Kane Biotech Completes U.S. FDA 510(k) Submission for revyve® Antimicrobial Wound Cleanser
Kane Biotech (TSX-V:KNE) has submitted a 510(k) clearance application to the FDA for its revyve® Antimicrobial Wound Cleanser. This marks the company's third product in the revyve line, complementing their existing Antimicrobial Wound Gel and Gel Spray products.
The new cleanser is designed for routine wound management, specifically for irrigating acute and chronic wounds to reduce bacterial load and remove loose material. The product's formulation is based on the existing revyve Antimicrobial Wound Gel. Notably, the U.S. wound cleanser market exceeded $200M USD in 2024.
Kane Biotech (TSX-V:KNE) ha presentato alla FDA una domanda di clearance 510(k) per il suo revyve® Antimicrobial Wound Cleanser. Si tratta del terzo prodotto della linea revyve, che si aggiunge ai già disponibili Antimicrobial Wound Gel e Gel Spray.
Il nuovo cleanser è pensato per la gestione di ferite di routine, in particolare per irrigare ferite acute e croniche al fine di ridurre la carica batterica e rimuovere materiale allentato. La formulazione si basa sull’attuale revyve Antimicrobial Wound Gel. Da segnalare che il mercato statunitense dei cleanser per ferite ha superato i 200 milioni di USD nel 2024.
Kane Biotech (TSX-V:KNE) ha presentado a la FDA una solicitud de autorización 510(k) para su revyve® Antimicrobial Wound Cleanser. Este es el tercer producto de la línea revyve, complementando los ya existentes Antimicrobial Wound Gel y Gel Spray.
El nuevo limpiador está diseñado para la gestión de heridas de rutina, específicamente para irrigar heridas agudas y crónicas con el fin de reducir la carga bacteriana y eliminar el material suelto. La formulación del producto se basa en el revyve Antimicrobial Wound Gel existente. Cabe señalar que el mercado estadounidense de limpiadores de heridas superó los 200 millones de USD en 2024.
Kane Biotech (TSX-V:KNE)는 FDA에 revyve® Antimicrobial Wound Cleanser의 510(k) 승인 신청서를 제출했습니다. 이는 revyve 라인의 세 번째 제품으로, 기존의 Antimicrobial Wound Gel과 Gel Spray 제품을 보완합니다.
새로운 클렌저는 일상적인 상처 관리를 위해 고안되었으며, 급성 및 만성 상처의 세균 부하를 줄이고 느슨한 물질을 제거하기 위해 세척합니다. 이 제품의 제형은 기존 revyve Antimicrobial Wound Gel을 기반으로 합니다. 주목할 점은 미국 상처 클렌저 시장이 2024년에 2억 달러를 넘었습니다.
Kane Biotech (TSX-V:KNE) a déposé auprès de la FDA une demande d’autorisation 510(k) pour son revyve® Antimicrobial Wound Cleanser. Il s’agit du troisième produit de la gamme revyve, complétant les produits Antimicrobial Wound Gel et Gel Spray déjà existants.
Le nouveau nettoyant est conçu pour la gestion routinière des plaies, en particulier pour irriguer les plaies aiguës et chroniques afin de réduire la charge bactérienne et d’éliminer les matières lâches. La formulation du produit est basée sur le revyve Antimicrobial Wound Gel existant. À noter que le marché américain des nettoyants pour plaies a dépassé 200 millions de USD en 2024.
Kane Biotech (TSX-V:KNE) hat bei der FDA einen 510(k)-Antrag für seinen revyve® Antimicrobial Wound Cleanser eingereicht. Damit ist es das dritte Produkt der Revvyve-Linie und ergänzt die bestehenden Produkte Antimicrobial Wound Gel und Gel Spray.
Der neue Reiniger ist für die Routine-Wundversorgung konzipiert und dient speziell der Spülung akuter und chronischer Wunden, um die bakterielle Last zu verringern und lose Materialien zu entfernen. Die Formulierung basiert auf dem vorhandenen revyve Antimicrobial Wound Gel. Bemerkenswert ist, dass der US-Markt für Wundreiniger im Jahr 2024 über 200 Mio. USD lag.
Kane Biotech (TSX-V:KNE) قدمت FDA طلب تصريح 510(k) لواسطتها revyve® Antimicrobial Wound Cleanser. وهذا يمثل المنتج الثالث في خط revyve، ليكمل منتجاتهم الحالية Antimicrobial Wound Gel و Gel Spray.
المنظف الجديد مصمم لـإدارة الجروح الروتينية، وبالتحديد لغرض ري جروح حادة ومزمنة لتقليل الحمل البكتيري وإزالة المواد الرخوة. تركيبة المنتج مستندة إلىRevvyre Antimicrobial Wound Gel الحالي. الجدير بالذكر أن سوق منظفات الجروح الأمريكية تجاوز 200 مليون دولار في 2024.
Kane Biotech (TSX-V:KNE) 已向美国食品药品监督管理局提交了 revyve® Antimicrobial Wound Cleanser 的 510(k) 审批申请。这是 revyve 系列的第三款产品，补充了现有的 Antimicrobial Wound Gel 与 Gel Spray。
新洁面剂旨在实现日常伤口管理，专门用于冲洗急性和慢性伤口，以降低细菌负荷并清除松散物质。该产品的配方基于现有的 revyve Antimicrobial Wound Gel。值得注意的是，2024 年美国产品伤口清洁剂市场已超过 2 亿美元。
- Expansion of product portfolio with third revyve product line offering
- Large market opportunity with U.S. wound cleanser market exceeding $200M USD
- Product complements existing revyve product line, creating potential synergies
- FDA approval pending and not guaranteed
- Entering a competitive wound care market
WINNIPEG, Manitoba, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX-V:KNE) (“Kane Biotech” or the “Company”) today announces that it has completed a U.S. Food and Drug Administration (“FDA”) 510(k) clearance submission for its revyve® Antimicrobial Wound Cleanser.
revyve Antimicrobial Wound Cleanser is the Company’s third product in its revyve product line and complimentary to Kane’s revyve Antimicrobial Wound Gel and Antimicrobial Wound Gel Spray products. This new companion product will be part of routine wound management, providing irrigation for the purpose of cleansing acute and chronic wounds to decrease the bacterial load and remove loose material. The formulation of the cleanser is based on revyve Antimicrobial Wound Gel.
The annual U.S. market size for wound cleansers exceeded
1 https://www.theresearchinsights.com/reports/u-s-wound-wash-market-542
2 https://www.researchandmarkets.com/reports/6055956/u-s-wound-wash-market-size-share-and-trends
3 https://www.credenceresearch.com/report/wound-wash-market
About Kane Biotech Inc. (TSX-V: KNE)
Kane Biotech is developing novel wound care treatments that disrupt biofilms and transform healing outcomes. Biofilms are one of the main contributors to antibiotic resistance in wounds which results in serious clinical outcomes and significant cost. revyve® addresses both biofilms and wound bacteria. revyve® Antimicrobial Wound Gel and revyve® Antimicrobial Wound Gel Spray are US FDA 510(k) cleared. revyve® Antimicrobial Wound Gel is Health Canada approved. To learn more about revyve, visit revyvegel.com or revyvegel.ca.
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| For more information: | |
| Dr. Robert Huizinga | Ray Dupuis |
| Interim CEO | Chief Financial Officer |
| Kane Biotech Inc. | Kane Biotech Inc. |
| rhuizinga@kanebiotech.com | rdupuis@kanebiotech.com |
| (780) 970-1100 | (204) 298-2200 |
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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 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+.ca. The Company cautions that the foregoing list of factors that may affect future results is not exhaustive.
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