GW Plastics Expands Silicones Division

GW Plastics Inc. is investing in itsfuture. The Bethel, Vt.-based custom contract molder/manufacturer broke ground in October on a new $3 million addition to its liquid silicone rubber (LSR) facility.

Currently housed in the company’s Tech Center in Royalton, Vt. (just five miles from headquarters), the LSR division’s expanded home initially will encompass 15,000 square feet and be scalable to 25,000 square feet,executives said. The division is staying in Royalton—a 242-year-old town of 2,603 residents situated in the heart of the Green Mountains—and will include a new ISO Class 8 (100,000) clean room for silicone molding and assembly. The building also will house an office, production floor and warehouse space dedicated to highly automated precision molding, internal mold design and build capabilities. Executives expect the new facility to be operational by the first quarter of 2012.

In addition to the clean room, production floor and warehouse space, GW’s expanded LSR facility will contain two new Engel (injection molding) machines that have a range of 50 to 200 tons. The new area will run between six and eight machines upon its debut, but eventually will have the ability to accommodate up to 18 Engel mechanisms.

GW Plastics started its Silicones Division in 2008. Executives said the company is expanding the division to meet increased demand from customers.

“We’ve had lots of growth, but it takes a while for projects to come together,” GWSilicones General Manager MarkHammond told plasticsnews.com. “Now, we’re gaining all the benefits of prototyping and it is starting to facilitate our production business.”

The expansion project is expected to add between 25 and 50 jobs to the local economy in the next three to five years.

GW Plastics serves the healthcare, automotive safety, and consumer/industrial markets. It operates facilities in San Antonio, Texas; Tucson, Ariz.; Queretaro, Mexico; Dongguan, China; and Cartago, Costa Rica.

Aesculap Acquires Aragon Surgical

Aesculap Inc. is expanding its product portfolio. The Center Valley, Pa.-based division of B. Braun Melsungen AG has acquired Aragon Surgical Inc., a 7-year-old designer and developer of radiofrequency electrosurgical instruments for tissue fusion and cutting. Terms of the deal were not disclosed.

The purchase gives Aesculap the right to incorporate Aragon Surgical’s signature device into its product portfolio. Aragon’s Caiman instruments feature an articulating jaw technology, which gives doctors better maneuverability during surgery.

“We are very excited about the inclusion of the Caiman product line into the Aesculap family of surgical instruments,” Aesculap President Chuck DiNardo said in prepared remarks. “The Caiman’s articulating jaw design and proprietary Lektrafuse technology provide improved clinical benefits. This acquisition will widen the scope of our surgical instrument portfolio and enhance Aesculap’s line of products to

improve patient care.”

Aragon executives said the merger would benefit their company as well—mostly through better distribution of Caiman products.

Founded in 1977, Aesculap provides surgical instruments, implants and medical supplies to companies worldwide. Its products include cranial fixation storage trays, plates and screws, hydrocephalus shunts, wire cutting scissors, bone wax, sutures, Histoacryl tissue adhesive, the Caspar cervical retractor and Spectrum anterior cervical plating system.

Texas City Merits Medical Research Facility

Merit Medical Systems Inc. is building a new research and development manufacturing facility on the Texas Gulf Coast.

The two-story building for 220 employees will be constructed on a 12-acre site in Pearland, Texas, a city of 91,252 residents in the Houston metropolitan area. Officials with the Pearland Economic Development Corporation (PEDC) said the new facility is going into a medical business park owned by the BETZ Companies, a Texas-based commercial real estate group that coordinated the site sale with Merit Medical through its realtor, Boyd Commercial of Houston. The park currently has only one occupant: Cardiovascular Systems Inc., a St. Paul, Minn.-headquartered vascular and coronary disease solutions provider that is leasing a 46,000 square-foot manufacturing plant there. Merit Medical’s cozy new spot across the street, though, should help ease Cardiovascular Systems’s loneliness.

Merit Medical executives looked at several states before deciding to build its 118,000 square-foot manufacturing plant in Texas. Both Pearland city officials and representatives with the PEDC teamed up with the Greater Houston Partnership and Harris County to recruit Merit Medical to the area, though Merit bigwigs claim financial incentives had little to do with their preference for Pearland.

“We wanted to be part of a community that was growing,” Greg Fredde, Merit Medical’s vice president of government affairs, said in a PEDC news release. “This is a location that provides Merit employees easy access to the facility with minimal disruptions. Pearland’s investments, infrastructure and retail amenities will also be beneficial to employees.”

Another fringe benefit for employees might very well be living in a city that in 2007 was ranked by Forbes magazine as the nation’s 34th fastest-growing suburb (which in turn, made it the 10th fastest-growing in Texas and the top city for growth in the Houston area).

“It has been a long-standing goal of the city to cultivate a broad spectrum of medical-related organizations in our community,” Pearland Mayor Tom Reid said in prepared remarks. “Merit’s selection of Pearland is a testament to our efforts and willingness to work with businesses interested in investing in our city.”

Based in Jordan, Utah, Merit Medical Systems develops, manufactures and distributes proprietary disposable medical devices used in interventional and diagnostic procedures (cardiology, radiology and endoscopy, for example). It serves hospitals worldwide and employs about 2,300 associates.

Cyberonics Invests in Sleep Apnea Device

Cyberonics Inc. is hoping to help the world sleep more soundly. The Houston, Texas-based firm has made an initial $4 million investment in ImThera Medical Inc., a startup company that is developing an implantable neurostimulation device to treat obstructive sleep apnea (OSA), a disorder characterized by pauses in breathing or abnormally low breathing during sleep.

Cyberonics’ investment in ImThera eventually can balloon up to $12 million if certain regulatory and clinical milestones are met, according to a news release. The initial outlay makes Cyberonics a minority shareholder in ImThera with certain rights, including representation on the early-stage firm’s board of directors. In addition to the Cyberonics investment, ImThera will raise up to $4 million from private investors, for a total Series C placement of up to $16 million.

“ImThera is pleased to have Cyberonics as an investor and partner. Cyberonics brings experience to our board, providing significant expertise to ImThera as we continue to execute our plan,” ImThera President and CEO Marcelo Lima said.

ImThera’s Targeted Hypoglossal Neurostimulation Sleep Therapy combines a multi-contact electrode specifically designed to control certain muscles of the tongue with an implantable pulse generator and an external programmer. The company currently is pursuing CE Mark regulatory approval in the European Union for the device and expects to initiate a pivotal clinical trial in the United States soon.

“OSA affects millions of people in the United States and around the world,” Cyberonics President and CEO Dan Moore noted. “We are excited about the opportunity to invest in a new technology outside our core business.”

ISO CERTIFICATIONS:

•Agilent Technologies Inc., a Santa Clara, Calif.-based measurement company, has been awarded ISO 13485:2003 certification to manufacture liquid chromatography/mass spectrometry systems, including 6100 Series single quadrupole and 6400 Series triple quadrupole systems. The 18,500-employee firm is divided into three business units: chemical analysis, life-sciences and electronic measurement.

•ISO 13485:2003 certification has been given to International Isotopes Inc. for the design and manufacture of its nuclear medicine and cobalt-60 products. The Idaho Falls, Idaho-based company develops nuclear medicine calibration and reference standards, high purity fluoride gases and various cobalt-60 products such as teletherapy sources. The firm also provides radioisotopes and radiochemicals for medical devices, calibration, clinical research, life-sciences, and industrial applications. President and CEO Steve Laflin said the certification improves the company’s capabilities and value as a contract manufacturer.

•Indian contract research organization Max Neeman International has achieved ISO 14155:2011 certification, a standard updating the 2003 rule governing clinical trials for medical devices. The revised standard’s new requirements pertain primarily to sponsor responsibilities, informed consent rules, ethics committees, study monitoring and data and risk management. Max Neeman helps pharmaceutical, biotechnology, medical device and nutraceutical firms conduct Phase II-IV clinical and device trials. The company is an ISO 9001:2008– and ISO 27001:2005-certified contract research organization for monitoring, site management and data management services.

•Modern Plastics Inc., a Shelton, Conn.-based distributor of high-performance, engineering-grade and medical-grade plastics, has achieved ISO 13485:2003 certification. President Bing Carbone said the certification demonstrates the firm’s commitment to service and quality.

•ISO 9001:2008 certification has been granted to Power Sources Unlimited Inc., a Wrentham, Mass.-based distributor of AC/DC power supplies and DC/DC converters. Founder, President and CEO Ray Newby said the achievement validates the company’s quality standards and its dedication to continuous improvement. “Achieving ISO 9001:2008 certification is recognition that for Power Sources Unlimited Inc., quality has been a way of life from the beginning.”

•Canadian healthcare information technology provider QHR Technologies Inc. has achieved ISO 13485:2003 certification for its electronic medical records (EMR) division. The Kelowna, British Columbia-based company operates its software business through three units: EMR, enterprise management software, and hosting.

•Vida Diagnostics Inc., a Coralville, Iowa-based developer of pulmonary analysis software for the detection, evaluation and treatment of pulmonary disease, has achieved ISO 13485:2003 certification for a diagnostic product called Apollo. The pulmonary image analysis solution is designed to detect, evaluate and treat such disorders as chronic obstructive pulmonary disease, emphysema, lung cancer and asthma. Company executives said the certification will enable Vida to commercialize Apollo in Switzerland and the European Economic Area, which includes Iceland, Liechtenstein and Norway.

BIOTECH IN BRIEF

Noxilizer Inc. and Sterilization Technology Group Inc. have joined forces to develop products for the isolator generator market. Noxilizer is licensing its proprietary nitrogen dioxide technology while Sterilization Technology Group is developing, manufacturing and marketing the product line… Biotechnology financing ran into some serious roadblocks during the third quarter, as Europe’s debt crisis and America’s own debt ceiling debacle combined to fuel a perfect storm of volatility on Wall Street over the summer. Public financing fell 66 percent to slightly under $3.1 billion compared with the second quarter, while venture capital plummeted 35 percent to $832 million, Burrill & Company reported. The volatility put a damper on initial public offerings (IPOs) as well: Of the five life-sciences firms that intended to take their companies public in September, none actually completed the deal. “While 2011 remains on track to be a year of solid performance for biotechnology, global financial problems and dysfunction in Congress have turned investors away from risk,” noted G. Steven Burrill, CEO of San Francisco, Calif.-based Burrill & Company, a global financial services firm focused on the life-sciences industry. “Despite what has been an upbeat year of developments for the sector, broader economic worries have thwarted access to the capital companies will need.” Those worries thwarted access in a big way, too—according to Burrill & Company, the amount raised through IPOs fell 72 percent to $151 million, follow-on financing dropped an incredible 80 percent to $453 million and private investment in public equity slid 53 percent to $211 million…Despite the rough quarter, however, the life-sciences industry remains an economic powerhouse in Maryland. The industry is responsible for 6 percent of the Old Line State’s gross domestic product, or $17.6 billion, according to a study drafted by the state Department of Business and Economic Development. It also accounts for roughly 71,600 jobs (3 percent of the statewide total) and contributed to one-third of the job gains between 2002 and 2010, during which time the industry’s annual salary jumped nearly 50 percent. Most Maryland life-sciences employees work in the private sector (33,600), though nearly as many—29,800—are in the federal system, while only 8,250 have dedicated themselves to academics. Regardless of the breakdown though, life-sciences workers in Maryland earn a pretty good living: The report estimates that the average employee takes home $91,100 annually, or $39,350 more than the average resident’s salary across all industries…Even with the life-science industry’s strong showing, Maryland still ranks below Massachusetts in total National Institutes of Health (NIH) funding. For 16 consecutive years, Boston, Mass., has lead the nation in NIH funding, accruing a total of $21.5 billion, according to a report from the Boston Redevelopment Authority. Boston consistently has received more money than such other major cities as Baltimore, Md., New York, N.Y., Philadelphia, Pa., and Seattle, Wash.; in 2009 and 2010, for instance, Beantown’s share of NIH funding topped the Big Apple’s by $575 million and $399 million, respectively. Between 2001 and 2010, Boston’s share of total NIH funding averaged 7.4 percent, though that average has been slightly higher (7.7 percent) since the city hosted the Biotechnology Industry Organization’s International Convention in 2007, the redevelopment authority report noted. In 2009 and 2010, NIH awards to Boston reached record levels, totaling $2.4 billion and $2.1 billion, with most of the money going to independent hospitals. “Boston is on a roll,” Mayor Thomas M. Menino said upon learning of his city’s NIH funding reign. “We’re the innovation capital of the world.”…Minnesota Gov. Mark Dayton might take offense to that statement—his state attracted more healthcare startup investment during the first half of 2011 than hisMidwestern neighbors. A report from Cleveland, Ohio-based BioEnterprise claims the North Star State garnered $88 million during the first six months of the year, thanks mostly to Minneapolis-based health IT firm Ability Network Inc., which raised $20 million; San Francisco, Calif.-based managed care provider SeeChange Health, which also raised $20 million; and Rotation Medical Inc. of Plymouth, which drummed up $10 million (the company’s focus is somewhat of a mystery, having changed from a biotech firm to “other healthcare,” according to a spring regulatory filing). Ohio placed second in the investment dollar arena, attracting $80 million, while Wisconsin came in at a distant third ($49 million), according to the BioEnterprise report. However, Ohio had more deals (nearly double) than Minnesota—the report concludes that 25 investment deals occurred in the Buckeye State in the first half of 2011, while Minnesota had 13. Pennsylvania followed closely behind with 12…Utah could soon see those kinds of numbers if the Beehive State keeps up with its efforts to attract new investment. The Governor’s Office of Economic Development recently awarded $1 million in financial incentives to four startup life-sciences firms; the incentives ranged from $100,000 to $350,000 and was given in the form of tax credits. The incentives, authorized under the Technology and Life Sciences Economic Development Act passed by the state legislature earlier this year, are contingent upon each of the companies adding staff over the next three years.