The pharmaceutical industry has a long history of addressing disease conditions, but there’s been a steady interest in non-drug alternatives. As such, creative innovators have been working hard to offer technologies that can either enhance the effectiveness of the pharmaceuticals or replace them. A prime example of this involves neuromodulation used to treat conditions ranging from incontinence to depression.

One such organization is LivaNova, a company that has its foot securely planted in the neuromodulation therapy space to address drug-resistant epilepsy. More recently, they’ve entered the obstructive sleep apnea arena to help patients there. In parallel, LivaNova supplies healthcare professionals with critical cardiopulmonary products, such as heart-lung machines, oxygenators, and other life-saving products used during open-heart surgery.

In the following interview, Vladimir Makatsaria, CEO of LivaNova, explains how his company serves two seemingly disparate clinical spaces, the focus it has on these segments, and what’s on the horizon.

Sean Fenske: What does LivaNova do? What are your clinical specialty areas? What types of medical devices or technologies do you offer?

Vladimir Makatsaria: LivaNova is a global medical technology company with nearly five decades of experience and strong, market-leading positions in the areas we serve.

In our Cardiopulmonary business, we provide heart-lung machines—including the Essenz Perfusion System—as well as oxygenators and other technologies essential for life-sustaining open-heart surgery. Today, our Cardiopulmonary portfolio supports more than 70% of all open-heart procedures performed worldwide, which really shows the scale and impact of what we do.

Our Epilepsy business delivers neuromodulation therapy for patients with drug-resistant epilepsy. Using small implantable devices that stimulate the vagus nerve, VNS Therapy helps control seizures when medications alone aren’t enough. More than 175,000 epilepsy patients and their families worldwide have already benefited from this therapy, and many rely on it throughout their lives.

We’re now preparing to bring similar neuromodulation technology to the obstructive sleep apnea (OSA) market through proximal hypoglossal nerve stimulation, or p-HGNS. With this differentiated approach, we’re positioned for rapid growth as we plan to scale a new business in an area of high unmet need.

We also see upside potential in using VNS Therapy to treat difficult-to-treat depression (DTD), pending a reimbursement decision from the U.S. Centers for Medicare and Medicaid.

Fenske: The clinical segments in which you operate seem unique. How and why were these areas brought together under one roof?

Makatsaria: LivaNova was formed in 2015 through the merger of Cyberonics in the U.S. and Sorin in Italy. While unique in terms of the customers and patients they serve, our core business units have something in common: high unmet needs with significant opportunities for innovation.

Between 2019 and 2022, LivaNova reshaped its portfolio by stepping away from several low-growth cardiovascular assets so we could focus on earlier-stage opportunities with stronger long-term potential. This shift created a transition period that slowed some core innovation, but it laid important groundwork.

In recent years, we’ve refocused on innovation in areas where we have a clear right to win. That included winding down our Heart Failure program and Advanced Circulatory Support business in 2024, allowing us to redirect financial resources, leadership attention, and operational capacity back into our strongest businesses.

This renewed focus—combined with targeted strategic investments, key talent upgrades, and improvements in operational excellence—has led to a recent track record of results we’re very proud of. This is the foundation for our next chapter. As we continue to reinvest in the core, we’re also leveraging our neuromodulation expertise to commercialize OSA, while preserving the upside to enter the DTD market.

Fenske: There’s growing interest in neuromodulation across healthcare. Is this a long-term growth opportunity for LivaNova?

Makatsaria: Yes, neuromodulation is an ongoing and significant growth opportunity for us. We have the capabilities to expand into new neuromodulation adjacencies, and our strategy is rooted in a strong right to win.

In fast-growing markets like OSA and DTD, we can build on the competencies we’ve developed through our Epilepsy business. That includes our expertise in implantable pulse generators and lead design, our shared cloud platform for digital and remote capabilities, and our clinical and regulatory experience with Class III implantable devices. These are real differentiators for LivaNova.

Our neuromodulation supply chain know-how also strengthens profitability and reliability as we scale. And our global commercial footprint—along with strong OR support capabilities—positions us to successfully launch and grow both OSA and DTD.

We also have deep experience creating referral pathways across distinct medical call points, such as neurologists and neurosurgeons for epilepsy, which helps accelerate adoption. Finally, ensuring reimbursement for implantable neuromodulation technologies is critical, and our market-access capabilities put us in a strong position to maximize long-term value.

Fenske: You recently introduced a technology for obstructive sleep apnea. What makes this device unique?

Makatsaria: In early 2025, we submitted our PMA (pre-market approval) application for our differentiated neurostimulation modality, p-HGNS, for the treatment of OSA. As we await FDA approval—which we expect in the first half of 2026—we’re continuing to advance product features and publish evidence demonstrating the therapy’s clinical differentiation.

Our submission is backed by the OSPREY clinical study, a true randomized controlled trial.¹ Unlike studies of first-generation devices, OSPREY randomized subjects to stimulation or sham control through month seven—the primary endpoint. Bringing this level of scientific rigor to the OSA space is something we’re very proud of. 

Another key difference is that other studies required drug-induced sleep endoscopy (DISE) to screen out patients with complete concentric collapse (CCC). OSPREY did not require DISE, and we did not exclude CCC patients. Since nearly one-third of OSA patients fall into this category—and are contraindicated for the current market leader—OSPREY reflects a broader, more real-world patient population.

Our p-HGNS technology uses six electrodes on the proximal trunk of the nerve, giving access to additional muscles affecting the tongue and airway. This expands control and allows us to treat a more diverse group of patients. Importantly, trials show that therapy benefits are maintained even after pausing stimulation for two weeks—something not observed in first-generation devices. And because of the nerve cuff’s location, the implantation procedure is less complex and results in shorter surgery time.

After FDA approval, we plan to file a PMA supplement for our MRI-compatible commercial device, enabling a limited market release in the first half of 2027, with full commercial launch expected in the second half of 2027.

Fenske: Are you incorporating artificial intelligence or machine learning into your technologies?

Makatsaria: Yes. We’re integrating advanced AI tools into our product development processes, including using agent-based systems to assist with software coding for our next-generation VNS Therapy. These tools help enhance speed and efficiency—always with close oversight from our engineers.

Fenske: What industry trends are you watching that could shape LivaNova going forward?

Makatsaria: We hold leadership positions in two attractive markets that grow at mid-single-digit rates, and our strategy is to continue outperforming in those core areas while expanding into higher-growth segments where we have a clear right to win.

In drug-resistant epilepsy—a $700 million market—there’s a meaningful opportunity, largely because non-drug therapies remain significantly underutilized. Although patients become drug resistant after failing two medications, it still takes an average of 15 years, and six failed medications for them to reach an advanced therapy.

We expect the next five years to bring major innovation that helps close that gap. That includes improved global access to care, earlier and more accurate diagnosis through new tools and wearable seizure-monitoring devices, and more personalized treatment options driven by biomarkers. Tele-epilepsy services will also play a major role in expanding access, especially in underserved regions.

By improving clinical outcomes, reducing care-pathway barriers, and watching closely for external technologies that complement our infrastructure, we can help accelerate market growth.

In Cardiopulmonary—a global market now exceeding $2 billion—several unmet needs persist, including improving perfusion outcomes, generating better decision-making insights, and ensuring consistent and reliable product supply. The market has recently grown faster than its historical baseline.

Key forces driving this acceleration include an aging population, increased patient complexity due to rising comorbidities, and expanding access to cardiac care in developing markets. We also continue to see growth in post-TAVR (transcatheter aortic valve replacement) surgical procedures, including surgical replacement of initial TAVR valves.

We’re responding through continued investment in manufacturing capacity, product innovation such as our next-generation oxygenator, and software-based enhancements to the Essenz platform—all of which support continued growth of our market-leading position.

Fenske: Given the strong M&A activity in medtech, is LivaNova pursuing inorganic growth opportunities?

Makatsaria: Yes. We see inorganic innovation as an important complement to our internal efforts and essential to our long-term health. Over the past year, we’ve refined our approach by learning from experience, benchmarking against industry standards, and upgrading governance, processes, role clarity, and talent across all functions involved in assessing external opportunities.

Our disciplined corporate development framework evaluates potential opportunities against four criteria: they must align with our strategic objectives, address meaningful unmet needs, leverage our internal competencies and right to win, and deliver attractive risk-adjusted returns.

Fenske: Where is LivaNova headed? What does the future hold?

Makatsaria: LivaNova is on a clear path to becoming a more disciplined, growth-oriented medtech leader with a sharper focus and a rigorous investment strategy grounded in our differentiated right to win. We have the right team, the right strategy, and the operational discipline to execute—and that gives me great confidence in our direction.

Our Cardiopulmonary and Epilepsy businesses provide a stable, profitable foundation with mid-single-digit (or better) growth and strong margins. Our entry into OSA is de-risked, supported by compelling data and differentiated technology that expands our portfolio’s growth potential. And our DTD program represents pure upside—a natural extension of our neuromodulation platform that could be transformative if CMS grants favorable reimbursement.

Overall, we’re well-positioned for transformative growth and long-term value creation for our shareholders.

Reference
¹ tinyurl.com/mpo260321