AxoGen, Inc., a leader in the development of treatment options for the repair of peripheral nerve injuries, announced today that the American Association of Tissue Banks (AATB) has awarded them the prestigious AATB accreditation. This accreditation affirms that AxoGen meets or exceeds all AATB safety standards required for screening, handling, packaging, processing, storage and distribution of tissue.
ALACHUA, Fla. (Business Wire EON) September 30, 2008 -- "This important accreditation from AATB represents yet another example of AxoGen's company-wide commitment to patient safety and to providing the highest quality products to surgeons across the country," said Mark Friedman, Ph.D., Director of RA/QA for AxoGen, Inc.
Peripheral nerves are the pathway for both motor and sensory signals between the central nervous system and muscles or organs throughout the body. Peripheral nerve damage caused by trauma, certain surgical procedures including prostatectomy, some cancers and other diseases collectively affect several hundred thousand people each year. Symptoms can include numbness, tingling, and pain as well as loss of muscle mass and motor control that can impair walking, hand and arm movement and other functions.
Surgeons can implant AVANCE Nerve Graft at the site of the damaged nerve in order to support restoration of lost function without the sacrifice of healthy nerves or the need for immunosuppression. AVANCE Nerve Graft was developed by AxoGen using a proprietary process that decellularizes the nerve tissue while preserving the naturally occurring growth promoters and maintaining the three dimensional structure of the nerve. The process also clears growth inhibitors that may impede regenerating nerve fibers. As a result, AVANCE Nerve Graft is able to support the regeneration of the nerve fibers, known as axons, that are essential to conduct nerve impulses from the brain to the arms, legs and other parts of the body.
"Since its introduction in 2007, AVANCE Nerve Graft has been implanted in hundreds of people with peripheral nerve damage to enable them to regain function safely and effectively. AVANCE Nerve Graft makes it possible for surgeons to repair peripheral nerves without the need for immunosuppression and without the need to transplant nerve tissue from elsewhere in the patient's body. These critical benefits combined with AxoGen's commitment to safety in the use of donor tissue represent a major advance in the treatment of nerve damage for patients," said Karen Zaderej, COO of AxoGen, Inc.
About American Association of Tissue Banks
The American Association of Tissue Banks (AATB) is dedicated to ensuring that human tissues intended for transplantation are safe and free of infectious disease, of uniform high quality, and available in quantities sufficient to meet national needs. To fulfill that mission, since 1984, the AATB has published the only authoritative industry standards for tissue banks, the AATB's Standards for Tissue Banking. Beginning 1986, the AATB initiated a mandatory Accreditation Program for its institutional members to ensure that tissue banking activities are performed in a professional manner in compliance with these Standards.
AxoGen, Inc. is a privately held company working to develop new and more effective products to treat peripheral nerve damage. With the focus of bringing the science of nerve repair to life, AxoGen is working to introduce new technologies to improve the standard of care for patients with injured peripheral nerves. With licensed technologies from the University of Florida, the University of Texas, and Emory University, researchers at AxoGen have developed an innovative technology platform making it possible to process allograft nerves while preserving the three dimensional scaffold and key components of the tissue. Based in Alachua, Florida, AxoGen has received funding from private investors including Accuitive Medical Ventures, Cardinal Partners, De Novo Ventures, Springboard Capital II, LLC, SynoGen, and Emergent Growth Fund of Gainesville, FL.
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