Seasoned medical device executive to direct company through significant milestones
NASHUA, N.H. – Conformal Medical, Inc., a privately-held medical device company developing next generation left atrial appendage closure (LAAC) technology, today announced the appointment of George Fazio to its board of directors. Currently, Mr. Fazio is the president and chief executive officer of Corvia Medical, a medical device company with a first-inclass structural heart device to treat heart failure.
Mr. Fazio brings more than three decades of executive experience in the cardiovascular space. Prior to joining Corvia in 2010, he held numerous senior leadership positions with St. Jude Medical, including serving as president of the U.S. and EMEA regions, and both the cardiovascular and cardiac surgery businesses. He also served as the president of Health Care Services where he built the national accounts function for managing cross-divisional contracting and general manager of Canadian operations, transitioning St. Jude Medical’s operations from a distributorbased model to direct.
“We are very pleased to have George join Conformal’s board of directors at this important time as we embark on our U.S. IDE trial,” commented Andy Levine, co-founder and chief executive officer of Conformal Medical. “We are confident that his strategic business insights, extensive knowledge in the cardiovascular market, and experience as an executive of a private medical device company will add tremendous value as we advance our technology through upcoming clinical and regulatory milestones.”
Conformal Medical’s CLAAS® System seals the left atrial appendage (LAA) in patients with atrial fibrillation (Afib) to reduce the risk of stroke without anticoagulants. Featuring a proprietary foam-based architecture, the CLAAS implant is designed to address the wide spectrum of LAA anatomies with only two sizes and provide simplified delivery, without the need for procedural TEE, allowing physicians to perform LAAC without general anesthesia. “I am very excited to join Conformal’s board and believe its innovative approach to LAA closure overcomes the limitations of first-generation devices,” commented Mr. Fazio. “The conformable foam implant aims to expand the treatable population, improve the patient experience, and has the potential to shape and transform the future of this large and growing market.”
In 2021, Conformal Medical will begin its randomized pivotal trial that will enroll approximately 1,400 patients at multiple sites globally to investigate the safety and effectiveness of the CLAAS technology compared to Boston Scientific’s Watchman products.
About Conformal Medical Founded in 2016, Conformal Medical, Inc. is a privately held medical device company developing next generation left atrial appendage closure (LAAC) technology. The company’s proprietary technology is intended to make LAAC achieve its true potential. The CLAAS device is currently in clinical testing and is not available for sale in any geography. 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 associated risk of bleeding. LAAC is emerging as an important alternative to blood thinners for preventing strokes in patients with AFib. First-generation LAAC devices are an estimated to reach $700M global market in 2021 and are expected to grow to over $3B in the next five years.2,3
1. https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm 2. Morgan Stanley Market Analyst Report September 2020 3. Boston Scientific Investor Update, TCT 2020, October 15, 2020