Ventris Medical Receives Additional FDA Clearance for Backpack® Bone Graft in the Intervertebral Disc Space

NEWPORT BEACH, Calif., April 8, 2025 /PRNewswire/ -- 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 for Backpack® (Porous Biologic Scaffold, K250556) for use in the Intervertebral Disc Space. Backpack® represents a new class of biomaterials designed for the optimization of cell proliferation and bone formation and is used in orthopedic and spinal fusion procedures. Backpack® is available in 2 versions. One version consists of a collagen mesh pouch filled with our osteoinductive Allocell® AF fibers and in the second version, the collagen mesh pouch is filled with our surface activated Amplify® granules.

Backpack® AF with Allocell® AF Allograft Fibers

In this format, the osteoinductive allograft fibers are completely enclosed inside a collagen mesh pouch. The 100% biologic graft system is the first of its kind in that both the containment pouch and allograft fibers contribute to the bone remodeling process at the graft site. The Allocell® AF allograft fill has a scaffold-like structure, enabling bone cells to attach and proliferate, which helps facilitate the natural healing process. The osteoinductive nature of the Allocell® AF fibers actively promote the differentiation of stem cells into bone-forming cells, which enhances bone regeneration. Backpack® AF is supplied in a ported pouch for easy hydration and is ready to use, simplifying the surgical process.

Backpack® AMP with Surface Activated Amplify® Granules

In this format, the surface treated biphasic Amplify® granules are completely enclosed inside the collagen mesh pouch. The hybrid mixture of surface-activated biphasic granules are 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. Backpack® AMP is supplied in a ported pouch for easy hydration and is ready to use, simplifying the surgical process.

Russell Cook, CEO of Ventris Medical commented, "We are very pleased to receive FDA clearance for both the Backpack® AF and Backpack® AMP Bone Graft Systems. This graft containment technology is the first of its kind and represents a huge step forward in the bone graft technology available in today's market. Backpack® combines 2 heavily studied components; osteoinductive allograft fibers and our patented surface activated biphasic mineral components and places them in a biologic containment system providing an anti-migration feature not found in any other bone graft offering. Our company mission is to continue 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 Backpack® technology platform is our latest venture in enhancing the surgeon experience and fusion outcomes. The sophisticated design of the containment system allows for precise delivery and retention of our clinically validated biphasic granules and allograft fibers, ensuring a more consistent healing response at the fusion site. This latest milestone establishes yet another platform for future product developments and further validates Ventris as a key innovator in the orthobiologics space."

About Ventris Medical

Ventris Medical is a leading medical device company focused on developing innovative proprietary platforms for tissue regeneration and bioresorbable bone graft products for a broad range of spinal and orthopedic fusion procedures. For additional information on Ventris Medical, please visit our website at www.ventrismedical.com

SOURCE Ventris Medical