FDA Grants Breakthrough Device Status to Theradaptive

By Julie A. Vetalice

FDA Grants Breakthrough Device Status to Theradaptive

Theradaptive announced that FDA has granted Breakthrough Medical Device designation to its Osteo-Adapt SP Spinal Fusion implant indicated for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, spondylolisthesis or retrolisthesis.

Theradaptive's regenerative implants are designed to permit precise tissue regeneration for a variety of tissue types and clinical indications. The new technology enables superior outcomes and safety, and greatly improved ease of use.

"This designation is a major milestone for Theradaptive as we aspire to change the practice of medicine by enabling precise tissue regeneration in a way that was not previously possible. This opens the door to entirely new treatments for conditions that currently have very few options," said John Greenbaum, Senior Vice President of Clinical & Regulatory Operations at Theradaptive.

In early 2021, the company closed a $6.2 million Series A investment round, bringing its total investment to $17.4 million to date. The funding will support the launch of Theradaptive’s lead biologic, AMP2, into clinical trials in 2022 and will propel the development of new therapeutics through the company’s proprietary protein engineering platform. AMP2 is designed for highly targeted delivery and has the potential to transform the treatment of orthopedic injuries and spinal fusion.

Source: Theradaptive

Product Labels: Lumbar Spine, Spinal Fusion

Tags: Regulatory