Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and
marketing innovative surgical solutions for peripheral nerve
injuries, today announced topline results from its
RECON Clinical Study comparing Avance Nerve Graft to conduits
in digital nerve injuries. The Phase 3 pivotal study met its
primary endpoint for the return of sensory function as measured by
static two-point discrimination, and the safety profile was
consistent with previously published data. This data will support
the company’s Biologics License Application (BLA) submission in the
second half of 2023.
Additional analysis of the study data found:
- Avance demonstrated statistical superiority for return of
sensory function (measured by static two-point discrimination) as
compared to conduits in gaps greater than 12 mm (p-value
0.021).
- Avance demonstrated statistical superiority for time to
recovery of static two-point discrimination as compared to
conduits, returning normal sensation* up to 3 months earlier in
gaps greater than 10 mm (p-value 0.037).
- Conduit repairs were observed to have an increased likelihood
of persistent and unresolved nerve pain with an incidence of 9 (8%)
conduit subjects as compared to 2 (2%) Avance subjects.
“I would like to share my appreciation for the RECON
investigators and their study teams. Their commitment to the
importance of this research was essential in completing a study
with this quality of data and rigor of evidence and execution,”
said Co-Lead Investigator Jonathan Isaacs, MD., Professor and
Chair, Division of Hand Surgery Virginia Commonwealth University.
“The study data confirmed that as gap lengths increased, Avance
returned superior levels of sensation, and this was achieved at
earlier time points than those observed for conduits.”
“We are thrilled that the RECON study has met its primary
endpoint. This is a critical milestone towards transitioning Avance
Nerve Graft to a licensed biologic and further supports the
expanded adoption of Avance,” said Karen Zaderej, chairman, CEO,
and president of Axogen, Inc. “This study will provide Level 1
clinical evidence important to surgeons choosing among treatment
options for patients with peripheral nerve injuries. I want to
thank all of the participating subjects, clinical sites,
investigators, and our Axogen employees who have contributed to
this landmark study.”
* Normal Sensation is defined by the Medical Research Council
Classification (MRCC) score as S4 or return of static two-point
discrimination outcomes of ≤ 6mm.
About RECON RECON is a multicenter,
prospective, randomized, subject and evaluator blinded comparative
clinical study of nerve cuffs (manufactured conduits) and Avance®
Nerve Graft, evaluating recovery outcomes for the repair of nerve
discontinuities. The phase 3 pivotal study is designed to test for
non-inferiority between the static two-point discrimination
outcomes for Avance Nerve Graft and manufactured conduit. The study
design also allows for a sequential test for superiority of Avance
Nerve Graft, following the non-inferiority analysis.
About Avance Nerve GraftAvance Nerve Graft is a
biologically active off-the-shelf processed human nerve allograft
for bridging severed peripheral nerves without the comorbidities
associated with a second surgical site. Avance provides structural
guidance for regenerating axons, and revascularizes and remodels
into the patient’s own tissue. It is available in a variety of
lengths and diameters.
A 2010 written agreement between the FDA and Axogen allows the
company to continue marketing Avance as a Human Cells, Tissues and
Cellular and Tissue Based Product (HCT/P) while taking the
necessary steps to file a Biologics License Application (BLA).
In 2018 the FDA granted a Regenerative Medicine Advance Therapy
(RMAT) designation for Avance Nerve Graft. 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. The RMAT designation provides access to a
streamlined approval process for regenerative medicine technologies
and ensures continued informal meetings with the FDA in support of
the BLA for Avance Nerve Graft.
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; 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.
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 impact of COVID-19 on our
business, including but not limited to global supply chain issues,
hospital staffing challenges and its impact on our business,
statements regarding our growth, our financial guidance and
performance, product development, product potential, regulatory
process and approvals, APC renovation timing and expense, sales
growth, product adoption, market awareness of our products,
anticipated capital requirements, including the potential of future
financings, data validation, expected clinical study enrollment,
timing and outcomes, our assessment of our internal controls over
financial reporting, our visibility at and sponsorship of
conferences and our educational events, regulatory process and
approvals and other factors, including legislative, regulatory,
political, geopolitical, and economic developments, including
global business disruption caused by Russia’s invasion of Ukraine
and related sanctions, not within our control. 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 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, 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.Ed Joyce, Director,
Investor
Relationsejoyce@axogeninc.com InvestorRelations@axogeninc.com
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