AxoGen, Inc. To Host First International Surgeon Training Course and Announces Presentation of New Clinical Data at European Hand Meeting
Nerve repair company AXGN continues expansion of international presence
ALACHUA, FL – June 15, 2015 – AxoGen, Inc. (NASDAQ: AXGN), a leading medical technology company focused on restoring quality of life through nerve repair, today announced full enrollment of its first OUS surgeon training course to be held immediately prior to the 20th Congress of the Federation of European Societies for Surgery of the Hand (FESSH), June 17-20 in Milan, Italy. The program, titled “Advances and Best Practices in Upper Extremity Nerve Repair”, will be led by a faculty of internationally known surgeons from the US and Europe including Dr. Peter Evans, Cleveland, OH; Dr. Bauback Safa, San Francisco, CA; Dr. Ivica Ducic, McLean, VA; Dr. Esther Voegelin, Bern, Switzerland; and Dr. Joaquim Casanas of Barcelona, Spain.
In addition to the course, the Company also announced acceptance of three clinical presentations at FESSH on the use of its processed human nerve allograft, Avance® Nerve Graft. Study investigator Dr. Bauback Safa of the Buncke Clinic will give the presentations based on data subsets from the RANGER® Study, an ongoing, multicenter, observational registry in peripheral nerve repair. The first presentation, “Outcomes from a Subgroup Analysis of a National Registry Study on the Utilization of Processed Nerve Allografts for Large Gap Nerve Discontinuities” will focus on the use of Avance® Nerve Graft to repair long gaps in nerve tissue in the hand and upper extremity. In the second presentation, “Multicenter Study Comparing Matched Outcomes of Processed Nerve Allograft, Tube Conduit and Nerve Autograft”, Dr. Safa will present a comparison of outcomes from nerve repairs in the upper extremity using Avance® Nerve Graft, hollow-tube conduit and autograft nerve tissue. The third presentation, “Outcomes of Digital Nerve Gap Reconstructions with Processed Nerve Allografts from a National Registry Study”, will focus on outcomes of digital nerve repairs made with Avance® Nerve Graft.
“In addition to being the largest multicenter clinical study in peripheral nerve repair, the depth of the RANGER® Study increasingly allows surgeons to understand the clinical outcomes of processed nerve allograft in specific nerve injury situations such as long gap and digital nerves,” said Dr. Safa. “AxoGen’s portfolio of off-the-shelf nerve repair products has changed the way I surgically repair injured and damaged nerves and I look forward to sharing and exchanging best practices with our European colleagues at the FESSH Congress.”
AxoGen will also be demonstrating its products at the FESSH technical exhibition for surgeons attending the FESSH congress.
The Federation of European Societies for Surgery of the Hand (FESSH) is an organization which represents national hand surgery societies in Europe and seeks to define the highest standards for hand surgery throughout Europe, to implement and sustain study and research, and to identify optimal training programs.
About the RANGER® Study
The RANGER® Study, A Multicenter Retrospective Study of Avance® Nerve Graft Utilization Evaluations and Outcomes in Peripheral Nerve Injury Repair is an active, multicenter clinical database with 18 contributing centers designed to continuously monitor and collect injury, repair, safety and outcomes data for peripheral nerve injuries repaired with processed nerve allograft (Avance® Nerve Graft), nerve autograft and hollow tubes. As of May 2015, more than 650 nerve repairs enrolled across 18 centers and 40 surgeons. The RANGER® Study, is an AxoGen sponsored ongoing open label registry study. Each patient outcome is dependent upon the nature and extent of nerve loss or damage, timing between nerve loss and repair and the natural course of the patient’s recovery. Results presented at the FESSH meeting may not represent typical clinical outcomes for individual patients.
About AxoGen, Inc.
AxoGen (NASDAQ: AXGN) is a leading medical technology company dedicated to peripheral nerve repair. AxoGen's portfolio of regenerative medicine products is available in the United States, Canada and several European countries and includes Avance® Nerve Graft, the only off-the-shelf commercially available processed nerve allograft for bridging severed nerves without the comorbidities associated with a second surgical site, AxoGuard® Nerve Connector, a porcine submucosa extracellular matrix ("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 the nerve reconstruction while preventing soft tissue attachments.
Avance® Nerve Graft is processed in the United States by AxoGen. AxoGuard® Nerve Connector and AxoGuard® Nerve Protector are manufactured in the United States by Cook Biotech Incorporated, and are distributed exclusively by AxoGen. AxoGen maintains its corporate offices in Alachua, Florida and is the parent of its wholly owned operating subsidiary, AxoGen Corporation.
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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", "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 commercialization and marketing efforts for its portfolio of peripheral nerve repair products, Avance® Nerve Graft, AxoGuard® Nerve Connector and AxoGuard® Nerve Protector, product development, financial performance, sales growth, product adoption, market awareness of our products, data validation and the intent to list on a national securities exchange. 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.
Source: AxoGen, Inc.
Lee Robert “Bob” Johnson, CFO
Released June 15, 2015