Biogennix Receives FDA Clearance for Expanded Use of Agilon Moldable and Morpheus Moldable Products
May 08 2024 - 12:49PM
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. 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.
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Paul Williams 310-569-0023 paul@medialinecommunications.com