Aziyo Biologics Announces Publication of a CanGaroo® Case Study Demonstrating Bioenvelope Benefits for Reoperative Procedures
August 30 2023 - 8:30AM
Aziyo Biologics, Inc. (Nasdaq: AZYO) (“Aziyo”), a company that
develops and commercializes biologic products to improve
compatibility between medical devices and the patients who need
them, today announced the publication of a case report highlighting
results that demonstrate the potential benefits of using a
biological device envelope during reoperative procedures for CIEDs.
The report, titled “Rehabilitation of an
Existing Device Implant Pocket Using a Biologic Extracellular
Matrix Envelope,” was published in the peer-reviewed journal Heart
Rhythm Case Reports. The results suggest a biological envelope may
mitigate the risks and procedural difficulty associated with
reusing fibrotic implant pockets, which could facilitate future
reoperations and decrease post-operative complications. This case
study builds upon interim results from the HEAL Study indicating
that CanGaroo can significantly reduce fibrous lead entrapment and
decrease procedural difficulty when used during initial device
implantation. CanGaroo is the only biological envelope available
for use with implantable electronic devices.
“This case study builds upon the interim HEAL
Study data presented earlier this year at Heart Rhythm 2023,” said
Dr. Michelle LeRoux Williams, Chief Scientific Officer of Aziyo.
“These results provide an opportunity to evaluate the use of
CanGaroo within a reoperative pocket. CanGaroo has proven to show
superior tissue remodeling properties and can provide a solution
for patients and their physicians seeking to avoid complications
associated with reoperations.”
Case Study Overview:
The patient was a 73-year-old man with normal
immune and kidney function who underwent a replacement procedure
for an Implantable Cardioverter Defibrillator (ICD). At the time of
the reoperation, the existing pocket was highly fibrotic. The ICD
was surgically removed and leads freed, but most of the fibrotic
tissue remained. To rehabilitate the fibrotic pocket, the new ICD
was placed into a CanGaroo envelope and implanted.
Five months later, an additional procedure was
performed to resolve a lead complication. At that time, the entire
pocket was observed to be lined with a soft vascularized capsule,
and now the leads were free of fibrosis and calcification.
A biopsy of the pocket showed a new pocket wall containing thin,
cellularized and vascularized tissue, consistent with a fully
remodeled envelope. The implanted CanGaroo was fully resorbed.
The patient had an uneventful recovery and
remains stable at three years post-operation. The findings in this
case study are consistent with previously reported data published
in Circulation demonstrating that CanGaroo prevents foreign body
reactions within the host, reducing hypovascular fibrous capsule
development.
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 any statements and
information concerning the effectiveness of the CanGaroo RM
Antibacterial Envelope. 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 ability
to successfully execute or realize the anticipated benefits under
our distribution arrangements with LeMaitre Vascular and Sientra;
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 ability to successfully execute or
achieve expected benefits from a divestiture of our Orthopedics
business; our products and our ability to enhance, expand, develop
and commercialize our product offerings; the impact on our business
of the recall of a single lot of our FiberCel product and the
discontinuation of its sales by our distribution partner;
consequences of our recall of a single lot of one of our viable
bone matrix products and market withdrawal of all of our viable
bone matrix products; our dependence on our commercial partners;
the impact of the bankruptcy of Surgalign Holdings, Inc., a
significant customer of the Company, on our future revenues;
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;
and 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.
Investors:Matt SteinbergFINN
Partnersmatt.steinberg@finnpartners.com
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