Theradaptive, a leading biotechnology company specializing in therapeutic delivery platforms, announced today that it has received a $4 million Technology & Therapeutic Development Award (TTDA) from the United States Department of Defense (DOD) through the Peer Reviewed Medical Research Program (PRMRP) of the Congressionally Directed Medical Research Programs (CDMRP). The contract will fund the first human clinical trials of its OsteoAdapt regenerative therapeutic product for spine and trauma repair.
Theradaptive’s OsteoAdapt product has been granted three breakthrough medical device designations by the US Food and Drug Administration (FDA) for various spinal indications in 2021 and 2022. OsteoAdapt was developed by combining AMP2, a novel bone regenerative biologic, with ReBOSSIS, a 510K-approved implant material. OsteoAdapt can precisely direct bone regrowth where it is required in the body.
The funds from the DOD contract will allow Theradaptive to continue its efforts to meet regulatory requirements and scale up GMP-compliant manufacturing of the OsteoAdapt product in preparation for clinical trials. Theradaptive will begin human clinical trials after submitting a request for an Investigational Device Exemption (IDE) to the FDA for approval.
In all preclinical studies to date, Theradaptive’s OsteoAdapt, powered by their proprietary AMP2 biologic, has outperformed the standard of care. The DOD funding will allow the development of OsteoAdapt, as well as the promise of life-changing surgery for Service Members and civilians suffering from degenerative or traumatic spinal, extremity, craniomaxillofacial, and dental injuries.
CEO and founder of Theradaptive, Dr. Luis Alvarez, Ph.D., believes the funding is a major step towards clinical trials: “This award affirms Theradaptive’s rapid and successful execution of earlier stage programs funded by Department of Defense, and provides funding crucial to advance a new kind of therapeutic that upon FDA approval will address massive unmet needs among Service Members, Veterans, and in the general population.”
Founded in 2016 and headquartered in Maryland, U.S., Theradaptive is a venture-backed biopharmaceutical company with the goal of leveraging their therapeutic delivery platform that can deliver biologics where they are needed in the body with high precision and persistence to address unmet medical needs. Theradaptive is led by CEO Luis Alvarez, Ph.D., and its innovative platform has started to enable new therapeutics in spine, orthopedic and soft tissue repair as well as targeted immuno-oncology.
