FREDERICK, Md., March 1, 2023 /PRNewswire/ — Today, Theradaptive, a leading biotechnology company specializing in therapeutic delivery platforms, announces a Technology & Therapeutic Development Award (TTDA) of $4 million from the U.S. Department of Defense (DOD) awarded 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.
Theradaptive’s OsteoAdapt, powered by their proprietary AMP2 biologic, has beaten the standard of care in all preclinical studies to date. The DOD funding will enable the development of OsteoAdapt and the promise of life-changing surgery for Service Members and civilians with degenerative or traumatic spinal, extremity, craniomaxillofacial, and dental injuries. 37% of adults over the age of 30 and over 80% of adults over the age of 50 have at least one degenerated vertebral disc.
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.”
“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. The support provided by this contract will accelerate the completion of product development milestones that will allow Theradaptive to reach clinical trials faster and get us one step closer to providing this game-changing therapy to patients who need it most.”
Dr. Leon J. Nesti, a surgeon at the Walter Reed National Military Medical Center offers additional perspective: “Starting from early inspiration from Luis’s military career, Theradaptive has made significant progress in developing a regenerative technology that has now been demonstrated for orthopedic repair. Their technology offers a transformative approach to address medical challenges through regenerative mechanisms that stimulate stem cells, including the potential to restore patients’ quality of life by accelerating the process of bone regeneration. This technology is one of the few that addresses the stem cell niche directly by delivering growth factors to those stem cells. This work will have a large scientific impact and will benefit Service Members and Veterans.”
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.
This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Congressionally Directed Medical Research Programs under Award No. (W81XWH-22-1-0875) for an amount of $3,979,465.00. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.