Biogennix Wins Expanded FDA Nods for Agilon, Morpheus Moldable Bone Grafts

Biogennix announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to expand the indication of its Agilon Moldable and Morpheus Moldable bone grafts.
 
The FDA nod expands its use to the intervertebral disc space as an autograft extender, with an FDA-cleared interbody fusion device for use with a bone void filler. Morpheus is the Irvine, Calif.-based company’s original moldable product.
 
The advanced, synthetic Agilon Moldable bone graft has a biologically active layer of nanocrystalline HCA (hydroxycarbanoapatite) that promotes cellular healing after being implanted. Biogennix claims it stimulates a bioactive layer superior to other bone grafts.
 
The company’s TrelCor technology was designed for optimal chemistry and architecture to heal bone. It mimics human cancellous bone with interconnected porosity and the healing process is enhanced with biomimetic architecture and advanced surface layer properties.
 
Biogennix also said it plans to launch additional products this year. The company hopes to position itself as a one-stop shop for bone grafting and wound care needs.
 
“Receiving expanded indications for our flagship Agilon Moldable and Morpheus products is exciting news,” said Biogennix CEO Chris MacDuff. “This enables us to make the products available for interbody applications performed by orthopedic and neuro spine surgeons throughout the U.S. Already well-established among spine surgeons, this new indication enhances the appeal of these best-in-class products with excellent handling properties. Based on enthusiastic feedback from over 75,000 successful cases to date, we anticipate increased market adoption this year for both Agilon and Morpheus moldable products.”