Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and
marketing innovative surgical solutions for damage or transection
to peripheral nerves, today announced completion of pilot phase
analysis for its REPOSE clinical study.
Analysis of the REPOSE study’s 15-subject single arm pilot phase
demonstrated that subjects experienced a clinically significant
reduction in pain from baseline at each of the 3, 6, 9, and 12
month timepoints following surgical excision of the neuroma and
placement of Axoguard Nerve Cap® (p<0.0001). Specifically, the
study observed a mean reduction in pain of 69 points at 3 months
and 80 points at 12 months as measured on the 100-point Visual
Analog Scale (VAS). Additionally, subjects experienced clinically
meaningful improvements in Fatigue, Physical Function, Sleep
Disturbance, Pain Interference, Pain Intensity, and Pain Behavior
as measured by the validated PROMIS® questionnaires, and pain
medication utilization data showed positive indicators for a
reduction of pain medication burden, including opioids, following
the procedure.
“Neuroma pain can be a challenging clinical condition to manage,
and results from historical treatment options, both surgical and
pharmacological, can be limited,” said Craig Thomajan, DPM, FACFAS,
FAENS, Peripheral Nerve Surgeon at Austin Foot and Ankle
Specialists, and the lead clinical investigator for REPOSE. “We are
pleased with the early successes from REPOSE and are excited to
continue this meaningful study. Access to impactful technologies
for the treatment and prevention of symptomatic neuromas offers
patients an opportunity for reduced pain and improved quality of
life.”
“We are pleased that the analysis of this pilot phase clinical
data demonstrates the potential impact our Axoguard Nerve Cap can
have on symptomatic neuroma pain. The outcomes reinforce the
assumptions used in our study modeling and exceed those reported
for standard neurectomy,” said Karen Zaderej, chairman, CEO, and
president. “We believe the comparative phase of the study will
support the role of Axoguard Nerve Cap in the management of
symptomatic neuroma. We continue to be committed to providing
surgeons with clinical evidence advancing the science of nerve
repair, including surgical treatments that provide clinically
meaningful improvements for patients suffering with chronic nerve
pain.”
Enrollment in the comparative phase of REPOSE is underway and
the company expects enrollment to be completed in the first quarter
of 2022, assuming limited impact from COVID-19.
About REPOSEA Multicenter, Prospective,
Randomized and Subject Blinded Comparative Study of Axoguard Nerve
Cap and Neurectomy for the Treatment of Symptomatic Neuroma and
Prevention of Recurrent End-Neuroma Pain (REPOSE) is the company’s
post-market study comparing placement of Axoguard Nerve Cap to
standard neurectomy alone for subjects with symptomatic neuroma
pain. The study design includes a 15 subject open label pilot
phase and up to 86 subjects in a randomized comparative phase. The
study requires a one year follow up period for all subjects and is
designed to assess changes in pain scores as measured by Visual
Analog Scale, quality of life outcomes, medication usage, and
subject satisfaction.
About Axoguard Nerve CapAxoguard Nerve Cap is a
porcine submucosa ECM product used to protect a peripheral nerve
end and separate the nerve from the surrounding environment to
reduce the development of symptomatic or painful neuroma. Axoguard
Nerve Cap provides protection for a peripheral nerve end or stump
where repair is unattainable or not desired.
About AxogenAxogen (AXGN) is the
leading company focused specifically on the science, development,
and commercialization of technologies for peripheral nerve
regeneration and repair. Axogen employees are passionate about
helping to restore peripheral nerve function and quality of life to
patients with physical damage or transection to peripheral nerves
by providing innovative, clinically proven, and economically
effective repair solutions for surgeons and health care providers.
Peripheral nerves provide the pathways for both motor and sensory
signals throughout the body. Every day, people suffer traumatic
injuries or undergo surgical procedures that impact the function of
their peripheral nerves. Physical damage to a peripheral
nerve, or the inability to properly reconnect peripheral nerves,
can result in the loss of muscle or organ function, the loss of
sensory feeling, or the initiation of pain.
Axogen's platform for peripheral nerve repair features a
comprehensive portfolio of products, including Avance® Nerve Graft,
a biologically active off-the-shelf processed human nerve allograft
for bridging severed peripheral 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 peripheral nerves; Axoguard® Nerve
Protector, a porcine submucosa ECM product used to wrap and protect
damaged peripheral nerves and reinforce the nerve reconstruction
while preventing soft tissue attachments; Axoguard Nerve Cap®, a
porcine submucosa ECM product used to protect a peripheral nerve
end and separate the nerve from the surrounding environment to
reduce the development of symptomatic or painful neuroma; and
Avive® Soft Tissue Membrane, a processed human umbilical cord
intended for surgical use as a resorbable soft tissue barrier. The
Axogen portfolio of products is available in the United States,
Canada, the United Kingdom, South Korea, and several other European
and international countries.
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,” “goals,” and variations of
such words and similar expressions are intended to identify such
forward-looking statements. The forward-looking statements may
include, without limitation, statements related to the
expected impact of COVID-19 on our business, statements
regarding our growth, product development, product potential,
financial performance, sales growth, product adoption, market
awareness of our products, data validation, our assessment of our
internal controls over financial reporting, our visibility at and
sponsorship of conferences and educational events. The
forward-looking statements are and will be subject to risks and
uncertainties, which may cause actual results to differ materially
from those expressed or implied in such forward-looking statements.
Forward-looking statements contained in this press release should
be evaluated together with the many uncertainties that affect our
business and our market, particularly those discussed under Part I,
Item 1A., “Risk Factors,” of our Annual Report on Form 10-K, as
amended on Form 10-K/A, for the fiscal year ended December 31,
2019, as well as other risks and cautionary statements set forth in
our filings with the U.S. Securities and Exchange Commission.
Forward-looking statements are not a guarantee 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 applicable
law, we assume no responsibility to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events, changed circumstances, or otherwise.
Contact:Axogen, Inc.Peter Mariani, Chief Financial
OfficerInvestorRelations@axogeninc.com
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