Sam Brusco, Associate Editor09.13.22
Orthobiologics and tissue regeneration company Ventris Medical has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Amplify synthetic bone graft putty.
Amplify is a synthetic biomaterial designed to optimize cell proliferation and bone formation. It’s made of Amplify biphasic (HA/βTCP) ceramic granules suspended in an alkylene oxide polymer carrier. It can be used either standalone combined with autograft bone (1:1 ratio) as a bone graft extender.
A patented surface activation process creates an encompassing network of polygonal microfilaments that extend from the granule surface. The texture acts as a bio-instructive vector to entrap critical healing elements and guide cellular processes. Activating the granule surface network increases surface area, porosity, and dissolution rate to create more bioavailable surface interactions.
Amplify’s mineral component is a hybrix mixture of surface-activated biphasic granules composed of two distinct HA-to-βTCP blends that resorb at different rates. These 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 early healing stages and supports progressive bone remodeling throughout fusion.
Amplify’s polymer blend offers 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, the polymer resorbs into surrounding tissues, allowing immediate access to activated biphasic granules and their healing effects.
Russell Cook, CEO of Ventris told the press, "We are very pleased to receive FDA clearance for Amplify Synthetic Bone Graft Putty. 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, Ph.D., COO of Ventris 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."
Amplify is a synthetic biomaterial designed to optimize cell proliferation and bone formation. It’s made of Amplify biphasic (HA/βTCP) ceramic granules suspended in an alkylene oxide polymer carrier. It can be used either standalone combined with autograft bone (1:1 ratio) as a bone graft extender.
A patented surface activation process creates an encompassing network of polygonal microfilaments that extend from the granule surface. The texture acts as a bio-instructive vector to entrap critical healing elements and guide cellular processes. Activating the granule surface network increases surface area, porosity, and dissolution rate to create more bioavailable surface interactions.
Amplify’s mineral component is a hybrix mixture of surface-activated biphasic granules composed of two distinct HA-to-βTCP blends that resorb at different rates. These 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 early healing stages and supports progressive bone remodeling throughout fusion.
Amplify’s polymer blend offers 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, the polymer resorbs into surrounding tissues, allowing immediate access to activated biphasic granules and their healing effects.
Russell Cook, CEO of Ventris told the press, "We are very pleased to receive FDA clearance for Amplify Synthetic Bone Graft Putty. 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, Ph.D., COO of Ventris 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."