Aziyo Biologics Announces Updated CanGaroo® Envelope Label in European Markets to Allow for Hydration in an Antibiotic Solution

Rhea-AI Summary

Aziyo Biologics (Nasdaq: AZYO) announced CE Mark approval for updated labeling of its CanGaroo® Envelope, allowing hydration with gentamicin prior to device implantation. This enhancement aims to reduce post-operative infections, bolstering product efficacy. The CanGaroo Envelope, a biological solution for implantable cardiac devices, is recognized for its ability to lower complication risks. Aziyo markets the CanGaroo primarily in Europe through BIOTRONIK and other distributors, expanding its portfolio in regenerative medicine.

Positive

• CE Mark approval received for CanGaroo Envelope to include gentamicin hydration.
• Potential to reduce post-operative infections and improve patient outcomes.
• CanGaroo is the only biological envelope shown to lower risk of complications associated with cardiac electronic devices.

Negative

• None.

SILVER SPRING, Md., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes in patients undergoing surgery, announced that it has received CE Mark approval for updated labeling of the Company’s biological CanGaroo® Envelope to allow for the addition of the antibiotic gentamicin. While the indications of the CanGaroo Envelope remain unchanged, this approval now permits the envelope to be hydrated in a gentamicin solution during device preparation prior to implantation at the discretion of the prescribing physician. Pre-clinical testing has demonstrated hydrating the CanGaroo Envelope in gentamicin prior to use can reduce or inhibit bacterial growth.

CanGaroo is the only commercially available biological envelope that forms a natural, systemically vascularized pocket for holding implantable cardiac electronic devices. Aziyo currently sells CanGaroo in Europe primarily through its distributor relationship with BIOTRONIK, as well as through non-exclusive agreements with independent distributors in select countries.

“We are very pleased to be able to offer this enhancement of CanGaroo to our European physicians and their patients,” said Ron Lloyd, President and CEO. “With the addition of gentamicin, we continue to advance our CanGaroo product platform. As the only known natural biologic envelope on the market that has shown to lower the risk of complications associated with implantable cardiac electronic devices, CanGaroo hydrated in gentamicin now offers the potential to also reduce post-operative infections.”

About the CanGaroo® Envelope
The CanGaroo Envelope is a small intestine submucosa extracellular matrix designed to mitigate complications deriving from implantable electronic devices and the shortcomings of synthetic envelopes. Once implanted, it creates a hospitable environment for the surrounding cells to migrate into the bio scaffold and start matrix turnover. The natural envelope is remodeled into a healthy pocket of systemically vascularized tissue, potentially reducing the risk of fibrotic capsule formation, migration and erosion of the implantable device through the skin, and complications associated with Twiddler’s syndrome. The CanGaroo Envelope may also facilitate the process of implantation and of device removal during its replacement, as well as enhance patient comfort.

About Aziyo Biologics
Aziyo Biologics is a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes in patients undergoing surgery, concentrating on patients receiving implantable medical devices. Since its founding in 2015, the Company has created a portfolio of commercial-stage products used in cardiovascular, orthopedic, and reconstructive specialties. 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. 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 CanGaroo and the potential results thereof, including potential results related to the addition of gentamicin. 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 our products and our ability to enhance, expand and develop our products; the adverse impacts of COVID-19 or adverse changes in economic conditions; physician awareness of the distinctive characteristics, and acceptance by the medical community, of our products; and our intellectual property rights, and other important factors discussed under the caption “Risk Factors” in Aziyo’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 filed with the Securities and Exchange Commission (“SEC”), as such risk factors may be updated from time to time in Aziyo’s other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Aziyo’s website at www.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. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement.

Media:
Courtney Guyer
Aziyo Biologics, Inc.
PR@aziyo.com

Investors:
Leigh Salvo
Gilmartin Group
investors@aziyo.com

FAQ

What recent approval did Aziyo Biologics receive for its CanGaroo Envelope?

Aziyo Biologics received CE Mark approval to update labeling for hydrating the CanGaroo Envelope with gentamicin.

How does gentamicin impact the CanGaroo Envelope?

Hydrating the CanGaroo Envelope with gentamicin before implantation may reduce or inhibit bacterial growth, potentially lowering post-operative infection risks.

In which regions is the CanGaroo Envelope marketed?

The CanGaroo Envelope is primarily marketed in Europe through a distributor relationship with BIOTRONIK and other independent distributors.

What are the key features of the CanGaroo Envelope?

The CanGaroo Envelope is designed to mitigate complications from implantable electronic devices and to create a vascularized pocket to enhance patient comfort.

What is the significance of the CanGaroo Envelope in the market?

It is the only commercially available biological envelope that lowers the risk of complications associated with implantable cardiac electronic devices.