FREDERICK, Md., May 22, 2024 /PRNewswire/ — Theradaptive, Inc., a regenerative medicine company developing targeted therapeutics, announced today it has been awarded funding from the Maryland Stem Cell Research Fund (MSCRF) to support human clinical trials for its lead product, OsteoAdapt SP. OsteoAdapt SP is currently in Phase I/II clinical studies for transforaminal lumbar interbody spinal fusion (TLIF) to treat degenerative disc disease, spondylolisthesis, and retrolisthesis.
Theradaptive was granted an Investigational Device Exemption (IDE) in January 2024 by the U.S. Food and Drug Administration (FDA) to begin its human clinical trial. This $1 million award from the MSCRF Clinical Program will enable Theradaptive to expand its OASIS human clinical study to sites in Maryland. More details can be found at ClinicalTrials.gov: identifier NCT06154005. Theradaptive also holds three Breakthrough Medical Device designations for various spine indications including TLIF, ALIF, and PLF.
“We are so grateful to the Maryland Stem Cell Research Fund for this generous support as we take OsteoAdapt SP through clinical development,” said Luis Alvarez, PhD, CEO and Founder of Theradaptive. “This grant will expand our ability to provide patients with limited options a much better alternative by accelerating the development of this ground-breaking technology.”
How OsteoAdapt SP is changing biologic implants
OsteoAdapt SP is a biologic-enhanced implant designed to stimulate anatomically precise local bone growth and promote rapid fusion following spinal surgery. It combines a proprietary protein called AMP2 that activates a patient’s own stem cells with a resorbable scaffold implant. This implant remodels into bone and completely resorbs, leaving no trace behind. This technology ushers in the next generation of regenerative therapeutics compared to the current standard of care by mitigating side effects and significantly improving safety and efficacy over traditional bone grafts and biologics.
“This funding will benefit us greatly as we work toward making this revolutionary therapy available to patients in need, putting Maryland at the forefront of innovation in regenerative bone repair” said Jonathan Elsner, PhD, Vice President of Clinical Operations. “We appreciate that MSCRF recognizes the importance of this program and look forward to dosing the first patient in the coming months.”
“Our goal is to accelerate the development of promising technologies by providing funding to help them reach patients as quickly as possible,” said Ruchika Nijhara, Executive Director of MSCRF. “We are enthusiastic about the potential of OsteoAdapt SP to benefit patients suffering from debilitating spine conditions.”
Theradaptive was spun out of the Massachusetts Institute of Technology in 2017 to commercialize a platform that immobilizes therapeutic proteins on implantable biomaterials. The company’s near-term focus is on regenerative treatments for musculoskeletal conditions and spinal fusion surgery.
Clinical sites investigating OsteoAdapt SP in TLIF procedures are currently enrolling patients across the U.S., including Maryland, and in Australia.
Theradaptive plans to file for marketing authorization with the U.S. Food and Drug Administration following successful completion of pivotal clinical studies.
About Theradaptive
Theradaptive, Inc. is a privately held regenerative medicine company developing therapeutic implants that harness the body’s own stem cells to regenerate tissues. The company’s proprietary AMP2 technology platform enables localized, sustained delivery of therapeutic proteins to trigger highly targeted regenerative responses.
Theradaptive’s lead clinical program, OsteoAdapt SP, is an investigational bone graft material designed to improve spinal fusion outcomes. For more information, visit www.theradaptive.com.
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SOURCE Theradaptive
