Carmell’s Product Pipeline
Both Product Candidates use the same Drug Substance
BHA designated as combination product (Plasma-based Bioactive Material & βTCP) regulated as a biologic in the US and is designated as a Class III Medical Device in the EU.
THA is a similar formulation to BHA minus the βTCP and is regulated as a biologic in the US.
Note: Gray arrow designates “to be confirmed with regulatory body interaction”
*HEAL II is powered to demonstrate superiority vs. standard of care and could potentially serve as one of the two pivotal clinical studies needed for BLA approval in the US.