Theradaptive, a Frederick-based biotechnology company specializing in therapeutic delivery platforms, Wednesday announced a $4 million Technology & Therapeutic Development Award (TTDA) from the Department of Defense through the Peer Reviewed Medical Research Program (PRMRP) of the Congressionally Directed Medical Research Programs (CDMRP).
The contract will fund its OsteoAdapt regenerative therapeutic product for spine and trauma repair to first in human clinical studies.
Theradaptive’s OsteoAdapt product was granted three breakthrough medical device designations by the U.S. Food and Drug Administration (FDA) in 2021 and 2022 for various spinal indications. OsteoAdapt is created by combining AMP2 protein, a novel bone regenerative biologic, with ReBOSSIS, a 510K-approved implant material. OsteoAdapt has the capability to precisely direct bone regrowth where it is needed in the body.
The funds from the DOD contract will enable Theradaptive to continue its work to meet regulatory requirements and scale up Good Manufacturing Practices-compliant manufacturing of the OsteoAdapt product in preparation for clinical studies. After a request for an Investigational Device Exemption (IDE) is submitted to the FDA for approval, Theradaptive will initiate human clinical trials.