Conformal Medical is now a part of W. L. Gore & Associates
Conformal Medical, Inc.
Conformal Medical is a wholly owned subsidiary of W. L. Gore & Associates; Conformal Medical remains focused on advancing its investigational technology and conducting clinical studies as planned.
*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.
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.
Chairman & Chief Medical Officer
Aaron Kaplan is an active medical device entrepreneur who has been on the founding team of several venture-backed medical device companies, including Conformal Medical, Tryton Medical, LocalMed, and Perclose (acquired by Abbott). He has consulted with many medical device companies and was an Entrepreneur-In-Residence at Three Arch Partners. Aaron is a practicing interventional/structural cardiologist at Dartmouth-Hitchcock Medical Center and a Professor of Medicine at Dartmouth's Geisel School of Medicine. In addition, he chairs the Dartmouth Device Development Symposium and is Co-Director of the 3DScholars Program. 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 over 80 peer-reviewed papers and 65 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.
Chief Financial Officer
Melissa has over 20 years of finance leadership experience in the medical device industry. She has held leadership positions with both public and private companies and brings a proven track record of strong financial strategy execution. Melissa recently served as the CFO of Neuspera Medical, a start-up medical device company developing implantable technologies for patients battling chronic illness and was a core team member as the company initiated the second phase of its U.S. IDE clinical trial. Prior to Neuspera, Melissa served as CFO of the Medical Division of Halma PLC, where she led strategy, capital and resource allocation, and merger and acquisition activity, delivering on growth and profitability goals for the division. Earlier in her career, Melissa held executive leadership positions at LivaNova and Becton Dickinson.
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 Operations
Aurelio boasts an extensive 30-year tenure within the medical device industry, where he has held pivotal roles as an operations leader across several well-established companies such as Cutera, Veniti (a Boston Scientific company), Medtronic, and Aptus Endosystems. His proven expertise lies in successfully expanding manufacturing processes and consistently delivering top-tier products that cater to patient needs, all while ensuring the company's financial and compliance objectives are met.
Vice President of Regulatory Affairs and Quality
Felipe brings over 20 years of experience in medical device regulation and clinical evidence development. Felipe has spent much of his career at the FDA’s Center for Devices and Radiological Health (CDRH), most recently as Deputy Director of the Office of Clinical Evidence and Analysis, where he led initiatives around IDE policy, real-world evidence, and oversight of biostatistics and epidemiology. He has also held leadership roles in the Cardiac Electrophysiology Branch and the Division of Neurological and Physical Medicine Devices. Additionally, Felipe has held regulatory leadership roles at AgNovos Bioscience and AtriCure, and served as a Program Director at the NIH’s National Institute of Neurological Disorders and Stroke (NINDS). He holds a BS and PhD in Biomedical Engineering from Tulane University and was a Distinguished Postdoctoral Fellow at Johns Hopkins University.
Vice President of Engineering
Justin brings more than 20 years of experience in Research, Development, and Operations leadership across the medical device industry, spanning early-stage ventures and global strategic organizations. He has consistently led the development, commercialization, and scale-up of complex, disruptive technologies that address significant unmet clinical needs.
Prior to joining Conformal Medical, Justin served as Senior Vice President of R&D and Chief Operating Officer at BrioHealth Solutions, where he directed global teams in the United States, China, and Israel in advancing novel mechanical circulatory support systems (LVAD). Earlier in his career, he held senior R&D leadership positions with Smith+Nephew (Biologics for Sports Medicine and Orthopedics), Abbott / St. Jude Medical / Thoratec (Mechanical Circulatory Support), and Rhythmia Medical (Electrophysiology Mapping, acquired by Boston Scientific), among others. Justin’s experience spans Interventional Cardiology, Electrophysiology, Cardiac Surgery, and Sports Medicine/Orthopedics. He holds a Bachelor of Science in Engineering from LeTourneau University.
Vice President of Clinical Affairs
Sarah brings over 20 years of medical device clinical research experience to Conformal. Throughout her career, she has led the development and execution of both pre- and post-market clinical trials and supported regulatory approvals globally. Before joining us, she held leadership roles at Melodi Health, Neovasc (acquired by Shockwave Medical), Medtronic, and St. Jude Medical.
Shephal Doshi, MD
Director, Cardiac Electrophysiology Pacific Heart Institute, CA
William Gray, MD
President, Lankenau Heart Institute, PA
Devi Nair, MD
Director of Cardiac Electrophysiology & Research, St. Bernards Medical Center, AR
Christopher Ellis, MD
Director, Cardiac Electrophysiology Laboratory and Director, LAA Closure Program, Vanderbilt Health, TN
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!