Theradaptive Awarded DOD Clinical Trial Award

Theradaptive was awarded a U.S. Department of Defense (DOD) Clinical Trial Award of up to $7.4 million with options, subject to FDA approval to begin phase I/II clinical studies. 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.

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.

FDA has already granted Theradaptive three Breakthrough Medical Device designations.

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.”

Source: Theradaptive