Miami Children’s Hospital Performs First Nerve Repair Surgery Using Avance® Nerve Graft Technology

MIAMI & ALACHUA, Fla.-- Miami Children’s Hospital, recognized by U.S. News & World Report for excellence in 10 pediatric subspecialties in 2011 and 2012, and AxoGen, Inc. (OTCBB: AXGN) have announced the hospital’s first nerve repair surgery with Avance® Nerve Graft. The processed nerve allograft technology was implanted during a surgery recently to repair a brachial plexus injury suffered by a 6 month-old baby girl.

John AI Grossman MD (Photo: Business Wire)

The surgery was performed by Dr. John A. I. Grossman, MD, FACS, Director of The Brachial Plexus Program at Miami Children’s Hospital, Clinical Associate Professor of Orthopedic Surgery at New York University’s School of Medicine, author of numerous studies on pediatric brachial plexus repair and an associate editor of the Journal of Brachial Plexus and Peripheral Nerve Injury. “The Avance® Nerve Graft is changing how we approach the surgical reconstruction of injured brachial plexus nerves and is a very valuable new tool,” offered Dr. Grossman.

The brachial plexus controls the movement of muscles and sensation in the shoulder, arm and hand. Brachial plexus injuries may occur if an infant’s neck is excessively stretched during birth or by traumatic injury. If left untreated, brachial plexus birth injuries can have lifelong consequences including paralysis or limited movement, numbness and weakness in the shoulder, arm, hand and fingers.

Dr. Grossman, who works at both Miami Children’s Hospital and NYU Hospital for Joint Diseases, runs one of the busiest programs in the country for treating these types of injuries. Depending on the severity of the injury, treatment often involves surgical repair and replacement of injured or torn nerves. Historically, healthy nerve was taken from elsewhere in the patient’s body and used to repair the damaged nerve in a procedure known as an autograft. Limitations in the amount of healthy nerve available for grafting created a market need for a nerve substitute. Dr. Grossman added, “Avance® Nerve Graft is the closest you can get to the patient’s own nerve in terms of structure, size and compatibility with the body’s healing processes. The technology also assures that we will have enough graft material to complete a successful surgical repair.”

AxoGen’s Chief Executive Officer, Karen Zaderej, noted, “With over 4 years of clinical use of our Avance® Nerve Graft in the United States and thousands of implantations, we often hear from surgeons and patients about their recovery journeys. We are pleased that this young patient can benefit from our technology.”

About Miami Children’s Hospital

Founded in 1950 by Variety Clubs International, Miami Children's Hospital® is South Florida’s only licensed specialty hospital exclusively for children, with more than 650 attending physicians and over 130 pediatric sub-specialists. The 289- bed hospital is renowned for excellence in all aspects of pediatric medicine with several specialty programs ranked among the best in the nation in 2008, 2009, 2010 and 2011 by U.S. News & World Report. The hospital is also home to the largest pediatric teaching program in the southeastern United States and has been designated an American Nurses Credentialing Center (ANCC) Magnet facility, the nursing profession’s most prestigious institutional honor.

About AxoGen, Inc.

AxoGen (OTCBB: AXGN) is a regenerative medicine company with a portfolio of proprietary products and 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 Avance® Nerve Graft, the only commercially available allograft nerve for bridging nerve discontinuities (a gap created when the nerve is severed) of 5mm to 70mm in length. AxoGen’s portfolio also includes AxoGuard® Nerve Connector, a coaptation aid allowing for close approximation of severed nerves gaps up to 5mm in length, and AxoGuard® Nerve Protector, a bioscaffold used to reinforce a coaptation site, wrap a partially severed nerve or isolate and protect nerve tissue.

AxoGen brings the science of nerve repair to life with thousands of surgical implants of AxoGen products and technology performed in hospitals and surgery centers across the United States, including military hospitals serving U.S. service men and women.

AxoGen is the parent of its wholly owned operating subsidiary, AxoGen Corporation. AxoGen’s principal executive office and operations are located in Alachua, FL.

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Cautionary Statements Concerning Forward-Looking Statements

This Press Release contains “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations or predictions of future conditions, events or results based on various assumptions and management’s estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as “expects”, “anticipates”, “intends”, “plans”, “believes”, “seeks”, “estimates”, “projects”, “forecasts”, “may”, “should”, variations of such words and similar expressions are intended to identify such forward-looking statements. The forward-looking statements may include, without limitation, statements regarding product development, product potential or financial performance. The forward-looking statements are subject to risks and uncertainties, which may cause results to differ materially from those set forth in the statements. Forward-looking statements in this release should be evaluated together with the many uncertainties that affect AxoGen’s business and its market, particularly those discussed in the risk factors and cautionary statements in AxoGen’s filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those projected. The forward-looking statements are representative only as of the date they are made, and AxoGen assumes no responsibility to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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Miami Children’s Hospital
Jennifer Caminas, 305-663-8476
Jennifer.Caminas@MCH.Com
www.mch.com
or
AxoGen, Inc.
Greg Freitag, 386-462-6856
Chief Financial Officer
InvestorRelations@AxoGenInc.com
www.axogeninc.com

Source: AxoGen, Inc.

Released June 26, 2012