*INNOVATION: Med-Device Company Gets FDA clearance for Bone Graft Product
An innovative med-device company that develops bone graft products for bone fusion procedures has received 510(k) clearance from the U.S. Food and Drug Administration for its newest product, Agilon.
Biogennix, with HQ in Irvine, said in a September 4 press release, that Agilon is now commercially available on the domestic market.
Biogennix designed Agilon, a bone grafting material that is fully biocompatible with human bone, to address surgeon demand for a collagen-enhanced product, complementing the company’s existing flagship products, Morpheus and osteoSPAN.
With Agilon, Biogennix introduces the addition of purely-sourced, type-1 bovine collagen, for optimal material handling properties, among other potential benefits.
The company said that what sets Agilon apart from other collagen-enhanced products on the market today is Biogennix’s TrelCor tech, a proprietary material engineered to mimic human cancellous bone.
TrelCor, which also serves as the foundation for Morpheus and OsteoSPAN, provides “optimal” chemistry and architecture for bone healing.
Studies have shown that TrelCor technology allows Biogennix’s bone grafting material to become incorporated into a bone fusion, while gradually resorbing over a six- to 12-month period – ideal for bone remodeling.
In preliminary testing, after handling Agilon side by side with other bone graft products, a majority of surgeons surveyed preferred Agilon over what they’re using today, most often citing the product’s exceptional handling as a key benefit.
Biogennix is now ramping up national distribution for Agilon, which is available in three optimized sizes: 3cc, 6cc, and 12cc.
The company is led by a team of scientists and industry veterans committed to delivering unique products for bone regeneration.
Biogennix designs, manufactures and distributes all of its products from its Irvine-based facilities.