Michael Barbella, Managing Editor05.23.23
Theradaptive has been granted a $4 million Technology & Therapeutic Development Award (TTDA) 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.
Theradaptive’s OsteoAdapt product has received three breakthrough medical device designations from 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, an FDA 510(k)-approved implant material. OsteoAdapt has the capability to precisely direct bone regrowth where it is needed in the body.
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.
“This award affirms Theradaptive’s rapid and successful execution of earlier stage programs funded by the Department of Defense, and provides funding crucial to advance a new kind of therapeutic that upon FDA approval will address massive unmet needs among aervice members, veterans, and in the general population,” Theradaptive Founder/CEO Luis Alvarez, Ph.D., said. “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 therapy to patients who need it most.”
Theradaptive’s OsteoAdapt, powered by a proprietary AMP2 biologic, has beaten the standard of care in all preclinical studies to date. The DoD funding will help the company further develop OsteoAdapt and provide a surgical option for those with degenerative or traumatic spinal, extremity, craniomaxillofacial, and dental injuries. Thirty-seven percent of adults over the age of 30 and over 80% of adults over the age of 50 have at least one degenerated vertebral disc.
“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," stated Dr. Leon J. Nesti, a surgeon at Walter Reed National Military Medical Center. "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, Theradaptive is a venture-backed company aiming to ldeliver biologics where they are needed in the body with high precision and persistence to address unmet medical needs. Its 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).
Theradaptive’s OsteoAdapt product has received three breakthrough medical device designations from 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, an FDA 510(k)-approved implant material. OsteoAdapt has the capability to precisely direct bone regrowth where it is needed in the body.
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.
“This award affirms Theradaptive’s rapid and successful execution of earlier stage programs funded by the Department of Defense, and provides funding crucial to advance a new kind of therapeutic that upon FDA approval will address massive unmet needs among aervice members, veterans, and in the general population,” Theradaptive Founder/CEO Luis Alvarez, Ph.D., said. “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 therapy to patients who need it most.”
Theradaptive’s OsteoAdapt, powered by a proprietary AMP2 biologic, has beaten the standard of care in all preclinical studies to date. The DoD funding will help the company further develop OsteoAdapt and provide a surgical option for those with degenerative or traumatic spinal, extremity, craniomaxillofacial, and dental injuries. Thirty-seven percent of adults over the age of 30 and over 80% of adults over the age of 50 have at least one degenerated vertebral disc.
“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," stated Dr. Leon J. Nesti, a surgeon at Walter Reed National Military Medical Center. "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, Theradaptive is a venture-backed company aiming to ldeliver biologics where they are needed in the body with high precision and persistence to address unmet medical needs. Its 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).
