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Studies Show AVANCE Nerve Graft Effective in Repair of Peripheral Nerve Damage.

Data From Multiple Studies Show AVANCE Effective for the Repair of Damaged Nerves Including Repairs up to 30mm; Results Presented At 13(th) Annual Meeting for Regenerative Medicine

ALACHUA, Fla. -- Results from several studies involving animal and human models show that treatment with Avance[R] Nerve Graft supports nerve repair and restoration of function in the repair of peripheral nerve damage. Results from recent studies were presented at the 13th Annual Meeting for Regenerative Medicine in Hilton Head, South Carolina.

In 2007, AxoGen began distribution of AVANCE Nerve Graft for use in the repair of peripheral nerve damage. Clinical data related to the use of AVANCE Nerve Graft have shown good to excellent recovery of function in treating peripheral nerve damage. AVANCE Nerve Grafts are decellularized allograft nerves recovered from cadaveric donors. The AVANCE proprietary process is designed to remove cellular components associated with a risk of tissue rejection while maintaining structural and neurotropic components designed to support nerve regeneration. AVANCE Nerve Graft is also treated to remove chondroitin sulfate proteoglycans (CSPGs), which inhibit nerve axon regeneration in peripheral nerves. To date, more than 500 AVANCE Nerve Grafts have been implanted in humans with no reports of tissue rejection or other adverse events.

Crystal Simon, PhD, product development engineer at AxoGen, presented the results from several studies involving treatment with AVANCE, including a review of efficacy data in both animal and human studies. In a recent study of adult rats, eight of nine rats implanted with chondroitinase-treated acellular grafts showed a positive response as compared to only two of nine rats implanted with untreated acellular grafts.1 In a separate sciatic nerve study in rats, AVANCE processed grafts were compared to the use of conduit and isograft (graft tissue from genetically identical donors).2 In 14mm and 28mm nerve gaps, treatment with AVANCE resulted in regeneration of greater than 20 times more myelinated axons compared to treatment with conduit for both 14mm and 28mm gaps. At 22 weeks, seven of nine rats treated with AVANCE to repair a 28mm gap responded with a foot twitch to electric stimulation, while none of the rats treated with conduits responded to electric stimulation.

Results from a third study involving 10 nerve injuries in nine human patients showed that AVANCE Nerve Graft restored nerve sensation to near normal levels within nine months following treatment to repair digital nerve injuries. Functional recovery was observed with graft lengths up to 3 cm with no reported cases of infection or tissue rejection. Overall, early clinical testing with AVANCE Nerve Graft has shown positive clinical outcomes in gaps ranging from 5mm to 30mm with good to excellent recovery of function.

"Based on findings from these studies and from the expanding data available from treatment in humans in recent years, AVANCE Nerve Graft is shown to be a viable option for the repair of peripheral nerve damage with the ability to support restoration of function in patients with peripheral nerve injuries," said Dr. Simon. "Ongoing investigations are aimed at determining the maximum lengths for successful nerve repair using AVANCE Nerve Graft."

Peripheral nerves provide the pathway for both motor and sensory signals between the central nervous system and muscles or organs throughout the body. These nerves support movement and register sensation including pain, cold or heat. On average, more than three hundred thousand people suffer traumatic injuries or have surgical procedures that disrupt or stop the function of peripheral nerves each year.3

About AxoGen

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.

AxoGen is a registered tissue bank with the FDA.

1Neubauer et al. (2007, Exp Neurol, 207(1):163-70)

2Whitlock et al., Muscle and Nerve, pending

3National Hospital Discharge Survey, 2001
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Date:Mar 9, 2009
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