May 2, 2023

NORRISTOWN, Pa. — (BUSINESS WIRE) — Thubrikar Aortic Valve, Inc., is happy to announce that results of the initial CE Mark-enabling study using the Optimum Transcatheter Aortic Valve (Optimum TAV™) in patients with severe aortic stenosis will be presented at the upcoming EuroPCR 2023 Conference. EuroPCR is an annual, world-leading conference on interventional cardiovascular medicine taking place from May 16-19, 2023, in Paris, France. Principal Investigator and Interventionalist, Jaroslaw Trebacz, MD, of the Specialty Hospital Jana Pawla II in Krakow, Poland, will discuss their experience and follow-up data up to one year during the moderated “TAVI: Late-Breaking Trials and Innovations” session.

“It is an honor to be selected as one of the featured companies at the EuroPCR TAVI session and to share data on the safety and performance of the Optimum TAV. We look forward to progressing with further implantations in additional sizes and ultimately CE Mark approval,” said Dr. Mano Thubrikar, Optimum TAV’s inventor, and the Company’s President and Founder.

Valve performance has been outstanding, with mean gradients and effective orifice areas (EOAs) better than most commercially available TAVI valves. “The Optimum valve, with its unique design, has the potential to overcome the limitations of currently available devices,” commented Jaroslaw Trebacz, MD.

Optimum TAV is the only short-profile, self-expanding TAV in the TAVI field, thus providing easy coronary access as well as the benefits of a self-expanding valve. It is designed to mimic the natural aortic valve with dimensional proportionality and leaflet surface geometry, no suture holes in the flexion zone of the leaflet, and a unique anti-calcification treatment.

Optimum TAV has shown preclinical durability up to 24 years, with less calcification than established bioprosthetic surgical heart valves in the juvenile sheep implant model. Optimum TAV is intended to meet the needs of a younger patient population requiring a long-lasting valve with excellent hemodynamic performance. In Brazil, the first patient implanted with Optimum TAV continues to do well at 4 years.
 
Dr. Susheel Kodali, Director of the Structural Heart & Valve Center at New York-Presbyterian/Columbia University Medical Center, and Dr. Mathew Williams, Director of the Heart Valve Center at NYU Langone Health, are long-standing Medical Advisors for the Company, and assisted in the development of the Company’s Precision 2™ Catheter – which further optimizes ease of valve delivery and long-term success. Drs. Williams and Kodali report disclosures with Thubrikar Aortic Valve, Inc.

About Thubrikar Aortic Valve and its Optimum TAVI System™

Thubrikar Aortic Valve, Inc. is a privately-held medical device company near Philadelphia, PA, that has developed the Optimum TAV, a next-generation transcatheter aortic valve designed using 30 years of research by the Company’s Founder, Dr. Mano Thubrikar. He served as Director of Surgical Research at the University of Virginia, Director of Biomedical Engineering at the Heineman Medical Research Center in Charlotte, Distinguished Research Scientist at Edwards Lifesciences, and Director of Biomedical Engineering at the South Dakota School of Mines and Technology. He is the author of The Aortic Valve, a leading textbook covering the fundamentals of valve structure and function. For more information, please visit www.tavi.us.