ALACHUA, Fla., June 21, 2016 (GLOBE NEWSWIRE) -- AxoGen, Inc. (NASDAQ:AXGN), a leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced the acceptance of four presentations at the Congress of the Federation of European Societies for Surgery of the Hand (FESSH) related to use of Avance® Nerve Graft, including data from the RANGER® Registry. The data to be presented highlights that sensory and motor recovery outcomes from Avance® Nerve Graft repairs, in this group of patients, were found to compare favorably with autograft (nerve transplanted from the patient’s own body). The data contained mixed nerve injuries up to 70 mm repaired with either Avance® Nerve Graft or autograft and both reported outcomes with greater than 85% meaningful recovery.
In addition to these scientific presentations, the FESSH congress, held June 22-25, 2016 at the Santander Exhibition Center in Santander, Spain, will feature two peripheral nerve repair pre-courses, a panel discussion on peripheral nerve repair and AxoGen’s full portfolio of nerve repair products at FESSH Booth 8.
“We are pleased to see the presentation of clinical and scientific data at this year’s FESSH conference supporting the role of Avance® Nerve Graft as a repair alternative for major nerve repairs,” stated Karen Zaderej, AxoGen’s President and Chief Executive Officer. “We believe surgeons gain confidence in our new technologies and convert their surgical decisions with increasing awareness of data and thoughtful peer-to-peer discussions. These initiatives reinforce AxoGen’s position as the preeminent choice for peripheral nerve repair surgery.”
The presentation details for the FESSH conference are as follows:
Tuesday, June 21, 2016
AxoGen Sponsored Pre-Course: Multidisciplinary Peripheral Nerve Disorders. Directors and Lecturers: Joaquim Casañas, Manuel Llusa, Victor Mayoral, A. Isabel Fernandez Conejero, A. Turon, Ivan Ducic, Jordi Serra, Gregory Buncke
Wednesday, June 22, 2016
AxoGen Sponsored Pre-Course: Advances & Best Practices In Upper Extremity Nerve Repair. Faculty: Gregory Buncke, MD, The Buncke Clinic; Joaquim Casañas, MD, Centro Médico Teknon; Ivan Ducic MD, PhD, Nerve and Headache Institute; Bauback Safa MD, MBA, The Buncke Clinic; and Peter Evans, MD, PhD, FRCSC, Cleveland Clinic.
Thursday, June 23, 2016
AxoGen Panel Discussion: Advances in Nerve Repair & Regeneration. Faculty: Joaquim Casañas, MD, Centro Médico Teknon; Bauback Safa MD, MBA, The Buncke Clinic; Peter Evans, MD, PhD, FRCSC, Cleveland Clinic, and Erick DeVinney, AxoGen.
Scientific presentation: A-0590 Comparison of Outcomes from Mixed Nerve Reconstructions in the Upper Extremity with Processed Nerve Allografts and Nerve Autograft from a National Registry Study. Authors: Bauback Safa, MD, MBA, Jason Ko, MD, Harry Hoyen, MD, Wesley Thayer, MD, Gregory Buncke, MD; The Buncke Clinic, San Francisco, USA; University of Washington, Seattle, USA; MetroHealth System, Cleveland, USA; Vanderbilt University Medical Center, Nashville, USA
Scientific presentation: A-0592 Characterization of Processed Human Nerve Allograft with an Organotypic Neurite Outgrowth Measurement. Authors: Jennifer Faleris, Erick DeVinney, Curt Deister, PhD; AxoGen
Scientific presentation: A-0594 Outcome Assessment by Gap Length of Digital Nerve Gap Reconstructions with Processed Nerve Allografts and Manufactured Tube Conduits from a National Registry Study. Authors: Bauback Safa, MD, MBA, Jason Ko, MD, Harry Hoyen, MD, Wesley Thayer, MD, Gregory Buncke, MD; The Buncke Clinic, San Francisco, USA; University of Washington, Seattle, USA; MetroHealth System, Cleveland, USA; Vanderbilt University Medical Center, Nashville, USA
Scientific presentation: A-0641 Novel Methodology for Automated Quantification and Assessment of Bioactive Laminin Endoneurial Tube Scaffolding in Peripheral Nerve Repair Implants.
Authors: Erick DeVinney, Jennifer Faleris, Curt Deister, PhD; AxoGen
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 synthetic tubes. As of May 2016, the study included more than 850 nerve repairs enrolled across 18 centers and 48 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 FESSH 2016
FESSH 2016 Congress is the key annual conference organized by the Federation of European Societies for Surgery of the Hand (FESSH), focused on hand, wrist and microsurgery. For more information on the conference, please visit www.fessh2016.com
AxoGen (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 other countries and includes Avance® Nerve Graft, an off-the-shelf processed human 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. Along with these core surgical products, AxoGen also offers AxoTouchTM Two-Point Discriminator and AcroValTM Neurosensory & Motor Testing System. These evaluation and measurement tools assist healthcare professionals in detecting changes in sensation, assessing return of sensory, grip and pinch function, evaluating effective treatment interventions, and providing feedback to patients on nerve function.
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 our growth, our 2016 guidance, product development, product potential, financial performance, sales growth, product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events. 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, except as required by law, AxoGen assumes no responsibility to update any forward-looking statements, whether as a result of new information, future events or otherwise.