Ventris Medical, a US-based orthobiologics company, has received the US Food and Drug Administration (FDA) 510(k) clearance for its synthetic bone graft putty, Amplify, for use in intervertebral disc space.

Amplify is a new class of synthetic biomaterials specifically engineered to optimise bone production and cell proliferation.

The synthetic bone graft putty is made using Amplify biphasic (HA/βTCP) ceramic granules suspended in an alkylene oxide polymer carrier.

According to Ventris Medical, the device can be used as a bone graft extender alone or in conjunction with autograft bone at a 1:1 ratio.

Ventris Medical CEO Russell Cook said: “We are very pleased to receive FDA clearance for Amplify Synthetic Bone Graft Putty for the intervertebral disc space.

“This technology combines two 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 orthobiologics company received its first FDA clearance for Amplify bone graft putty in September 2022, for its use as a bone graft extender.

To increase remodelling potential, Amplify granules undergo a unique surface activation method to a network of polygonal microfilaments.

This advanced surface texture functions as a bio-instructive vector that directs cellular processes and entraps essential healing components.

The activation of the granule surface network is said to produce more bioavailable surface interactions for cellular adhesion, proliferation, and remodelling.

Additionally, this increases the granules’ surface area, porosity, and dissolving rate, Ventris Medical said.

Amplify contains a hybrid mixture of surface-activated biphasic granules made of two separate HA-to-βTCP blends that resorb at various rates.

This combination produces a bimodal dissolution profile that is said to promote progressive bone remodelling during the fusion process and nourishes the fusion site during the early phases of healing.

The orthobiologics firm said that Amplify’s polymer mixture creates a cohesive, mouldable matrix between the granules to help with precise graft placement and confinement at the defect site.

Furthermore, this biocompatible polymer resorbs into the surrounding tissues following implantation, providing quick access to the activated biphasic granules and their restorative properties.