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

Therapeutic innovation is at the forefront of Theradaptive's mission, as evidenced by their recent FDA approval for a pivotal study on spinal fusion. The Maryland-based company, renowned for its targeted regenerative therapeutics, has received the green light to initiate a global Phase I/II trial for its flagship product, OsteoAdapt SP. This development comes in response to the growing need for effective treatments amidst an aging demographic, where spinal conditions are increasingly prevalent.

OsteoAdapt SP is designed to revolutionize transforaminal lumbar interbody fusion (TLIF) procedures, offering a minimally invasive approach to fusing vertebrae and addressing conditions such as degenerative disc disease and spinal stenosis. The product's innovative platform focuses on enhancing treatment efficacy and safety by utilizing recombinant proteins that adhere to medical devices, implants, and injectable carriers. This ensures precise, sustained therapeutic delivery tailored to the patient's anatomy.

The FDA's Investigational Device Exemption (IDE) approval is a significant milestone for Theradaptive, marking the transition into a clinical-stage entity. The upcoming trial, set to begin in April, will involve 80 patients and is expected to yield crucial data on the safety and efficacy of OsteoAdapt SP, as well as determine the optimal dosage for future pivotal studies.

Theradaptive's journey to FDA approval has been notably expedited by three Breakthrough Medical Device Designations, a testament to the technology's potential to transform current treatment paradigms. John Greenbaum, Senior Vice President of Regulatory and Clinical Affairs, highlighted the FDA's role in facilitating the development of groundbreaking medical devices like OsteoAdapt SP.

Dr. Brett Freedman, Chair of the Spine Surgery Division at Mayo Clinic, underscored the significance of the FDA's decision and the potential of OsteoAdapt SP to meet unmet needs in spinal fusion. Theradaptive's research is bolstered by support from the Department of Defense and the Maryland Stem Cell Research Fund, reflecting the product's promise in advancing medical care.

Beyond spinal applications, Theradaptive is exploring OsteoAdapt's potential in various fields, including trauma, orthopedics, and sports medicine. The company's CEO, Luis Alvarez, PhD, envisions a future where OsteoAdapt is integrated into 3D printed implants, a collaboration with 3D Systems, to develop regenerative solutions for cranial repair and sports medicine.

Founded in 2016, Theradaptive is a venture-backed enterprise committed to delivering biologics with precision and persistence, aiming to fulfill unmet medical needs across various therapeutic areas. The company's dedication to innovation is driving the development of new treatments in spine, orthopedics, and soft tissue repair, as well as targeted immuno-oncology.