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