Aziyo Biologics Announces Product Design Completion for its Next Generation CanGaroo® Envelope for Implantable Electronic Devices

Rhea-AI Summary

Aziyo Biologics (Nasdaq: AZYO) has completed the product design for CanGaroo^® with antibiotics, enhancing its existing CanGaroo Envelope. This innovative product aims to mitigate post-operative infection risks by incorporating rifampin and minocycline into the biologically-derived envelope. The CanGaroo Envelope is designed to create a natural tissue pocket for implantable devices, promoting healthier tissue integration. Aziyo has partnered with Cook Biotech for further development, with plans for FDA submission anticipated in early 2022.

Positive

• Completion of product design for CanGaroo with antibiotics.
• Potential reduction of post-operative infection risks with new antibiotic formulation.
• Partnership with Cook Biotech to enhance product development.
• Anticipated FDA submission by early 2022, signaling progress towards commercialization.

Negative

• Dependency on external partners for product development may pose risks.
• Market acceptance and physician awareness of new product features remain uncertain.

SILVER SPRING, Md., Feb. 11, 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 today product design completion for CanGaroo^® with antibiotics, the next generation of the Company’s CanGaroo Envelope.

CanGaroo is the only commercially available biological envelope that forms a natural, systematically vascularized pocket for holding implantable electronic devices. The new product design includes the safety and performance of the CanGaroo tissue technology enhanced with the antibiotics rifampin and minocycline intended to reduce the potential risk of post-operative infections.

“We are delighted to reach this important milestone in the advancement of our CanGaroo platform,” said Ron Lloyd, President and Chief Executive Officer of Aziyo. “In addition to evidencing an inherent ability to establish healthy tissue and secure implantable electronic devices in place, incorporating antibiotics with our biological envelope has the potential to reduce the risk of infection in patients receiving these devices. Importantly, we remain on track towards the next critical steps of manufacturing validation and data collection through in vivo and in vitro studies.”

Aziyo is partnering with Cook Biotech, a leading supplier in the regenerative medicine market for the development and supply of CanGaroo with antibiotics.

“Cook Biotech was a natural partner for us in this critical next step in the advancement of our CanGaroo platform. We look forward to collaborating with them as we gather additional data and advance towards FDA submission, which we anticipate in early 2022,” concluded Lloyd.

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 our CanGaroo product candidate, its ability to reduce the risk of post-operative infections and the timing of our in vivo and in vitro studies and our anticipated FDA submission. 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; our dependence on our commercial partners; 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; our ability to obtain regulatory approval or other marketing authorizations; 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 is the significance of the CanGaroo with antibiotics announcement by Aziyo (AZYO)?

The announcement highlights the completion of product design for CanGaroo with antibiotics, aimed at reducing post-operative infection risks for patients receiving implantable devices.

When does Aziyo plan to submit the CanGaroo with antibiotics for FDA approval?

Aziyo anticipates FDA submission for the CanGaroo with antibiotics in early 2022.

What are the benefits of the CanGaroo Envelope for implantable devices?

The CanGaroo Envelope creates a vascularized pocket that enhances tissue integration, potentially reducing complications like infection and fibrotic capsule formation.

Who is partnering with Aziyo for the CanGaroo with antibiotics development?

Aziyo is collaborating with Cook Biotech for the development and supply of CanGaroo with antibiotics.

What are the new features of the CanGaroo Envelope?

The new CanGaroo Envelope includes antibiotics rifampin and minocycline, designed to mitigate post-operative infection risks.