Theradaptive Secures Third FDA Breakthrough Designation for Spinal Fusion
FREDERICK, Md. and BOSTON, June 22, 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 the use of OsteoAdapt SP in Anterior Lumbar Interbody Fusion. This is the third Breakthrough Designation for Theradaptive in spinal fusion, along with transforaminal interbody and posterolateral fusion, allowing it to address over 90% of lumbar spinal fusion procedures.
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. Expedited review of the PMA is included as a benefit.
“Evidenced by this being the third Breakthrough Designation awarded by FDA to Theradaptive for this technology, there is a significant need for it in the bone grafting space. I see immense opportunity and advantages to the utility of OsteoAdapt SP in ALIF indications. It is exciting to explore the potential advantages of this new product compared to current commercial offerings.” said Dr. Jay Jolley, the founder of Southeastern Spine, Brain and Joint and the Riverfront Surgery Center in Chattanooga, TN.
Theradaptive’s regenerative implants are best-in-class and are designed to permit precise and directed tissue regeneration for a variety of tissue types and clinical indications. This new technology can enable superior outcomes and safety as well as greatly improved ease of use.
“This is Theradaptive’s third Breakthrough designation from the FDA and broadens our portfolio of spinal fusion approaches. This significantly increases the number of patients who can potentially benefit from this game-changing technology. Theradaptive has now been granted Breakthrough Status on three indications for use. No other orthopedic manufacturer has achieved this” said John Greenbaum, Senior Vice President of Clinical & Regulatory Affairs at Theradaptive.
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, Orlando, FL, Tennessee, and Boston, MA.
For more information on Theradaptive, please visit https://www.theradaptive.com
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