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Theradaptive gained approval from FDA for their Investigational Device Exemption submission to begin enrolling patients into OASIS, their global Phase I/II Feasibility study in spine fusion.
Theradaptive’s spinal fusion product, OsteoAdapt SP, aims to provide safer and more effective treatments for transforaminal lumbar interbody fusion. It is used for a range of conditions including degenerative disc disease, lumbar spondylolisthesis and spinal stenosis.
Theradaptive’s therapeutic platform aims to improve efficacy and safety by creating material-binding variants of recombinant proteins that bind to medical devices, implants and injectable carriers to achieve anatomically-precise and locally-sustained therapeutic delivery.
Starting in April, this study of 80 patients will assess the safety and efficacy of OsteoAdapt SP. The feasibility study will also identify the required OsteoAdapt SP dose that will be investigated in a future pivotal study.
Theradaptive’s path to FDA IDE approval has been aided by their unprecedented three Breakthrough Medical Device Designations which provide them with priority review and interactive communication regarding device development and clinical trial protocols.
John Greenbaum, SVP of Regulatory & Clinical Affairs at Theradaptive, said: “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 CEO and founder Luis Alvarez, PhD, 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.”
Source: Theradaptive
Theradaptive gained approval from FDA for their Investigational Device Exemption submission to begin enrolling patients into OASIS, their global Phase I/II Feasibility study in spine fusion.
Theradaptive’s spinal fusion product, OsteoAdapt SP, aims to provide safer and more effective treatments for transforaminal lumbar interbody fusion. It is...
Theradaptive gained approval from FDA for their Investigational Device Exemption submission to begin enrolling patients into OASIS, their global Phase I/II Feasibility study in spine fusion.
Theradaptive’s spinal fusion product, OsteoAdapt SP, aims to provide safer and more effective treatments for transforaminal lumbar interbody fusion. It is used for a range of conditions including degenerative disc disease, lumbar spondylolisthesis and spinal stenosis.
Theradaptive’s therapeutic platform aims to improve efficacy and safety by creating material-binding variants of recombinant proteins that bind to medical devices, implants and injectable carriers to achieve anatomically-precise and locally-sustained therapeutic delivery.
Starting in April, this study of 80 patients will assess the safety and efficacy of OsteoAdapt SP. The feasibility study will also identify the required OsteoAdapt SP dose that will be investigated in a future pivotal study.
Theradaptive’s path to FDA IDE approval has been aided by their unprecedented three Breakthrough Medical Device Designations which provide them with priority review and interactive communication regarding device development and clinical trial protocols.
John Greenbaum, SVP of Regulatory & Clinical Affairs at Theradaptive, said: “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 CEO and founder Luis Alvarez, PhD, 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.”
Source: Theradaptive
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
