Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and
marketing innovative surgical solutions for peripheral nerve
injuries, is pleased to announce that it has initiated the rolling
submission process with the U.S. Food and Drug Administration for a
Biologics License Application (BLA) for licensure of Avance Nerve
Graft® on May 15, 2024.
“Today’s milestone represents a significant step
in our regulatory transition of Avance Nerve Graft to a biologic,”
said Karen Zaderej, chairman, CEO, and president of Axogen, Inc. “I
am grateful to our Axogen team and their diligence as we work
towards completing the rolling BLA submission process.”
The initial submission to the U.S. FDA includes
the complete non-clinical data package for the BLA. Consistent with
the agreed schedule, we plan to provide the remaining Clinical and
Chemistry, Manufacturing and Controls (CMC) components in the
coming months. The rolling submission process allows for the
submission of pre-agreed components of the BLA to be submitted as
they are completed, which can streamline the regulatory review
process.
Avance Nerve Graft was granted a Regenerative
Medicine Advanced Therapy (RMAT) designation. The RMAT designation,
under the 21st Century Cures Act, aims to streamline the
development of regenerative medicine therapies intended for the
treatment of serious diseases and life-threatening conditions. A
regenerative medicine therapy is eligible for the designation if it
is intended to treat, modify, reverse, or cure a serious or
life-threatening disease or condition, and preliminary clinical
evidence indicates that the product has the potential to address
unmet medical needs for such a disease or condition. RMAT
designation provides a number of benefits including FDA guidance on
efficient drug development and potential priority review of the
BLA. Axogen will request priority review status for this BLA which,
if granted, could reduce the standard review timeline from 10
months to the priority timeline of 6 months.
Approximately 45 to 60 days after the final
components are submitted, FDA will provide a notification of formal
acceptance and the review timeline. We anticipate the BLA filing to
be completed in the third quarter of 2024 and we believe the
procedural timelines for review combined with the rolling
submission process will allow for approval around mid-2025.
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 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
markets.For more information, visit www.axogeninc.com.
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. Forward-looking statements include the
Company’s statements of its expectations and estimates regarding
completion of the rolling BLA submission in the third quarter of
2024, statements of its plan to provide the remaining Clinical and
Chemistry, Manufacturing and Controls components of the BLA to the
FDA in the coming months, statements of the estimated time of
potential BLA approval in mid-2025, and statements of optimism
regarding priority review. 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 potential 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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