Ventris Medical, a privately held orthobiologics and tissue regeneration company, today announced that the United States Food and Drug Administration has granted 510(k) clearance in the intervertebral disc space for Synthetic Bone Graft Putty (Amplify®). Amplify® represents a new class of synthetic biomaterials designed for the optimization of cell proliferation and bone formation and is comprised of Amplify® biphasic (HA/βTCP) ceramic granules suspended in an alkylene oxide polymer carrier. The device can be used either standalone or in combination with autograft bone (1:1 ratio) as a bone graft extender.
Surface Activated Granules
To enhance remodeling potential, the Amplify® granules undergo a patented surface activation process that creates an encompassing network of polygonal microfilaments that extend from the granule surface. This advanced surface texture acts as a bio-instructive vector that can entrap critical healing elements and guide cellular processes. Activation of the granule surface network increases the surface area, porosity, and dissolution rate of the granules, which creates more bioavailable surface interactions for cellular attachment, proliferation, and remodeling.
Bimodal Dissolution
The mineral component in Amplify® comprises a hybrid mixture of surface-activated biphasic granules composed of two distinct HA-to-βTCP blends that resorb at different rates. These surface-activated granules are derived from conventional HA/BTCP granules with ratios of 20/80 (faster resorbing) and 60/40 (moderate resorption), resulting 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.
Proprietary Carrier
The proprietary polymer blend in Amplify® provides a cohesive, moldable matrix between the granules that facilitates accurate graft placement and containment at the defect site and can readily be mixed with autograft bone. After implantation, this highly biocompatible polymer resorbs into the surrounding tissues, allowing immediate access to the activated biphasic granules and their healing effects.
Russell Cook, CEO of Ventris Medical commented, "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. 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."
John Brunelle, PhD, COO of Ventris Medical added: 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. This milestone sets the stage for future product developments and establishes Ventris as a key innovator in the orthobiologics space."
