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Devices Neurosurgery Regenerative Medicine

 News Release - September 14, 2011

AxoGen Avance(R) Nerve Graft Clinical Study Results Presented at the American Society of Surgery of the Hand

Results from the Study, A Multicenter Retrospective Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair, were presented during the 66th annual meeting for the American Society for Surgery of the Hand (ASSH) by Dr. Darrell Brooks of the world renowned Buncke Clinic;

Study results demonstrate that Avance® Nerve Graft is a safe method for reconstructing nerve discontinuities with 87.3% of the injuries achieving meaningful recovery


ALACHUA, Fla.--(Healthcare Sales & Marketing Network)-- AxoGen announced today the presentation of data from a clinical registry study entitled, Analysis of Quantitative Endpoints from a Multicenter Retrospective Registry Study on the Use of Acellular Nerve Grafts for Sensory, Mixed and Motor Nerve Reconstructions. The outcomes from this study were presented by Darrell Brooks, MD of The Buncke Clinic on Saturday September 10, 2011 during the annual meeting of the ASSH. AxoGen believes this study is the largest multi-center clinical study conducted to date in peripheral nerve gap reconstruction.

This twelve center clinical study shows an analysis of outcomes for patients with peripheral nerve injuries reconstructed with Avance® Nerve Graft. The study enrolled 103 patients with 132 peripheral nerve injuries treated with Avance® Nerve Graft. The peripheral nerve injuries were varied from traumatic injuries to surgical resections and included acute (reconstructed less than 3 weeks post-injury) to delayed (reconstructed more than 3 months post-injury) and multiple nerve types (sensory, motor and mixed nerves) in all regions of the body. This analysis included quantitative outcome data on a subgroup where 55 nerves were repaired with Avance® Nerve Graft using study center standard of care for treatment as well as follow up evaluation. The quantitative subgroup analyzed consisted of patients with an average age of 44 years old (ranging in age from 18 to 86 years). The average gap length in the transected nerve was 24.0 mm, with a range of 5 mm to 50 mm.

The study results demonstrate that Avance® Nerve Graft is a safe method for reconstructing nerve discontinuities with 87.3% of the injuries achieving meaningful recovery. Meaningful recovery was achieved in a majority of cases regardless of nerve type repaired (including mixed and motor), increased age, prolonged time-to-repair, or larger gap length (up to 50mm) variables classically associated with poorer axon regeneration and prognosis. The Avance® Nerve Graft did not see the length limitations historically observed with nerve conduits.

Karen Zaderej, CEO of AxoGen, stated, “We are very pleased with the findings from this study of the Avance® Nerve Graft and we believe this data will be a valuable resource for surgeons.”

Dr. Darrell Brooks, partner at The Buncke Clinic and Principal Investigator of the study, declared, “The data from the study will help change the treatment paradigm for surgeons with patients that have peripheral nerve discontinuities. It gives the surgeon a viable option for treatment of peripheral nerve injuries without the sacrifice of healthy nerve function. ”

This study is currently in open enrollment. Data will be continuously monitored and will be updated regularly to incorporate additional outcomes and findings.

About AxoGen

AxoGen is a private regenerative medicine company focused on the development and commercialization of technologies for peripheral nerve reconstruction and regeneration. Every day people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body and their damage can result in the loss of function and feeling. In order to improve surgical reconstruction and regeneration of peripheral nerves, AxoGen has developed and licensed patented and patent-pending technologies, which are used in its portfolio of products. This portfolio includes the Avance® Nerve Graft which AxoGen believes is the first and only commercially available allograft nerve for bridging nerve discontinuities (a gap created when the nerve is severed). AxoGen’s portfolio also includes the AxoGuard® Nerve Connector, a coaptation aid allowing for close approximation of severed nerves, and the AxoGuard® Nerve Protector that protects nerves during the body’s healing process after surgery. AxoGen is bringing the science of nerve repair to life with over 4,000 surgical implants of AxoGen products performed in hospitals and surgery centers across the United States, including military hospitals serving U.S. service men and women.

AxoGen is a registered tissue establishment with the FDA.

Visit AxoGen at: www.axogeninc.com

Follow @AxoGen on Twitter!


Source: AxoGen

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