Axogen, Inc. Begins Processing Avance® Nerve Graft at New State-of-the-Art Facility in Dayton, Ohio
21 Agosto 2023 - 8:00AM
Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and
marketing innovative surgical solutions for peripheral nerve
injuries, today announced the successful first week of processing
for Avance Nerve Graft at the newly opened Axogen Processing Center
(APC), in Dayton, Ohio.
“We are pleased to mark this significant milestone as we begin
processing Avance Nerve Graft in our new APC facility,” commented
Karen Zaderej, Axogen's Chairman, CEO, and President. “The APC is a
world-class tissue processing center that will support our
Biologics License Application (BLA) submission in the first half of
2024 and our long-term growth. The BLA will further solidify our
leadership in the nerve market, as we continue to provide surgeons
and their patients with improved quality-of-life solutions for
nerve-related challenges.”
The commencement of Avance processing in the APC is an
important step towards the biologics validation that will
support the submission of the BLA. The new 107,000 square feet
facility includes ISO14644 clean rooms, internal quality labs, a
surgeon and tissue agency training lab, and state-of-the-art
support systems and redundancies required of high-quality, biologic
processes. The APC provides up to three times the current
processing capacity and was designed for future growth and
expansion.
“The local team in Dayton has done an impressive job in the
construction of this world-class processing center,” remarked Todd
Puckett, Vice President, Manufacturing. “We have assembled an
excellent team of nearly 100 employees who are deeply committed to
honoring the gift of tissue donation as we continue to
revolutionize the science of nerve repair. We also appreciate our
partnership with the State of Ohio, the City of Vandalia, and the
Dayton Development Coalition for their support in the development
of the APC.”
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 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 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 statements on the
timetable for the BLA submission in the first half of 2024, the
role of the APC in supporting the BLA submission, future APC
capacity and expansion capabilities, and statements on future
growth. Actual results or events could differ materially from those
described in any forward-looking statements as a result of various
factors, including, without limitation, statements related to the
continued impact of COVID-19, global supply chain issues, record
inflation, hospital staffing issues, product development, product
potential, expected clinical enrollment timing and outcomes,
regulatory process and approvals, APC renovation 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, 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.InvestorRelations@axogeninc.com
Media Inquiries:Ignacio
Guerrero-Ross, Ph.D.Russo
Partners646.942.5604ignacio.guerrero-ros@russopartnersllc.com
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