Aziyo Biologics Provides Update on FDA Submission for CanGaroo® RM Antibacterial Envelope
March 20 2023 - 8:00AM
Aziyo Biologics, Inc. (Nasdaq: AZYO), a company that develops and
commercializes biologic products to improve compatibility between
medical devices and the patients who need them, provides an update
on its submission to the U.S. Food and Drug Administration (FDA)
for the CanGaroo® RM Antibacterial Envelope, the Company’s
next-generation biomaterial envelope. The device is intended to
securely hold a cardiac implantable electronic device or
neurostimulator, creating a stable environment when implanted in
the body. The CanGaroo RM Antibacterial Envelope contains the
antibiotics rifampin and minocycline, which have been shown in
preclinical testing to reduce bacterial colonization on the
envelope.
As previously announced, the Company submitted a
510(k) premarket notification for the CanGaroo RM
Antibacterial Envelope to the FDA in April 2022. As a combination
product containing device and drug components, the filing was
reviewed by the Center for Devices and Radiological Health (CDRH)
and the Center for Drug Evaluation and Research (CDER). On March
16, 2023, the Company received a Not Substantially
Equivalent determination from FDA. The notice defined the
outstanding items that need to be addressed in order to obtain
market clearance. The items relate to drug testing, primarily a
request by FDA to modify an in vitro drug release assay employed as
a manufacturing control. As a result, the Company does not expect
to appeal the decision, as it believes the most expeditious path
forward is to work with FDA to provide the additional data
requested.“While we are disappointed with the delay, we are
gratified that the completed review did not raise any questions
surrounding the appropriateness of the pathway or majority of the
data submitted to support the filing,” said Dr. Randy Mills,
President and Chief Executive Officer of Aziyo Biologics. “We
have our marching orders and are confident that we can address the
FDA’s questions promptly.”
As a reminder, Aziyo Biologics’ management team
will be hosting its previously scheduled conference call and
webcast to discuss its fourth quarter and full-year 2022 financial
results on Wednesday, March 22, 2023 at 4:30 p.m. ET. The Company
will provide additional information at that time.
About Aziyo BiologicsAziyo
develops and commercializes biologic products to improve
compatibility between medical devices and the patients who need
them. With a growing population in need of implantable
technologies, Aziyo’s mission is to humanize medical devices to
improve patient outcomes. For more information,
visit www.Aziyo.com.
Forward-Looking StatementsThis
press release contains “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements can be identified by words such as
“projects,” “may,” “will,” “could,” “would,” “should,” “believes,”
“expects,” “anticipates,” “estimates,” “intends,” “plans,”
“potential,” “promise” or similar references to future periods. All
statements contained in this press release that do not relate to
matters of historical fact should be considered forward-looking
statements, including statements regarding the potential regulatory
clearance of CanGaroo RM. Forward-looking statements are based on
management’s current assumptions and expectations of future events
and trends, which affect or may affect the Company’s business,
strategy, operations or financial performance, and actual results
may differ materially from those expressed or implied in such
statements due to numerous risks and uncertainties. Forward-looking
statements are inherently subject to risks and uncertainties, some
of which cannot be predicted or quantified, and other important
factors that may cause actual results, performance or achievements
to differ materially from those contemplated or implied in this
press release, including, but not limited to, risks regarding the
Company’s products and its ability to enhance, expand, develop and
commercialize its product offerings; the Company’s significant
litigation related to the impact on the Company’s business of the
recall of a single lot of its FiberCel product and the
discontinuation of its sales by its distribution partner; the
Company’s dependence on its commercial partners; the Company’s
future capital needs and available sources of funding; the adverse
changes in economic conditions and instability and disruption of
credit markets; physician awareness of the distinctive
characteristics, and acceptance by the medical community, of the
Company’s products; the ability to obtain regulatory approval or
other marketing authorizations; and the Company’s intellectual
property rights, and other important factors which can be found in
the “Risk Factors” section of Aziyo’s public filings with the
Securities and Exchange Commission (“SEC”), including Aziyo’s
Annual Report on Form 10-K for the year ended December 31, 2021, as
such factors may be updated from time to time in Aziyo’s other
filings with the SEC, including, without limitation, Aziyo’s
Quarterly Report on Form 10-Q for the quarterly period ended
September 30, 2022, accessible on the SEC’s website at www.sec.gov
and the Investor Relations page of Aziyo’s website
at https://investors.aziyo.com. Because forward-looking
statements are inherently subject to risks and uncertainties, you
should not rely on these forward-looking statements as predictions
of future events. Any forward-looking statement made by Aziyo in
this press release is based only on information currently available
and speaks only as of the date on which it is made. Except as
required by applicable law, Aziyo expressly disclaims any
obligations to publicly update any forward-looking statements,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise.
Investors:Matt SteinbergFINN
Partnersmatt.steinberg@finnpartners.com
Media:Courtney GuyerAziyo Biologics,
Inc.PR@aziyo.com
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