Ventris Medical recently received FDA 510(k) clearance for its Amplify standalone bone graft putty in the intervertebral disc space.
The Newport Beach, California-based company designed Amplify to optimize cell proliferation and bone formation. It comprises the Amplify biphasic (HA-to-βTCP) ceramic granules suspended in an alkaline oxide polymer carrier. It can be used standalone or combined with autograft bone as a bone graft extender.
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“We are very pleased to receive FDA clearance for Amplify Synthetic Bone Graft Putty for the intervertebral disc space. This technology combines 2 heavily studied biphasic mineral components, which are surface activated through our patented process and suspended in our proprietary polymer carrier,” CEO Russell Cook said in a news release. In a market crowded with a plethora of commodity offerings, our company mission is to develop next-generational devices that bring excitement to the surgeon community as well as our distribution partners.”
The surface-activated granules create a network of polygonal microfilaments that extend from the granule surface. The advanced surface texture is a bio-instructive vector that can entrap critical healing elements and guide the cellular processes. Amplify’s activation of the granule surface network also increases the surface area, porosity and dissolution rate of the granules to create more bioavailable surface interactions for cellular attachment, proliferation and remodeling.
Amplify also has a mineral component that comprises of a hybrid mixture of surface-activated biphasic granules composed of two distinct HA-to-βTCP blends that resorb at different rates. The surface-activated granules are derived from conventional HA/BTCP granules with ratios of 20/80 (faster resorbing) and 60/40 (moderate resorption). This results in a bimodal dissolution profile that nourishes the fusion site in the early stages of healing and supports progressive bone remodeling throughout the fusion process.
“The Amplify technology platform is intended to address critical gaps in current treatment algorithms while bringing greater efficiency to the surgeon experience. Our surface-activated granules combine the established clinical efficacy of traditional biphasic materials with state-of-the-art processing techniques, providing a bone graft that is more synchronized with the natural healing process,” Chief Operating Officer John Brunelle said. “This milestone sets the stage for future product developments and establishes Ventris as a key innovator in the orthobiologics space.”
