NEWS: Biogennix Receives FDA Clearance for Expanded Use of Moldable Bone Grafting Solution in Spine Procedures
An Irvine osteo-biologics company that creates bone graft products has received FDA clearance for an expanded indication for Agilon, a collagen-enhanced synthetic bone graft.
Biogennix said in a press release from earlier this month that this expanded indication clears Agilon for use in postero-lateral spine procedures, when mixed with autograft, taking tissue from one part of the body and using it in another part.
Biogennix said it designed Agilon to address surgeon demand for a collagen-enhanced product, complementing the company’s existing flagship products, Morpheus and osteospan.
Agilon, which received initial marketing clearance last year, contains a high purity type of bovine collagen, which provides a site for cell attachment, among other things.
The added collagen also enhances the material handling properties of Agilon.
Agilon is also the latest of Biogennix’s products to contain TrelCor tech, a proprietary material engineered to provide the optimal chemistry and architecture for bone healing.
TrelCor, which also serves as the foundation for Morpheus and osteoSPAN, can mimic some types of human bone.
Biogennix is ramping up national distribution for Agilon, which is available in three sizes: 3cc, 6cc, and 12cc. A
It requires no hydration prior to use and comes packaged in an open-barrel syringe.
Chris MacDuff is the CEO of Biogennix.