Kane Biotech Receives ISO 13485:2016 MDSAP Quality Certification
July 17 2024 - 8:30AM
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
InformationThis 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.
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