Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and
marketing innovative surgical solutions for peripheral nerve
injuries, today announced positive topline results from its REPOSE
clinical study comparing standard-of-care neurectomy of symptomatic
neuroma to neurectomy and protection of the terminated nerve end
with Axoguard Nerve Cap. The post-marketing study met its primary
endpoint for reduction in pain as measured by visual analog scale
(p-value <0.05).
Additional data analysis found that over the
12-month course of follow-up, the Axoguard Nerve Cap group
demonstrated statistical superiority for reduction in the total
pain reported by participants compared to the standard-of-care
neurectomy group (p-value <0.05).
“We are pleased with the study outcomes and the
quality of data gathered in the REPOSE study,” said Lead
Investigator Craig Thomajan, DPM, Founder and Managing Partner of
Austin Foot & Ankle Specialists. “The data suggest that the
addition of Axoguard Nerve Cap to isolate and protect the
peripheral nerve ends following a neurectomy is a better treatment
option than standard-of-care neurectomy alone for managing
symptomatic neuroma pain.”
“This data builds on our body of clinical
evidence that supports increased adoption of Axoguard Nerve Cap
amongst surgeons and their patients who are seeking solutions that
may enhance quality of life following nerve resection to manage
chronic neuropathic pain,” commented Karen Zaderej, chairman, CEO,
and president. “I am grateful to all study participants and
investigators, as well as the Axogen team for their unwavering
commitment to delivering improved solutions for patients suffering
from peripheral nerve injuries.
About REPOSE®
REPOSE is a multicenter, prospective,
randomized, subject blinded comparative clinical trial of standard
neurectomy and neurectomy followed by placement of Axoguard Nerve
Cap, evaluating recovery outcomes for the treatment of symptomatic
neuroma. The post-market study is designed to test for
non-inferiority between the pain visual analog scale outcomes for
neurectomy with Axoguard Nerve Cap and standard neurectomy. The
study design also allows for a sequential test for superiority of
neurectomy with Axoguard Nerve Cap, following the non-inferiority
analysis.
About Axoguard Nerve Cap®
Axoguard Nerve Cap is a proprietary surgical implant derived
from porcine submucosal extracellular matrix that is remodeled
during healing and is used to isolate and protect a peripheral
nerve end from the surrounding environment to reduce symptomatic or
painful neuroma development.
About Axogen
Axogen (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 that are used across
two primary application categories: scheduled, non-trauma
procedures and emergent trauma procedures. Scheduled procedures are
generally characterized as those where a patient is seeking relief
from conditions caused by a nerve defect or surgical procedure.
These procedures include providing sensation for women seeking
breast reconstruction following a mastectomy, nerve reconstruction
following the surgical removal of painful neuromas, oral and
maxillofacial procedures, and nerve decompression. Emergent
procedures are generally characterized as procedures resulting from
injuries that are initially present in an ER. These procedures are
typically referred to and completed by a specialist either
immediately or within a few days following the initial injury.
Axogen’s product portfolio includes 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 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
HA+ Nerve Protector™, a porcine submucosa ECM base layer coated
with a proprietary hyaluronate-alginate gel, a next-generation
technology designed to enhance nerve gliding and provide short- and
long-term protection for peripheral nerve injuries; and 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. The Axogen portfolio of products is available in the
United States, Canada, Germany, the United Kingdom, Spain, South
Korea, and several other countries.
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,” “goals,” and variations of such words and similar
expressions are intended to identify such forward-looking
statements. Forward-looking statements include the outcome of the
REPOSE Clinical study of Axoguard Nerve Cap after full data is
available, statements and expectations regarding the adoption of
Axoguard Nerve Cap among surgeons and their patients, and
statements regarding the use of Axoguard Nerve Cap following a
neurectomy being a better treatment option for managing chronic
neuropathic pain as compared to standard neurectomy." Actual
results or events could differ materially from those described in
any forward-looking statements as a result of various factors,
including, without limitation, potential disruptions caused by
leadership transitions, global supply chain issues, record
inflation, hospital staffing issues, product development, product
potential, expected clinical enrollment timing and outcomes,
regulatory process and approvals, APC transition timing and
expense, financial performance, sales growth, surgeon and product
adoption, market awareness of our products, data validation, our
visibility at and sponsorship of conferences and educational
events, global business disruption caused by Russia’s invasion of
Ukraine and related sanctions, recent geopolitical conflicts in the
Middle East, as well as those risk factors described under Part I,
Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the
most recently ended fiscal year and Part II, Item 1A., “Risk
Factors,” for our Quarterly Report on Form 10-Q for the most
recently ended fiscal quarter. 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.
For more information, visit www.axogeninc.com
Contact:Axogen, Inc.Harold D.
Tamayo, Vice President of Finance and Investor
Relationshtamayo@axogeninc.com
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