Carmell Therapeutics was granted Fast Track designation by FDA for the company’s Bone Healing Accelerant (BHA). Expedited review allows for more frequent meetings with FDA and rolling review for a Biologic License Application (BLA). Rolling review allows for a shorter period of time for approval after a clinical trial is complete.
At the close of 2019, FDA cleared the company's Investigational New Drug application for the BHA. This clearance enables Carmell to begin enrolling patients in a pivotal study for long bone fractures to support a BLA.
Carmell Therapeutics’ Plasma-based Bioactive Materials technology platform can be delivered in multiple formats to the site of injury – from putties to pastes to surgical screws. Carmell currently has two PBM products in development – a Bone Healing Accelerant and a Tissue Healing Accelerant.
“Carmell Therapeutics is now on a path to be the first company in the bone healing space with a BLA supported by two prospective, randomized, multicenter clinical studies demonstrating superiority to the current standard of care,” said Donna Godward, Carmell Therapeutics’ Chief Quality Officer.
Randy Hubbell, CEO of Carmell Therapeutics, described for ORTHOWORLD the company’s proprietary process as a regenerative medicine company, and mapped out their regulatory approach.