in this segment rose 5.6% to ¥185.3 billion, with the bulk of sales derived domestically (¥142.7 billion).

Certainly, fostering the segment’s FY22 profit was the domestic launch of the Dexcom G6 continuous glucose monitoring (CGM) system, and partnerships with both Glooko and Diabeloop.

The latter union aims to supply Europe with automatic insulin delivery (AID) solutions while the Glooko pairing enhances diabetes data sharing solutions.

Terumo debuted the Dexcom G6 CGM system in late July 2021 (the firm has exclusive distribution rights in Japan). The product allows for real-time glucose monitoring through a small, wearable sensor and transmitter that measures and automatically sends glucose level readings wirelessly to a smart device or receiver every five minutes. The constant data flow enables users to track their glucose levels throughout the day and determine whether they are within their target range. The system also displays trend arrows to show the speed and direction glucose levels are heading.

In addition, the Dexcom G6 CGM system features customizable alerts to proactively warn patients when their glucose levels are out of range and an “Urgent Low-Soon (ULS) Alert” that warns users 20 minutes before a severe hypoglycemic event, giving them time to take appropriate action.

“The launch of Dexcom G6 CGM System in Japan is an important milestone for Terumo as we promise to commit to contribute to diabetes care comprehensively,” Yoshiya Kikawa, Terumo’s general manager DM and Consumer Healthcare Group, said in prepared remarks. “With our product lineup of CGM blood glucose system, and Japan’s first tubing-free insulin patch pump, we will continue to strive to improve the quality of life for people living with diabetes.”

Terumo also continued its quest to improve blood and plasma supplies. During fiscal 2022, its company’s Blood and Cell Technologies business forged several partnerships, launched new software, and received regulatory approvals for two new products.

Terumo paired with CSL Plasma in April 2021 to deliver a new plasma collection platform at CSL’s U.S. collection centers, joined the Process Analytical Technology Consortium in June to help streamline cell and gene therapy manufacturing, and teamed up with BioCentriq in October (2021) to expand its cell and gene therapy market footprint.

The BioCentriq collaboration involves equipping the company’s laboratories with Terumo’s solutions, including its Quantum Cell Expansion and Finia Fill and Finish systems. Quantum is a functionally closed, automated cell expansion system enabling process control for various adherent cells, suspension cells, viral vectors, and exosomes. The Finia System automates the final steps of cell and gene manufacturing.

Terumo upgraded the Finia System last fall, adding automated procedure configuration, enhanced reporting, and offline mode to its capabilities. The offline mode allows the system to run without network connectivity and removes any risk of delay from IT complications. Its Cell Processing Application can manage multiple Finia devices from a central server, supporting cGMP compliance with user authentication, electronic batch reporting, and workflow configuration.

The two regulatory approvals Terumo scored for its Blood and Cell Technologies business this past fiscal year occurred seven months apart. Health Canada greenlighted the Mirasol Pathogen Reduction Technology System in mid-August; it is routinely used at more than 100 blood centers in over 20 countries in Europe, the Middle East, Africa, Asia, and Latin America. Employing riboflavin (vitamin B2) and ultraviolet light, Mirasol is designed to reduce the pathogen load of various disease-causing agents such as viruses, parasites, and bacteria in blood products before transfusions. Mirasol also inactivates white blood cells to help reduce certain transfusion reactions.

Twenty-nine weeks after Health Canada’s Mirasol approval, the U.S. Food and Drug Administration cleared Terumo’s next-generation automated plasma collection system. Designed to collect plasma in 35 minutes or less, the Rika system features an advanced control system to enhance donor safety; it monitors the collection process and guides the operator through alerts and visual cues, while the platform itself makes automatic adjustments during each procedure.

The Blood and Cell Technology segment’s mix of partnerships and new products helped boost FY22 sales 10.1% to ¥120.6 billion. Blood center product sales in Japan fell 1.2% to ¥12 billion due to lower demand for blood bags. Overseas revenue rose 11.5% to ¥108.5 billion, as demand recovered for whole blood collection, automated blood processing products, and therapeutic apheresis systems in Europe and North America. Proceeds in China surged 30% on improved sales of blood component collection systems for blood centers.

Cardiac and Vascular revenue followed a similar trajectory in FY22, sans a domestic loss. Although Japan’s moderate COVID-19 recovery limited profits at home, robust carotid artery stents sales lifted sales 1.9% to ¥51.1 billion. Overseas proceeds skyrocketed 24.3% to ¥345.9 billion, driven by strong demand for interventional and neurovascular solutions.

Overall, the Cardiac and Vascular segment grew sales 21% in fiscal 2022, generating ¥397.1 billion—more than double Blood and Cell Technologies’ total. Like its segment siblings, Cardiac and Vascular profited from a mix of strategic alliances and expanded product offerings during the year, including:

• • A collaboration with Etiometry to provide advanced clinical decision support to adult cardiac surgery patients during and after their procedures.

• • A co-marketing agreement with Corazon Inc. The pair will use Terumo’s proprietary ePRISM technology to improve outcomes for cardiac patients and Corazon’s E3 approach to accreditation as a means to monitor and recognize such improvements.

• • FDA and PMDA (Japanese Pharmaceuticals and Medical Devices Agency) approval of the RelayPro Thoracic Stent-Graft System for treating thoracic aortic aneurysms. The device was also approved by the FDA to treat penetrating atherosclerotic ulcers, and was implanted in the first U.S. patient in September 2021. The RelayPro’s first “Upon Request” implant took place in January 2022.

• • PMDA approval and the first commercial implant of the TREO Endovascular Device in Japan. The product’s three-piece design features in-situ limb adjustability and provides a range of aortic device configurations to specifically address individual patient anatomies.

• • FDA Breakthrough Device Designation for the RelayBranch Thoracic Stent-Graft System, intended for treating thoracic aortic arch pathologies that includes coverage of the innominate and left common carotid arteries. The System consists of a main body graft that is deployed in the ascending aorta and features two anterograde tunnels giving way to a large cannulation window. Branch grafts are then deployed within these tunnels for both the innominate artery and left common carotid artery.

• • The introduction of the AZUR Vascular Plug. Terumo claims the plug is the only such device compatible with a microcatheter to occlude arteries up to 8mm in diameter. It has a conformable nitinol braid that stays in place, even in tortuous anatomy.

• • The launch of a multi-center, multi-arm, post-market study of Terumo’s knitted and woven surgical grafts and cardiovascular patches. The PANTHER study will enroll about 900 patients and follow them for more than a decade.

• • The successful implantation of a customized thoracoabdominal hybrid device to treat thoracoabdominal aortic disease.

• • The launch and first commercial case of the Aortic Balloon in the United States. The device assists physicians in the expansion of the aorta when using TREO and RELAY stent-grafts in endovascular aortic repair.

• • The first U.S. clinical case using the next-generation FRED X Flow Diverter. The product features MicroVention X technology, a proprietary nano-polymer surface modification designed to reduce material thrombogenicity, or tendency for surface clot formation.

$5.57 Billion
Prior Fiscal: $5.83 Billion
Percentage Change: -4.5%
No. of Employees: 23,319

Terumo business MicroVention Inc., a U.S.-based neurovascular device company, welcomed a new leader last September. New president and CEO Carsten Schroeder touts an over 25-year tenure in senior experience roles across pharma, medical devices, and in-vitro diagnostics—serving as president and CEO of Grifols, president of diagnostics at Novartis, and various VP positions at Boston Scientific.

“I am very excited to be joining the MicroVention team,” Schroeder noted in a press release. “MicroVention’s reputation in their industry makes them well-positioned to becoming the global leader in the neurovascular market.”

In December, MicroVention filed a second lawsuit against Balt USA and four previous Terumo employees for trade secret misappropriation. It follows a patent lawsuit filed in July 2019 that is also ongoing.

MicroVention alleges during discovery in the first lawsuit, Balt reluctantly produced an enormous number of individual documents purloined from MicroVention. These documents were found to be part of MicroVention’s controlled docments library and knowledge management system, and MicroVention seeks $100 million in damages. At the time of writing, the lawsuit has not been resolved.

MicroVention represents a section of Terumo’s Cardiac and Vascular Company, which also manufactures interventional, cardiovascular, and vascular graft products. The business accrued 350.5 billion yen ($3.18 billion) of the company’s total $5.57 billion in total revenue in its most recent fiscal year (ended March 31, 2021). Like many others in the Top 30, that represented a loss—in Terumo’s case, of 4.5 percent. The Cardiac and Vascular Company was the firm’s most active last year.

Last January Terumo received FDA premarket approval for its FRED (Flow Re-Direction Endoluminal Device) to treat brain aneurysms. The flow diverter uses a self-expanding braided nitinol mesh to redirect blood flow and promote aneurysm occlusion. Its interwoven nitinol design facilitates smooth delivery, reliable opening, and vessel wall apposition.

Also last January, the firm launched its fluorinated urethane polyether prepolymer surgical sealant AQUABRID in the EMEA market. Specially developed for aortic procedures, it reacts with water (blood) and forms an elastic layer in three to five minutes that adheres to tissue. It has been proven safe and effective to achieve hemostasis, even when blood coagulation is inhibited during surgery.

The company’s BioPearl Microspheres gained EU approval last April. They were a new option for loco-regional embolization of target artery blood supply to liver cancer. They’re designed to preserve post TACE target artery access to open the possibility for cyclic treatment.

April also saw breakthrough device designation granted to the Thoraflex Hybrid stent for complex aortic arch repair. The single-use stent combines a gelatin-sealed woven polyester graft with a nitinol self-expanding stent graft to repair or replace damaged or diseased aortic arch vessels and descending aorta. Thoraflex Hybrid became the world’s first multi-branched “frozen elephant trunk” prosthesis when it earned a CE mark in 2012.

Terumo Aortic garnered FDA approval for the TREO abdominal aortic stent-graft system to treat abdominal aortic aneurysms last May. The endovascular aneurysm repair (EVAR) device touts dual proximal fixation and lock stent technology. A three-piece design with in situ limb adjustability allows for a wide range of aortic device configurations. According to recent clinical studies, its proximal clasping mechanism and leave-behind sheath simplify the procedure, as well. TREO launched in the U.S. in September.

Terumo purchased Netherlands-based healthcare startup Quirem Medical last July, acquiring 80.1 percent of Quirem shares and making it a wholly owned Terumo subsidiary to the tune of $45 million. Quirem produces microspheres for selective internal radiation therapy (SIRT) to treat liver tumors. QuiremSpheres contain the radioactive isotope Holmium-166, which recent trials have shown as safe and effective against unresectable liver cancer. They can be visualized and quantified in low concentrations by using single-photon emission computed tomography (SPECT) and MRI. Also brought into Terumo’s portfolio were QuiremScout, a low-dose holmium microsphere to evaluate microsphere biodistribution before therapy, and the Q-Suite dosimetry software package to plan QuiremSpheres treatments based on QuiremScout dose imaging.

A month later, following FDA emergency use authorization for COVID-19 patients with imminent or confirmed respiratory failure, Terumo and CytoSorbents Corp. began collaborating to sell the CytoSorb extracorporeal cytokine adsorber to hospitals in 10 U.S. COVID-19 hotspots. Combining Terumo’s extracorporeal membrane oxygenation (ECMO) with CytoSorb enables gas exchange and cytokine storm reduction, letting the lungs rest and potentially reduce time on mechanical lung support.

The General Hospital Company claimed 171 billion yen ($1.55 billion) in proceeds last year.

Thanks to FDA GMP certification last August, the firm began manufacturing Hulio (adalimumab-fkjp), a biosimilar to AbbVie’s Humira, on contract. Hulio treats rheumatoid and psoriatic arthritis, filled in Terumo’s PLAJEX prefillable syringe whose material reduces drug adsorption risks and impurity dissolution. In June 2020, the product also received approval in Japan.

November saw a CE mark for the MEDISAFE WITH insulin pump system. The tubing-free patch pump was designed to be wearable and lightweight, consisting of two parts including detachable pump and patch. Insulin is administered subcutaneously through a cannula attached to the patch. Basal and bolus settings can be adjusted with a remote controller.

The Blood and Cell Technologies Company makes up the remainder of Terumo’s business, and pocketed 107.1 billion yen ($972 million) in its most recent fiscal year.

In April the firm obtained FDA emergency use authorization for its Spectra Optia apheresis system combined with Marker Therapeutics’ D2000 adsorption cartridge to treat adult COVID-19 patients in the ICU with imminent respiratory failure to lower pro-inflammatory cytokine levels. The devices filter the patient’s blood to reduce the number of cytokines and other small active proteins that control a cell’s immune response.

Prior Fiscal: $5.41 Billion
Percentage Change: +4.9%
No. of Employees: 26,438

Many companies take various actions to ensure future health. Some invest heavily in R&D while others have an aggressive M&A strategy to grow through acquisition. In 2019, however, Terumo embarked on a slightly different approach. The company invested $50 million into two U.S.-based venture capital funds—Strategic Healthcare Investment Partners and Catalyst Health Ventures. Each received $25 million from the firm.

The strategy has been successful for the organization in the past as an opportunity to complement internal R&D with new technology, expanded strategy, and further complement business development and acquisition.

As a limited partner of Emergent Medical Partners, Terumo has reviewed more than 2,000 startups over the last six years based on its network built through this relationship. While investing in the fund, Terumo also directly invested in multiple startups.

With the latest pair of investments, the company is positioned to be involved in more geographically and technically diversified deals.

Perhaps a result of this type of investment, in November 2019, Terumo announced it was acquiring Aortica Corporation, a U.S.-based company dedicated to advancing the science of personalized vascular therapy. At the time of the deal, the firm had several products either on the market or in development.

Its primary offering, AortaFit, is an automated case planning software designed to precisely match fenestrations on an endograft with the unique locations of each individual patient’s branch arteries during fenestrated endovascular aortic repair (FEVAR). The solution is intended to improve graft anchoring while minimizing the potential for endoleaks and migration. The first 30 FEVAR cases incorporating AortaFit were reported as successful, including 16 which used the TREO AAA stent-graft from Terumo Aortic.

The company was also developing the BoulEVARd covered stent graft built specifically for FEVAR. The balloon expandable device is designed to enable reliable engagement into the main body graft while improving conformability to the native artery.

Although the price of the acquisition was not revealed, Teurmo did state the transaction would be funded with cash on hand. The organization also said it planned to continue the development of Aortica’s products and launch into markets around the globe.

Aortica joined a company that enjoyed success in terms of growth of revenue over the prior year. By the end of its latest fiscal (ended March 31, 2020), the firm reported a revenue increase of 4.9 percent over the previous period. That translated into 628.9 billion yen, compared to the 599.5 billion yen it saw during the prior 12 months.

All three of Terumo’s segments saw increases in sales compared to the previous fiscal. The largest gains were enjoyed by the firm’s largest business—Cardiac and Vascular Company—which encompasses Interventional Systems, Neurovascular, Cardiovascular, and Vascular Graft. The revenue from sales rose from 328.5 billion yen to 350.6 billion yen.

While less substantial, the growth observed in the other two segments—General Hospital Company and Blood and Cell Technologies Company—were still noteworthy. General Hospital, which is divided into Hospital Systems—infusion/syringe pumps, solution sets, pain management products, adhesion barriers, blood glucose monitoring systems, and more—and Alliance—contract manufacturing of prefilled syringes and devices to pharmaceutical companies for use in drug kits—bumped up to 170 billion yen from 165.8 billion yen. Blood and Cell Technologies, which provides blood bags, automated blood collection systems, automated blood component processing systems, pathogen reduction technology, and other solutions, went from 105 billion yen to 107.2 billion yen during its latest fiscal term.

As a way to ensure the momentum in terms of sales growth continues, Terumo made a couple of moves and launched several products toward that effort. For example, in June 2019, the organization announced it had secured exclusive global development and commercialization rights to Virtue Sirolimus-Eluting Balloon (SEB) as a result of a strategic partnership with Orchestra BioMed. Per the agreement, Terumo would provide a one-time $30 million payment, an equity commitment of $5 million, and future clinical and regulatory milestone payments to Orchestra. Terumo also committed to finance and execute a global clinical program in collaboration with Orchestra BioMed to gain regulatory approval of the Virtue SEB. The Virtue SEB is a non-coated drug-eluting angioplasty balloon that delivers a proprietary bioabsorbable, sustained-release formulation of sirolimus.

Terumo also announced it was embarking on a joint research effort with Kikuna Memorial Hospital, located in Kanagawa, Japan, to develop artificial intelligence for percutaneous coronary intervention (PCI). The partners have targeted 2023 for development of the solution, which will assist physicians to improve PCI accuracy and efficiency.

As mentioned, Terumo also sought answers to the challenge of ensuring long-term growth by looking within their own facilities—through new product developments and launches.

• Expanded its footprint for AQUABRID—a surgical sealant especially developed for aortic procedures—into the EU as well as Eastern Europe, Middle East, and Africa.
• U.S subsidiary MicroVention gained FDA premarket approval of the FRED (flow re-direction endoluminal device) for the treatment of brain aneurysms.
• Received manufacturing and marketing approval of its Woven EndoBridge Device for the treatment of intracranial wide neck bifurcation aneurysms in Japan. It gained approval in the U.S. at the start of 2019.
• A new osteoporosis medication, Teribone 28.2 µg subcutaneous autoinjector, has launched in the Japanese market for patients with a high risk of fractures.
• As part of a partnership between Mallinckrodt and Terumo BCT, UVADEX received regulatory approval in Australia for extracorporeal administration with the THERAKOS CELLEX Photopheresis System.
• Terumo BCT launched its latest cell therapy technology, the Finia Fill and Finish System—a device developed to help bring reproducibility and control to cell therapy manufacturing to get therapies to more patients who need them.
• At the 31st Transcatheter Cardiovascular Therapeutics Conference in September, Terumo Medical introduced the R2P MISAGO RX Self-expanding Peripheral Stent, providing physicians with a radial access approach to patients with peripheral artery disease.

AT A GLANCE
$5.41 Billion
Prior Fiscal: $5.53 Billion
Percentage Change: -2.2%
No. of Employees: 23,319

Masayuki Okano, the 85-year old president of “painless” hypodermic needle maker Okano Kogyo, built his business over decades, honing his skills and forming countless relationships. And in about a year, it seems it will be over.

Okano had contemplated handing his Tokyo-based company to a younger member of his family, but reconsidered. He had always said he wanted to retire at 55 but carried on as new opportunities emerged. Okano Kogyo has its roots in 1924, traced back to a company his father had founded. The company got its start in the metal press business, forging parts like battery cases for cell phones out of sheet metal.

The company received its big break in 2000. An engineer from medical equipment manufacturer Terumo stopped by a pediatric clinic one day, the waiting room full of children with diabetes awaiting one of four painful daily insulin injections. The engineer felt for the children, who winced at each injection.

The question of how to painlessly administer insulin swam in his mind. The clear solution was to make the needle thinner. Easier said than done—the thinner the needle, the more difficult it is to inject the insulin. Terumo devised a method to make one side of the needle wider than the other to allow insulin flow, but the company wasn’t equipped to mass produce the needles. They needed a partner.

After being denied by about a hundred small factories, Terumo encountered Okano Kogyo and its six-man team. The company’s skill with mold and presses to make hypodermic needles with high precision caught Terumo’s eye, and today the companies churn out millions of painless needles. A patent co-owned with Terumo protects the product, but no competitor could copy its technology regardless, Okano Kogyo told Nikkei Asian Review last year.

The technology will endure—Okano intends to transfer his company’s secret recipe to Terumo. Several years ago, he recruited some Terumo employees and spent three to four years, bringing them up to speed. Though Okano will let his company die a natural death, Terumo will continue his legacy, easing the lives of those requiring multiple daily insulin injections.

Of course, needles are a small—albeit, important—part of Terumo’s portfolio. The Japanese medical device maker offers products spanning cardiac and vascular devices and equipment, general hospital products, and blood management technology. Terumo’s revenue differential is somewhat deceptive at first glance. The firm reported an almost 12-billion-yen sales expansion from the previous fiscal year, but once converted, foreign currency exchange fluctuation resulted in a 2.2 percent slip to reach the most recent fiscal year total of $5.41 billion.

The firm’s Cardiac and Vascular Company, which consists of interventional systems, neurovascular products, CV systems, and vascular graft offerings, made up the bulk of the company’s sales with 328.5 billion yen. Though this was a 1.4 percent bump, a Q&A session at the FY18 financial results briefing concerning the most recent fiscal year revealed Cardiac and Vascular revenue fell 12.5 billion yen lower than the expected guidance.

Shipping delays during last summer for products from its Ashitaka Factory, which makes certain cardiovascular products, proved to be responsible for the shortcoming. Terumo discovered there were issues in the procedure that optimizes the sterilization process, causing shipments of some products from that factory to be placed on hold last May. The firm resumed shipping last August but took a sales blow of about 11 billion yen. Terumo also cites that drug-eluting stent (DES) sales failed to grow as expected.

However, Terumo expanded its DES business by purchasing Beijing, China-based Essen Technology for 879 million Chinese yuan (about $129 million) upfront last July. Essen, a DES maker, offered Terumo an introduction into the Chinese coronary stent market, in which the company had not yet established a presence. The buy expanded the company’s DES sales coverage to over 40 countries and gave it an even stronger footprint in the rapidly growing Chinese market.

The Ultimaster Tansei DES obtained a CE mark last April and it launched in Europe in May. Ultimaster Tansei inherited the same stent, drug, polymer, and coating methods used for its predecessor Ultimaster DES, adding improvement to the tip and shaft to ease stent delivery in complex lesions with both radial and femoral access. The new stent touts a 54-size lineup ranging from 2.25 mm to 4 mm, and lengths from 9 mm to 38 mm. Terumo launched the Ultimaster Tansei DES in Japan last September.

The Kanshas drug-coated balloon catheter won a CE mark last June. Used to treat lower extremity peripheral arterial disease, Kanshas employs Terumo’s Unicoat uniform micro-crystal coating to ensure the coated drug is less likely to migrate before reaching the lesion. It then quickly transfers to vascular tissue when the balloon is expanded. Terumo introduced Kanshas in Europe last September, making it the first Japanese company to launch DCB sales there.

To streamline its Cardiac and Vascular business, Terumo merged its subsidiaries Vascutek and Bolton Medical into Terumo Aortic last April. Terumo Aortic is expected to accrue sales of almost $200 million and host over 1,100 employees worldwide. Its primary R&D and manufacturing facilities will remain in Glasgow, Scotland, (Vascutek) and Sunrise, Fla. (Bolton Medical). The combined business includes surgical grafts for abdominal, cardiothoracic, and peripheral applications as well as hybrid and catheter-based stent graft systems for abdominal and thoracic aortic aneurysms.

Last March, Terumo forked over $20 million for the XPro System, Taiwanese Medeon Biodesign’s large bore vascular closure system. The automated suture-mediated closure device simultaneously delivers two pairs of sutures during percutaneous large bore procedures. This includes TAVR, endovascular and thoracic endovascular aneurysm repair, and percutaneous balloon aortic valvuloplasty procedures. At the time of the acquisition, the XPro System was undergoing evaluation for CE mark certification in Europe.

The CDI Blood Parameter Monitoring System 550 was granted FDA clearance last November. During cardiopulmonary bypass surgery, continuous in-line monitoring is integral to perfusion safety. It quickly informs clinicians of changes in patient status and provides information on key parameters to help manage perfusion cases. The CDI System 550 measures or calculates the 12 critical blood parameters: pH, pCO2, pO2, K+, temperature, SO2, hematocrit, hemoglobin, base excess, bicarbonate, oxygen consumption, and oxygen delivery.

MicroVention, a U.S.-based Terumo subsidiary that specializes in catheter-based, minimally invasive neuroendovascular technologies, gained FDA approval for LVIS and LVIS Jr. last May. At the time, these were the first and only stents approved for stent-assisted intracranial aneurysm coil embolization. The conformable, resheathable, and retrievable stents provide high metal coverage and end-to-end visualization to ensure supports for the tiniest neurovascular embolization coils to treat wide-necked saccular intracranial aneurysms.

MicroVention’s SOFIA Catheter (Soft TOrqueable catheter For Intracranial Access) acquired an expanded indication last June. The new clinical indication included the contact aspiration technique to revascularize patients with acute ischemic stroke, secondary to intracranial large vessel occlusive disease.

The Terumo BCT (Blood Management) business, which manufactures blood component, therapeutic apheresis, and cellular technologies, accrued 105 billion yen last fiscal year, remaining mostly flat—with a very slight increase—from the year prior.

Terumo BCT president and CEO David Perez announced his retirement last August. He began his tenure with the company—then called COBE BCT—in 1999, guiding it through multiple ownership transitions. “Under his leadership, the company grew revenue almost sixfold, nearing $1 billion, and introduced multiple innovative products that have fundamentally changed and improved blood transfusion and cellular therapies,” Terumo Corp.  executives said in a statement at the time of Perez’s retirement announcement.

Former executive VP of global commercial Antoinette Gawin assumed Terumo BCT’s presidency last October and took the reins as CEO this past April. Gawin joined Terumo BCT in 2016, having migrated from global medical device manufacturer Baxter; she worked for 22 years at GE before that. “I am honored to be selected as David’s successor,” she said to the press at the time of Perez’s announcement. “I’m looking forward to working with David and other leaders over the coming months to ensure a smooth handover and continue to develop plans for 2019 and beyond.”

Terumo BCT’s Sodium Citrate 4% w/v Anticoagulant Solution USP obtained FDA approval last July. The solution anticoagulates whole blood during automated apheresis procedures. Sodium citrate, which blood centers and plasma collection organizations use during apheresis to gather plasma, had been on the official FDA shortage list for more than a year at the approval date. “We heard from numerous customers that the shortage of sodium citrate was starting to have an impact on patients,” Tim Costello, a VP at Terumo BCT, told the press. “This FDA approval will help alleviate the U.S. shortage and improve patient lives.”

The General Hospital division posted a 4.3 percent revenue gain, rising to 165.7 billion yen. This segment produces infusion pumps, syringe pumps, solution sets, syringes, IV solutions, pain management products, nutritious food, adhesion barriers, blood glucose monitoring systems, digital thermometers, and blood pressure monitors. It also houses a business responsible for contract manufacturing of prefilled syringes and devices to pharmaceutical companies for use in drug kits (prefillable syringes, needles for pharmaceutical packaging business).

Last December, a biosimilar that uses Terumo’s PLAJEX prefillable syringe launched in Europe. This was the first overseas commercial launch involving PLAJEX. Terumo makes Hulio (a biosimilar to Humira) on contract to Mylan N.V. It will be available as both a prefilled autoinjector suited for self-injection and a prefilled syringe focused on medical safety. Going forward, Terumo intends to use its material manufacturing technologies and prefillable syringe filling capabilities to augment its alliance businesses with pharmaceutical companies.

$4.6 Billion
NO. OF EMPLOYEES: 22,441

Medtech has become an industry where a strategic M&A scheme has transformed from one dimension of business into a critical element to help ensure a company’s survival. Organizations are leveraging acquisitions of other firms as a way to grow business with new customers, technology offerings, and market regions. Terumo utilized the plan to increase the size of each of its three Cardiac & Vascular Company businesses in the firm’s 2016 fiscal year (how Terumo refers to the coverage period in its 2017 annual report, which spans the 12 months from April 1, 2016 to March 31, 2017).

While the industry was surprised to hear of yet another megamerger being announced in April 2016—which ended up as the largest of the calendar year—Terumo capitalized on an opportunity. Specifically, the enormous deal saw Abbott making a $25 billion bid for St. Jude Medical. There was a hitch, however, which brought Terumo into the fold months later.

In October, Abbott announced it would sell some of St. Jude’s, as well as a portion of its own, medical devices to Terumo for approximately $1.12 billion. Abbott stated the divestiture of certain products was key to the completion of the St. Jude purchase (the aforementioned “hitch”); of course, the transaction with Terumo was also contingent on the completion of that buy. The Abbott/St. Jude deal ultimately did close in January 2017, which subsequently resulted in the completion of the Terumo arrangement only a few days later. The sale passed St. Jude Medical’s Angio-Seal and FemoSeal vascular closure product lines and Abbott’s Vado Steerable Sheath to Terumo. In addition, Terumo took in Kalila Medical Inc., a company Abbott had just acquired in February 2016, two months before the announcement of the St. Jude purchase. Kalila Medical, the company behind the Vado Sheath, was developing next-generation access technologies used in cardiac electrophysiology procedures. All of the deal’s assets became a part of Terumo Interventional Systems.

“The acquisition, which brings us vascular closure devices, will enable Terumo to provide customers with a comprehensive product offering in minimally invasive entry site management and lesion access,” said Yutaro Shintaku, then president and CEO of Terumo Corporation. “We expect the acquisition will enhance our presence in the United States, which is the largest market for medical devices.”

In June 2016, Terumo subsidiary MicroVention Inc.—a part of the Neurovascular business—entered into an agreement to acquire Sequent Medical for $280 million. According to a news release announcing the transaction, Sequent developed, manufactured, and sold a unique device that is the first commercial device in an important new category of aneurysm embolization systems referred to as intrasaccular flow disruptors.

“The acquisition of Sequent Medical by our parent company gives MicroVention the opportunity to market an important new device that is already being sold in Europe, and to the U.S. market at some point in the future,” said Richard Cappetta, MicroVention’s president and CEO. “The WEB System is intended especially for ruptured and unruptured intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous fistulae or AVF. Importantly, it adds another unique and complementary technology to our portfolio of neurovascular products that provides us substantial advantages in the marketplace.”

While the device had obtained a CE mark for use in all major markets in Europe in 2010, FDA’s approval had not yet been secured. The technology, however, had already been used to treat more than 3,000 patients worldwide at the time of the sale to Terumo. It uses the company’s proprietary MicroBraid technology—a dense mesh constructed from a large number of extremely fine wires. According to MicroVention, the WEB System enables physicians to treat wide-neck bifurcation aneurysms with the familiarity of an intrasaccular approach while using established biomaterials.

Rounding out the Cardiac & Vascular Company’s M&A trifecta, the Vascular Graft business was also provided with new offerings during the company’s same fiscal year. In January 2017, Terumo announced it was purchasing Bolton Medical—a provider of endovascular solutions for aortic disease, including thoracic and abdominal stent graft systems—from its parent company, WerfenLife Group. The purchase price was not disclosed.

“The acquisition will enhance Terumo’s existing product portfolio in the global stent graft market and our vascular graft business will be further strengthened in the U.S., in what is the largest stent graft market today,” said Shinjiro Sato, then president of the Cardiac and Vascular Company.

In April 2018, Terumo merged Bolton Medical with Vascutek to create Terumo Aortic. The combined division is expected to post revenues of approximately $200 million. That would of course be combined with the revenue of a company that’s been, for the most part, on the rise over the last several years.

While Terumo’s 2017 fiscal year revenue was virtually flat against the prior year (514 billion yen in 2016 compared to 525 billion yen in 2015) the total has steadily risen from 2012’s 402 billion yen. The company also sees a fair share of those sales within its home country of Japan. The country provided Terumo with 187 billion yen (36 percent) of its net sales in fiscal 2016. The majority, however, still comes from the rest of the world—64 percent—representing 327.2 billion yen. Broken down, the Americas bring in the greatest amount in international sales at 139.7 billion yen (27 percent of the firm’s total net sales), followed by EMEA at 95 billion yen (19 percent), and Asia and others at 92.5 billion yen (18 percent).

Of Terumo’s three companies, the majority contributor to the sales total is the Cardiac and Vascular Company, which posted 261.5 billion yen—51 percent of the company’s net sales. Obviously, the aforementioned acquisitions in this segment helped the company’s sales in fiscal 2017 and will continue to do so, broadening the firm’s product portfolio in the cardiovascular therapy space.

Terumo’s General Hospital Company accounts for 31 percent of the net sales, notching 157.9 billion yen. This company is now divided into two segments—Hospital Systems and Alliance—reorganized from the previous three units. Hospital Systems provides products that support pharmaceutical needs and delivery such as infusion systems, blood glucose monitoring, peritoneal dialysis, and prefilled syringes. Alliance is a type of contract manufacturing service for pharmaceutical companies, fulfilling needs for prefillable syringes, intradermal injection devices, and needle packaging.

Contributing 18 percent of net sales (94.5 billion yen), Terumo BCT (the Blood Management Company) provides solutions for blood centers such as a blood bag system with leukocyte reduction filter, automated blood collection systems, and automated blood component processing systems, while also offering technologies for therapeutic apheresis and cell processing.

Further assisting with the company’s performance, in June 2016, FDA declared the company had successfully completed the second and final phase of its remediation activities at its Ann Arbor, Mich., facility. In its letter, the FDA stated, “Terumo is no longer enjoined under Paragraph 5 of the Consent Decree from manufacturing, packing, storing, installing, and/or distributing the above listed products from the Ann Arbor Facility.” The location served the Cardiac and Vascular Company, developing, manufacturing, and distributing electromechanical devices used in cardiac surgery, such as heart-lung machines and blood parameter monitoring systems.

$4.7 Billion
NUMBER OF EMPLOYEES: 20,697

Editor’s Note: Due to confusion between Terumo’s annual report and the company’s reported fiscal year, the 2016 annual report was incorrectly used as the basis for last year’s report instead of the 2015 annual report. As such, we are rerunning this report, which now accurately reflects data from the company’s 2016 annual report. We apologize for any confusion.

Since the Pharmaceutical and Medical Device Act (PMD Act), enacted in 2014, initiatives to commercialize regenerative medicine products have been briskly pursued by companies and institutions. One such company leading this charge was Terumo, whose “HeartSheet” was the first regenerative medicine product in Japan to receive rapid approval in September 2015, with specific conditions and time restrictions under the act.

HeartSheet is the end result of the cell sheets Terumo began developing in 2007 as part of its cardiac regenerative therapy R&D. Following successful clinical trials at three Japanese medical institutions from 2012 to 2014 and Terumo’s October 2014 application for approval, HeartSheet was conditionally approved for manufacture and sale in Japan in September 2015. The particular conditions of the approval were as follows:

• • 60 HeartSheet cases demonstrating the product and treatment’s efficacy

• • Superiority compared to current existing treatment to 120 cases

• • An application for official approval within five years

HeartSheet is an autologous skeletal myoblast sheet, designed to treat severe heart failure resulting from ischemic heart disease. The skeletal myoblasts inside the thigh muscle are cultured into cell sheets, and transplanted to the heart under open chest surgery. Affixing these sheets to damaged sites of the patient’s heart muscle is expected to improve the condition of severe heart failure. According to the company, what is most noteworthy about HeartSheet therapy is that no risk of adverse reaction occurs, since the cells have been harvested directly from the patient’s own body.

ANALYST INSIGHTS: In 2014, Terumo established an innovation entity, leading us to believe that more state-of-the-art products will be released in the near future. In addition, if Terumo’s history is any indication, strategic alliances will be key in getting new products to market.

—Dave Sheppard, Co-Founder and Principal, MedWorld Advisors

Financial Landscape

Terumo’s business is organized into three segments: Cardiac and Vascular, General Hospital, and Blood Management. Together, these achieved 525 billion yen ($4.66 billion) in fiscal year 2015 (ended Mar 31, 2016) net sales, which represented a 7.3 percent increase from the prior fiscal year. The company’s “Asia, outside Japan” region demonstrated the largest growth in 2015/16 with sales of 92.5 billion yen, a 21.1 percent rise compared to the previous year. Terumo cited Chinese economic trends as the main driver behind this region’s growth: Although the pace of economic growth slowed somewhat during the year, promotion of reforms to the country’s healthcare systems brought about a continued trend upward in healthcare demand.  The Americas region also displayed impressive growth of 14.5 percent with sales of 143.5 billion yen, and in the “Other overseas region” (consisting of the overseas Neurovascular intervention business), sales totaled 337.8 billion yen, a 10.3 percent increase from the previous year.

Although the company’s Japanese revenue topped the prior fiscal year with sales of 187.2 billion yen, its growth was somewhat meager with a 2.2 percent rise. Terumo explained this, saying “…the [Japanese] government is aiming to moderate national healthcare expenditures to improve the company’s fiscal health.” The European market’s 101.8 billion yen in sales represented the only loss by region—revenue dropped 2.7 percent from the year prior.

Terumo’s Cardiac and Vascular segment [which consists of sub-segments Interventional Systems (TIS), Neurovascular, CV Systems, and Vascular Graft] experienced a steady trend upward in both its TIS and Neurovascular intervention businesses, which resulted in 13.9 percent growth from the previous year, with sales of 258.6 billion yen. A large portion of the increase was attributed to the October 2015 launch of the company’s “Ultimaster” drug-eluting stent in Japan, and continued sales from its release in Europe, Central and South America, and Asia during the previous fiscal year.

In August 2015, Terumo received approval to manufacture and sell the Ultimaster, a drug-eluting coronary stent. It was first released in Europe in May 2014, and launched in Japan in October 2015. Ultimaster’s drug-coating material is a bioresorbable polymer, coated only on the outer surface coming into contact with blood vessel tissues. The stent itself was made of a cobalt chromium alloy designed for easier implantation along vessel curvature.

The General Hospital Company (which consists of divisions General Hospital Products, D&D, and DM and Consumer Healthcare) achieved fiscal year 2015 total sales of 161.4 billion yen. Although sales growth for needleless infusion systems, as well as peritoneal dialysis and diabetes management products occurred in Japan, this segment displayed a marginal decrease in revenue from the year prior. The blood management segment, however, reported an increase of 3.9 percent from the previous year with revenue of 105 billion yen.

Japanese sales in this segment decreased as a result of an ongoing decline in blood donations, which impacted demand for related products. Expanded sales of therapeutic apheresis systems and cell processing systems, coupled with growth of products delivered to blood centers in emerging countries, was more than enough to make up for that loss.

FDA Warning Letter

Just shy of the 2015 fiscal year end on St. Patrick’s Day 2016, Terumo received the dread of all medical device companies—an FDA warning letter. According to the letter, the company’s guiding sheaths for renal, carotid, and peripheral use were adulterated under the Federal Food, Drug, and Cosmetic Act. The October 2015 inspection of the company’s Elkton, Md., facility yielded a number of manufacturing flaws that violate the Quality System regulation.

Among these violations were failure to maintain and establish procedures to control or dispose of nonconforming products; failure to develop, conduct, control, and monitor production processes to ensure a device conformed to its specifications; failure to establish and maintain procedures to verify device design; and failure to establish and maintain procedures to monitor and control process parameters for validated process to ensure specified requirements continue to be met. Pre-market approval applications for devices related to the violations would not be considered until issues in the letter were addressed.

When asked what the impact the FDA warning letter might have on Terumo’s business, an executive responded, “We have been manufacturing guiding sheaths at this factory for a long time. We received a finding that some files were old. We have already responded to the FDA, and are working on improvement. The Terumo group is subject to a considerable number of FDA inspections a year and has passed them. We are not anticipating a negative impact on sales and profits at present.”

$4.7 Billion
NUMBER OF EMPLOYEES: 20,697

Since the Pharmaceutical and Medical Device (PMD) Act, enacted in 2014, initiatives to commercialize regenerative medicine products have been briskly pursued by companies and institutions. One such company leading this charge was Terumo Corporation, whose “HeartSheet” was the first regenerative medicine product in Japan to receive rapid approval in September 2015, with specific conditions and time restrictions under the act.

HeartSheet is the end result of the cell sheets Terumo began developing in 2007, as part of its cardiac regenerative therapy R&D. Following successful clinical trials at three Japanese medical institutions from 2012 to 2014 and Terumo’s October 2014 application for approval, HeartSheet was conditionally approved for manufacture and sale in Japan in September 2015. The particular conditions of the approval were as follows:

• • 60 HeartSheet cases demonstrating the product and treatment’s efficacy

• • Superiority compared to current existing treatment to 120 cases

• • An application for official approval within five years

HeartSheet is an autologous skeletal myoblast sheet, designed to treat severe heart failure resulting from ischemic heart disease. The skeletal myoblasts inside the thigh muscle are cultured into cell sheets, and transplanted to the heart under open chest surgery. Affixing these sheets to damaged sites of the patient’s heart muscle is expected to improve the condition of severe heart failure. According to the company, what is most noteworthy about HeartSheet therapy is that no risk of adverse reaction occurs, because the cells are harvested directly from the patient’s own body.

Financial Landscape

Terumo’s business is organized into three segments: Cardiac and Vascular, General Hospital, and Blood Management. Together, these units generated 525 billion yen ($4.66 billion) in fiscal 2015 net sales (year ended March 31, 2016), which represented a 7.3 percent increase from the previous fiscal year. The company’s “Asia, outside Japan” region demonstrated the largest growth in 2015/16 with sales of 92.5 billion yen, a 21.1 percent rise compared to FY14. Terumo cited Chinese economic trends as the main driver behind this region’s growth. Although the pace of economic growth slowed somewhat during the year, promotion of reforms to the country’s healthcare systems brought about a continued trend upward in healthcare demand.  The Americas region also displayed impressive growth of 14.5 percent with sales of 143.5 billion yen, and in the “Other overseas region” (consisting of the overseas Neurovascular intervention business), sales totaled 337.8 billion yen, a 10.3 percent increase from the previous year.

Although the company’s Japanese revenue topped the prior fiscal year with sales of 187.2 billion yen, its growth was somewhat meager with a 2.2 percent rise. Terumo executives explained this in the company’s FY15 annual report, noting “…the [Japanese] government is aiming to moderate national healthcare expenditures to improve the company’s fiscal health.” The European market’s 101.8 billion yen sales represented the only loss by region—revenue dropped 2.7 percent from the prior year.

Terumo’s cardiac and vascular segment (which consists of sub-segments Interventional Systems (TIS), Neurovascular, CV Systems, and Vascular Graft) experienced a steady trend upward in both its TIS and Neurovascular intervention businesses, which resulted in 13.9 percent growth from the previous year, garnering sales of 258.6 billion yen. A large portion of the increase was attributed to the October 2015 launch of the company’s “Ultimaster” drug-eluting stent in Japan, and continued sales from its release in Europe, Central and South America, and Asia during the previous fiscal year.

In August 2015, Terumo received approval for manufacturing and sales of Ultimaster, a drug-eluting coronary stent. It was first released in Europe in May 2014, and launched in Japan in October 2015. Ultimaster’s drug-coating material is a bioresorbable polymer, coated only on the outer surface coming into contact with blood vessel tissues. The stent itself is made of a cobalt chromium alloy designed for easier implantation along vessel curvature.

The General Hospital Company (which consists of divisions General Hospital Products, D&D, and DM and Consumer Healthcare) achieved FY15 sales of 161.4 billion yen. Although sales growth for needleless infusion systems, as well as peritoneal dialysis and diabetes management products occurred in Japan, this segment displayed a marginal decrease in revenue from the 2014 fiscal year. The blood management segment, however, reported an increase of 3.9 percent from FY14 with revenue of

105 billion yen. Japanese sales in this segment decreased as a result of an ongoing decline in blood donations, which impacted demand for related products. Expanded sales of therapeutic apheresis systems and cell processing systems, coupled with growth of products delivered to blood centers in emerging countries, was more than enough to make up for that loss.

An FDA Warning Letter

Just shy of fiscal 2015’s end on St. Patrick’s Day 2016, Terumo received a communication dreaded by all medical device companies—a U.S. Food and Drug Administration (FDA) warning letter. According to the letter, the company’s guiding sheaths for renal, carotid, and peripheral use were adulterated according to the Federal Food, Drug, and Cosmetic Act. The October 2015 inspection of Terumo’s Elkton, Md. facility yielded a number of manufacturing flaws that violate the agency’s Quality System regulation.

Among these violations were failure to maintain and establish procedures to control or dispose of nonconforming products; failure to develop, conduct, control, and monitor production processes to ensure a device conforms to its specifications; failure to establish and maintain procedures to verify device design; and failure to establish and maintain procedures to monitor and control process parameters for validated process to ensure specified requirements continue to be met. Pre-market approval applications for devices related to the violations would not be considered until the issues in the letter were addressed.

When asked what the impact the FDA warning letter might have on Terumo’s business, an executive responded, “We have been manufacturing guiding sheaths at this factory for a long time. We received a finding that some files were old. We have already responded to the FDA, and are working on improvement. The Terumo group is subject to a considerable number of FDA inspections a year and has passed them. We are not anticipating a negative impact on sales and profits at present.”

$4.1 Billion
NO. OF EMPLOYEES: 19,934

Where profit is, loss is hidden near by. 

— Japanese proverb

Words to live by in the highly regulated and fiercely competitive medical device sector (as if any professional in this business could forget). For venerable Japanese medical technology firm Terumo, the story of fiscal year 2014 (ended March 31, 2015) mostly was one of steady, modest growth—and profit. For the year, the 94-year-old company posted sales and profit gains, both through increased organic sales but also through favorable currency exchange rates.

Sales for the 2014 fiscal year were 489.5 billion yen, up 5 percent ($4.09 billion). Net income was 38.5 billion yen ($321 million), up 13 percent.

Net sales outside Japan (which made up 63 percent of the company’s revenue) grew 10 percent (which takes into account the impact foreign currency exchange rates, as do the following international figures). Sales in Japan, 37 percent of the company’s annual take, slipped 3 percent. The Americas showed the largest growth at 13 percent to 125.3 billion yen ($1.05 billion). Sales in Europe grew 8 percent to 104.6 billion yen ($874 million). The sector the company calls “Asia and Others” grew 12 percent to 51.9 billion yen ($434 million). The Chinese market grew 2 percent to 24.5 billion yen ($205 million).

The company separates into three sectors: Cardiac & Vascular (intravascular ultrasound systems, catheters for the treatment of coronary artery disease, drug-eluting stents, angiographic catheters, abdominal and peripheral endovascular coils, heart-lung machines, oxygenators with integrated arterial filter, and artificial vascular grafts); Blood Management (automated blood collection systems, automated blood component processing devices, blood bag systems, pathogen reduction technology systems, therapeutic apheresis systems, and cell expansion systems); and General Hospital (intravenous catheters, infusion sets, syringe pumps, blood glucose monitoring systems, lancing devices for blood collection, blood pressure monitors, peritoneal dialysis systems).

By business segment, the Cardiac & Vascular division was responsible for 47 percent of sales, and grew 10 percent to 229.2 billion yen ($1.92 billion). General Hospital sales, 33 percent of revenues, shrank 2 percent to 161.5 billion yen ($1.35 billion). Sales for the Blood Management division grew 4 percent to 98.9 billion yen ($827 million).

Notable Fiscal-Year Mile Markers

The company launched 13 new products across all three divisions and in diverse markets globally.

In February this year, Terumo execs announced that the company would establish a research and development (R&D) center in Southern California to enhance the R&D capability of the coronary and peripheral interventional therapeutic area. The company will invest approximately 10 billion yen (roughly $83.5 million based on exchange rates when the project was announced) in the center. The target start date will be within fiscal 2017. MicroVention Inc., a Terumo subsidiary in Tustin, Calif., has served as an innovation center for Terumo.

“The region is one of the leading medtech business clusters in the U.S. and offers access to a pool of medtech experts,” officials noted in a statement at the time. Terumo bigwigs decided to build the new R&D center for the development of cutting-edge interventional systems products by leveraging MicroVention’s capability and networking resources in a high-technology area such as Southern California. The initiative, according to officials, “will accelerate the growth of the company’s interventional business growth in the United States.” The facility also will drive neurovascular device development by MicroVention.

In addition, Terumo has been actively pumping money into Silicon Valley—investing in a venture capital fund since 2013, establishing its own venture subsidiary in 2014, and this year, setting up its own R&D center. The venture capital fund searches for cutting-edge technologies and new innovative ideas. The venture subsidiary is responsible for incubating innovation, while the R&D center pursues early-stage product development.

In December, the company began sales of the Tercross PTA (percutaneous transluminal angioplasty) balloon catheters in Europe. Tercross is designed for treating peripheral artery disease including ones below the knee. PTA is a procedure in which a small balloon, having a diameter around 1 millimeter, is at the end of thin catheter and inflated in the narrowed or occluded lesions of peripheral blood vessels in the arms and legs to restore blood flow. In addition to conventional drug-based treatment and surgery, peripheral intervention with PTA balloon catheters and stents is a minimally invasive therapy for the treatment of patients with peripheral artery disease. Accordingly, its application is expected to further expand. Tercross uses hydrophilic coating on part of its surface, which increases lubrication when it contacts blood, in order to enhance lesion crossability. Physicians can choose between two types of balloons. One is non-compliant balloon with high-pressure resistance, suitable for calcified lesions. Another is flexible semi-compliant balloon designed to enhance crossability in stenotic lesions. In addition, to accommodate the long lesions often found below the knee, Terumo offered a lineup of six balloons with different lengths ranging from 20 to 200 millimeters. Terumo also reinforced the catheter shaft with rigid materials in order to improve its pushability.

Going forward, Terumo executives said the company is planning to broaden the product lineup of its peripheral intervention business. The release of Tercross was part of that plan, executives said.

Also in December, the company continued to expand its cardiovascular portfolio with CE mark approval for a line extension of its Ultimaster drug-eluting stent (DES). The addition brought the product line up to 48 items, with diameters ranging from 2.25 millimeters to 4 millimeters and lengths from 9 millimeters to 38 millimeters.

A stent is an implant device used in the treatment of angina pectoris, myocardial infarction, and other coronary events caused by blood vessels around the heart (coronary artery) that are blocked. After expanding coronary artery with a balloon catheter, the stent is implanted in the vessel. However, since restenosis (re-blockage of the artery) may occur after implanting, drug-eluting stent often are used.

Drug-eluting stents reduce tissue proliferation that may cause restenosis by gradually releasing anti-blockage drugs into surrounding tissues.

In September 2014, Terumo’s Ann Arbor, Mich.-based Cardiovascular Group began distributing Nonin Medical Inc.’s SenSmart Model X-100 Universal Oximetry System to adult and pediatric cardiovascular hospitals in the United States. The agreement was an expansion of the distribution pact between Terumo and Nonin, which originally was signed in May 2013. The Nonin SenSmart Universal Oximetry System is a dedicated oximeter system that provides measurements of both regional oximetry (rSO2) and pulse oximetry (SpO2). The SenSmart system provides comprehensive monitoring of up to six-channels of rSO2 and SpO2 in a side-by-side view. At the time, the Nonin claimed, no other oximeter system provided more than four channels of monitoring. The signal processor is substantially smaller than previous versions, making the SenSmart system a good choice for use in a variety of settings where space is an issue, such as the cardiovascular operating room or intensive-care unit. The system allows anesthesiologists, perfusionists, cardiovascular surgeons and other clinicians to quickly identify tissue ischemia events before they become critical. Terumo Cardiovascular Group manufactures and markets medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting. Nonin Medical is headquartered in

Plymouth, Minn.

In May last year, the company launched the Glideway Ureteral Access Sheath, adding to the company’s technology portfolio used in minimally invasive urologic procedures including ureteroscopy and percutaneous nephrolithotomy (PCNL). Conventional access sheaths currently used for urologic intervention have been tied to complications and injury including perforation and significant bleeding. The new family of Glideway sheaths has been designed to minimize trauma while ensuring maximum and efficient access.

Ureteroscopy and PCNL are current standards of care for minimally invasive urologic intervention especially for stone management in the urinary tract. One out of 11 people in the United States suffers from kidney stone disease, and the prevalence is growing driven by incidence of obesity and diabetes, which are common risk factors for stone disease.  In 2013, more than 350,000 ureterosopy and PCNL procedures were performed in the United States, according to figures cited by Terumo, and that number is expected to grow consistently over the next decade with the need for less-invasive surgical procedures.

“Glideway Access Sheaths offer unique characteristics with the potential to reduce urothelial trauma and simplify access into the kidney,” said Duane Baldwin, M.D., professor at Loma Linda University in California, and one of the primary investigators in early studies of expanding sheath technologies. A study using a one-step balloon-expandable PCNL sheath demonstrated successful access and visualization in patients of different ages, body mass indexes, and renal stone locations without instances of collecting system injuries.

“The Glideway Access Sheath portfolio launch is an important milestone for Terumo in advancing our urology interventional platform,” Chris Pearson, vice president of marketing for Terumo Interventional Systems, said at the time of the system’s launch. “It builds on our proven performance in urologic access with the Glidewire Hydrophilic Guidewire and demonstrates our commitment to the urology space.”

$4.55 Billion
No. of Employees: 20,000

For a company that started 93 years ago providing just thermometers, Terumo Corp. has come a long way. Today, the company separates into three sectors: Cardiac & Vascular (intravascular ultrasound systems, catheters for the treatment of coronary artery disease, drug-eluting stents, angiographic catheters, abdominal and peripheral endovascular coils, heart-lung machines, oxygenators with integrated arterial filter, and artificial vascular grafts); Blood Management (automated blood collection systems, automated blood component processing devices, blood bag systems, pathogen reduction technology systems, therapeutic apheresis systems, and cell expansion systems; and General Hospital (IV catheters, infusion sets, syringe pumps, blood glucose monitoring systems, lancing devices for blood collection, blood pressure monitors, peritoneal dialysis systems).

Oh, in case you were wondering… the company still makes thermometers—they’re digital.

All of these product categories add up to a significant sum for the company that claims it’s Japan’s largest medical device firm.
Net sales for the company in FY13 (ended March 31 this year) grew 16 percent year over year to 467.4 billion yen ($4.55 billion). Growth was 4 percent excluding foreign exchange. Operating income grew 23 percent to 65.3 billion yen ($635 million). Net income, however, declined year over year by 27 percent to 34.1 billion yen ($330.6 million).

The company’s General Hospital sector increases sales 6 percent (2 percent growth excluding the impact of foreign currency) to 164.1 billion yen ($1.6 billion). Operating profit for the division decreased 12 percent (down 16 percent, including impact of foreign currency) to 20.8 billion yen ($202 million). The company attributed the drop in earnings to “delay in new product expansion” and lower productivity at overseas manufacturing sites. The pre-filled syringe market grew by double digits, officials reported. Glucose monitoring sales also grew in Japan.

Cardiac & Vascular product sales rose 24 percent year year (up 7 percent excluding currency fluctuations) to 210.5 billion yen ($2 billion). Sector profit grew 51 percent (14 percent minus currency exchange) to 43.9 billion yen ($427 million). Access device sales grew, in the United States, in particular. Lower costs were achieved by transferring some manufacturing to a new factory in Vietnam.

The firm’s Blood Management businesses also expanded revenues by 24 percent (5 percent without currency impact) to 92.7 billion yen ($902 million). Profit jumped 35 percent to 18.6 billion yen ($181 million). The growth rate was only 4 percent when currency exchange impact is taken into account. Terumo bigwigs claim that sales of “highly value-added products” such as automated blood component processing (in the European Union) and therapeutic apheresis systems (in the United States and Japan) helped the sector’s bottom line. Increased production at factories in India and Vietnam helped to reduce costs. Asia and Latin America saw double-digit growth in sales.

Sales outside Japan were approximately $2.71 billion, up 29 percent year over year (in yen, and 6 percent if you exclude the impact of favorable foreign currency exchange rates).  China—excluding the impact of currency—grew the most (13 percent). By comparison, sales in Europe and the Americas grew at 3 and 5 percent, respectively.

Research and development (R&D) expenses for the year were approximately $292 million—up 11 percent in yen.
Building on ongoing R&D investments, the company introduced many new products in FY13, including the following:

• Early in 2014, toward the end of the FY13, the company received CE mark approval for its Ultimaster drug-eluting stent. Ultimaster employs bioresorbable polymer as its drug coating material. In addition, polymer and drug are applied only to the surface to contact vessel tissues. These features are expected to reduce the rate of very late stent thrombosis, according to the company. Ultimaster is based on unique stent design with a cobalt chromium alloy. These features are designed to enable the physicians to navigate the stent in difficult anatomy and facilitate placement of the stent conformable to vessel curvature, further reducing stress on vessel wall.
• Terumo Medical Corp., the Somerset, N.J.-based U.S. subsidiary of Terumo, introduced the SurGuard 3 safety hypodermic needle featuring three modes of activation—thumb, finger or hard surface. The needle will be available in sizes ranging from 18 gauge to 30 gauge and incorporate Terumo’s proprietary T-sharp technology. Terumo Medical Products shifted its business direction to discontinue many of its conventional hypodermic products to focus on satisfying the growing demand in the alternate care setting for Sharps with Engineered Sharps Injury Protections (SESIPS). Exposure to blood-borne pathogens from accidental sharps injuries in healthcare and other occupational settings continues to be a serious problem. Each year, there are approximately 400,000 needle-stick injuries among healthcare workers in the United States, according to figures cited by the company. To help reduce the risk, the Occupational Safety and Health Administration has implemented guidelines for employers to identify, evaluate, and implement safer medical devices. “The acute care market already embraces safety device technology, while a disproportionate amount of primary care customers still have not converted to safety devices. As the physician marketplace continues to consolidate, we expect increased demand for safety hypodermic devices,” Steve Omiecinski, vice president and general manager, Terumo Medical Products. “This decision allows us to redirect production capacity and increase our commitment to satisfying the growing safety market in the United States.”
• Terumo Medical’s Interventional Systems division released the AZUR CX peripheral coil system, which the company says is the first and only peripheral embolization coil designed to provide cross-sectional coverage incorporating the benefits of Terumo’s patented hydrogel technology. The AZUR CX is an expansion of Terumo’s AZUR family of embolization coils for endovascular occlusion of peripheral vessels. It has a unique coil construction with hydrogel on the inside for a soft, flexible design. The hydrogel technology creates a scaffold for neointimal growth formation and allows mechanical occlusion of the vessel with less reliance on thrombus for embolization. The system creates a complex shape that enhances cross-sectional coverage by filling the vessel, leaving no gap in the center. It can be deployed with minimal catheter manipulation. “Placing embolic coils in high-flow vessels is always a challenge, because of the possibility the coil will move after placement. Maintaining control is critical. From the first loop, the AZUR CX with hydrogel technology instills confidence, because it creates a stable anchor in the vessel,” said Frank R. Arko III, M.D., Sanger Heart and Vascular Institute, Carolinas Medical Center, Charlotte, N.C. “The coil has minimal preparation time and with the AZUR detachment controller I can achieve precise placement.” The U.S. market for peripheral vascular embolization coil procedures is expected to grow by approximately 5.8 percent annually through 2016, according to figures cited by Terumo. The increase primarily is driven by innovation in detachable coil technology and access devices, which allow physicians to treat a wider variety of patient conditions. Compared to traditional pushable embolic coils, detachable coils offer enhanced clinical benefits, including more precise positioning, that allow physicians to extend further into more tortuous anatomy, where distal embolization is a concern.
• Terumo’s Interventional Systems business also launched its 0.018-inch Glidewire Advantage peripheral guidewire in the United States and Canada. According to the company, the Glidewire Advantage incorporates Terumo’s DuoCore technology that fuses the original hydrophilic-coated Glidewire guidewire construction with a stiffer nitinol core encapsulated by a spiral, polytetrafluoroethylene coating. This design eliminates the need for multiple wire exchanges, which may reduce the risk of patient complications, noted Terumo. With the addition of a new size, the Glidewire Advantage line of specialty guidewires can now be used in a broader range of procedures including visceral, above- and below-the-knee applications. The guidewire enables physicians to cross the lesion, deliver the interventional device, and maintain access throughout the procedure using a single wire, according to Terumo.

Distribution Deals
In January this year, Terumo signed a deal for San Diego, Calif.-based CareFusion Corp. (see it’s Top Company Report profile on page 125) to co-brand, market and distribute Terumo’s SurFlash line of safety peripheral IV catheters for the acute care segment across the United States. The agreement—for which financial details were not disclosed—includes both SurFlash and SurFlash Plus Safety IV catheters, which Terumo claims improve the success of catheter placement on the first attempt by an average of 20 percent. The higher success rate for first placement can potentially enhance the patient experience, reduce wasted catheters and save clinician time, all of which reduce costs for the hospital.

“This agreement broadens our vascular access portfolio and adds a critical link to enable CareFusion to provide an expanded range of products,” said Vivek Jain, president of Procedural Solutions for CareFusion. “From skin preparation to needle-free connectors and IV sets, the SurFlash brand builds on our established leadership of clinically differentiated products for vascular access procedures. We are proud to collaborate with a global medical technology leader like Terumo.”

Terumo’s agreement with CareFusion will focus solely on the U.S. acute care hospital market.

“CareFusion’s world-class clinical and commercial presence in acute care infusion will accelerate the U.S. market impact of these safety products faster than Terumo might otherwise achieve,” said Hideo Arase, president and CEO of Terumo Medical Corporation and Terumo Americas Holding Inc. “The synergies are clear.”

SurFlash and SurFlash Plus Safety IV catheters have a passive safety technology that completely encapsulates the needle reducing the risk of needle stick injuries and exposure to blood borne pathogens. The automatic engagement of this safety feature requires no intentional effort from the clinician, allowing for minimal technique change and faster adoption. These products are also the only catheters with the double-flash SurFlash feature that gives visual confirmation of when both the needle and catheter gain entry into a vessel, minimizing the risk for failed attempts.

The SurFlash Plus Safety IV catheter also incorporates a proprietary blood control safety valve designed to minimize the risk of blood exposure between the removal of the needle and the attachment of the IV set. This helps create a cleaner access site and IV hub area to reduce the risk of physical and visual exposure to blood.

Legal Win
In May last year, Terumo came out on top following a patent squabble with Vascular Solutions. Minneapolis, Minn.-based Vascular Solutions will stop manufacturing and selling a device—R-Band Radial Hemostasis Device—Terumo charged infringed on its intellectual property.

The R-Band Radial Hemostasis Device is designed to wrap around a patient’s wrist and stop access-point bleeding after an arterial access procedure. In February, Terumo filed suit, claiming Vascular Solutions’ device infringed on the patents for its TR Band Radial Compression Device, seeking an injunction on production and distribution. Vascular Solutions elected to voluntarily discontinue the device, not admitting any infringement in the process.

“We are thankful for the opportunity to successfully defend our TR Band device, which is a critical part of our trans-radial solutions portfolio,” said James Rushworth, president, Terumo Interventional Systems. “As a market leader, Terumo is committed to doing what is right for our business and, when appropriate, we will vigorously protect our investments, assets and intellectual property.”

Key Acquisition
In November last year, Terumo BCT (Terumo’s blood component, therapeutic apheresis and cellular technologies division) acquired GADA Turkey, a supplier and distributor of blood bank components and equipment to Turkish public and private healthcare facilities. GADA Turkey has been a Terumo BCT distributor to blood banks and hospitals since 2009. The acquisition provides Terumo BCT with a direct relationship with Turkish blood banks and the ability to drive further adoption of critical blood transfusion technologies that can improve the safety and quality of blood in Turkey. The acquisition will also enable hospitals to have expanded access to Terumo BCT’s therapeutic aphaeresis technologies. Prior to the acquisition, GADA Turkey was a subsidiary of The GADA Group Holding, a United Kingdom-based distributor of specialized medical technology devices and equipment and a provider of health care services supplies and integrated project to public and private facilities. GADA Turkey is active in two major segments: blood technologies and general hospital. The blood technologies segment is composed of three different areas: blood banking, transfusion and therapeutics. The general hospital segment focuses on high-technology single-use devices and disposables.

$4.27 Billion
NO. OF EMPLOYEES: 18,893

“Achievement is largely the product of steadily raising one’s levels of aspirations and expectation.”
— Jack Nicklaus

Terumo Corp. executives certainly are an ambitious bunch. At the dawn of the millennium, company leaders devised a three-year plan to raise the firm’s annual operating income by nearly 20 percent.

Upon achieving that goal, officials set their sights on a bigger target: 300 billion yen in net sales and 63 billion yen in operating income by the end of fiscal 2007. Then, after reaching that milestone, management really upped the stakes, aiming for 400 billion yen in net sales/85 billion yen in operating income by fiscal 2011, half a trillion yen in net sales by the start of fiscal 2013, and an unprecedented 1 trillion yen in net sales by 2020 with an operating ratio of more than 20 percent.

Though their plans were obliterated by the Great Recession, Terumo’s top brass maintains big aspirations for growth. Their newest blueprint for near-term prosperity—unveiled in May—scales back a bit on the sales pool, obviously reflective of the governmental funding cutbacks, shrinking reimbursement rates, regulatory rigmarole, American healthcare reform and other forces that have reshaped the global medtech industry in recent years. Terumo’s higher-ups are still dreaming big—but setting more realistic goals.
“Market growth is slowing down and tighter regulations have been introduced in key regions,” Shoji Hatano, an executive officer with Terumo’s Strategy Planning department, explained in a Power Point presentation that outlined the company’s new growth strategy. “In developed markets, demand is weakening…in the U.S., QSR [quality system regulation] and its related inspections are becoming tighter. In China, unique regulations and standards have been introduced. Also, distribution reforms as well as domestic preferential policies are conducted by the government. Despite these factors, we believe there is still room for growth…”

Whether enough room exists to achieve 1 trillion yen in sales over the next eight years remains to be seen (Hatano made no mention of that goal in his presentation). Executives, however, are confident of their chance of fulfilling their next objective—580 billion yen in sales and 120 billion yen in operating profit in fiscal 2016 (using an exchange rate of 95 yen to the dollar and 123 yen to the euro).

The company is off to a decent start, having grown sales 4 percent to 402.3 billion yen ($4.27 billion) in fiscal 2012 (ended March 31). Gross profit inched up 0.5 percent to 205.7 billion yen ($2.18 billion) and net income nearly doubled to 47 billion yen ($498.6 million).

Sales rose in all product segments, with Cardiac & Vascular posting the largest gain despite the impact of revised domestic drug price standards and a decrease in Nobori drug-eluting stent revenue. Strong international demand for transradial coronary catheterization systems, particularly in China and North America, offset the disappointing Nobori stent sales and 13 percent loss in domestic cardiac/vascular revenue to boost segment proceeds 6 percent to 169.7 billion yen ($1.8 billion).

Terumo’s Blood Management business performed a similar balancing act in fiscal 2012, counteracting declining blood transfusion volume in North America with solid sales of therapeutic apheresis systems and an increase in domestic market share for automated blood component collection systems. The company also bolstered its presence in eastern Europe with the March acquisition of Polish blood product distributor Medservice, but the deal did not impact earnings. Nonetheless, the segment grew sales 4.1 percent to 74.7 billion yen ($792.5 million), with domestic revenue sustaining a 2.8 percent loss and overseas dividends climbing 5.7 percent to 61.9 billion yen ($656.9 million).

The General Hospital segment, which ingested the company’s Consumer Healthcare business in the first fiscal quarter, gained some extra cash with the February sale of its home oxygen therapy system and home infusion pump businesses, though it was unclear from Terumo’s fiscal 2013 earnings analysis whether the transaction impacted growth. The unit posted a 2.3 percent increase in net sales to 157.8 billion yen ($1.67 billion), thanks mostly to steady demand for electrolyte infusion solutions, semi-solid nutritious foods for the chronic care market, and contrast media/business services in the Drug and Device product division. Strong performances from Japan and China offset weak sales in Europe and the Americas.

Emerging markets like China, Brazil, India and Poland are a key component of Terumo’s near-term growth strategy. Executives spent 32.2 billion yen, or 8 percent of the company’s fiscal 2012 earnings, on capital improvements, expanding production capacity in the Philippines and Vietnam, and opening an 80,000-square-foot neurovascular manufacturing plant in Costa Rica.

Terumo, however, isn’t giving up on established markets, though. During fiscal 2012, the firm expanded production at its factories in Ashitaka, Fujinomiya and Kofu, and began building a new facility in Yamaguchi. In addition, the company completed enrollment in a safety/efficacy study of its Misago self-expanding stent, taking advantage of a pilot program that unites the U.S. Food and Drug Administration (FDA) and Japan’s Pharmaceuticals Medical Devices Agency.

Under the FDA’s Harmonization by Doing program, Terumo enrolled 200 patients in the United States and 100 in Japan to test the stent’s ability to treat atherosclerotic stenosis and occlusions of the superficial femoral artery. Launched in 2010, the initiative is designed to expedite approvals in both countries.

Available in Europe, Misago is a nitinol stent pre-mounted into a rapid-exchange delivery catheter system. The device has three radiopaque markers located on each of its ends, allowing for accurate placement in lesions. The study’s primary endpoints are patency after one year and freedom from major adverse events.

“Peripheral vascular disease is a leading cause of disability in the U.S. It is critical that physicians and their patients have faster access to the latest technologies to maximize treatment options,” said J. Fritz Angle, M.D., professor of radiology at the University of Virginia and principal U.S. investigator in the Misago study. “I look forward to analyzing and discussing the data with all of the trial investigators. The international experience and testing efficiencies obtained from our collective participation in this HBD initiative could have a dramatic effect on the way important medical devices reach the market in the future.”

$4 Billion
NO. OF EMPLOYEES: 14,761

In 1921, a group of medical scientists founded Terumo Corporation based on a corporate philosophy of “contributing to society through healthcare.” It is still the company’s mantra. Ninety years ago (the company celebrated its anniversary in September 2011) the company began making thermometers, which, incidentally, is how the firm’s name was derived. It comes from the German pronunciation of word thermometer.

The basic temperature-gaging devices are still on Terumo’s list of products, along with 21st century technology in different areas of medical technology including medical devices for cardiothoracic surgery, left-ventricular assist system for end-stage heart failure, minimally invasive coronary and endovascular interventional and neuro-interventional technologies of cerebral aneurysms, transfusion technology, and an array of syringe and hypodermic needle products for hospital and physician office use.

In August last year, Forbes magazine ranked Terumo Corp. 14th on its list of top 100 innovative companies. According to editors at the financial magazine, the ranking was based on findings from an eight-year study led by a team of independent industry researchers who assessed companies based on an “innovation premium,” a measure of investor expectation for future innovation such as new product development services and market development.

For the 2011 fiscal year (ended March 31), the overall company’s sales were approximately $4 billion, an increase of 3.3 percent (in yen). Net income increased 10 percent to $390 million. By product segment, the company’s General Hospital business recorded $1.8 billion in sales, up 2 percent; the Cardiac & Vascular division totaled sales of $1.7 billion, up 6.5 percent; Blood Management had sales of $296 million, up 2.5 percent; and Consumer Healthcare division revenue fell 32 percent to $52 million.

Japan is the largest market for the company, responsible for approximately $2 billion in sales, which grew marginally at 1.9 percent. The Americas made up the second-largest segment at $687 million in revenue, up 6 percent compared to the prior period. Europe followed close behind with sales of $683 million, up 16 percent. Though not a revenue leader, other Asian markets outside Japan showed the most significant sales growth, increasing 18 percent to about $452 million.

The company’s executives have vowed to aggressively pursue growth opportunities, and acquisition has been one of the clear paths to that goal. The company’s blockbuster deal of the year was its deal in March 2011 to buy CaridianBCT from Sweden-based Gambro AB for $2.6 billion, including debt. The purchase price was about 15 times CaridianBCT’s 2010 earnings before interest, taxes, depreciation and amortization. CaridianBCT, based in Lakewood, Colo., makes machines that collect blood components and filter pathogens, and are used by blood banks and hospitals. Buying the unit will boost annual sales by about $851 million and add customers in North America, Terumo officials said. Terumo’s transfusion division sells mainly low-tech products such as blood bags, blood filters and aphaeresis systems that are used to separate blood components.

“The increasing number of cancer patients in the aging populations of the developed world will increase the demand for platelet transfusion,” officials said in a statement released on the company website. Terumo is aiming for at least 10 percent annual growth in sales from its blood business, Koji Nakao, an executive vice president, told reporters at a press conference in Tokyo following the announcement.

A strong yen bolstered the buying power of Japanese companies looking for U.S. and European companies to buy in 2011. The acquisition made Terumo the world’s biggest maker of blood transfusion equipment, overtaking Haemonetics Corp. of Braintree, Mass., Terumo officials claimed in an interview with Bloomberg.

The company continued to make strategic buys throughout 2011.

In May last year, Terumo announced a deal to purchase Plymouth, Mass.-based Harvest Technologies Corp., a biotechnology company working to commercialize the world’s first point-of-care technology that allows physicians to derive highly concentrated autologous, adult stem cells from their patients in just 15 minutes. The acquisition for $70 million provides Terumo access to Harvest Technologies’ two medical device therapies that show promising benefits in optimizing the body’s natural healing process. The SmartPrep 2 APC+ system allows physicians to rapidly prepare highly concentrated, autologous platelet rich plasma (PRP) enriched with growth factors to naturally stimulate the body’s healing process for bone and soft-tissue wounds, according to Terumo. Harvest Technologies’ SmartPReP 2 BMAC is considered a potential breakthrough technology because it can process and concentrate the cellular components from autologous bone marrow, including adult stem cells, within 15 minutes, while some concentration techniques require hours, or in some cases days, to prepare.
The concentrate produced by this system has been documented to generate more total nucleated cells with enhanced viability that affect a desired outcome in animal models compared to concentrations obtained by using the most common laboratory methods described in successful clinical studies—while being significantly easier to implement and requiring half the amount of aspirate of bone marrow from the patient.

Both applications have shown promising results in the treatment of cardiovascular and peripheral artery disease, according to analysts.

Harvest Technologies focused its initial sales efforts in Europe to support clinical research for the treatment of end-stage critical limb ischemia (CLI), a result of peripheral artery disease, which often leads to lower-limb amputation and increased patient morbidity and mortality rates. Harvest also is conducting a 42-patient pilot, randomized, controlled, safety cardiac study of its BMAC system in three U.S. medical centers. The BMAC product is injected into the patient’s heart muscle during bypass surgery to study its safety and effectiveness in this patient population. Previous studies using similar techniques have shown clinical promise.

On the new product front, the company gained 510(k) clearance from the U.S. Food & Drug Administration to market its new K-Pack Surshield hypodermic needle featuring integrated, passive sharps protection for use with pre-filled syringes for intramuscular and subcutaneous pharmaceutical applications. The K-Pack Surshield comes individually packaged and sterile in a rigid container with a tamper-evident and color-coded label. Initially, U.S. customers will have access to the K-Pack Surshield with Terumo’s 25-gauge needle designed for minimal patient trauma. Terumo also applied for 510(k) clearance of its smaller 27-gauge needle. The K-Pack Surshield 25-gauge needle has CE Mark approval outside the United States as well. Company officials noted that unique packaging distinguishes the device from similar devices.

Like many Japanese companies, Terumo Corp. was impacted by the earthquake and tsunami disasters in early March 2011. The company donated approximately $1.2 million in supplies and money to support disaster relief in Japan. In addition, the company, in cooperation with the American Red Cross, enacted an internal dollar-for-dollar matching contribution program to raise additional funds. The initial disaster caused no damage or casualties at the company’s headquarters or at any other Japan-based manufacturing plants. An aftershock created minor damage to one Terumo plant, but it didn’t affect manufacturing operations. As a result of the devastation, however, Terumo initiated a program to assess all of its Japanese suppliers who provide raw materials for the production of products at all its global plants.

Though Terumo has facilities throughout the United States, The fiscal year included the expansion of a lab and manufacturing facility in Elkton, Md. The company’s U.S. headquarters are in Somerset, N.J.

25. Terumo Medical

$3.4 Billion

KEY EXECUTIVES:

Takashi Wachi, Representative Director and Chairman

Koji Nakao, Director and Exec. VP, Group President of Diabetes Business Group & Production, Logistics, Supply ChainManagement & IT Planning Departments

Hiroshi Matsumura, Director and Exec. VP, Group President of General Hospital Business Group, Domestic Sales Department, R&D Headquarters

Takayoshi Mimura, Director & Sr. Managing Exec. Officer,China Business

Shogo Ninomiya, Director & Sr. Exec. Officer, Presidentand CEO, Terumo Europe N.V.

Kenji Sekine, Director & Sr. Exec. Officer, Group Presidentof Transfusion Business Group

Hideo Arase, Director & Sr. Exec. Officer, Group Presidentof Cardiac and Vascular Business Group, Legal Department

NO. OF EMPLOYEES: 13,740

GLOBAL HEADQUARTERS: Tokyo, Japan

Most corporate chieftains realize that innovation is key to the long-term success of their organizations, but few know how to turn such a loosely-defined concept into a sound future growth strategy. Vijay Govindarajan has figured it out though, and he believes the answer is simple: Dream big. Really big.

“I think the most important thing a [company] leader can do is dream. And dream big,” the business professor and student of corporate innovation told Inc. Magazine in its February edition. “Big ideas and big concepts lead to major change.”

Executives at Terumo Corp. certainly hope their big dreams and big ideas will lead to major change at the Japanese medical product and equipment manufacturer. The management team has always dreamed big, but its latest vision is perhaps the most ambitious to date—reaching 1 trillion yen in net sales within a decade.

“Opportunities for growth can be said to exist across all business fields and regions where the company operates,” Yutaro Shintaku, Terumo’s representative director and president, told shareholders in a letter included in the firm’s most recent annual report. “This situation demands that we leverage Terumo’s advantages as we boldly and vigorously tackle new business opportunities.”

Terumo executives plan to tackle growth on three fronts. The first front involves pursuing business opportunities in five medical sectors that are poised for explosive growth over the next several decades: drug-device combination products, diabetes, blood transfusion products and services, left ventricular assist systems and a category bigwigs referred to as “people-friendly treatment.”

Terumo executives also plan to infiltrate emerging markets such as China, India and Brazil to take advantage of the rising demand for products to combat heart disease and diabetes as well as age-related conditions such as degenerative disc disease and osteoarthritis. In addition, the company intends to devote more resources at home, where geriatric medicine and nursing care are expected to drive future growth.

Perhaps one of the more important strategies the company is planning to employ to foster future growth involves transforming its workforce into a dynamic force that will foster innovation and create the firm’s future global leaders. “We hope to create a dynamic company by entrenching an approach across our organization where entire teams pull together to carry out their prescribed mission,” Shintaku said in his message to shareholders. “Our workforce is the engine that drives our growth.”

In fiscal 2009 (ended March 31, 2010), that engine boosted sales by 9.7 percent to 316 billion yen, or $3.4 billion. Executives attributed the increase to steady growth in Japan of prefilled syringes and interventional safety systems as well as higher sales of digital thermometers due to an H1N1 influenza outbreak in Japan. Sales growth also received a boost from the company’s switch to direct sales of its vascular grafts. (Editor’s note: Percentages reflect changes based on the local currency in which the financials were reported—in this case, the Yen—and do not take into account annual foreign currency exchange fluctuations. Dollar amounts were converted using the exchange rate on the last day of the reporting period, which in this case, was March 31, 2010).

Operating income jumped 23 percent to $682.6 million (63.2 million yen) thanks to increased production, cost reduction measures and higher depreciation and amortization mainly associated with the completion of a new wing at the firm’s manufacturing plant in Fujinomiya, Shizuoka. Net income climbed 16 percent to $439.3 million, and research and development expenses ballooned to $189 million, a 7.2 percent increase compared with the $176.3 million in R&D funds the company expended in fiscal 2008 (ended March 31, 2009).

General hospital products were the top sellers in FY2009, according to Terumo’s annual report. Driven by sales of prefilled syringes and infusion devices in Japan, general hospital product sales climbed 6.6 percent to $1.6 billion. Operating income amounted to $362.4 million, a 14 percent increase compared with the $316.5 million in operating income this segment posted in fiscal 2008.

Cardiac and vascular products netted $1.4 billion in net sales for Terumo in fiscal 2009 and $417 million in operating income.

Robust sales of blood bags and apheresis systems in Japan helped push sales to $257.8 million in Terumo’s blood transfusion product segment. Blood bags sold briskly in Asia, Central and South America, but were adversely affected in the rest of the world by a strong yen. Operating income in this division totaled $36.6 million, a 7.6 percent increase compared with fiscal 2008 operating income.

Sales growth was greatest in fiscal 2009 within the company’s consumer healthcare product division, where revenue spiked 27 percent to $69 million. Executives attributed the increase to new product launches, including a new type of blood pressure monitor, and increased demand for digital thermometers (spurred by an outbreak of H1N1).

Sales were flat in Europe and the Americas, inching up 0.1 percent in Europe to 55.8 billion yen and 0.6 percent in the Americas to 56.9 billion yen. Japan, naturally, recorded the most sizable sales increase, posting a 7.3 surge in year-on-year transactions to 173.9 billion yen. Asia and other parts of the world posted a 3.9 percent sales increase, thanks mostly to China, which led growth in sales of interventional systems.

“23. Terumo Medical

$3.1 billion

KEY EXECUTIVES:
Takashi Wachi, Representative Director and Chairman
Akira Takahashi, Representative Director and President
Kazuaki Kitabatake, Exec. Officer, Chairman and CEO, Terumo Medical Corporation
Takahiro Kugo, Director and Sr. Managing Exec. Officer, OTC Business Group
Hiroshi Matsumura, Director and Sr. Managing Exec. Officer, Group President of
General Hospital Business Group
Takayoshi Mimura, Director and Managing Exec. Officer, China Business and Asia Business
Yutaro Shintaku, Director and Managing Exec. Officer, General Manager of Strategy Planning Dept.,
General Manager of International Business Division
Akira Oguma, Director and Sr. Exec. Officer, Quality Assurance Department
Shogo Ninomiya, Director and Exec. Officer, President and CED Terumo Europe N.V.
Kenji Sekine, Director and Exec. Officer, Group President of Transfusion Business Group
Hideo Arase, Director and Exec. Officer, Group President of Cardiac & Vascular Business Group

NO. OF EMPLOYEES: 13,740

GLOBAL HEADQUARTERS: Tokyo, Japan

Terumo Corp. executives are not giving up on their dream.

Undaunted by disappointing earnings in fiscal 2008, bigwigs at the Japanese firm are continuing to implement a long-term growth plan to increase the company’s net sales to 400 billion yen and operating income to 85 billion yen by the end of fiscal 2010. That goal, however, ultimately may be out of reach.

“Exchange rates have diverged significantly from our original assumptions, making it extremely difficult to achieve our initial targets,” Takashi Wachi, Terumo’s representative director and chairman, told shareholders in a letter included in the firm’s most recent annual report. “It is still only a year since the plan started, however, and rather than surrendering we intend to pursue a range of growth opportunities.”

In fiscal 2008 (ended March 31, 2009), those opportunities included the start of a clinical trial in the United States for the company’s DuraHeart Left Ventricular Assist System that currently is sold in Europe. Implanted in 100 patients worldwide, the DuraHeart is a third-generation rotary blood pump that incorporates a centrifugal flow rotary pump with an active magnetically levitated impeller, featuring three position sensors and magnetic coils that optimize blood flow while minimizing device wear and tear. The U.S. clinical trial for the DuraHeart involves 140 patients in up to 40 centers nationwide in a multi-center, prospective, non-randomized study.

Terumo’s other growth focal points in fiscal 2008 were the start of operations at the firm’s Vietnamese factory, and the start of construction on a new wing at its Ashitaka factory (in Japan). Executives said the Ashitaka facility will help the company increase production of its interventional systems. “Considering that the global economic downturn will likely persist for some time, the need for medical devices that can reduce the total cost of medical care will continue to grow,” the company’s report stated. “Since interventional systems help to shorten hospital stays significantly, they are ideally suited to fulfill this need. With demand for these devices likely to continue increasing on a global basis, the new wing at the Ashitaka factory will help support expanded production volume.”

The global growth potential of interventional systems likely convinced Terumo executives to acquire all the shares in Clinical Supply Co., Ltd., a Japanese firm that specializes in the research, development and manufacture of medical equipment. The move, which took place in June 2008, is expected to strengthen Terumo’s domestic interventional business.

Another alliance that most likely will play a key role in Terumo’s future growth is its partnership with Fuji Pharmaceutical Co. Ltd., announced in February 2009. Terumo acquired 643,500 shares of Fuji Pharmaceutical, or roughly 5 percent of the company’s total outstanding shares. The two firms are working together to develop new supplies and medical equipment in the field of agglutination (the clumping together of particles).

Executives hope the steps they took to ensure future growth and fulfill their vision of becoming a “new Terumo with a global presence” will pay off handsomely in the next several fiscal years. Overall sales and revenue were weak in fiscal 2008, as the economic downturn that circled the globe began to impact the healthcare industry. Net sales rose a mere $100 million to $3.1 billion (302 billion yen), but operating income fell 17 percent, as rising raw material costs, revision of reimbursement prices for drugs and medical equipment, and a sudden appreciation of the yen impacted the company’s bottom line. Net income fell 15 percent to $376.3 million (36.8 billion yen).

Blood transfusion products and cardiac devices were the top sellers in fiscal 2008, according to Terumo’s annual report. Driven by sales of apheresis systems in Japan and sterile connecting devices throughout the rest of the world, blood transfusion product sales climbed 1.4 percent to $243.5 million. Operating income amounted to $34 million.

Catheter and cardiovascular products generated $$1.3 billion for Terumo, a 1.8 percent increase compared with the $1.2 billion these products earned for the company in fiscal 2007. Devices such as the PTCA balloon catheter, the intravascular ultrasound diagnostic catheters and products from Terumo Clinical Supply Co., Ltd., contributed to higher sales.

General hospital product sales fell 3.6 percent to $1.5 billion, due mostly to the downward revision of pharmaceutical prices in Japan’s National Health Insurance System, the loss of market share and increased competition. Outside of Japan, the yen’s high value combined with a drop in business to European and American pharmaceutical firms led to a decline in sales. Inventory adjustments by hospitals and wholesalers also played a role in the decrease. Operating income for the segment was $316.5 million.

Lower sales of digital thermometers and blood pressure monitors mostly was responsible for the 11.9 percent plunge in consumer healthcare product sales. In fiscal 2008, consumer healthcare product sales totaled $54.5 million and operating income amounted to $2 million.

Besides the economic downturn, appreciation of the yen and reimbursement pricing revisions, revenue in fiscal 2008 further was hampered by a decline in sales within three of the company’s four selling regions. The Americas suffered the worst dive, due mostly to currency exchange rates. Net sales in this region totaled $580 million and operating income was $25.6 million.

Europe’s performance was not much better: Sales fell 1.9 percent to $572.5 million, and operating income amounted to $72 million. Executives attributed the sales decline to currency exchange rates, which trounced strong sales of the company’s drug eluting stent and blood transfusion products.
Sales in Japan, Asia and other parts of the world remained flat, with Japanese revenue falling 0.2 percent to $1.6 billion and sales in Asia and other parts of the world rising 0.3 percent to $292 million. Robust sales of infusion sets and blood transfusion products in Japan was offset by declines in pharmaceutical, cardiac and vascular products. Interventional systems sales grew strongly in China in fiscal 2008, but that revenue was thwarted by “significant across-the-board” drops in the value of local currencies.”

$3 Billion
NO. OF EMPLOYEES: 13,439 (total)

Several years ago, executives at Terumo Corp. set a rather lofty goal for the company: to amass 300 billion yen in net sales and 63 billion yen in operating income by the end of fiscal 2007.

Terumo achieved that goal within its self-imposed deadline, posting $3 billion ($306 billion yen) in net sales and $669 million (66 billion yen) in operating income in fiscal 2007, ended March 31, 2008. Net sales increased 10.8 percent compared with the $2.35 billion (276.4 billion yen) the company reported in fiscal 2006, and operating income jumped 14.5 percent compared with the $497.2 million (58.4 billion yen) Terumo posted in the previous fiscal year.

“Over the three-year period…we have improved our performance in all of our business and geographical segments, and these improvements will definitely contribute to the further growth of the Terumo Group,” Takashi Wachi, Terumo representative director and chairman, wrote in the company’s 2007 annual report. “Of course, we are not satisfied with our current position. Rather, we see the successful achievement of our targets merely as a stepping stone toward attaining higher goals.”
If the company’s fiscal 2007 results are any indication, Terumo is well on its way toward attaining those higher goals. Net sales improved across all business segments, with the General Hospital division posting a 9.2 percent increase to end the year with $1.5 billion in revenue. Operating income was $268.8 million, a 19.8 percent increase compared with fiscal 2006. Hospital equipment sales generated more than half the revenue in this division in fiscal 2007, contributing $859.1 million to the bottom line. Blood transfusion systems sales grew 17.2 percent to $235.4 million. Executives attributed the double-digit growth of blood transfusion systems to a switch to the use of in-line filter bags that remove leukocytes and thus, improve the safety of transfusions. Demand for these bags was high in Japan and Asia.

Cardiac and vascular product sales increased 14 percent to $1.2 billion in fiscal 2007. Interventional systems sales grew 20.5 percent, totaling $770.8 million, while cardiovascular systems products generated $381.2 million in revenue for the division. Terumo executives attributed the growth of interventional and cardiovascular systems sales to several new products that were released in fiscal 2007, including Hiryu, a percutaneous transluminal coronary angioplasty dilation catheter that features high pressure resistance and capability in reaching peripheral blood vessels. Market share and sales of the product have steadily increased since its debut in October 2007.

Other products that contributed to the sales growth of interventional products were the DuraHeart, an implantable third-generation left ventricular assist system that was released in Europe in August 2007, and Nobori, a drug-eluting stent system that was approved for sale in Europe in February 2008.

Vascular graft product sales totaled $95.4 million, a 0.4 percent decrease compared with the $81.5 million these devices garnered for Terumo in fiscal 2006. Executives did not give a reason for the slight sales slip, though the company voluntarily recalled its vascular graft Triplex in December 2007.

Terumo did not specify the problem with the graft, saying only that it found one defective product and could not “rule out the possibility that the same defect may be found in products in the market.”

Demand for the company’s cardiac and vascular products was high in Eastern Europe, Russia, and North and South America. Asia and other parts of the world showed a preference for general hospital equipment and blood glucose monitors, which captured a 24 percent share of the Japanese market.

Diabetes care products, which include blood glucose monitors, generated nearly half the total revenue in Terumo’s Home Health Care division in fiscal 2007. Of the $306.7 million in total division sales, $141.5 million came from diabetes care products and $71 million was raised from the sale of continuous ambulatory peritoneal dialysis systems. Other product sales garnered $94.1 million for the division. Amid stagnant growth of the home-based medicine market in Japan, sales of home infusion and oxygen therapy systems showed an 11.6 percent increase in fiscal 2007.

“$2.3 Billion

KEY EXECUTIVES:

Takashi Wachi, Chairman
Akira Takahashi, President
Takahiro Kugo, Sr. Managing Executive Officer
Hachiro Hara, Sr. Managing Executive Officer

NO. OF EMPLOYEES:

12,000

GLOBAL HEADQUARTERS:

Tokyo, Japan

Part of Tokyo, Japan-based Terumo Corp.’s plan for success is to tackle the global healthcare market full force, and it seems to be succeeding.

For fiscal 2007 (ended March 31), the cardiovascular and interventional technology company reported that operations in the United States, in particular, proved to be a significant source of growth, with overall sales climbing more than 30%. Terumo’s has a significant network in the United States. Its US base is in Somerset, NJ, and the Terumo Heart group is located in Ann Arbor, MI (among other subsidiaries located in the United States).

Terumo attributes its recent expansion to a new direct sales structure for its interventional systems and the 2006 acquisition of MicroVention Inc., a California-based manufacturer and marketer of coils for the treatment of cerebral aneurysms. In Europe and Asia, sales also showed double-digit percentage growth, with cardiac and vascular products leading the way, thanks also to the positive effects of a weak yen. Total overseas sales climbed 26.9% compared with the previous fiscal year and accounted for 44.8% of net sales, up 5.3 percentage points.

In April this year, the company unveiled a new three-year business plan called “Phoenix 2010: Challenge for Dramatic Leap.” The goal is to create “a Terumo with global presence,” according to a company statement. Management has initiated ambitious financial targets to achieve 400 billion yen (approximately $4 billion using the company’s end of fiscal 2008 conversion of yen to dollars) in sales and 85 billion yen (approximately $850 million) in operating income by the fiscal year ending March 2011 and to grow to 500 billion yen (approximately $5 billion) in net sales within five years.

According to the company’s management, another critical variable in Terumo’s equation to gain market share will be a slight shift in corporate philosophy. As part of a more in-depth product development and research initiative, the company plans to maximize contact with various stakeholders throughout the healthcare value chain, including patients, nurses, pharmacologists and clinical engineers, according to President Akira Takahashi.

“By doing so, Terumo will be better positioned to extract the true needs of the medical field and glean accurate opinions about healthcare and medical devices,” he wrote in Terumo’s 2007 annual report. “The company will also work to enhance its medical offerings, such as Terumo product usage training for medical staff and solutions for improving hospital management practices and routines.”

For fiscal 2007, the company reported a sales increase of 19% to $2.34 billion. Net income also rose by double digits—14.7%—to $315 million. General hospital products—disposable medical equipment, medical electronic products, blood transfusion products—made up 50% of total sales ($1.2 billion, 6.4% growth). Interventional systems (catheters and stents), cardiovascular systems (heart and lung machines) and vascular grafts comprised 9.6% of sales ($927 million, 23.1% increase). The Home Health division—diabetes care products, dialysis systems—contributed 10.4% to total 2007 revenue ($243 million, 1.9% increase).

For fiscal 2008 (ended March 31), net sales increased 10.8% to $3.1 billion. Net income bested 2007, with a 16.5% increase to $437 million. Sales for the company’s General Hospital division grew 9.2% to produce $1.5 billion. Compared with 2007, the Home Health unit reported a significant increase of 6.5%, reaching $309 million. Catheter and cardiovascular systems, making up Terumo’s Interventional group, totaled $1.3 billion, an increase of 13.9%.

Part of the Interventional group’s continued solid performance in 2008 was the result of Terumo receiving CE Mark approval in Europe for its Nobori drug-eluting stent. The company got the European regulatory nod in January. As part of plans to establish long-term safety and efficacy, the company plans to enroll more than 5,000 patients in randomized trials as part of a post-marketing registry in Europe, Asia, New Zealand and Africa.

In addition, in June, Terumo Heart, Inc. received approval from the institutional review board at the University of Michigan to move forward with the DuraHeart Left Ventricular Assist System (LVAS) US pivotal trial for a bridge-to-transplant indication. The trial is a multi-center, prospective, non-randomized study of 140 patients and will include up to 40 centers. The DuraHeart LVAS is a third-generation circulatory support device intended to provide cardiac support for patients who are at risk of death due to end-stage left ventricular failure. It currently is CE marked in Europe for other indications and is not available for sale in the United States.”

$2.2 Billion
No. of Employees: 11,572

Acquisitions and partnerships made it a defining year for Japanese medical device manufacturer Terumo Corporation, which boosted its sales by 7.4% over the prior year in the midst of corporate expansion in FY 2006 and beyond.

Terumo manufactures more than 1,500 medical products in its four Japanese-based factories and has 31 other locations throughout the world. The company’s North American headquarters is located in Somerset, NJ. With a strong international presence that shows no sign of ceasing, Terumo had sales of $2.18 billion in FY 2006, ended March 31, 2006. Net income was $286 million, up 13%.

With FY 2007, ended March 31, having closed, the company shows continued strength in annual performance. While FY 2006 had shown an increase of 7.4% over FY 2005, the company managed to grow sales by 11.9% in FY 2007, with a total of $2.362 billion.

Each of the company’s business segments have continued to grow, albeit some more so than others. Sales in the company’s Catheter and Cardiovascular System segment have grown dramatically, with a 19% rise from $785 million in FY 2006 to $935 million in FY 2007. In addition, the company’s largest source of sales, the General Hospital Products division, grew from $1.15 billion in FY 2006 to $1.18 billion in FY 2007. The Home Health Care Products division’s sales were just about flat. The company, which does not disclose individual product sales, said in a recent Web presentation that its top performers for FY 2007 were its cardiovascular systems, angiographic catheters and syringes.

The company remained steadfast in its effort to increase growth initiatives in early 2007. In January, the company completed its purchase of Chile-based company Salymed Ltda. and renamed it Terumo Chile Ltda. Since 1980, Salymed Ltda. had been the exclusive distributor of Terumo in that market and has sold syringes, blood bags and cardiovascular systems. Terumo already has 100% owned subsidiary distributors in Mexico and Brazil, and, with the addition of another overseas affiliate, the company hopes to further strengthen its presence in the Latin American market.

Terumo continued its shopping spree in March, when its subsidiary Vascutek Ltd. acquired the tissue heart valve division of Köhler Chemie Ltd. Vascutek Ltd. developed a biological valve conduit (made of biological valve and synthetic vascular graft), BioValsalva, for aortic root repair.

During this time, Terumo announced the opening of its long-anticipated new production plant in Vietnam. The company will use this facility for operations pertaining to disposable medical devices, including closed infusion systems and infusion sets. With Japan and other Asian markets a strategic focus for the company, two other plants are planned to be built on the same site.

A month later, Terumo launched a joint venture with Olympus Corp. and Olympus Biomaterial Corp. . to pursue specialization in the biomaterials market. Olympus Biomaterial Corp., which focuses on biomaterials and regenerative medicine, was integrated with Terumo’s collagen business and renamed Olympus Terumo Biomaterials Corp.

Looking ahead, the company is in the midst of awaiting CE Mark approval to launch its Norobi drug-eluting stent  in Europe. (The company also received a CE Mark for its Duraheart left ventricular assist system in February.)

$1.8 Billion ($41.3B Total)
No. of Employees: 9,624

In light of broad healthcare reform recently enacted by the Japanese government, Terumo Corporation was able to post its 11th successive year of increased corporate sales. For the year ended March 31, 2005, medical device sales reached $1.8 billion, a 6% increase from the prior year. Already, 2006 numbers indicate the company’s progression is steady if not remarkable, as FY 2006 closed with 7.4% gain.

Terumo’s consistent growth is attributable to the company’s Cardiac and Vascular Business, comprised of Catheter, Cardiovascular and Vascular Grafts segments.

Net sales in the Cardiac and Vascular Business division grew 14% to $688 million, with the Catheter Systems segment producing an astounding 19% increase in net sales. Among the core sellers were the Tsunami coronary stent and the Interpass V, a CTO catheter. Sales were also bolstered by the launch of the Ryujin OTW-1 and RX-2 catheters.

The Cardiovascular Systems segment came in second with a 10% increase to $254 million. Sales of Speedpack, a combination oxygenator and blood circuit, grew in Japan and overseas. Further, with the acquisition of the cardiopulmonary business from Edwards Lifesciences Corp. in January 2005, Terumo occupies the top global share of the Cardiovascular market.

The Vascular Grafts segment and General Hospital Business division also grew, albeit by smaller single-digit percentages.

The Home Health Care Business division has been booming for the company as the number of Japanese citizens with diabetes keeps climbing. The company is poised to keep capitalizing on this trend.

While Japan is still a profitable area for the company, with $1.3 million in sales from that country, areas outside of Japan contributed $810 million to the bottom line, in large part because of increased demand for catheter systems and cardiopulmonary systems. Europe and the United States are on similar footing in terms of sales.

In 2006, Terumo has been continuing its upward momentum with numerous product launches and acquisitions. In February, Terumo entered into a definitive agreement to acquire Aliso Viejo, CA-based MicroVention Inc., a medical device company focused on endovascular coils and related products. With the worldwide market for endovascular treatment of cerebral aneurysms currently estimated at more than $200 million, Terumo is expecting to step up its growth in this segment over the next several years.

“As Terumo continues to expand its cardiac and vascular businesses, we believe that the acquisition of MicroVention provides a great strategic opportunity for Terumo to further strengthen our intervention business by entering the high growth area of endovascular coiling,” said Takashi Wachi, Terumo CEO. “The experience and capabilities Terumo expects to gain from this transaction can significantly contribute to Terumo’s sustained success in this key market segment.”

A key alliance created in April 2001 between Olympus Medical Systems Corporation and Terumo also resulted in the January 2005 launch of the VirtuoSaph endoscopic vein harvesting system in North America, Thailand, Singapore and Malaysia, with eventual planned introductions in Europe and Asia. In light of the successful alliance, the two companies formed a task force that spring to explore further opportunities for collaboration.

In November, Terumo launched Heartrail II, a PTCA guiding catheter used to treat angina and myocardial infarction, in Japan. The company has set a sales target of $13 million for the first year after launch.

In more recent activity, Terumo announced in March that it would establish a new production plant in Vietnam to meet increasing demand growth anticipated in mid- and long-term operations. Terumo plans to start production operations of disposable medical devices including closed infusion systems and infusion sets in mid-2007 for Japan and Asia.