IRVINE, Calif.--(BUSINESS WIRE)--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.

加利福尼亚州欧文市——（商业新闻短讯）——总部位于欧文市的Biogennix，LLC是一家专门从事融合手术骨移植产品的骨生物制剂公司，今天宣布，该公司已获得美国食品和药物管理局（FDA）510（k）的许可，以扩大其Agilon可模塑和Morpheus可模塑骨移植产品的适应症。

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..

新的间隙允许产品在椎间盘空间用作自体移植物延长剂，并带有FDA批准的椎间体融合装置，用于骨空隙填充物。。

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是一种先进的合成骨移植物，以其HCA表面层，纳米晶体表面和仿生结构而闻名，被认为是市场上最好的处理产品之一。该公司最初的可模塑产品Morpheus也收到了这一扩展指示。。

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.

Agilon Moldable在可模塑合成骨移植物中是独一无二的，因为它既含有带有有机聚合物载体的胶原蛋白，又含有Biogennix专有的TrelCor颗粒。TrelCor颗粒具有纳米晶HCA（羟基氨基甲酸酯）的生物活性层，其在植入时促进细胞愈合，刺激优于其他骨移植物的生物活性层。

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..

TrelCor技术旨在为骨骼愈合提供最佳的化学和结构。该技术模仿人体松质骨，通过仿生结构和先进的表面层特性提供完全互连的孔隙率，从而增强骨骼愈合过程。。

'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.

Biogennix首席执行官克里斯·麦克达夫（ChrisMacDuff）说，我们的旗舰产品Agilon Moldable和Morpheus产品的适应症得到了扩大，这是一个令人兴奋的消息这使我们能够将产品用于美国各地的骨科和神经脊柱外科医生进行的椎体间应用。这种新的适应症已经在脊柱外科医生中得到了很好的认可，增强了这些具有优异处理性能的同类最佳产品的吸引力。

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.'.

基于迄今为止75000多个成功案例的热情反馈，我们预计今年Agilon和Morpheus可模塑产品的市场采用率都会提高。”。

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.

该公司还计划今年推出更多产品，以增强其产品，并将自己定位为满足所有骨移植和伤口护理需求的“一站式商店”。

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

Biogennix通过其位于欧文的设施设计、制造和分销其所有产品。

About Biogennix

关于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.

Biogennix®是一家完全集成的骨生物制品公司，总部位于欧文，开发、制造和分销用于骨融合手术的专有骨移植产品。该公司致力于推进天然骨移植解决方案，提供卓越的质量、非凡的价值和以客户为中心的卓越。

Learn more at biogennix.com..

更多信息，请访问biogennix.com。。

“TrelCor” is a registered trademark of Biogennix.

“TrelCor”是Biogennix的注册商标。