Short-term, Carmell plans to build on the success of Pilot (Phase II) study for long bone fractures conducted in South Africa. This study showed a statistical reduction in bone healing time, wound healing time and infection rates versus the control. Carmell™ has received IND (Investigational New Drug) clearance from FDA to conduct a pivotal study in long bone fracture. FDA also granted expedited review (Fast Track) for this lead program. The next step is to conduct a Pivotal (Phase II/III) study that, along with the data from the Pilot Study, will be used for regulatory approval in the US and in the Europe Union. In the EU, the first product, Bone Healing Accelerant (BHA), is expected to be approved via CE Mark, as a Class III Medical Device with a label as a bone void filler with the ability to accelerate and enhance healing. The broad label will allow for early experience in long-bone fracture, spine fusion and dental bone healing as a primary product or adjunct to other bone void fillers.
This first indication of Bone Healing Accelerant will be the first step in the journey to realize Carmell’s vision – To create a world class regenerative medicine company delivering biologic solutions in multiple therapeutic areas with high regulatory rigor and substantial clinical evidence that accelerates healing and reduces infections.
Carmell plans to immediately pursue an IND to begin a Phase II Randomized Clinical Trial for the accelerated regrowth of dental bone using the same formulation as the current IND for long bone fracture. All of the products and programs that Carmell intents to pursue will utilize the same active ingredient that has already been cleared for a pivotal study.