KNE:CC - Kane Biotech’s Coactiv+™ Technology Could Address a Pricey and Painful Problem: Lack of Healing in Chronic Wounds Due to Microbial Biofilm Formation
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By Richard Dal Monte
Chronic wounds are apersistent and pricey problem for patients and health care systemsaround the world.
Definedas “wounds that fail to proceed through the normal phases ofwound healing in an orderly and timely manner,” chronic wounds rangefrom severe burns to bedsores to diabetic ulcers.
Whatever the cause,they all carry costs in medical care as well as pain and decreasedquality of life, and many can be attributed to something you may havenever heard of: biofilms.
“Biofilms are formed when bacteria and/or fungiadhere to surfaces and excrete a glue-like substance that acts as ananchor and provides protection from the environment,” making“bacteria up to 1,000 times more resistant to antibiotics,antimicrobial agents, disinfectants and the host immune system,”according to Kane Biotech Inc. (TSX-V: KNE | OTCQB: KNBIF).
The Canadian company’s latest product,coactiv+ ™ Antimicrobial Hydrogel, is designed to addressbiofilms and the problems they cause in chronic wounds — and at aprice that will allow it to be covered by Medicare in the U.S. as wellas insurers around the globe, a crucial distinction for a premiumproduct.
“Thethings we normally used very effectively to kill bacteria — likeantibiotics, our own immune cells, our antibodies — they frequentlyare ineffective in killing these biofilm bacteria,” explains Dr.Gregory Schultz, a University of Florida professor emeritus and KaneBiotech’s chief scientific officer.
Schultz says Kane’s coactiv+ ™ technology not only addresses biofilm-impaired healing, but it alsocontains an antimicrobial molecule that allows it to be effective inhealing chronic wounds. And he notes the gel could be applied by adoctor, nurse or even patients themselves.
Biofilms are a seriousproblem in the majority of chronic wounds
“It’s a great technology. It’simportant technology,” says Marc Edwards, Kane Biotech’s CEO,noting biofilms are one of the largest unresolved problems associatedwith chronic wounds.
Studies have shown a prevalence of biofilms in more than 78 per cent of chronic wounds and the U.S. Centers for DiseaseControl and Prevention have identified resistant bacteria, to whichbiofilms are a major contributor, as a serious burden to health caresystems.
Edwardssays that Kane has filed a 510(k) application with the U.S. Food and Drug Administration —asubmission that demonstrates that the medical device (in this case,Kane’s coactiv+ ™ Antimicrobial Hydrogel) “is as safeand effective, that is, substantially equivalent, to a legallymarketed device” — so it can bring the product to market. Thereview process is well underway, and approval is expected by thesecond quarters of 2023, with a commercial launch planned for thethird quarter.
Edwards is optimistic about the product’s prospects becauseof the cost of chronic wounds to health care systems. For instance , “Studies of [U.S.] Medicare data estimate the costto treat these wounds at between US$28 billion and US$96 billion.”And according to a 2022 report by Grand View Research Inc., the globalwound care market is estimated to grow to US$29.6 billion by 2030 .
In addition, Hydrogelsare used daily by wound care practitioners, Edwards says, representinga $150-$200 million market in the U.S. that is ripe for a clearlydifferentiated, premium product such as coactiv+ ™ .
The Kane product isdistinct both in its ability to inhibit biofilm formation as well asin its thermo-reversible formulation, which means it gels at warmertemperatures and liquifies at cooler temperatures; thus, it can becooled to be poured on to burn wound — it will gel when in contactwith body heat — and rinsed off easily with cold water.
Kane Biotech will soonbe in the South American market thanks to partnership
Already, Kane Biotechhas taken steps to access the market for wound care and hydrogels by signing a distribution agreement earlier this year with SaludPharma S.A., which will, once the product has received FDA approval,commercialize coactiv+ ™ (as well as Kane’sDermaKB ™ scalp care products) throughout Colombia, Panamaand Costa Rica.
Photo: The DermaKB ™ product line up.
In addition to woundand surgical care, Kane Biotech — which has been grantedapproximately US$3.1 million in research funding from the U.S.Department of Defense for DispersinB®, the company’s other patentedantibiofilm technology — is also focused on dermatology and animalhealth.
Thecompany has also developed DermaKB ™ scalp detoxifiers andshampoos designed to break down biofilm. Containing its proprietarycoactiv+ ™ technology, these lineups of products areproven to help with scalp conditions such as dandruff and seborrheicdermatitis.
Edwards notes Kane’s anti-biofilm technology serves as aplatform on which to build a variety of products.
“Besides our focus inR&D, we are also a product development firm. We’re looking tobuild multiple royalty streams,” Edwards says.
“We’re really at aninflection point. With the launch of our coactiv+ ™ Antimicrobial Wound Gel and developing product pipeline, we aim to tapinto a multi-million-dollar market that is ripe for the picking. Sincethis market is still relatively untouched, we believe that there is areal opportunity to own it.”
Learn more about Kane Biotech Inc. on its website as well as:
Thisarticle was originally published on Benzinga here .
KaneBiotech is a biotechnology company engaged in the research,development and commercialization of technologies and products thatprevent and remove microbial biofilms. The Company has a portfolio ofbiotechnologies, intellectual property (80 patents and patentspending, trade secrets and trademarks) and products developed by theCompany's own biofilm research expertise and acquired from leadingresearch institutions. StrixNBTM, DispersinB®, Aledex™,bluestem™, bluestem®, silkstem™, goldstem™, coactiv+™,coactiv+®, DermaKB™ and DermaKB Biofilm™ are trademarks of KaneBiotech Inc. The Company is listed on the TSX Venture Exchange underthe symbol "KNE" and on the OTCQB Venture Market under thesymbol “KNBIF”
This presentation containsforward-looking statements, which are made pursuant to the safeharbour provisions of the U.S. Securities Litigation Reform Act of1995. Forward-looking statements involve known and unknown risks anduncertainties which could cause the Company's actual results todiffer materially from those in the forward-looking statements. Suchrisks and uncertainties include, but are not limited to, theavailability of funds and resources to pursue R&D activities, thesuccessful and timely completion of clinical studies, the ability ofthe Company to take advantage of business opportunities in itsspecific industry, and uncertainties related to the regulatory processand general changes in economic conditions. Investors should consultthe Company's ongoing filings which are available on SEDAR foradditional information on risks and uncertainties relating toforward-looking statements. Investors are cautioned not to rely onthese forward-looking statements nor does the Company undertake toupdate or revise any these forward-looking statements containedherein.
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