SILVER SPRING, Md., Jan. 28, 2021 — 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.
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.
Aziyo Biologics, Inc.