Thubrikar Aortic Valve partners with MAC’s MEDICAL Group and expands the TAVI-1 CE Mark trial of the Optimum TAVI System™

COLLEGEVILLE, Pa.--(BUSINESS WIRE)--Thubrikar Aortic Valve, Inc. today announced its partnership with MAC’s MEDICAL Group, a distributor of cardiovascular devices in Europe, and MAC’s CEO, Ante Cicin-Sain. As part of the exclusive distribution rights agreement for Europe, Mr. Cicin-Sain, MAC’s MEDICAL Group, and their affiliates will co-participate in financing up to 50 implants toward the CE Mark approval of the Optimum TAVI System™. They will also have the option to invest an additional $2 Million in Thubrikar Aortic Valve (the “Company”).

Mr. Cicin-Sain has already funded 3 recent implants in Poland by investing in the Company, joining several heart specialists, Labcor Laboratorios of Brazil; affiliates of China Cardiovascular Research Foundation; and multiple angel groups and individual investors. These 3 implants further demonstrate consistency in the ease of valve delivery as well as the performance of Optimum TAV. MAC’s MEDICAL Group will expand the Optimum TAVI System CE Mark trial to Croatia, Serbia, and other countries.

Dr. Mano Thubrikar, the Company’s Founder and President, stated, “We are very excited to partner with MAC’s MEDICAL Group for expanding and supporting the completion of our CE Mark Trial, and for their vast experience with European marketing and sales of implantable cardiovascular devices.”

Interventional Cardiologist and TAVI-1 CE Mark trial Principal Investigator, Dr. Jaroslaw Trebacz, again conducted the procedures at the John Paul II Hospital in Krakow, Poland. Dr. Trebacz remarked, “The hemodynamic performance of the Optimum Valve has been outstanding in all patients throughout up to four years of follow-up. In particular, the results are exceptionally encouraging when compared with my extensive experience over many years using commercially available devices in patients with similarly small annuli. The consistently excellent outcomes observed with the Optimum Valve underscore its remarkable effectiveness in this challenging patient population.” Most clinical-stage TAVR valves require tall frames that cage the coronaries, or balloon-expansion, and most have reduced durability. Dr. Thubrikar added, “The Optimum TAV™ and the Precision 2™ Catheter represent a true next-generation system built to offer increased valve durability for all patients.” Currently, the Optimum TAV is the only short and self-expanding TAVR valve.

To date, the Optimum TAV has been successfully implanted in 16 patients, with the global FIH patient doing well at 7 years. This data will soon be submitted for publication to the Journal of the American College of Cardiology (JACC: Cardiovascular Interventions).

The Optimum TAVI system has been named “Top Aortic Valve Implantation System 2026” by the publication MED TECH Outlook. A detailed interview of Dr. Thubrikar, author of the 1991 textbook “The Aortic Valve”, is now available in their June 1 issue and on their website.

About Thubrikar Aortic Valve

Thubrikar Aortic Valve, Inc. is a privately held medical device company on a mission to revolutionize the treatment of Aortic Stenosis by bringing to the hands of physicians, and their patients, a transcatheter aortic valve durable enough for all patients. Dr. Mano Thubrikar, a leading authority on the aortic valve, founded the Company. For more information, visit www.tavi.us and follow the Company on LinkedIn.

About MAC’s MEDICAL Group

MAC's MEDICAL Group is a leading distributor of cardiovascular implants, interventional radiology, and general surgery products, offering innovative surgical and medical solutions. MAC's MEDICAL is headquartered in Austria. They are an organization of 11 local companies covering 16 countries in Europe, with a team of 34 employees. The company focuses on providing high-end solutions for physicians.