Biogennix received FDA 510(k) clearance of 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 hydroxycarbanoapatite (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 contains both collagen with an organic polymer carrier and Biogennix’s proprietary TrelCor granules. TrelCor granules feature a biologically active layer of nanocrystalline HCA that promotes cellular healing upon implantation. 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 surface layer properties that enhance the bone healing process.
Chris MacDuff, Biogennix’s CEO, said, “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.”
Biogennix received FDA 510(k) clearance of 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...
Biogennix received FDA 510(k) clearance of 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 hydroxycarbanoapatite (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 contains both collagen with an organic polymer carrier and Biogennix’s proprietary TrelCor granules. TrelCor granules feature a biologically active layer of nanocrystalline HCA that promotes cellular healing upon implantation. 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 surface layer properties that enhance the bone healing process.
Chris MacDuff, Biogennix’s CEO, said, “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.”
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