Theradaptive Inc., a regenerative medicine company developing targeted therapeutics, Wednesday was awarded $1 million 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) inJanuary by the U.S. Food and Drug Administration (FDA) to begin its human clinical trial. The award from the MSCRF Clinical Program will enable Theradaptive to expand its OASIS human clinical study to sites inMaryland.

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 patients 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.

The company was spun out of theMassachusetts Institute of Technologyin 2017 to commercialize a platform that immobilizes therapeutic proteins on implantable biomaterials. The companys 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 in Maryland and across the United States and inAustralia.

Theradaptive plans to file for marketing authorization with the U.S. Food and Drug Administration following successful completion of pivotal clinical studies.

View post:
Frederick biotech Theradaptive secures $1M in funding from MD Stem Cell Research Fund for human clinical trials - Maryland Daily Record