Detailed Narrative
Cardiopulmonary Business Momentum
LivaNova's Cardiopulmonary segment reported $222 million in revenue, a 10% increase year-over-year, primarily driven by strong performance in Europe. Heart-lung machine revenue grew in the mid-teens, fueled by increased Essenz placements and favorable price premiums. Consumables saw high single-digit growth, with oxygenators and perfusion tubing kits growing low double-digits, supported by improved component availability and manufacturing optimization.
Oxygenator Output Expansion Strategy
The company is actively expanding its oxygenator output to capitalize on unmet market demand. This involves internal manufacturing process improvements, a new production line going live in the second half of 2026, and a long-term agreement with Thermo Fisher Scientific to secure critical component supply. These initiatives are expected to strengthen the growth outlook for the oxygenator business, with a next-generation oxygenator planned for launch in 2028.
Epilepsy Segment Strength
Epilepsy revenue increased 10% year-over-year, with Europe and Rest of World regions growing 15% and the U.S. growing 8%. This performance was attributed to favorable realized pricing (due to reduced volume discounting and annual price increases), increased volume, impactful clinical evidence from the CORE data, and improved reimbursement. CMS' preliminary recommendation to maintain VNS Therapy in the New Tech APC and propose an additional increase in end-of-service APC reimbursement for 2027 further supports the business trajectory.
OSA Program Updates and PolySync Data
The PMA supplement submission for the next-generation MRI-compatible OSA system is now expected between the second half of 2026 and the first half of 2027, a slight adjustment due to design verification. Despite this, the long-term 2030 revenue target of $200 million to $400 million remains unchanged. New data on the PolySync algorithm showed an increased cumulative AHI response rate to approximately 85%, significantly reducing non-responders and strengthening the competitive profile.
Depression Trial Progress and CMS Engagement
The 36-month data from the RECOVER trial for difficult-to-treat depression has been submitted to a preprint server, demonstrating sustained improvements in depressive symptoms, function, and quality of life for patients on VNS Therapy. The company remains in active engagement with CMS regarding reimbursement, awaiting peer-reviewed publication of the data for formal consideration.
Capital Allocation and Investments
LivaNova increased its full-year capital spending guidance to $135 million to support Cardiopulmonary capacity expansion, next-generation oxygenator manufacturing scale-up, and IT infrastructure investments. This increased investment, along with funding for the Thermo Fisher agreement, led to a revised (lower) adjusted free cash flow guidance for the year.