COLLEGEVILLE, PA — Thubrikar Aortic Valve Inc. has entered an exclusive European distribution agreement with MAC’s MEDICAL Group that includes financing for up to 50 additional implants in the company’s pivotal CE Mark study and a potential $2 million investment, providing new capital as the medical device developer advances its transcatheter heart valve program.
Under the agreement, MAC’s MEDICAL Group and its affiliates will help fund implants needed to support European regulatory approval of Thubrikar’s Optimum TAVI System and will receive exclusive distribution rights in Europe, the company said.
The partnership also expands the CE Mark clinical trial beyond Poland into Croatia, Serbia and other European markets.
MAC’s Chief Executive Officer, Ante Cicin-Sain, has already invested in the company and financed three recent valve implants performed in Poland.
The Optimum TAV has now been implanted in 16 patients, according to the company. Thubrikar said its first-in-human patient continues to do well seven years after implantation.
The procedures were performed by principal investigator Jaroslaw Trebacz at John Paul II Hospital.
Trebacz said the valve’s performance has remained strong in patients with small aortic annuli, a population that can be challenging to treat with existing transcatheter devices.
Thubrikar is developing the Optimum TAV as a self-expanding transcatheter aortic valve replacement system. The company said the device differs from many commercially available systems because of its shorter frame design.
The company plans to submit clinical data from the implants for publication in the JACC: Cardiovascular Interventions.
The agreement provides Thubrikar with additional financial backing and a commercial partner in Europe as it pursues CE Mark approval, a key milestone that could open the door to broader commercialization of its heart valve technology.
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