FDA Approves Theradaptive's IDE for Phase I/II Spinal Fusion Trials

Therapeutic company Theradaptive, renowned for its targeted regenerative treatments, has received approval from the U.S. FDA to initiate a global Phase I/II study for its spinal fusion product, OsteoAdapt SP. This approval comes amidst a growing need due to an aging population that frequently experiences spinal issues. The product is designed to enhance the safety and efficacy of transforaminal lumbar interbody fusion (TLIF) procedures, which are used to treat conditions such as degenerative disc disease and spinal stenosis.
Theradaptive's innovative approach involves the development of recombinant proteins that can bind to medical devices, implants, and injectable carriers, ensuring precise and sustained therapeutic delivery. The FDA's approval is a significant step for the company, marking the beginning of its transition into a clinical-stage entity. The study, set to start in April, will involve 80 patients and will not only evaluate the product's safety and efficacy but also determine the optimal dosage for future pivotal trials. Early results will be available for interim assessments, with further information accessible through ClinicalTrials.gov under the identifier NCT06154005.
The FDA's decision to approve the IDE was facilitated by three Breakthrough Medical Device Designations granted to Theradaptive, a distinction that expedites the review and development process for potentially transformative medical devices. John Greenbaum, SVP of Regulatory & Clinical Affairs at Theradaptive, highlighted the significance of these designations and the technology's potential impact on various medical fields.
Dr. Brett Freedman of the Mayo Clinic's Spine Surgery Division echoed the optimism, noting that OsteoAdapt SP has outperformed current standards in preclinical studies and holds promise for spinal fusion patients. Theradaptive's research is partially funded by the Department of Defense and the Maryland Stem Cell Research Fund, and the company is also developing OsteoAdapt-based products for other areas, including trauma, orthopedics, and sports medicine.
Theradaptive's CEO, Luis Alvarez, PhD, also mentioned a partnership with 3D Systems to integrate OsteoAdapt into 3D printed implants, aiming to create innovative regenerative implants for cranial repair and sports medicine applications. The company, established in 2016 and based in Maryland, is dedicated to addressing unmet medical needs through its precise therapeutic delivery platform, with ongoing development in various medical sectors, including immuno-oncology. The Assistant Secretary of Defense for Health Affairs has endorsed their work with a substantial grant, emphasizing the importance of their research.

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