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Theradaptive announced a Technology & Therapeutic Development Award of $4 million from the U.S. Department of Defense. 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 for various spinal indications. OsteoAdapt is created by combining AMP2 protein, a novel bone regenerative biologic, with ReBOSSIS, a 510(k)-cleared implant material. OsteoAdapt has the capability to precisely direct bone regrowth where it is needed in the body.
The funds from the 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 is submitted to the FDA for approval, Theradaptive will initiate human clinical trials.
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.”
Source: Theradaptive
Theradaptive announced a Technology & Therapeutic Development Award of $4 million from the U.S. Department of Defense. 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...
Theradaptive announced a Technology & Therapeutic Development Award of $4 million from the U.S. Department of Defense. 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 for various spinal indications. OsteoAdapt is created by combining AMP2 protein, a novel bone regenerative biologic, with ReBOSSIS, a 510(k)-cleared implant material. OsteoAdapt has the capability to precisely direct bone regrowth where it is needed in the body.
The funds from the 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 is submitted to the FDA for approval, Theradaptive will initiate human clinical trials.
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.”
Source: Theradaptive
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
