Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and
marketing innovative surgical solutions for peripheral nerve
injuries, announces the launch of its newest product, Avive+ Soft
Tissue Matrix™. Avive+™ is intended for use as a soft tissue
barrier and is a resorbable, multi-layer amniotic membrane
allograft that provides temporary protection and tissue separation
during the critical phase of peripheral nerve healing. Avive+ is
processed and distributed in accordance with U.S. Food and Drug
Administration (FDA) requirements for Human Cellular and
Tissue-based Products (HCT/P) under 21 CFR Part 1271 regulations,
U.S. State regulations as a 361 human tissue product.
“Product innovation is integral to our mission
at Axogen," stated Karen Zaderej, Chairman, CEO, and President.
"With the introduction of Avive+ Soft Tissue Matrix, we are excited
to enhance our comprehensive solutions for nerve protection and
address a significant need for patients with compression or
non-transected nerve injuries.”
Nerve protection represents approximately $800
million of the overall nerve repair market and covers a wide range
of injuries and defects including carpal and cubital tunnel
syndromes, crush injuries, and other non-transected traumatic nerve
injuries. The diversity of these injury types and their anatomical
locations present unique challenges and Axogen is committed to
optimizing outcomes for patients, using its targeted portfolio of
solutions to address the needs of each injury type, and the healing
process. Avive+ Soft Tissue Matrix complements the Company’s
existing portfolio of nerve protection products, which includes
Axoguard Nerve Protector® and Axoguard HA+ Nerve Protector™.
"As a hand surgeon, I've seen the positive
impact of using Avive+ Soft Tissue Matrix,” stated Sunishka
Wimalawansa, MD, Associate Professor of Orthopedic and Plastic
Surgery at Wright State University in Dayton, OH. "The multi-layer
design provides ideal handling, a robust barrier that retains the
inherent properties of an amniotic membrane, and most importantly,
the opportunity to improve patient outcomes after acute traumatic
injury."
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 used across various
applications and surgical specialties, including traumatic
injuries, oral and maxillofacial surgery, breast reconstruction,
and the surgical treatment of pain. These applications encompass
both scheduled and emergent procedures. Specifically, scheduled
procedures are often pursued by patients seeking relief from
conditions caused by a nerve defect or previous surgical
interventions. Such procedures include providing sensation for
women undergoing breast reconstruction following a mastectomy,
nerve reconstruction after the surgical removal of painful
neuromas, and oral and maxillofacial procedures, as well as nerve
decompression. Conversely, emergent procedures typically arise from
injuries that initially present in an emergency room, with
specialists intervening either immediately or within a few days
following the initial injury. This broad range of applications
underscores Axogen’s vital role in addressing diverse patient needs
in peripheral nerve repair.
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
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; Avive+ Soft
Tissue Matrix™, a multi-layer amniotic membrane allograft used to
protect and separate tissues in the surgical bed during the
critical phase of tissue repair; 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, the United
Kingdom, South Korea, and several other European and international
countries.
For more information, visit www.axogeninc.com
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 Ms. Zaderej’s
statement that Avive+ Soft Tissue Matrix will address a significant
need for patients with compression or non-transected nerve
injuries, as well as statements relating to the estimated size of
the nerve protection market. Actual results or events could differ
materially from those described in any forward-looking statements
as a result of various factors, including, without limitation,
global supply chain issues, hospital staffing issues, product
development, product potential, clinical outcomes, regulatory
process and approvals, 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, potential disruptions due to
management transitions, 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. 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.
Contact:Axogen, Inc.Harold D. Tamayo, Vice
President of Finance, and Investor
Relationshtamayo@axogeninc.com
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