Theradaptive, a biotechnology company specializing in therapeutic delivery platforms, received a Technology & Therapeutic Development Award (TTDA) of $4 million from the U.S. 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 company’s OsteoAdapt regenerative therapeutic product for spine and trauma repair to first in human clinical studies.

“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,” said Luis Alvarez, CEO Theradaptive.

“We understand the challenges that many service members face, particularly when traumatic extremity injuries progress to limb amputation or when years of physical activity lead to spinal degeneration, disc injury, and pain,” said Alvarez.

Alvarez noted that the support provided by the DOD contract will accelerate the completion of product development milestones that will allow Theradaptive to reach clinical trials faster and get the company one step closer to providing this game-changing therapy to patients who need it most.

Theradaptive’s OsteoAdapt product was granted three breakthrough medical device designations by the U.S. 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 GMP-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.

The company said that its Theradaptive’s OsteoAdapt, powered by their proprietary AMP2 biologic, has beaten the standard of care in all preclinical studies to date.