Kane Biotech Receives FDA Approval to Increase Dosage Allowance of its revyve™ Antimicrobial Wound Gel
Kane Biotech (TSX-V:KNE; OTCQB:KNBIF) has received FDA approval to increase the dosage allowance of its revyve™ Antimicrobial Wound Gel. The FDA has eliminated the previous 90 grams/month usage limitation, paving the way for the introduction of revyve™ Antimicrobial Wound Gel Spray. This new spray format is expected to be ideal for application on large wounds.
The removal of the usage restriction allows for increased use of the revyve™ product line in both prescription and over-the-counter (OTC) channels. This development is significant for Kane Biotech as it expands the potential market for their antimicrobial wound care products.
Kane Biotech (TSX-V:KNE; OTCQB:KNBIF) ha ricevuto l'approvazione della FDA per aumentare il limite di dosaggio del suo revyve™ Gel Antimicrobico per Ferite. La FDA ha eliminato il precedente vincolo di utilizzo di 90 grammi/mese, aprendo la strada all'introduzione dello Spray Antimicrobico per Ferite revyve™. Questo nuovo formato spray è previsto come ideale per l'applicazione su ferite di grandi dimensioni.
La rimozione della restrizione sull'uso consente un utilizzo maggiore della linea di prodotti revyve™ sia nei canali prescrittivi che in quelli da banco (OTC). Questo sviluppo è significativo per Kane Biotech poiché amplia il mercato potenziale per i loro prodotti per la cura delle ferite antimicrobici.
Kane Biotech (TSX-V:KNE; OTCQB:KNBIF) ha recibido la aprobación de la FDA para aumentar el límite de dosificación de su gel antimicrobiano para heridas revyve™. La FDA ha eliminado la limitación de uso anterior de 90 gramos/mes, allanando el camino para la introducción del spray antimicrobiano para heridas revyve™. Se espera que este nuevo formato en spray sea ideal para la aplicación en heridas grandes.
La eliminación de la restricción de uso permite un mayor uso de la línea de productos revyve™ tanto en canales de prescripción como en venta libre (OTC). Este desarrollo es significativo para Kane Biotech, ya que amplía el mercado potencial para sus productos de cuidado antimicrobiano de heridas.
Kane Biotech (TSX-V:KNE; OTCQB:KNBIF)는 revyve™ 항균 상처 젤의 복용 허용량 증가를 위한 FDA 승인을 받았습니다. FDA는 이전의 월 사용 한도인 90그램을 제거하고 revyve™ 항균 상처 젤 스프레이의 도입을 위한 길을 열었습니다. 이 새로운 스프레이 형식은 큰 상처에 적용하기에 이상적일 것으로 예상됩니다.
사용 제한의 제거는 처방전과 일반의약품(OTC) 채널에서 revyve™ 제품 라인의 사용 증가를 가능하게 합니다. 이 개발은 Kane Biotech에게 항균 상처 치료 제품의 잠재적 시장을 확장하는 데 중요한 의미가 있습니다.
Kane Biotech (TSX-V:KNE; OTCQB:KNBIF) a reçu l'approbation de la FDA pour augmenter la limite de dosage de son gel antimicrobien pour blessures revyve™. La FDA a supprimé la limitation d'utilisation précédente de 90 grammes par mois, ouvrant la voie à l'introduction du spray antimicrobien pour blessures revyve™. Ce nouveau format en spray devrait être idéal pour l'application sur des plaies de grande taille.
La suppression de la restriction d'utilisation permet d'accroître l'utilisation de la gamme de produits revyve™ tant dans les canaux de prescription que dans ceux en vente libre (OTC). Ce développement est significatif pour Kane Biotech, car il élargit le marché potentiel pour leurs produits de soins antimicrobiens des blessures.
Kane Biotech (TSX-V:KNE; OTCQB:KNBIF) hat die FDA-Zulassung erhalten, um die Dosierungsgrenze seines revyve™ antimikrobiellen Wundgels zu erhöhen. Die FDA hat die vorherige Nutzungseinschränkung von 90 Gramm/Monat aufgehoben, was den Weg für die Einführung des revyve™ antimikrobiellen Wundgel-Sprays ebnet. Dieses neue Sprühformat wird als ideal für die Anwendung auf großen Wunden erwartet.
Die Aufhebung der Nutzungseinschränkung ermöglicht eine erhöhte Nutzung der revyve™ Produktlinie in verschreibungspflichtigen und rezeptfreien (OTC) Kanälen. Diese Entwicklung ist bedeutend für Kane Biotech, da sie den potenziellen Markt für ihre antimikrobiellen Wundpflegeprodukte erweitert.
- FDA approval for increased dosage allowance of revyve™ Antimicrobial Wound Gel
- Elimination of 90 grams/month usage limitation
- Potential for expanded market reach in prescription and OTC channels
- Introduction of revyve™ Antimicrobial Wound Gel Spray for large wound applications
- None.
Paves the Way for Kane’s revyve™ Antimicrobial Wound Gel Spray
WINNIPEG, Manitoba, July 23, 2024 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX- V:KNE; OTCQB:KNBIF) (“Kane Biotech”, “Kane” or the “Company”) announces that the US Food and Drug Administration (FDA) has eliminated its usage limitation on the Company’s 510(k) cleared revyve™ Antimicrobial Wound Gel (“revyve™”). Prior to the removal of this restriction, there was a 90 grams/month limit to the amount of revyve™ product that could be administered to patients.
This now clears the way for the introduction and extended use of Kane’s revyve™ Antimicrobial Wound Gel Spray which is expected to be filled in spray cans in a higher quantity making it ideal for application on large wounds.
“This is yet another important development for Kane as it allows for increased use of the revyve™ product line throughout the standard of care in both prescription and over-the- counter (OTC) channels,” said Marc Edwards, President & CEO.
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 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 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.
FAQ
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