Kane Biotech Receives ISO 13485:2016 MDSAP Quality Certification
Kane Biotech Inc. (TSX-V:KNE; OTCQB:KNBIF) has achieved ISO 13485:2016 Medical Device Single Audit Program (MDSAP) Quality Certification as a designer, developer, and manufacturer of medical devices. This certification demonstrates Kane's commitment to quality products and allows the company to apply for regulatory approval of its revyve™ Antimicrobial Wound Gel in Canada, Australia, New Zealand, and Brazil.
The MDSAP certification enhances Kane's previous quality certification, which enabled FDA 510(k) clearance for revyve™. It signifies Kane's comprehensive quality management system focusing on patient safety, product performance, and reliability. This milestone brings Kane closer to improving the quality of products available for Canadian patients with chronic wounds and opens opportunities for expanding its product portfolio in these jurisdictions.
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Provides access to Canadian, Australian, New Zealand and Brazilian markets
WINNIPEG, Manitoba, July 17, 2024 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX-V:KNE; OTCQB:KNBIF) (“Kane Biotech” or “Kane”) announces that it has received ISO 13485:2016 Medical Device Single Audit Program (“MDSAP”) Quality Certification as a designer, developer and manufacturer of medical devices. This achievement speaks to Kane’s demonstrated commitment to bringing quality products to market. These standards require the existence of a comprehensive quality management system with a focus on areas directly impacting patient safety, product performance and reliability.
Obtaining the ISO 13485:2016 MDSAP certification allows Kane to apply for regulatory approval of its revyve™ Antimicrobial Wound Gel in Canada, Australia, New Zealand and Brazil. MDSAP is an enhancement of Kane’s previous quality certification which enabled Kane to receive US Food and Drug Administration 510(k) clearance for revyve™.
“This is yet another important milestone for Kane,” said Marc Edwards, President and CEO of Kane Biotech. “There is a need to significantly improve the quality of products that are available to Canadian patients suffering from chronic wounds and today’s announcement brings us one step closer to that end. It also opens the door to Kane expanding its certification and submitting other products for regulatory approval in order to build a comprehensive portfolio of advanced wound care products in these jurisdictions.”
The MDSAP program was first introduced in 2016 and allows for an MDSAP-recognized auditing organization to conduct a single audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
“Through these processes Kane has established a robust quality program associated with the medical device lifecycle to provide assurance consumers will receive safe and reliable products,” said Lori Christofalos, Chief Quality Officer. “I would like to thank the team for all of their hard work as the challenges of preparing a first MDSAP audit are substantial but so are the long-term benefits. One audit allows Kane to meet the quality requirements of multiple regulators.”
About Kane Biotech
Kane Biotech Inc. is a biotechnology company engaged in the research, development and commercialization of technologies and products that prevent and remove microbial biofilms. Kane has a portfolio of biotechnologies, intellectual property (67 patents and patents pending, trade secrets and trademarks) and products developed by Kane's own biofilm research expertise and acquired from leading research institutions. DispersinB®, coactiv+™, coactiv+®, DermaKB™, DermaKB Biofilm™, and revyve™ are trademarks of Kane Biotech Inc. Kane is listed on the TSX Venture Exchange under the symbol “KNE” and on the OTCQB Venture Market under the symbol “KNBIF”.
For more information:
| Marc Edwards | Ray Dupuis | |||
| Chief Executive Officer | Chief Financial Officer | |||
| Kane Biotech Inc | Kane Biotech Inc | |||
| medwards@kanebiotech.com | rdupuis@kanebiotech.com | |||
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Caution Regarding Forward-Looking Information
This press release contains certain statements regarding Kane Biotech Inc. that constitute forward-looking information under applicable securities law. These statements reflect management’s current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, risks relating to Kane’s: (a) financial condition, including lack of significant revenues to date and reliance on equity and other financing; (b) business, including its early stage of development, government regulation, market acceptance for its products, rapid technological change and dependence on key personnel; (c) intellectual property including the ability of Kane to protect its intellectual property and dependence on its strategic partners; and (d) capital structure, including its lack of dividends on its common shares, volatility of the market price of its common shares and public company costs. Further information about these and other risks and uncertainties can be found in the disclosure documents filed by Kane with applicable securities regulatory authorities, available at www.sedarplus.ca. Kane cautions that the foregoing list of factors that may affect future results is not exhaustive.
FAQ
What certification did Kane Biotech (KNBIF) receive on July 17, 2024?
How does the MDSAP certification benefit Kane Biotech (KNBIF)?
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How does the MDSAP certification differ from Kane Biotech's previous certification?
