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Collagen Matrix, Inc. Receives FDA 510(k) Clearance for DuraMatrix(TM) Collagen Dura
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Added: 12/15/2004
Type: Summary
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Collagen Matrix, Inc. Receives FDA 510(k) Clearance for DuraMatrix(TM) Collagen Dura
Franklin Lakes, NJ December 9, 2004 -- Collagen Matrix, Inc. is pleased to announce that it has received FDA’s 510(k) clearance of its DuraMatrix™ Collagen Dura Substitute Membrane. DuraMatrix is a safe, resorbable, conformable, collagen-based membrane intended for use as a dura substitute in the repair of dura mater.
Dura mater is the tough, fibrous membrane that covers and protects the brain and spinal cord. When the dura mater is damaged due to surgery or trauma, surgeons look to repair the injury with a dura substitute material. Collagen Matrix has developed a collagen-based membrane that possesses key characteristics of an ideal dura substitute that can be implanted as an onlay graft or as a suturable graft. DuraMatrix is biocompatible, resorbable, has a thickness similar to that of native dura, and conforms to the contours of the brain. The unique conformability of the membrane combined with its mechanical strength allows the membrane matrix to be implanted with or without sutures. The characteristics of the device, including its pore structure, are designed to aid and support the healing of the dura mater in accordance with the accepted principle of guided tissue regeneration. DuraMatrix is easy to handle and can be trimmed, either dry or hydrated, to fit the size of the defect.
The safety and effectiveness of DuraMatrix are supported by a clinical study and a large-scale animal study. The animal study, including 64 rabbits, was a comprehensive dural repair study comparing the effectiveness of DuraMatrix with currently marketed collagen-based dural substitutes. DuraMatrix was evaluated against DuraGen® Dural Repair Graft manufactured by Integra LifeSciences and DuraGuard® Dural Repair Patch manufactured by Synovis Surgical Innovations. DuraMatrix was the only dural substitute that demonstrated an ability to facilitate the healing with balanced in vivo resorption of the device and regeneration of host tissue. The clinical study confirmed the findings of the animal study with no CSF leakage observed in any of the patients and no device-related adverse effects reported.
“The FDA clearance of DuraMatrix is a major milestone for Collagen Matrix. We expect this product to contribute significantly to the growth of the Company in 2005,” said Shu-Tung Li, Ph.D., Founder and CEO of Collagen Matrix, Inc.
Collagen Matrix is launching DuraMatrix and Neuroflex Flexible Collagen Nerve Cuff in the United States and Europe through a network of independent distributors managed by Collagen Solutions LLC, founded by Michael M. Bailey and Mark Roberson. Mr. Bailey, President and CEO of Collagen Solutions, has over 23 years of experience in the distribution of orthopedic and spine products. Through collaborations with key orthopedic surgeons and neurosurgeons, Mr. Bailey has been an integral contributor to the rapid growth of Blackstone Medical, Inc., a manufacturer and supplier of devices and instruments for spinal surgery. Mark Roberson, Executive Vice President of Sales, brings extensive experience in sales of medical devices, including orthopedic, spine, and neurosurgical products. Through his previous sales and management experience, Mr. Roberson has gained a strong knowledge of the target market and has built relationships with key opinion leaders in the field of neurosurgery. With a network of highly skilled distributors in the neurosurgery field in the U.S. and Europe, Collagen Matrix along with Collagen Solutions are well-positioned for the launch and anticipated growth of product sales in the near future.
“We are very excited about collaborating with Mike Bailey and Mark Roberson. Their combined experience and track record of success are tremendous assets as we launch DuraMatrix and Neuroflex globally,” added Shu-Tung Li, Ph.D.
Collagen Matrix, Inc. is a leader in the design and engineer of collagen-based extracellular matrices for tissue and organ repair and regeneration. Since its inception in 1997, the Company has received many government grants for the development of innovative collagen-based matrix products in the areas of neurological, vascular, urological, and orthopedic tissue regeneration applications. The Company currently manufactures collagen-based finished medical devices in the areas of oral surgery and neurosurgery. More information about the Company can be found at www.collagenmatrix.com.
Contact:
Shu-Tung Li, Ph.D.
201-405-1477
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