Kane Biotech Announces FDA 510(k) Clearance for its coactiv+™ Antimicrobial Wound Gel
May 25 2023 - 10:38AM
Kane Biotech Inc. (TSX-V:KNE OTCQB:KNBIF) (the “Company” or “Kane
Biotech”) announces that on May 24, 2023 it received 510(k)
clearance of its coactiv+
™ Antimicrobial Wound Gel
from the U.S. Food and Drug Administration (FDA) for the management
of ulcers (including diabetic foot and leg ulcers and pressure
ulcers), 1st and 2nd degree burns, partial & full thickness
wounds, large surface area wounds and surgical incisions for adult
populations.
“FDA clearance of our coactiv+ Antimicrobial Wound Gel, is a
major milestone for Kane,” said Marc Edwards, President and Chief
Executive Officer. “We’re bringing an effective, differentiated,
and accessible product to the annual USD $200 million1 U.S.
antimicrobial wound hydrogel market. This clearance also opens the
door for a large number of global markets. Building on our
previously announced agreements with ProgenaCare Global LLP
(“ProgenaCare”) (United States) and Salud Pharma S.A. (Panama,
Columbia and Costa Rica), we anticipate future global distribution
agreements. This clearance triggers a USD $500,000 initial payment
from ProgenaCare which it anticipates receiving later this
month.”
“We recently introduced our coactiv+ gel to potential
distribution and licensing partners at both the Symposium on
Advanced Wound Care (SAWC) in Washington in late April 2023 and the
European Wound Management Association (EWMA) in Milan, Italy in May
2023 and it was very well received,” said Mr. Edwards.
“coactiv+ is a triple threat combination of: (1) EFFICACY thanks
to Kane Biotech’s patented coactiv+ technology; (2) EASE OF USE due
to its thermo-gelling properties that’s easy to apply, stays on the
wound and is easy to remove; (3) ACCESSIBILITY as Kane intends to
offer its gel at a price point that fits within Medicare and
private payer allowables. It should be very well received by
practitioners as it checks all the boxes,” said Dr Greg Schultz,
Kane’s Chief Scientific Officer.
More information about Kane’s coactiv+ Antimicrobial Wound Gel
can be found at www.coactivplus.com.
Chronic wounds present a significant financial burden to the
U.S. healthcare system. Studies of Medicare data estimate the cost
to treat these wounds at between $28 billion and $96 billion2. 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 wounds3. Biofilm formation can make bacteria up to 1,000
times more resistant to antibiotics, antimicrobial agents,
disinfectants, and the host immune system. coactiv+ Antimicrobial
Hydrogel will significantly increase the ability of healthcare
clinicians to effectively treat chronic wounds and burns.
About coactiv+
coactiv+ Antimicrobial Wound Gel is indicated for management of
ulcers (including diabetic foot and leg ulcers and pressure
ulcers), 1st and 2nd degree burns, partial & full thickness
wounds, large surface area wounds and surgical incisions for adult
populations. It is also indicated for management of minor skin
scrapes, minor cuts, minor lacerations, minor burns (1st degree
burns) and abrasions for adult populations.
coactiv+ Antimicrobial Wound Gel is a white, odorless hydrogel
that provides a moist wound environment conducive to wound healing.
coactiv+ Antimicrobial Wound Gel can facilitate debridement through
a moist wound environment.
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 (80 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 |
Notes to Editor/References:
1. Based on market research conducted on Kane’s
behalf.
2. Sen, C. K. (2021, March 31). Human wound and its burden:
Updated 2020 compendium of estimates. Human Wound and Its Burden:
Updated 2020 Compendium of Estimates from
https://www.liebertpub.com/doi/10.1089/wound.2021.0026
3. 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.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/9966d5cc-a82c-4f40-90f5-3852b293f060
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