June 30, 2021
THERADAPTIVE: shaping the future of regenerative medicine at military treatment facilities
The Geneva Foundation released a case study highlighting their work with FITCI member, Theradaptive.
Theradaptive is shaping the future of regenerative medicine with a new platform to deliver therapeutics that promote targeted native tissue repair. Their lead therapeutic, AMP2, is applied to an orthopedic implant to regenerate damaged bone, therefore significantly helping to speed up the injury healing process. For service members with combat trauma this can mean the difference between amputation and limb preservation.
Geneva, a 501(c)3 non-profit organization that advances military medicine through innovative scientific research, exceptional program management, and a dedication to U.S. service members and veterans, their families, and the global community, set the foundation for the development of this technology by fast-tracking the R&D development and regulatory milestones. Geneva Program Manager Linzie Wagner said, “Partnering with Theradaptive to accelerate their technology’s development to various platforms was an important step for them. Geneva was able to leverage its expertise in DoD advanced technology development and identify turnkey applications and opportunities to thrust this product forward, bringing it one step further to first in human and ultimately the Warfighter.”
The technology has demonstrated superiority over standard of care in all preclinical studies conducted to date, including studies at the Cleveland Clinic and Mayo Clinic, where scientists were able to correct a bone defect about 5 centimeter (2 inch). In 2020, Theradaptive opened an R&D facility in Frederick, Maryland, expanding capabilities in therapeutic manufacturing, implant design, and additive manufacturing of medical implants. The company is establishing cGMP manufacturing capabilities to produce therapeutics able to enter clinical trials in late 2022.Theradaptive was also able to leverage funds provided by DoD contracts to further preclinical development. The company was the recipient of the 2018 and 2019 Maryland Stem Cell Research Fund Commercialization Grant and was named a finalist for the 2018 First Coast Innovation Challenge. The company was also selected for contract award under the Advanced Regenerative Manufacturing Institute (ARMI) BioFabUSA program.
Theradaptive has developed a platform technology that enables the conversion of therapeutic proteins into variants that bind to implants very tightly, supporting healing in tissues like bone and cartilage in extremities to avoid amputation. The technology can also be applied to any recombinant protein, thus enabling long-term, localized therapeutics for cancer treatment, vascular, dermal, or cartilage repair. Theradaptive received federal phase II funding under the Defense Health Agency's Small Business Innovation Initiative Research Program and has a partnership on two DoD contracts valued at over $5.2M to develop next-generation 3D-printed regenerative spinal fusion devices.
Theradaptive, Inc., is a privately held biotechnology company focused on regenerative medicine technology, and on getting their therapeutic platform into the clinic since 2017.