AxoGen, Inc. Announces CE Mark Approval for AxoGuard® Nerve Protector and AxoGuard® Nerve Connector
Full Nerve Repair Product Portfolio Now Approved in Europe
Alachua, FL (PRWEB) May 01, 2013
AxoGen, Inc. (OTCBB: AXGN), a leading regenerative medicine company focused on the commercialization of proprietary products and technologies for peripheral nerve reconstruction and regeneration, today announced European CE Mark approval for two of its nerve repair products, AxoGuard® Nerve Protector and AxoGuard® Nerve Connector.
AxoGuard® Nerve Connector and AxoGuard® Nerve Protector are derived from a porcine submucosa extracellular matrix. The AxoGuard® Nerve Connector is a coaptation aid for tensionless repair of severed nerves and the AxoGuard® Nerve Protector is used to wrap and protect injured peripheral nerves and reinforce coaptation sites while preventing soft tissue attachments. AxoGen will utilize its existing distribution partners in Europe to sell the products. The AxoGuard® Products are complementary to AxoGen´s Avance® Nerve Graft, the only commercially available processed nerve allograft for bridging nerve discontinuities (gaps created when nerves are severed),which is available in the US, Canada, Austria, Italy and Switzerland. AxoGen has also recently completed the regulatory registration process for Avance® Nerve Graft in the UK and the Netherlands, and has partnered with Hospital Innovations (UK) and Taureon (Netherlands) to distribute its full family of nerve repair products.
AxoGen CEO Karen Zaderej commented, “The CE Mark approval for AxoGuard® Nerve Protector and AxoGuard® Nerve Connector is a significant milestone in our effort to expand availability of the AxoGen family of products to Europe and is an important step in our growth strategy. It allows our EU distribution partners to build on the initial launch of Avance® Nerve Graft in Europe and bring the rest of our portfolio of nerve repair products to surgeons and patients. Similar to the experience in the US, we believe these products will be well received to treat a wide variety of peripheral nerve injuries from simple lacerations of the finger to complex extremity reconstructions.”
About AxoGen, Inc.
AxoGen (AXGN) is a regenerative medicine company dedicated to advancing the science and commercialization of peripheral nerve repair solutions. The Company´s innovative approach to regenerative medicine has resulted in first-in-class products that will define their product categories. AxoGen´s products offer a full suite of surgical nerve reconstruction solutions including Avance® Nerve Graft, the only commercially available processed nerve allograft for bridging severed nerves without the comorbidities associated with a second surgical site, AxoGuard® Nerve Connector, a porcine submucosa ECM coaptation aid for tensionless repair of severed nerves, and AxoGuard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect injured peripheral nerves and reinforce coaptation sites while preventing soft tissue attachments. For more information, visit our website at http://www.axogeninc.com.
AxoGuard® Nerve Connector and AxoGuard® Nerve Protector are manufactured in the United States by Cook Biotech Incorporated, West Lafayette, Indiana, and are distributed exclusively by AxoGen.
AxoGen is the parent of its wholly owned operating subsidiary, AxoGen Corporation. AxoGen´s principal executive office and operations are located in Alachua, FL.
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”, “continue”, “may”, “should”, “will” 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, financial performance, sales growth, product adoption, market awareness of our products and data validation. 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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