PITTSBURGH--(BUSINESS WIRE)--PECA Labs, a medical device company reimagining the field of vascular grafts and valves with durable polymeric cardiovascular devices designed to fit, grow, and last, has added Joseph E. Bavaria, MD to its board of directors. Dr. Bavaria, an internationally renowned cardiac and thoracic surgeon and an expert in repairing and replacing cardiac valves, will provide key leadership to PECA as it continues to develop and commercialize cardiovascular implants based on its novel tunable polymeric material platform.
Dr. Bavaria adds more than 30 years of experience in cardiac and thoracic surgery, research and leadership to PECA’s board. He is currently chair of Cardiac Surgery at Jefferson Health and executive director of the Jefferson Heart and Vascular Institute in Philadelphia. Previously he spent more than three decades at Penn Medicine where he served in a number of leadership roles, including vice chief, Division of Cardiovascular Surgery, director of the Thoracic Aortic Surgery Program, co-director of the Transcatheter Valve Program, and founder of the Penn Aorta Center. Dr. Bavaria has completed extensive research and served in international leadership positions including president of the Society of Thoracic Surgeons, president of the Thoracic Surgery Foundation, board member of the Heart Valve Society, and executive committee member of the European Association of CardioThoracic Surgery. He is program director of this year’s Aortic Valve Repair Symposium. Dr. Bavaria earned his Bachelor of Science in Chemical Engineering and Medical degrees from Tulane University, and completed residencies at the Hospital of the University of Pennsylvania and Children’s Hospital of Philadelphia.
Dr. Bavaria was also chair of the Medical Board CardiAQ, which developed a transcatheter mitral valve and was acquired by Edwards Lifesciences for over $350M.
“Dr. Bavaria’s extensive leadership in cardiovascular surgery, particularly in innovating valve repair and replacement, will be immeasurable as we continue to develop and commercialize our MASA Valve and our STEALTH valve technologies,” said Doug Bernstein, CEO of PECA Labs. “Few have the combination of hands-on, research and educational experience as Dr. Bavaria, making him an enormous asset as we move closer to our goal to provide devices that reduce or eliminate the need for replacement surgeries, thereby reducing the risk of morbidity and mortality in at-risk patients.”
The addition of Dr. Bavaria to PECA’s board follows the appointment of Dr. Jeffrey P. Carpenter, Jeffrey O’Donnell, Sr. and Samuel E. Navarro to the board and the elevation of Mr. O’Donnell to executive chairman. PECA also recently opened a new facility for polymeric processing, moving critical manufacturing in-house to provide the company with greater control of its manufacturing processes and the ability to scale quickly as it grows.
PECA Labs’ MASA Valve is a durable polymeric valved conduit for pulmonary valve reconstruction. Designed for pediatrics, the MASA Valve is designed to help patients avoid repeat surgeries and reduce morbidity and mortality. The novel polymeric valve previously received Humanitarian Use Device (HUD) and Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). Enrollment continues at four clinical sites in the U.S. as part of its MASA Valve Early Feasibility Clinical Study (MVEFS).
PECA Labs developed the MASA Valve to be made entirely of polymeric materials that help avoid body’s immune response and valve calcification that are inherent to biologic valved conduits and the leading cause of valve failure. Engineered for greater durability, the MASA Valve is constructed of PECA’s proprietary conduit and leaflet membrane, allowing for the production of a wide array of sizes to ensure a match with each patient’s unique anatomy. The MASA Valve could help reduce the need for replacement surgeries and interventions, thereby reducing the risk of morbidity and mortality. If approved, the MASA Valve would be the only non-biologic valve replacement option for this important procedure, and aims to be the first fully polymeric valve on the market.
PECA’s first FDA-cleared implant is the exGraft, a polymeric graft indicated for use as a vascular prosthesis. exGraft recently received a new CE Mark as well to allow for the use of over-sized balloon dilation. Post-operative expansion is designed to allow for increasing graft diameter, which may enable the graft to match growth in pediatric populations or help to avoid restenosis (narrowing) in adults. PECA Labs’ exGraft family of vascular grafts are intended for use as vascular prostheses for replacement or bypass of diseased or injured vessels, and includes instructions for post-operative expansion up to 140 percent with the use of oversized balloon catheters. Pre-operatively, the controlled dilation may help address unique anatomies. The exGraft’s capability to be balloon-expanded in the cath lab provides cardiac care teams greater flexibility in treating patients.
“PECA Labs is working to solve some important challenges in cardiovascular implants, including the use of next-generation polymeric materials, which could make significant improvements to patient outcomes,” said Dr. Bavaria. “I look forward to working with the company and rest of the board of directors in an effort to create a meaningful impact with its technologies.”
About PECA Labs
PECA Labs is reimagining the field of vascular grafts and valves with durable polymeric cardiovascular devices that are designed to fit, grow and last to help patients avoid repeat surgeries and reduce morbidity and mortality. PECA’s proprietary technologies, a controllably-expandable graft and low- thrombosis polymeric membrane, consist of a proprietary tunable polymer material platform that represents a new approach in engineering synthetic materials for greater durability and customization than currently available cardiovascular implants. The company’s grafts and conduits are designed to lead to a longer lifespan compared to currently available products, due to resistance to thrombosis, calcification and immune response, and by providing growth potential, customization, and noninvasive visualization. For more information visit www.pecalabs.com.
