{"id":741187,"date":"2023-03-20T08:25:05","date_gmt":"2023-03-20T12:25:05","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/aziyo-biologics-provides-update-on-fda-submission-for-cangaroo-rm-antibacterial-envelope\/"},"modified":"2023-03-20T08:25:05","modified_gmt":"2023-03-20T12:25:05","slug":"aziyo-biologics-provides-update-on-fda-submission-for-cangaroo-rm-antibacterial-envelope","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/aziyo-biologics-provides-update-on-fda-submission-for-cangaroo-rm-antibacterial-envelope\/","title":{"rendered":"Aziyo Biologics Provides Update on FDA Submission for CanGaroo\u00ae\u00a0RM Antibacterial Envelope"},"content":{"rendered":"
\n

SILVER SPRING, Md., March 20, 2023 (GLOBE NEWSWIRE) — 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, provides an update on its submission to the U.S. Food and Drug Administration (FDA) for the CanGaroo\u00ae<\/sup>\u00a0RM Antibacterial Envelope, the Company\u2019s next-generation biomaterial envelope. The device is intended to securely hold a cardiac implantable electronic device or neurostimulator, creating a stable environment when implanted in the body. The CanGaroo RM Antibacterial Envelope contains the antibiotics rifampin and minocycline, which have been shown in preclinical testing to reduce bacterial colonization on the envelope.<\/p>\n

As previously announced, the Company submitted a 510(k) premarket notification for the CanGaroo\u00a0RM Antibacterial Envelope to the FDA in April 2022<\/a>. As a combination product containing device and drug components, the filing was reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER). On March 16, 2023, the Company received a\u00a0Not Substantially Equivalent\u00a0determination from FDA. The notice defined the outstanding items that need to be addressed in order to obtain market clearance. The items relate to drug testing, primarily a request by FDA to modify an in vitro <\/em>drug release assay employed as a manufacturing control. As a result, the Company does not expect to appeal the decision, as it believes the most expeditious path forward is to work with FDA to provide the additional data requested.<\/p>\n

\u201cWhile we are disappointed with the delay, we are gratified that the completed review did not raise any questions surrounding the appropriateness of the pathway or majority of the data submitted to support the filing,\u201d said Dr. Randy Mills, President and Chief Executive Officer of Aziyo Biologics.\u00a0\u201cWe have our marching orders and are confident that we can address the FDA\u2019s questions promptly.\u201d<\/p>\n

As a reminder, Aziyo Biologics\u2019 management team will be hosting its previously scheduled conference call and webcast to discuss its fourth quarter and full-year 2022 financial results on Wednesday, March 22, 2023 at 4:30 p.m. ET. The Company will provide additional information at that time.<\/p>\n

\n About Aziyo Biologics<\/strong>
\n
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\u2019s mission is to humanize medical devices to improve patient outcomes. For more information, visit\u00a0www.Aziyo.com<\/a>.<\/p>\n

\n Forward-Looking Statements<\/strong>
\n
This press release contains \u201cforward-looking statements\u201d 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 \u201cprojects,\u201d \u201cmay,\u201d \u201cwill,\u201d \u201ccould,\u201d \u201cwould,\u201d \u201cshould,\u201d \u201cbelieves,\u201d \u201cexpects,\u201d \u201canticipates,\u201d \u201cestimates,\u201d \u201cintends,\u201d \u201cplans,\u201d \u201cpotential,\u201d \u201cpromise\u201d 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 regarding the potential regulatory clearance of CanGaroo RM. Forward-looking statements are based on management\u2019s current assumptions and expectations of future events and trends, which affect or may affect the Company\u2019s 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 Company\u2019s products and its ability to enhance, expand, develop and commercialize its product offerings; the Company\u2019s significant litigation related to the impact on the Company\u2019s business of the recall of a single lot of its FiberCel product and the discontinuation of its sales by its distribution partner; the Company\u2019s dependence on its commercial partners; the Company\u2019s future capital needs and available sources of funding; the adverse changes in economic conditions and instability and disruption of credit markets; physician awareness of the distinctive characteristics, and acceptance by the medical community, of the Company\u2019s products; the ability to obtain regulatory approval or other marketing authorizations; and the Company\u2019s intellectual property rights, and other important factors which can be found in the \u201cRisk Factors\u201d section of Aziyo\u2019s public filings with the Securities and Exchange Commission (\u201cSEC\u201d), including Aziyo\u2019s Annual Report on Form 10-K for the year ended December 31, 2021, as such factors may be updated from time to time in Aziyo\u2019s other filings with the SEC, including, without limitation, Aziyo\u2019s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2022, accessible on the SEC\u2019s website at www.sec.gov and the Investor Relations page of Aziyo\u2019s website at\u00a0https:\/\/investors.aziyo.com<\/a>. 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.<\/p>\n

\n Investors:<\/strong>
\n
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com<\/p>\n

\n Media:<\/strong>
\n
Courtney Guyer
Aziyo Biologics, Inc.
PR@aziyo.com<\/p>\n


\n
\n \n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

SILVER SPRING, Md., March 20, 2023 (GLOBE NEWSWIRE) — 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, provides an update on its submission to the U.S. Food and Drug Administration (FDA) for the CanGaroo\u00ae\u00a0RM Antibacterial Envelope, the Company\u2019s next-generation biomaterial envelope. The device is intended to securely hold a cardiac implantable electronic device or neurostimulator, creating a stable environment when implanted in the body. The CanGaroo RM Antibacterial Envelope contains the antibiotics rifampin and minocycline, which have been shown in preclinical testing to reduce bacterial colonization on the envelope. As previously announced, the Company submitted a 510(k) premarket notification for the CanGaroo\u00a0RM Antibacterial … <\/p>\n

Continue reading “Aziyo Biologics Provides Update on FDA Submission for CanGaroo\u00ae\u00a0RM Antibacterial Envelope”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-741187","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nAziyo Biologics Provides Update on FDA Submission for CanGaroo\u00ae\u00a0RM Antibacterial Envelope - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/aziyo-biologics-provides-update-on-fda-submission-for-cangaroo-rm-antibacterial-envelope\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Aziyo Biologics Provides Update on FDA Submission for CanGaroo\u00ae\u00a0RM Antibacterial Envelope - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"SILVER SPRING, Md., March 20, 2023 (GLOBE NEWSWIRE) — 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, provides an update on its submission to the U.S. Food and Drug Administration (FDA) for the CanGaroo\u00ae\u00a0RM Antibacterial Envelope, the Company\u2019s next-generation biomaterial envelope. The device is intended to securely hold a cardiac implantable electronic device or neurostimulator, creating a stable environment when implanted in the body. The CanGaroo RM Antibacterial Envelope contains the antibiotics rifampin and minocycline, which have been shown in preclinical testing to reduce bacterial colonization on the envelope. 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