Sam Brusco05.23.24
Theradaptive was awarded funding from the Maryland Stem Cell Research Fund (MSCRF) to support human trials for its OsteoAdapt SP.
OsteoAdapt SP is currently in Phase I/II studies for transforaminal lumbar spinal interbody fusion (TLIF) for treatment of degenerative disc disease, spondylolisthesis, and retrolisthesis. The company received a $7.4 million clinical trial award from the U.S. Department of Defense in 2023 to help scale production of OsteoAdapt.
The company received an investigational device exemption (IDE) by the U.S. Food and Drug Administration (FDA) to initiate its human clinical trial in January 2024. The $1 million MSCRF award will allow Theradaptive to broaden its OASIS human clinical study to sites in Maryland.
Theradaptive possesses three breakthrough device designations for 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 Theradaptive founder and CEO Luis Alvarez, Ph.D. "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."
After successfully completing pivotal studies, the company said it plans to file for FDA marketing authorization. Clinical sites in the U.S. (including Maryland, now) and Australia are currently enrolling patients to investigate OsteoAdapt SP.
It combines the company’s proprietary AMP2 protein that activates a patient’s stem cells with a resorbable scaffold implant. The implant remodels into bone and resorbs. Theradaptive believes it will provoke the next generation of regenerative therapeutics by mitigating side effects and 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, Ph.D., Theradaptive’s VP 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."
Theradaptive was spun out of MIT in 2017 to commercialize a platform to immobilize therapeutic proteins on implantable biomaterials. Its near-term focus is regenerative treatments for musculoskeletal conditions and spinal fusion.
OsteoAdapt SP is currently in Phase I/II studies for transforaminal lumbar spinal interbody fusion (TLIF) for treatment of degenerative disc disease, spondylolisthesis, and retrolisthesis. The company received a $7.4 million clinical trial award from the U.S. Department of Defense in 2023 to help scale production of OsteoAdapt.
The company received an investigational device exemption (IDE) by the U.S. Food and Drug Administration (FDA) to initiate its human clinical trial in January 2024. The $1 million MSCRF award will allow Theradaptive to broaden its OASIS human clinical study to sites in Maryland.
Theradaptive possesses three breakthrough device designations for 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 Theradaptive founder and CEO Luis Alvarez, Ph.D. "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."
After successfully completing pivotal studies, the company said it plans to file for FDA marketing authorization. Clinical sites in the U.S. (including Maryland, now) and Australia are currently enrolling patients to investigate OsteoAdapt SP.
More about OsteoAdapt SP
The biologic-enhanced implant stimulates anatomically precise local bone growth and promotes rapid fusion after spinal surgery.It combines the company’s proprietary AMP2 protein that activates a patient’s stem cells with a resorbable scaffold implant. The implant remodels into bone and resorbs. Theradaptive believes it will provoke the next generation of regenerative therapeutics by mitigating side effects and 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, Ph.D., Theradaptive’s VP 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."
Theradaptive was spun out of MIT in 2017 to commercialize a platform to immobilize therapeutic proteins on implantable biomaterials. Its near-term focus is regenerative treatments for musculoskeletal conditions and spinal fusion.