Axogen Announces Independent Publication of Comparative Nerve Gap Repair Meta-Analysis of 35 peer-reviewed studies of Allograft, Autograft, and Conduits
05 January 2023 - 11:00PM
Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and
marketing innovative surgical solutions for peripheral nerve
injuries, today announced the independent publication of a
comprehensive, retrospective clinical review comparing the
meaningful recovery rates between allograft, autograft, and
conduits using a meta-analysis methodology. The comparative
peer-reviewed analysis was published online ahead of print by
Plastic and Reconstructive Surgery. The publication, “A systematic
review and meta-analysis of nerve gap repair: Comparative
effectiveness of allografts, autografts, and conduits,” analyzed 35
peer-reviewed studies with a total of 1,559 nerve repairs including
711 nerve allograft, 670 autograft, and 178 conduit repairs.
- The analysis concluded that meaningful
recovery rates for allograft and autograft repairs were comparable
across all gap lengths up to 70 millimeters.
- There were no statistical differences
between allograft and autograft outcomes for either short (5-30 mm)
or long (31-70 mm) gap lengths for both sensory and motor
repairs.
- Allograft and autograft repairs
delivered significantly better rates of meaningful sensory recovery
in short gaps as compared to conduit repairs; 87.1% and 81.6% vs.
62.2%, respectively, p<0.05.
- The cost analysis found that allograft
does not represent an increased economic burden compared to
autograft.
“The analysis found that meaningful recovery rates
for allograft and autograft repairs showed no significant
differences regardless of the gap length or nerve type; sensory,
motor, or mixed, and both groups were significantly better than
conduit repairs,” said senior author Joseph Styron, M.D., Ph.D.,
Orthopedic Surgeon at the Cleveland Clinic.
Study authors also noted that, although autograft
has been the historical standard of care for repairing peripheral
nerve injuries, it is important to consider autograft donor site
complications that may impact patient quality of life. These
complications can include infection at the donor site or pain
associated with neuroma formation.
“This paper provides the strongest clinical
evidence to-date of the performance of Avance® Nerve Graft, the
nerve allograft included in this study, across all gap lengths and
nerve types. This comprehensive analysis of peer-reviewed studies
illustrates that compared to autograft, Avance is just as
effective, with similar procedure costs, while eliminating the
potential for complications or reduced quality of life resulting
from autograft nerve harvesting,” commented Karen Zaderej,
chairman, CEO, and president of Axogen, Inc. “With more than 50,000
implants since launch, Avance is a proven solution for providing
patients the opportunity to achieve meaningful functional recovery
without the need for autograft harvest.”About the
StudyThe primary aim for the study was to compare the
meaningful recovery rates of autograft, allograft, and conduit
nerve repair alternatives. The clinical studies analyzed were found
by screening publications from the last 40 years in the National
Library of Medicine’s MEDLINE database while following the
Preferred Reporting Items for Systematic Reviews and Meta-Analyses
(PRISMA) guidelines. Two independent reviewers evaluated each study
against inclusion criteria requiring nerve injury type, repair
type, gap length, and outcomes reported using standard two-point
discrimination, Semmes-Weinstein monofilament testing, and/or
Medical Research Council Classification (MRCC) such that meaningful
recovery rates (≥MRCC S3/M3) could be determined. For techniques
with non-significant differences, an additional analysis was
performed to assess procedural costs. This analysis was conducted
using national Medicare hospital claims data for 2018. Axogen Inc.
provided funding for the study. The paper can be accessed on the
Plastic and Reconstructive Surgery website.
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.
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, Germany, the United Kingdom, Spain,
South Korea, and several other countries.
Contact:Axogen, Inc.Ed Joyce, Director,
Investor Relationsejoyce@axogeninc.com
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