Biogennix Receives FDA Clearance for Expanded Use of Agilon Moldable and Morpheus Moldable Products

Irvine-based Biogennix, LLC an osteobiologics company specializing in bone graft products for fusion procedures, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for an expanded indication for its Agilon Moldable and Morpheus Moldable bone grafting products. The new clearance allows the products to be used in the intervertebral disc space as an autograft extender, with an FDA-cleared intervertebral body fusion device for use with a bone void filler.

Agilon Moldable has been recognized as an advanced synthetic bone graft, known for its HCA surface layer, nano-crystalline surface and biomimetic architecture, and is considered one of the best-handling products on the market. Morpheus, the company's original moldable product has also received this expanded indication.

Agilon Moldable is unique among moldable synthetic bone grafts, as it contains both collagen with an organic polymer carrier and Biogennix's proprietary TrelCor granules. TrelCor granules feature a biologically active layer of nanocrystalline HCA (hydroxycarbanoapatite) that promotes cellular healing upon implantation, stimulating a bioactive layer superior to other bone grafts. TrelCor technology is engineered to provide optimal chemistry and architecture for bone healing. The technology mimics human cancellous bone, offering fully interconnected porosity with a biomimetic architecture and advanced surface layer properties that enhance the bone healing process.

"Receiving expanded indications for our flagship Agilon Moldable and Morpheus products is exciting news," said Chris MacDuff, Biogennix's CEO. "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."

The company is also planning additional product launches this year to enhance its offerings and position itself as a "one stop shop" for all bone grafting and wound care needs.

Biogennix designs, manufactures, and distributes all of its products from its Irvine-based facilities.

About Biogennix

Biogennix® is a fully integrated osteobiologics company headquartered in Irvine, developing, manufacturing, and distributing proprietary bone grafting products for bone fusion procedures. The company is committed to advancing natural bone grafting solutions, delivering outstanding quality, exceptional value, and customer-focused excellence. Learn more at biogennix.com.

"TrelCor" is a registered trademark of Biogennix.