Axogen RECON(SM) Clinical Study Completes Subject Follow-up
September 01 2021 - 7:00AM
Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and
marketing innovative surgical solutions for damage or discontinuity
to peripheral nerves, today announced that the RECON Clinical Study
supporting its Biologics License Application (BLA) for Avance Nerve
Graft has completed follow-up of study subjects.
RECON reached its enrollment target of 220 subjects in July
2020. The study remains on schedule with a top line study data
read-out expected in the second quarter of 2022, followed by filing
of the BLA submission in 2023. RECON compares Avance Nerve Graft to
manufactured conduits in digital nerve injuries with a primary
endpoint of recovery of static two-point discrimination, a measure
of sensation, and secondary endpoints for quality of life and
subject satisfaction. The BLA will transition Avance Nerve Graft
from a human tissue product to a biological product.
“We are pleased to have reached this milestone and thank the
study investigators and research teams for their dedication and
commitment to this landmark study,” commented Karen Zaderej,
chairman, CEO, and president of Axogen. “The RECON study is
designed to provide Level 1 clinical data for our BLA, and will
provide additional evidence for surgeons in their clinical decision
making for the repair of peripheral nerve injuries.”
About the RECON Clinical StudyRECON 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 September 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.
Contact:Axogen, Inc.Peter Mariani, Executive Vice
President and Chief Financial
OfficerInvestorRelations@axogeninc.com
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