Realheart in discussions with the FDA – the US Food and Drug Administration

Realheart aims at the US market and confirms its development plan towards the first trial in human patients.

The United States is the world’s largest market for total artificial hearts and thus very important for Realheart, which intends to sell its product, Realheart TAH, there. Before this can happen, it is necessary that Realheart’s products comply with all the requirements from the US Food and Drug Administration (FDA).

Realheart has now begun discussions with the FDA, which clarifies the requirements for product development and trials for the US market.

These kinds of discussions are preceded by a formal process in which the first step is tosubmit a comprehensive report describing achieved research results and future plans. Realheart submitted this report in January and asked the administration for a meeting. Realheart was invited to a meeting in Washington DC on April 2 and the follow-up discussions have just recently been concluded. Among other things, animal studies,biocompatibility tests, endurance tests, blood tests, and clinical trials were discussed.

The discussion was conducted in a constructive spirit according to Realheart and led to the parties reaching agreement on all issues that were discussed.

“We see this as a very significant step. We now have an established roadmap for the future and feel vitalized by having even clearer goals to work towards. The FDA’s requirements so far are reasonable, and we look forward to new positive discussions going forward,” says Realheart´s CEO Azad Najar.