Biogennix issued the following announcement on Sep. 4.
Irvine-based Biogennix, an osteobiologics company that develops, manufactures, and distributes proprietary bone graft products used for bone fusion procedures, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its newest product, Agilon™. 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.
What sets Agilon apart from other collagen-enhanced products on the market today is Biogennix’s TrelCor™ technology, a proprietary material meticulously engineered to mimic human cancellous bone. TrelCor technology, which also serves as the foundation for Morpheus and OsteoSPAN, provides the optimal chemistry and architecture for bone healing. TrelCor technology provides full interconnected porosity within naturally-sourced calcium phosphate/calcium carbonate composite (CP/CC) granules. The interconnected pores average 500 microns (µ) in size, which closely emulates the natural blueprint of human cancellous bone. With TrelCor technology, all surfaces throughout the porosity are covered by a thin layer (4 microns) of calcium phosphate, the primary mineral content of bone. Studies have shown that TrelCor technology allows Biogennix’s bone grafting material to become incorporated into a bone fusion, while gradually resorbing over a 6-12 month period – ideal for bone remodeling.
“We are very excited to be making Agilon available to the US market,” said Biogennix CEO Chris MacDuff. “Agilon was intentionally created after many years of research and development with both surgeons and patients in mind, to not only bring an effective, easy-to-handle product to the market, but also a product that may lead to improved healing and overall outcomes in patients. Based on the enthusiastic feedback we’ve received from surgeons and distributors in our market testing, we anticipate the launch of Agilon to be an exciting addition to our product offering.”
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.
“Agilon is a significant addition to our product portfolio of bone graft materials,” said Dr. Edwin Shors, President of Biogennix. “We have received steady positive feedback from surgeons on a regular basis for our existing products Morpheus and OsteoSPAN, and the natural next step for us, based on clinician feedback, has been to provide a similar product with even greater handling capabilities and the added benefits of collagen. We firmly believe that Agilon can fast become a new standard of effectiveness, convenience, and handling when it comes to bone graft products.”
Biogennix is ramping up national distribution for Agilon, which is now available in three optimized sizes: 3cc, 6cc, and 12cc. To date, Agilon is the only collagen-enhanced synthetic bone graft that comes packaged in an open-barrel syringe, providing the utmost convenience and ease of use for surgeons and OR staff.
Biogennix is a leading developer of osteobiologic products specifically designed for spine fusion and bone trauma. 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.
Original source can be found here.