Britecyte’s adipose tissue allograft earns FDA “Safe to Proceed” status

Amarex announced that work on behalf of Britecyte resulted in a “safe to proceed” status from the U.S. Food and Drug Administration (FDA) for Britecyte’s Adipose Tissue Allograft (BRC-OA).

BRC-OA is intended for the treatment of osteoarthritis (OA). OA affects over 30 million people and is the most common cause of disability in adults.

“Regenerative medicine products may provide renewed hope for patients to walk without pain,” said Alla Danilkovitch, Founder and Chief Scientific Officer of Britecyte. “Our collaboration with Amarex has resulted in the successful initiation of the clinical phase for our development program.”

Potential BRC-OA benefits highlighted in the announcement include on-demand availability, prolonged storage, minimally invasive injection, no matching or immunosuppression required, and a robust manufacturing and testing process.