Aziyo Biologics Announces Voluntary Recall of Viable Bone Matrix Products
14 July 2023 - 6:30AM
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,
today announced a voluntary recall of its viable bone matrix
products, which are bone repair products made from human tissue
that are used primarily in orthopedic and spinal procedures.
Notice of the voluntary recall was issued to centers after the
Company learned of post-surgical Mycobacterium tuberculosis (MTB)
infections in two patients treated with viable bone matrix product
from a single donor lot. Prior to release, samples from this
specific lot had tested negative for MTB by an independent
laboratory using a nucleic acid test that is designed to
specifically detect the MTB organism. Aziyo is fully cooperating
and investigating the events in coordination with the U.S. Food and
Drug Administration and the U.S. Centers for Disease Control and
Prevention (CDC).
Out of an abundance of caution, the Company has suspended
shipments of all viable bone matrix products from all donor lots.
The Company is also working closely with CDC staff to notify
physicians of the patients who received the particular donor lot at
issue to initiate post-exposure prophylaxis.
“We are taking immediate action to safeguard patients by
implementing a full product recall as we work with the CDC to
investigate this event,” said Dr. Randy Mills, President and Chief
Executive Officer of Aziyo Biologics. “The people of Aziyo care
deeply about the patients we serve and will continue to work with
the medical community, patients, and regulatory authorities as we
gather additional information.”
About Aziyo Biologics
Aziyo 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 Statements
This 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 and information
concerning the suspension of sales of the Company’s viable bone
matrix products, and any impact of the recall and suspension of
sales of these products on the Company’s business. Forward-looking
statements are based on management’s current assumptions and
expectations of future events and trends, which affect or may
affect our 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 technical complexity and requisite high levels of
quality control and precision in processing of tissue needed for
the Company’s products, including viable bone matrix; defects,
failures or quality issues associated with the Company’s products
that lead to product recalls or safety alerts, adverse regulatory
actions, litigation, including product liability claims, and
negative publicity; sufficient insurance coverage and reimbursement
for procedures incorporating the Company’s products; product
liability claims, including those that may arise from the recall of
viable bone matrix, for which the Company may not receive adequate,
if any, product liability coverage; the Company’s risk exposure
from warranty claims on its products; our inability to generate
sufficient revenue to achieve or sustain profitability; adverse
changes in economic conditions and instability and disruption of
credit markets; our ability to continue as a going concern; our
products and our ability to enhance, expand, develop and
commercialize our product offerings; our dependence on our
commercial partners; physician awareness of the distinctive
characteristics, and acceptance by the medical community, of our
products; the ability to obtain regulatory approval or other
marketing authorizations; our 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, 2022, as such factors may be
updated from time to time in Aziyo’s other filings with the SEC,
including, Aziyo’s Quarterly Reports on Form 10-Q, 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.
Contact:Matt SteinbergFINN
Partnersmatt.steinberg@finnpartners.com
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