FREDERICK, Md., Dec. 10, 2024 /PRNewswire/ -- Theradaptive, a privately held, clinical stage biologics company developing protein therapeutics for spine, orthopedics, soft tissue repair, and targeted immuno-oncology, announced today that the US Food and Drug Administration (FDA) has approved an expansion to its Phase I/II clinical program, broadening it to include three spinal fusion indications and tripling the number of investigational sites in the US.

The OASIS trial was approved by the FDA earlier this year to assess the safety and efficacy of OsteoAdapt™ SP, Theradaptive's implant with targeted biologics to treat degenerative disc disease, in a transforaminal interbody fusion (TLIF) approach. The recent approval encompasses two other common spinal fusion approaches: anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion (LLIF). The company anticipates enrollment of its first ALIF and LLIF study subjects in early 2025.

Emmes®, part of Emmes Group®, a leading specialty tech and AI-enabled global contract research organization (CRO), today announced the appointment of Bryan Patterson to the newly created role of Senior Vice President, Government Business Development & Capture. This strategic expansion of Emmes’ leadership team underscores the company’s commitment to the U.S. Federal Government clinical research efforts, and to exceed expectations, drive innovation, and deliver even greater value.