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Ventris Medical Secures 510(k) Additional Clearance for Amplify® Standalone Bone Graft Putty

Thursday, March 14, 2024

Ventris Medical, a privately owned company specializing in orthobiologics and tissue regeneration, has announced today that the United States Food and Drug Administration has granted 510(k) clearance for the use of their Synthetic Bone Graft Putty (Amplify®) in the intervertebral disc space. Amplify® is a novel synthetic biomaterial designed to enhance cell proliferation and bone formation. It consists of biphasic (HA/βTCP) ceramic granules suspended in a polymer carrier. The device can be used alone or in combination with autograft bone as a bone graft extender, with a ratio of 1:1.

To improve its remodeling potential, the surface of the Amplify® granules undergoes a patented activation process, creating a network of microfilaments that enhances cellular processes. This advanced surface texture increases surface area, porosity, and dissolution rate, promoting cellular attachment, proliferation, and remodeling.

Amplify® features a bimodal dissolution profile, with granules composed of two distinct HA-to-βTCP blends that resorb at different rates. This profile supports early-stage healing and progressive bone remodeling throughout the fusion process.

The proprietary polymer blend in Amplify® forms a moldable matrix between the granules, facilitating accurate graft placement and containment. After implantation, the polymer resorbs into surrounding tissues, allowing access to the activated biphasic granules and their healing effects.

This FDA clearance marks a significant milestone for Ventris Medical, paving the way for future product developments and establishing the company as an innovator in the orthobiologics field.


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