Frost & Sullivan Applaud AxoGen's Proprietary Process for Producing Decellularized Nerve Allografts

MOUNTAIN VIEW, Calif., Jan. 6, 2014 /PRNewswire/ -- Based on its recent analysis of the peripheral nerve repair market, Frost & Sullivan recognizes AxoGen, Inc. with the 2013 North American Frost & Sullivan New Product Innovation Leadership Award for developing the Avance® Nerve Graft, a decellularized nerve allograft. Avance® Nerve Graft is the only commercially available processed nerve allograft product available in the United States and is unique because it is free of all the cells and cellular debris from the donor, retaining only the extracellular matrix.

The removal of the donor's nerve cells from the allograft makes Avance® a superior grafting option, as it eliminates the strong and prolonged immune response from the patient's body, which can be so severe that the body rejects the transplant. The second innovative feature of Avance® is its intact three-dimensional (3D) internal architecture of the extracellular matrix, which enables guided cellular regrowth. Competing products, which are hollow tube conduits, have an enclosed environment for cell migration but provide only an approximate alignment of the regenerating nerve fibers. In contrast, Avance® enables robust regeneration by acting as a scaffold and presenting the regenerating fibers with the body's natural microarchitecture.

Processing of a nerve graft begins after the nerve has been extracted from donors. Nerve fibers contain a protein known as chondroitin sulfate proteoglycan (CSPG), which inhibits axonal (nerve) regeneration after injuries. AxoGen uses a proprietary enzyme and buffer wash process to remove CSPG from donor nerve tissues. This step is vital in enabling axonal re-growth. Following the removal of CSPG, the process is designed to completely remove any cells or cellular debris from the donor tissue.

The current clinical standard of nerve repair is autografting, a process in which a nerve from a healthy part of the patient is extracted and implanted into the injury site. Although autografting ensures immuno-compatibility and robust regeneration, there often exists a loss of sensation and/or function at the site from where the nerve segment is removed. The length, diameter, and the number of nerves available for autografting are also limited, which sometimes makes the process unviable, especially if the patient has multiple nerve injuries or large nerve injuries.

"Avance® brings to the table, for the very first time, important features of an autograft, such as an intact structure and compatibility, while completely eliminating the need for another surgical site to extract a healthy nerve," said Frost & Sullivan Research Analyst Bhargav Rajan. "As the AxoGen nerves are obtained from deceased donors and then specially processed,, there is a continuous supply of nerves available. Nerve size (length and diameter) matching is also an important value-added feature offered by Avance® Nerve Graft."

Clinical and animal studies performed by independent research groups have reported a 57 percent failure rate when hollow tube conduits were used to bridge gaps greater than 5 mm and a 60 percent failure rate when they were used on sensory, mixed and motor nerves. Avance®, on the other hand, is indicated for use to bridge gaps of up to 70 mm. For injuries where nerve loss is greater than 50 mm, as is often the case with severe traumatic injuries, Avance® is the only available commercial solution. RANGER®, AxoGen's active clinical registry, has recorded 87 percent positive outcomes with Avance® Nerve Graft from more than 130 nerve reconstructions—a success rate comparable to that of autografts, the current clinical gold standard.

Due to the wider range of sizes, Avance® is routinely used as an implant option in both children and adults. Importantly, Avance® Nerve Graft also has the potential to save significant operating room costs, as the need for a second surgery, size matching, and post-surgical infection treatment are avoided. The operating time is also considerably lower than with autografts, as the graft is already processed and ready to be used by the surgeon.

"Avance®'s established track record of safety and efficacy across a wide range of injury cases, and its innovative and superior product features, give it a definite edge over other commercially available peripheral nerve repair options," noted Rajan. "AxoGen's impressive portfolio of products and the new product ideas in its pipeline make it an exciting company to watch in the field of regenerative medicine."

Each year, Frost & Sullivan presents this award to the company that has developed an innovative element in a product by leveraging leading-edge technologies. The award recognizes the value-added features/benefits of the product and the increased ROI it offers customers, which, in turn, increases customer acquisition and overall market penetration potential.

Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.

About AxoGen, Inc
AxoGen (NASDAQ: AXGN) is a regenerative medical device company based in Alachua, Florida. Founded in 2002, AxoGen is the only company to completely focus on peripheral nerve repair. AxoGen's portfolio of products includes Avance® Nerve Graft, a processed human nerve allograft; AxoGuard® Nerve Connector and AxoGuard® Nerve Protector, both processed porcine extracellular matrix products intended as coaptation and encapsulation devices, respectively.

In developing the Avance® Nerve Graft, AxoGen has successfully leveraged cutting-edge technologies to develop the only commercially available, off-the-shelf grafting solution for traumatic nerve injuries. Avance® is commercially available in the United States, Canada and a number of European countries.

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SOURCE Frost & Sullivan