Theradaptive Wins Additional FDA Breakthrough Designation for Spinal Fusion
FREDERICK, Md. and BOSTON, Feb. 15, 2022 /PRNewswire/ — Theradaptive, a privately held biopharmaceutical company pioneering a new class of regenerative implants announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Medical Device designation for its OsteoAdapt SP Spinal Fusion implant indicated for posterolateral spinal fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis. This is the second Breakthrough Designation for Theradaptive in spinal fusion.
The Breakthrough Devices Program is a program for select medical devices that provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Theradaptive with priority review and interactive communication regarding device development and clinical trial protocols during the premarket review process.
“This is an important development and the potential for patients is significant. Gaining a Breakthrough Designation from the FDA for posterolateral fusion is a strong indication of the promise of this approach. The expansion into additional indications for spine expands access to a wider potential patient population,” said Dr. Mark Shasti of Inova Loudoun Hospital.
Theradaptive’s regenerative implants are best-in-class and are designed to permit precise tissue regeneration for a variety of tissue types and clinical indications. This new technology enables superior outcomes and safety, and greatly improved ease of use.
“This is Theradaptive’s second Breakthrough designation from the FDA in four months and expands our portfolio into the posterolateral fusion approach. This significantly increases the number of patients who can potentially benefit from this game-changing device,” said John Greenbaum, Senior Vice President of Clinical & Regulatory Affairs at Theradaptive.
About Precision Regenerative Implants
As of 2021 there are no precision regenerative implants available to treat spinal fusion, orthopedic repair, or craniomaxillofacial repair. The current state of the art is based on technology that is over 20 years old and has several serious safety issues. The annual cost of revision procedures in these clinical areas represents a significant burden to the healthcare system.
Theradaptive is a venture-backed biopharmaceutical company developing a therapeutic delivery platform technology for targeted tissue regeneration with a total addressable market of over $10B in several clinical indications. Theradaptive was spun out of the Massachusetts Institute of Technology and has received significant research and development support from the US Department of Defense. Theradaptive has operations in Frederick, MD and Boston, MA.