Conformal Medical Names James Reinstein as President and CEO

September 7, 2022—Conformal Medical, Inc., a medical device company developing next-generation left atrial appendage occlusion (LAAO) technology, announced the appointment of James Reinstein as President and Chief Executive Officer. He succeeds Andy Levine, who will continue to serve as an advisor to the company.

According to the company, Mr. Reinstein has worked for more 3 decades in the medical device industry and served as CEO for public and private companies, including Saranas Inc. (private), Aptus Endosystems (acquired by Medtronic), Cutera (public; NASDAQ), and Drawbridge Health (acquired by Thorne Health Tech). Earlier in his career, he served as Senior Vice President and Chief Commercial Officer for Cyberonics Inc. and Vice President, Asia Region for Boston Scientific Corporation.

Mr. Reinstein stated in the press release, “Conformal’s LAAO technology is a next-generation innovation poised to simplify the procedure, improve the patient experience, and expand the treatable population. 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 toward commercialization.”

On June 22, the company announced the launch of the CONFORM pivotal trial that will evaluate the safety and efficacy of the company’s CLAAS LAAO system compared to commercially available LAAO devices. The study, conducted under an investigational device exemption, will support FDA premarket approval of the CLAAS system.

The prospective, multicenter, randomized controlled study will enroll approximately 1,600 patients in the United States, Canada, and Japan.

Aaron Kaplan, MD, Co-Founder and Board Chair for Conformal Medical, “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.”

Dr. Kaplan continued, “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.”

Mr. 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.”