Conformal Medical, Inc.
Conformal® is a privately held medical device company that designed the CLAAS System* to seal the LAA to reduce the risk of stroke, without the need for anticoagulants.
*Currently in clinical testing and not available for sale.
Provide a solution that overcomes the limitations of first-generation devices and transforms LAAO to an outpatient procedure.
Improve the patient’s experience with a short, same-day procedure using an implant that consistently delivers a customized, anatomic seal without the need for general anesthesia or TEE.
Design an LAAO System that expands the treatable population due to its ease of use and ability to be performed without general anesthesia or post procedural anticoagulation.
Chairman & Chief Medical Officer
Aaron Kaplan is an active medical device entrepreneur who has been on the founding team of a number of venture-backed medical device companies including Conformal Medical, Tryton Medical, LocalMed and Perclose (acquired by Abbott). He has consulted to many medical device companies and was an Entrepreneur-In-Residence at Three Arch Partners. Aaron is a practicing interventional cardiologist at Dartmouth-Hitchcock Medical Center and a Professor of Medicine at the Geisel School of Medicine at Dartmouth. In addition, he directs the Synergy Clinician-Entrepreneur Fellowship and chairs the Dartmouth Device Development Symposium. Prior to joining the Dartmouth Faculty, Dr. Kaplan was Director of Interventional Cardiology at the Palo Alto VA and served on the Faculty at Stanford University. Aaron has more than 65 peer-reviewed papers, 45 U.S. Patents, and was inducted into the National Academy of Inventors (Class of 2015). He received a B.S. in Engineering Sciences (Cum Laude) from Tufts University, M.D. from Wake Forest University, medical training at Northwestern University and cardiology training at Stanford University.
President and CEO
James is a seasoned medical device executive with over three decades of senior leadership expertise in strategic planning, commercial excellence, and M&A. Prior to joining Conformal, Reinstein served as President, CEO, and board member at Saranas Inc. where he was responsible for raising capital, scaling the organization, and initiating enrollment of its ongoing clinical trial. Preceding his time with Saranas, he served as the President, CEO, and board member for several other medical device and diagnostic companies including Cutera Inc., Drawbridge Health Inc., and Aptus Endosystems Inc. Earlier in his career, Reinstein also served as Senior Vice President and Chief Commercial Officer for Cyberonics Inc (now LivaNova) and Vice President, Asia Region for Boston Scientific. Additionally, he is a general partner with Palo Alto Medtech Advisors. Reinstein holds a bachelor’s in business administration, marketing, from the University of Georgia and Executive Management training from INSEAD in Fontainebleau, France.
Chief Scientific Officer
Carol has over 30 years of experience in the development of medical devices, primarily transcatheter cardiovascular implants. She has extensive experience in emerging technologies, with a focus on structural heart repair, including devices for closure of intracardiac defects, LAA occlusion, and heart failure. Carol has taken several cardiovascular implants from concept through commercialization including a drug/biologic/device combination and is also experienced in intellectual property strategy and development. Carol has been a consultant in the medical device field since 2011 and the Chief Scientific Officer of Conformal Medical since 2016. Prior to that, for 16 years she served as Vice President of R&D for NMT Medical, a publicly held company focused on the transcatheter repair of intracardiac defects. She started her medical device career at C.R. Bard, where she held several technical and management positions over the course of 10 years. Carol is an inventor on over 30 issued US patents, has authored several articles and book chapters, and lectured on medical device design. Carol holds a B.S. in Chemical Engineering and an M.S. in Plastics Engineering, both from the University of Massachusetts/Lowell.
Vice President of Engineering
David has over 25 years of experience in the design, development and manufacture of medical devices, and has successfully demonstrated the early problem-solving skills necessary to launch companies and bring new technologies to the market. He has been employed in increasingly senior engineering positions at CR Bard, Focal, Boston Scientific, Confluent Surgical, GI Dynamics and Conformal Medical. His experience includes the development of products for cardiology, radiology, general, thoracic, spinal and cranial surgery, gastroenterology, urology and gynecology. David holds over 40 US issued patents and has co-authored several technical publications. He has a BS in Mechanical Engineering from the University of Massachusetts at Lowell.
Vice President of Clinical Affairs
David has over 30 years of experience with cardiovascular medical devices including cardiac rhythm management, ASD/PFO closure, heart failure management, and surgical and transcatheter heart valves. David has diverse experience building teams and developing and executing clinical strategies. He started his medical device career in business development within the Medical Device and Diagnostics Division of Eli Lilly and Company. This division was spun off from Lilly to become Guidant Corporation in 1995. David held field clinical and several cross functional management positions in finance and marketing over the next 10 years. He began his clinical focus at St Jude Medical on post market study development and execution, holding positions of increasing responsibility in clinical development of heart valves, ASD/PFO closure, and optical coherence tomography (OCT). David established the field clinical engineering team at Tendyne (transapical mitral valve acquired by Abbott in 2015) during its early human experience and led the clinical organization during CE Mark study enrollment and submission. Tendyne received CE Mark in January 2020. At Cephea/Abbott and at VDyne, he led early-stage clinical development of novel transcatheter mitral/tricuspid valve replacement devices. He holds a B.S. in Pharmacy and an MBA from Purdue University.
Vice President of Therapy Development
Dana has over 30 years of commercial experience in the medical device industry. He has held leadership positions in Field Sales, Marketing, M&A integrations, and Commercial Operations. Prior to joining Conformal, Dana was a Sales Director and the Director of Commercial Operations at Abiomed (Mechanical Circulatory Support (Impella) acquired by Johnson and Johnson in December of 2022). Prior to Abiomed, Dana was at Boston Scientific Corporation (BSX) for 25 years in various commercial roles of increasing responsibility. He was the commercial lead of BSX’s integration of British Technology Group (BTG) in 2019. The $4.2B acquisition of BTG is the second largest acquisition in BSX history. Earlier in his career, Dana lead the marketing efforts at Biosphere Medical (acquired by Merit Medical) which was the first device approved for the embolization of uterine fibroids. He has broad market experience in Interventional Cardiology, Interventional Radiology, Vascular Surgery, and Cardiac Surgery. He has a BA in History from Framingham State University.
Director of Regulatory Affairs
Stephanie joined Conformal in mid-2021 with over 15 years of experience leading and authoring regulatory submissions, developing global regulatory strategies, and compliance activities for medical devices including cardiovascular, laser, diagnostics, general surgery, and diabetes. She began her regulatory career in point-of-care diagnostics and was most recently Regulatory Affairs Manager for mechanical circulatory support devices at Abbott / Thoratec. During her time with Abbott, Stephanie held various roles of increasing responsibility and leadership. She has a B.S. in Biology from the University of Lowell (now the University of Massachusetts Lowell).
Director of Operations
Steve has over 30 years of medical device experience leading Operations, Research & Development, and Quality Assurance organizations with both start-up and large corporations. Prior to joining Conformal, he held various Operations and Research & Development management roles at Miracor, Mitralign, Percardia in addition to Quality Assurance positions with Boston Scientific and the USCI Division of CR Bard. Steve received a Bachelor of Science degree in Plastics Engineering from the University of Lowell (now the University of Massachusetts Lowell).
Advisor
Andy Levine is an entrepreneur with over 35 years of engineering, marketing and general business experience developing medical devices and starting companies. He is a co-founder of Conformal Medical. He previously held a position in business development for medical devices at Harvard University’s Wyss Institute for Biologically Inspired Engineering. In 2003, Andy founded GI Dynamics, which developed an endoscopic device for the treatment of diabetes. In 2000 he was a co-founder of Seedling Enterprises, a medical device incubator that started GI Dynamics, Lumerx and Angstrom Medical and licensed out two technologies: IsoCool (J&J) and a Multipurpose Laparoscopic Instrument (Aesculap). Additional start-ups include EnteraStim (GI motility), EndoCellutions (regenerative medicine devices), Microsurge (laparoscopic instruments) and Bard’s Reproductive Systems (fertility devices). Andy’s diverse experience includes work to conceptualize, design, develop and commercialize products with applications in cardiovascular medicine, gastroenterology, gynecology, general surgery, thoracic surgery and urology. He possesses technical expertise in biomaterials, mechanism design, fluid mechanics and heat transfer, holds over 70 patents and has authored over 20 technical publications. He holds a M.S. in Mechanical Engineering from the University of Wisconsin-Madison and a B.S. in Mechanical Engineering from Tufts University.
Aaron Kaplan, MD
Chairman & Chief Medical Officer
James Reinstein
CEO & President
George Fazio
Director - President & Chief Executive Officer, Corvia Medical
Joshua Phillips
Director - Founder & Managing Partner, Catalyst Health Ventures
Scott Ward
Director - Chairman, President & CEO, Cardiovascular Systems, Inc.
Tasneem Dohadwala
Board Observer - Founding Partner of Excelestar Ventures
Shephal Doshi, MD
Director, Cardiac Electrophysiology Pacific Heart Institute, CA
William Gray, MD
President, Lankenau Heart Institute Wynnewood, PA
Jamie Kim, MD
Catholic Medical Center Manchester, NH
Robert Sommer, MD
Director, Structural Interventions New York-Presbyterian Hospital / Columbia Medical Center, NY
Conformal Medical is looking for highly-skilled professionals to join our team. We are driven by the challenge of developing innovative medical devices that improve patients’ lives. If you share in this passion, please contact us!