FITCI Grad builds upon an unprecedented three Breakthrough Medical Device designations by the FDA
Theradaptive, a leading biopharmaceutical company using protein engineering to create targeted therapeutics, has been awarded a U.S. Department of Defense (DOD) Clinical Trial Award of up to $7.4M with options, subject to FDA approval to begin phase I/II clinical studies. Awarded through the DOD’s Peer Reviewed Medical Research Program (PRMRP), the award recognizes the scientific merit of Theradaptive’s work in targeted regenerative therapeutics to create safer and more efficacious treatments for patients with conditions such as spinal degenerative disc disease, orthopedic trauma, and craniomaxillofacial and dental repair.
The Clinical Trial Award is aimed at providing assistance to companies implementing clinical trials for biologics or medical devices focused on improving the patient outcomes of military service members and veterans. This award will help Theradaptive scale up the production of its OsteoAdapt regenerative therapeutic product for spine and trauma repair and will become clinically available upon initiation of first in human clinical trials in early 2024.
The FDA has already granted Theradaptive an unprecedented three Breakthrough Medical Device designations, accelerating the approval process of their products. Since its establishment, Theradaptive has leveraged its rapid progress, also receiving multiple grants and awards from the DOD. Through his research at MIT, Theradaptive’s founder and CEO, Luis Alvarez, set out to develop ultra-persistent local delivery of therapeutics to regenerate bone and other tissues after witnessing first-hand the problem of delayed amputation in veterans following traumatic injury. In 2021, 67% of military veterans with service-related injuries had musculoskeletal injuries. Theradaptive’s technology promises to elevate the standard of care for patients suffering from degenerative or traumatic spinal, extremity, and craniomaxillofacial injuries. However, Theradaptive’s ability to convert recombinant proteins into material-binding variants gives their technology broad applicability across a host of clinical indications outside of orthopedics, including targeted immuno-oncology therapeutics.
Commenting on the award, Theradaptive CEO and founder, Luis Alvarez, Ph.D. said, “The CDMRP Clinical Trial Award comes at a pivotal time for our company as we prepare for first in human clinical trials. Veterans and service members are disproportionally likely to suffer from traumatic extremity injuries or spinal degeneration and disc injury, and currently lack efficacious treatments with very few options. We have already demonstrated superior outcomes in preclinical studies, showing the promise of our technology. With this CTA award we are one step closer to providing new and improved therapies to patients and aligning with CDMRP’s strategic goal of trying to increase post-injury quality of life by halting or slowing orthopedic disease progression in servicemembers and veterans.”
Dr. Brett Freedman, Orthopedic Surgeon and Head of Spine Surgery at Mayo Clinic, said, “Theradaptive is addressing significant unmet needs with their regenerative therapeutics, and this award shows the US Government resolutely recognizes this. The company’s game-changing treatments are enhancing therapeutic performance and providing patients with more effective solutions. Their safe and precise therapeutic delivery platform promises to revolutionize the orthopedics industry and make a significant positive impact to millions of lives.”
About Theradaptive
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 was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $7.4m, through the Peer Reviewed Medical Research Program under Award No. (HT9425-23-1-0693). Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense.
Contact: Marcus McCabe, marcus@flamepr.com
SOURCE Theradaptive
