BiVacor wins FDA IDE for first-in-human artificial heart study

The BiVacor Total Artificial Heart (TAH) [Image courtesy of BiVacor]BiVacor announced today that the FDA granted investigational device exemption (IDE) for its total artificial heart (BTAH).

IDE approval allows BiVacor to begin its first-in-human early feasibility study (EFS) for the BTAH system. The Houston-based company aims to evaluate BTAH’s safety and feasibility as a bridge to a heart transplant for patients with biventricular heart failure.

BiVacor tapped 10 hospital locations for the study, for which it plans to initially enroll three patients. The company expects to begin the study in 2024 and to use its findings to lead into a subsequent pivotal study. This falls in line with the company’s timeline shared in March when it raised $18 million to support the BTAH’s development.

“I am eager to begin the BiVacor Total Artificial Heart EFS to evaluate what I believe is a promising and potentially life-saving technology,” said Dr. Josep…

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Artificial heart developer Carmat could receive up to €17.5M in funding

The Aeson artificial heart. [Image from Carmat’s website]Carmat announced today that the European Council selected it to join its EIC Accelerator program for innovative companies in Europe.

The total funding could reach €17.5 million ($18.6 million).

Paris-based Carmat develops a total artificial heart. It designed the platform to provide a therapeutic alternative for those suffering from end-stage biventricular heart failure.

EIC Accelerator funds European companies aiming to bring innovations to market. The council selected Carmat and its Aeson artificial heart, recognizing it as a “high-quality medical innovation,” according to a news release.

As a result of the selection, Carmat received the maximum possible funding available. It picked up a non-dilutive grant of €2.5 million ($2.7 million) to support the industrialization of Aeson. Additionally, Carmat received an optional equity financing of €15 million ($15.9 million). This f…

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