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. The next step is to conduct a Pivotal (Phase III) study that, along with the data from the Pilot Study, will be used for regulatory approval in the US for use in long bone fractures.
This first indication of REPAIR™ Putty will be the first step in the journey to realize Carmell’s vision – to be the leading biosurgical platform technology company focused on improving the healing process across aspects of medicine where unmet needs exist.
In parallel with the Pivotal trial, Carmell will conduct pre-clinical studies to gain validation for additional indications and applications for advancement as a platform technology. Carmell will also be taking a systematic approach to building a robust quality management system that will ensure successful and timely regulatory approvals as well as be considered a significant company asset.