FDA OKs Theradaptive’s spinal fusion trial

Regenerative therapeutics company Theradaptive has gained FDA approval to enroll patients in its Oasis spine fusion study. 

Advertisement

Theradaptive’s OsteoAdapt SP for spinal fusions aims to offer safer and more effective options for transforaminal lumbar interbody fusion procedures. 

It can treat degenerative disc disease, lumbar spondylolisthesis and spinal stenosis, according to a Feb. 1 press release. 

Theradaptive’s therapeutic platform creates material-binding variants of recombinant proteins that bind to medical devices, implants and injectable carriers to achieve anatomically precise and locally sustained therapeutic delivery.

Beginning in April, 80 patients will test the safety and efficacy of OsteoAdapt SP. The study will also identify the proper OsteoAdapt dose, which will be investigated in further studies. 

Theradaptive has earned three breakthrough medical device designations, which helped prioritize the company’s trial for FDA approval. 

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

Advertisement

Next Up in Spine

Advertisement

Comments are closed.