Conformal Medical Announces Appointment of Felipe Aguel, PhD, as Vice President of Regulatory Affairs and Quality

NASHUA, N.H. – July 17, 2025 – Conformal Medical, Inc., a medical device company developing a next-generation left atrial appendage closure (LAAC) technology, today announced the appointment of Felipe Aguel, PhD, as Vice President of Regulatory Affairs and Quality. Felipe brings over 20 years of experience in regulatory science and clinical evidence generation, with an extensive track record spanning government, industry, and academic institutions.

"I am honored to join an organization that prioritizes innovation, patient safety, and operational excellence,” said Felipe Aguel. “The team’s commitment to quality and compliance is evident, and I’m eager to contribute to strengthening our regulatory strategy and quality systems as we grow. I look forward to supporting the advancement of our pipeline while upholding the highest standards that define our mission and impact."

Most recently, Felipe served as Deputy Director of the Office of Clinical Evidence and Analysis, at the FDA’s Center for Devices and Radiological Health (CDRH), where he led several key initiatives to modernize regulatory pathways. In this role, he also provided strategic oversight of the IDE policy, human subject protections, bioresearch monitoring, and expedited access programs. He also oversaw CDRH’s biostatistics and epidemiology divisions and led national efforts to expand the use of real-world evidence (RWE) to support device labeling and indication expansions.

Felipe’s FDA career also included leadership positions in the Cardiac Electrophysiology and Monitoring Branch, where he served as Branch Chief, and the Division of Neurological and Physical Medicine Devices where he served as Deputy Division Director. His breadth of regulatory knowledge and technical expertise has helped shape the evolving medical device landscape, particularly in cardiovascular and neurological applications.

In addition to his public service, Felipe held senior regulatory affairs roles at AgNovos Bioscience and AtriCure. He served as a Program Director at the National Institute of Neurological Disorders and Stroke (NINDS) at the NIH, further strengthening his multidisciplinary perspective on device development and clinical research.

Felipe earned both his BS and PhD in biomedical engineering from Tulane University and completed a postdoctoral fellowship in biomedical engineering at the Johns Hopkins University.

“We are pleased to welcome Felipe to the Conformal leadership team,” said James Reinstein, President and CEO of Conformal. “His experience across the FDA, NIH, and industry will be instrumental as we advance our regulatory strategy and prepare for future commercialization. Felipe’s leadership will help ensure our commitment to delivering safe, effective, and innovative solutions to patients around the world.”


About Conformal Medical Conformal Medical, Inc. is a medical device company developing devices to prevent stroke in patients with non-valvular atrial fibrillation. 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/.

About Left Atrial Appendage Closure
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 the associated risk of bleeding. Left Atrial Appendage Occlusion (LAAO) is emerging as an important alternative to blood thinners for preventing strokes in patients with non-valvular Afib. First-generation LAAO devices are an estimated $1.4B global market in 2023 and are expected to grow to over $6B by 2030.2,3

CAUTION: Investigational Device.
The CLAAS System is limited by Federal (or United States) law to investigational use.

NCT05147792

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. Piper Sandler Market Analyst Report, September 2023.
3. Boston Scientific Investor Update, September 2023.