Kane Biotech Announces 510(k) Submission for its coactiv+™ Antimicrobial Hydrogel
November 03 2022 - 7:30AM
Kane Biotech Inc. (TSX-V:KNE OTCQB:KNBIF) (the “Company” or “Kane
Biotech”) announces that it has recently submitted a 510(k)
premarket notification, which has been received by The Center for
Devices and Radiological Health (CDRH) of the U.S. Food and Drug
Administration (“FDA”), for a new Wound Care
coactiv+™ Antimicrobial Hydrogel.
The Company’s device, which uses its patented
coactiv+™ technology in a thermo-reversible gelling system,
provides ease of use and is optimised for sensitive wounds. The
Company aims to make the wound gel accessible to patients, taking
into consideration current reimbursement levels under the surgical
dressing policy in the U.S.
“This is yet another major milestone for Kane” said
Marc Edwards, President and Chief Executive Officer. “We are
optimistic about the opportunities ahead as we expand Kane’s core
technologies. I would like to recognize our team who have worked
diligently on this initiative and continue to work through the FDA
review process. I believe that this technology will be
well-received by the FDA and help a lot of people suffering from
chronic wounds.”
Chronic wounds present a significant financial
burden to the U.S. healthcare system. The treatment of chronic
wounds is a major challenge for health care providers, with a high
failure rate leading to amputation, sepsis, and death. One of the
major reasons for this failure is the formation of bacterial
biofilms, which are present in over 80% of chronic wounds1. Biofilm
formation can make bacteria up to 1,000 times more resistant to
antibiotics, antimicrobial agents, disinfectants, and the host
immune system.
About Kane Biotech
Kane Biotech is a biotechnology company engaged in
the research, development and commercialization of technologies and
products that prevent and remove microbial biofilms. The Company
has a portfolio of biotechnologies, intellectual property (74
patents and patents pending, trade secrets and trademarks) and
products developed by the Company's own biofilm research expertise
and acquired from leading research institutions. StrixNB™,
DispersinB®, Aledex™, bluestem™, bluestem®, silkstem™, goldstem™,
coactiv+™, coactiv+®, DermaKB™ and DermaKB Biofilm™ are trademarks
of Kane Biotech Inc. The Company is listed on the TSX Venture
Exchange under the symbol "KNE" and on the OTCQB Venture Market
under the symbol "KNBIF".
For more information: |
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Marc Edwards |
Ray Dupuis |
Nicole
Sendey |
Chief Executive Officer |
Chief Financial Officer |
Investor Relations/PR |
Kane Biotech Inc |
Kane Biotech Inc |
Kane Biotech Inc |
medwards@kanebiotech.com |
rdupuis@kanebiotech.com |
nsendey@kanebiotech.com |
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Notes to Editor/References:
1. Kresser, C. (2019, October 10). Biofilm: What it
is and how to treat it. Kresser Institute.
https://kresserinstitute.com/biofilm-what-it-is-and-how-to-treat-it/
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 the Company’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 the Company 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 the Company with
applicable securities regulatory authorities, available
at www.sedar.com. The Company cautions that the foregoing list
of factors that may affect future results is
not exhaustive.
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