Theradaptive, a biopharma company developing a new class of regenerative implants, has earned U.S. Food and Drug Administration (FDA) breakthrough status for OsteoAdapt SP in anterior lumbar interbody fusion (ALIF).
 
This is the company’s third breakthrough designation in spinal fusion, along with transforaminal interbody and posterolateral fusion. It allows Theradaptive to address over 90% of lumbar spinal procedures.
 
The regenerative implants foster precise and directed tissue regeneration for a variety of tissue types and indications.
 
“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.” Dr. Jay Jolley, founder of Southeastern Spine, Brain and Joint and the Riverfront Surgery Center told the press.
 
“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,” added John Greenbaum, senior VP of clinical and regulatory affairs at Theradaptive.