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FDA Grants Theradaptive Breakthrough Medical Device Designation

You might have the best protein therapeutic on the market, but it will become nothing more than a dust collector on a shelf if it can’t successfully be delivered to the place in the body that needs it.

Frederick-based Theradaptive is developing exciting new ways to combat this problem and improve therapeutics delivery, which would enhance efficacy while reducing off-target side effects. The company’s unique approach was inspired by the needs of injured service members returning from combat, who would have delayed amputations weeks or even months after their initial injury.

Their innovative protein-engineering technology is able to convert recombinant proteins, which often do not have the most favorable drug characteristics, into variants that can bind more effectively to materials such as implants, devices, and injectable carriers. We’re thrilled to see that they have received Breakthrough Medical Device designation from the FDA, and look forward to seeing what else is in store.

Theradaptive, a privately held biopharmaceutical company pioneering a new class of regenerative implants announced that the U.S. Food and Drug Administration (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.

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