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,
2016AxoGen 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,
2016AxoGen 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,
2016AxoGen 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® StudyThe
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 2016FESSH 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
About AxoGen 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
StatementsThis 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.
Contacts:
AxoGen, Inc.
Peter J. Mariani, Chief Financial Officer
386.462.6856
InvestorRelations@AxoGenInc.com
The Trout Group – Investor Relations
Brian Korb
646.378.2923
bkorb@troutgroup.com
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