FDA Approves Theradaptive IDE Phase I/II Clinical Trials

Theradaptive, target regenerative therapeutic company, has gained FDA approval for their Investigational Device Exemption (IDE) submission to being their global Phase I/II Feasibility study in spine fusion.
 
The study will begin in April containing 80 patients to assess the safety and efficacy of Theradaptive’s OsteoAdapt SP spinal fusion product. The study will identify the required OsteoAdept SP does as well as produce early interim data to permit interim assessments of safety and efficacy. 
 
OsteoAdapt SP is designed to provide safe and effective treatments for transforaminal lumbar interbody fusion (TLIF) procedures, where vertebrae in the lower back as fused in a minimally invasive posterior procedure. This surgery is used for spinal stenosis, degenerative disk disease, lumbar spondylolysis, and other conditions. 
 
Theradaptive’s platform aims to create material-binding variants of recombinant proteins that bind to medical devices, injectable carriers, and implants for anatomically precise and locally sustained therapeutic delivery. 
 
The IDE approval is a key milestone for OsteoAdapt SP, generating its first human clinical data. 
 
John Greenbaum, SVP of Regulatory & Clinical Affairs at Theradaptive, told the press: “The FDA created Breakthrough Device Designations to accelerate the clinical trials and approval processes for devices that promise to improve on current treatments for life-threatening and debilitating conditions. The fact that OsteoAdapt has been awarded three Breakthrough Device Designations is an indicator of the ground-breaking nature of the technology. The FDA has extensive experience with rh-BMP2, which was used to design the AMP2 biologic within OsteoAdapt. Based on the safety profile of OsteoAdapt, we will be allowed to combine Phase I and II trials. We can now apply these insights to our other programs in dental, orthopedics, and sports medicine.”
 
Theradaptive’s gained its IDE approval with help from thier three Breakthrough Medical Device Designations.
 
Company founder and CEO Luis Alvarez, commented on synergies with these other programs: “Advancing OsteoAdapt into the clinic under this IDE will also enable acceleration of partnered programs that use OsteoAdapt as a component. One key example is our partnership with 3D Systems where we are developing products that incorporate OsteoAdapt in 3D printed implants using our OrthoTex 3D printable graft containment system. This accelerates the development of truly regenerative 3D printed implants for applications in cranial repair and sports medicine.”