Conformal Medical Announces Leadership Transition

Seasoned Medical Device Executive, James Reinstein, Appointed as Chief Executive Officer

NASHUA, N.H., Sept. 7, 2022 /PRNewswire/ -- Conformal Medical, Inc., a medical device company developing next-generation left atrial appendage occlusion (LAAO) technology, today announced the appointment of James Reinstein as President and Chief Executive Officer. With over three decades in the medical device industry, Reinstein has served as CEO for public and private companies. He succeeds Andy Levine, who will continue to serve as an advisor to the company.

"We are excited to welcome James to the company. His experience leading private and public companies positions Conformal well as we continue to achieve important milestones and proceed forward," commented Aaron Kaplan, MD, Co-Founder and Board Chair for Conformal Medical. "We also acknowledge and thank Andy who built a terrific team and successfully executed on a product that is now a commercially appropriate implant being evaluated in the CONFORM pivotal trial." Levine added, "It has been a terrific journey and I am proud of all that we have accomplished. I look forward to working closely with James and I know Conformal is in good hands."

Reinstein has been the CEO of many companies including Saranas Inc. (private), Aptus Endosystems (Acquired by Medtronic), Cutera (NASDAQ), and Drawbridge Health (Acquired by Thorne Health Tech). Earlier in his career, Reinstein served as Senior Vice President and Chief Commercial Officer for Cyberonics Inc. and Vice President, Asia Region for Boston Scientific Corporation.

"Conformal's LAAO technology is a next-generation innovation poised to simplify the procedure, improve the patient experience, and expand the treatable population," stated Reinstein. "I am pleased to join the organization at this important time as we advance the clinical program and build a robust body of evidence that will validate the technology and allow us to drive towards commercialization."

The CLAAS System is designed to seal the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation (Afib) to reduce the risk of stroke without the need for anticoagulants. Featuring a proprietary foam-based architecture, the CLAAS implant is designed to conform to a broad range of LAA anatomies with only two sizes and aims to simplify the procedure by allowing off-axis positioning while providing a more uniform seal. The implant also aims to eliminate the need for procedural transesophageal echocardiogram so that physicians may perform the procedure without general anesthesia, a significant advancement with the potential to shift clinical practice to a single operator procedure performed under conscious sedation without general anesthesia.

Recently, Conformal initiated the CONFORM pivotal trial, an investigational device exemption (IDE) study that will evaluate the safety and efficacy of the company's CLAAS® System compared to commercially available LAAO devices. The prospective, multicenter, randomized controlled study will enroll approximately 1,600 patients in the U.S., Canada, and Japan and will support U.S. Food and Drug Administration (FDA) pre-market approval.

About Conformal Medical

Founded in 2016, Conformal Medical, Inc. is a medical device company developing devices to prevent stroke in patients with non-valvular Afib. The company's proprietary technology is intended to make left atrial appendage closure a same day, single operator procedure. For more information, visit https://conformalmedical.com/. 

More than six million people in the United States suffer from AFib, placing them at an increased risk of stroke.¹ Current standard of care for stroke prevention is chronic oral anticoagulants, which are not well accepted by patients due to concern about associated risk of bleeding. LAAO is emerging as an important alternative to blood thinners for preventing strokes in patients with non-valvular Afib. In 2021, the global LAAO market was estimated at $900M and is expected to exceed $2B in 2024.^2,3

1. Kornej J, Börschel CS, Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020 Jun 19;127(1):4-20.
2. Boston Scientific Investor Presentation, September 2021.
3. Key Takeaways from the SVB Leerink Global Healthcare Conference, February 2022.

SOURCE Conformal Medical / SPRIG Consulting