US-based orthobiologics company Ventris Medical has received the US Food and Drug Administration (FDA) 510(k) approval for its synthetic bone graft putty, Amplify.

Amplify forms a new type of synthetic biomaterial that facilitate optimisation of cell proliferation and bone formation.

It contains a hybrid mixture of biphasic granules, with two distinct blends of HA-to-βTCP that resorb at different rates, suspended in an alkylene oxide polymer carrier.

The surface-activated granules are derived from HA/BTCP granules with a faster resorbing ratio of 20/80 and a moderate resorption rate of 60/40.

The resultant bimodal dissolution profile is said to nourish the fusion site in the early stages of healing and support bone remodelling throughout the fusion process.

In addition, the device can be used either standalone or in combination with autograft bone (1:1 ratio) as a bone graft extender, said the company.

Ventris Medical CEO Russell Cook said: “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.”

The Amplify granules undergo a patented surface activation process that creates an encompassing network of polygonal microfilaments to enhance remodelling potential

The advanced surface texture that extends from the granule surface serves as a bio-instructive vector by holding the healing elements and guiding cellular processes.

In addition, activation of the surface network is said to increase the surface area, porosity, and dissolution rate of the granules, enhancing cellular attachment, proliferation, and remodelling.

The unique polymer blend in Amplify is said to provide a cohesive, mouldable matrix that facilitates accurate graft placement and containment at the defect site.

Post-implantation, the highly biocompatible polymer will be resorbed into the surrounding tissues, enabling the activated biphasic granules to show healing effects.

Ventris Medical COO John Brunelle said: “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 synchronised 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.”