-- AxoGen is the only regenerative medicine company that is
completely focused on peripheral nerve repair
MOUNTAIN VIEW, California,
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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