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Kane Biotech Completes U.S. FDA 510(k) Submission for revyve® Antimicrobial Wound Cleanser
Globenewswire· 2025-09-16 21:05
Core Insights - Kane Biotech Inc. has completed a U.S. FDA 510(k) clearance submission for its revyve Antimicrobial Wound Cleanser, marking a significant step in its product development [1][2] Product Development - The revyve Antimicrobial Wound Cleanser is the third product in the revyve line, complementing the existing revyve Antimicrobial Wound Gel and Antimicrobial Wound Gel Spray [2] - This new product aims to enhance routine wound management by providing irrigation to cleanse both acute and chronic wounds, thereby reducing bacterial load and removing debris [2] Market Opportunity - The annual U.S. market size for wound cleansers surpassed $200 million USD in 2024, indicating a substantial market opportunity for Kane Biotech's new product [3]
Kane Biotech Completes Enrollment in U.S. Case Series Studies of its revyve® Antimicrobial Wound Gel and Spray
Globenewswire· 2025-09-10 21:05
Core Insights - Kane Biotech Inc. has successfully enrolled 28 participants in its revyve Antimicrobial Wound Gel and Spray U.S. Case Series Studies, surpassing the initial target of 25 participants [1] - The company’s products, including the revyve Antimicrobial Wound Gel and Spray, have received U.S. FDA 510(k) clearance, indicating regulatory approval for their use [3][4] - Data from the clinical series is expected to be presented at various medical meetings in 2025 and 2026, highlighting the growing interest from clinicians and patients [4] Company Overview - Kane Biotech is focused on developing innovative wound care treatments that target biofilms, which are significant contributors to antibiotic resistance in wounds [4] - The company aims to improve healing outcomes for patients suffering from challenging wounds and burns through its revyve product line [4] - The revyve products are designed to address both biofilms and wound bacteria, potentially transforming the treatment landscape for wound care [4]
Kane Biotech to Present revyve® Clinical Data at Symposium on Advanced Wound Care (SAWC) Fall Conference
Globenewswire· 2025-09-04 12:00
Core Insights - Kane Biotech Inc. is presenting clinical data on wound healing at the SAWC Fall conference, showcasing the effectiveness of their revyve Antimicrobial Wound Gel in treating complex wounds over two years old [1][4]. Group 1: Clinical Data Presentation - The first presentation discusses the clinical use of revyve Antimicrobial Wound Gel on a two-year-old non-healing Stage 4 sacral ulcer, resulting in pain reduction from 10/10 to 0 and a decrease in wound size over three weeks [2]. - The second presentation highlights the use of revyve Antimicrobial Wound Gel combined with vibrational debridement on a non-healing venous leg ulcer, achieving a 60% reduction in wound size over eight weeks and pain levels decreasing from 5/10 to 0 [3]. Group 2: Product Information - Kane Biotech's revyve Antimicrobial Wound Gel and Wound Gel Spray have received FDA 510(k) clearance and will be exhibited at the conference, with the Interim CEO meeting potential US distributors [4][6]. - The revyve products are designed to disrupt biofilms and improve healing outcomes, addressing antibiotic resistance in wounds, and are also approved by Health Canada [7].
Kane Biotech Announces Second Quarter 2025 Financial Results
Globenewswire· 2025-08-28 21:05
Financial Performance - Total revenue for Q2 2025 was $27,997, a significant decrease from $620,437 in Q2 2024, primarily due to the sale of the animal health business [9] - Gross loss for Q2 2025 was $(45,526), compared to a gross profit of $360,490 in Q2 2024 [9] - Total operating expenses for Q2 2025 were $229,930, down from $1,463,397 in Q2 2024, attributed to staff reductions and other cost-saving measures [9] - Net loss for Q2 2025 was $(348,541), an improvement from a net loss of $(1,215,996) in Q2 2024 [9] Corporate Governance - Three new directors were elected at the Annual and Special Meeting of Shareholders on June 25, 2025, alongside the reelection of three existing directors [2] - Mr. Shameze Rampertab was appointed as Chair of the Audit and Compensation Committee, and Ms. Anne Greven as Chair of the Governance & Nomination Committee [3] Product Development and Clinical Engagement - Kane Biotech presented novel preclinical data and clinical observations at two major North American wound care conferences in 2025 [4] - The company is engaging with key wound care specialists in the U.S. and is completing a clinical case series program to generate additional clinical data [5] Distribution and Financial Obligations - The company terminated its exclusive distribution agreement with ProgenaCare due to material breaches and is in discussions with potential new distributors [6] - Kane Biotech received a notice of default from Prairies Economic Development Canada regarding approximately $1.4 million outstanding from a $2.5 million Contribution Agreement [8] Strategic Outlook - The company aims to enhance its distributor networks in the U.S. and is focused on generating compelling clinical evidence to support the commercialization of its revyve portfolio [10] - The addition of three qualified directors is expected to strengthen the company's strategic capabilities during a pivotal growth stage [10]
Kane Biotech Showcases revyve™ Preclinical and Clinical Case Study Findings at North American Wound Care Conferences
Globenewswire· 2025-07-30 12:00
Core Insights - Kane Biotech Inc. presented novel preclinical data and clinical case observations at major North American wound care conferences, showcasing the potential of its product revyve in wound care [1][2][3] Preclinical Data - In vitro studies demonstrated revyve's effectiveness in inhibiting key proteases, achieving over 80% reduction in matrix metalloproteinases (MMPs) activity, 82% reduction in elastase activity, and complete inhibition of collagenase and TACE [6][7] - Chronic wounds may exhibit TNF-α levels that exceed those in acute wounds by up to 100-fold, highlighting the need for effective treatments [2] Clinical Observations - Clinical case series indicated significant improvements in chronic wound patients using revyve, with clinically meaningful reductions in wound size and pain over a period of 6 to 12 weeks [6] - Specific cases reported include a 60% reduction in wound size over two months for a venous leg ulcer and complete pain elimination in a painful pressure wound [8] Conference Engagement - Kane Biotech engaged healthcare professionals at the NSWOCC and SAWC conferences, providing educational materials and product demonstrations of revyve [5][9] - The presentations aimed to reinforce the company's innovation in wound care and demonstrate the clinical value and commercial potential of revyve [9] Product Overview - Revyve is designed to address biofilms and wound bacteria, which are significant contributors to antibiotic resistance in wounds, potentially leading to serious clinical outcomes and high costs [9]
Kane Biotech Provides Further Corporate Update
Globenewswire· 2025-06-18 21:05
Core Viewpoint - Kane Biotech Inc. is undergoing a reorganization phase, which includes terminating its distribution agreement with ProgenaCare and addressing financial obligations with PrairiesCan while advancing its clinical plans for product introduction in the U.S. market [1][2][6]. Group 1: Distribution and Financial Agreements - The company has terminated its exclusive distribution agreement with ProgenaCare due to material breaches [1]. - Kane Biotech received a notice of default from PrairiesCan regarding a Contribution Agreement, which involved repayable contributions totaling $2,491,266, with repayments starting on April 1, 2023 [2]. - The company has made all required repayments except for the payment due on June 1, 2025, and is in communication with PrairiesCan to restructure the remaining loan repayments [2][3]. Group 2: Financing and Related Transactions - An insider provided an unsecured demand loan of $1 million, which will be converted into a five-year, unsecured convertible debenture, subject to TSX Venture Exchange approval [4]. - The debenture will accrue interest at 3% per annum and is convertible into common shares at a price of $0.10 per share [4]. - The conversion of the loan to the debenture is classified as a related party transaction, exempting the company from formal valuation and minority approval requirements [5]. Group 3: Clinical Development - The company is executing its clinical plan for the commercial introduction of its revyve Antimicrobial Wound Gel and Spray in the U.S. market [6]. - Clinical case series are being conducted with medical professionals in chronic wound care and burn care, with data expected to be presented in late 2025 and 2026 [6]. Group 4: Company Overview - Kane Biotech is focused on developing novel wound care treatments that target biofilms, which contribute to antibiotic resistance and adverse clinical outcomes [8].
Kane Biotech Announces Fourth Quarter and Full Year 2024 Financial Results, Narrows Strategic Focus and Makes Leadership Change
Globenewswire· 2025-04-28 20:05
Financial Performance - Total revenue for Q4 2024 was $125,859, an increase from $57,788 in Q4 2023, primarily driven by contract animal health manufacturing revenue [3] - Gross loss for Q4 2024 was $(87,204), compared to a gross profit of $34,300 in Q4 2023, with $209,775 in inventory write-downs related to the DermaKB product line [3] - Total operating expenses for Q4 2024 were $933,479, down from $1,292,635 in Q4 2023, mainly due to adjustments in short-term incentive expenses [3] - Net income for Q4 2024 was $227,321, a significant improvement from a net loss of $(1,522,425) in Q4 2023, aided by a deferred tax recovery of $1,310,256 [3] - For the full year 2024, total revenue reached $2,080,879, up from $148,980 in 2023, attributed to higher product revenue [3] - Gross profit for the year was $872,096, compared to $109,470 in 2023, with similar inventory write-downs as in Q4 [3] - Total operating expenses for 2024 were $4,795,093, an increase from $3,466,856 in 2023, driven by higher employee compensation and consulting expenses [3] - Net loss for the year was $(3,161,097), an improvement from $(4,562,345) in 2023, with the same deferred tax recovery impacting both years [3] Corporate Strategy - The company is focusing on four verticals of its coactiv+ biofilm dispersion technology-based wound care product portfolio, particularly the revyve product line in the U.S. market [2] - New activities will be undertaken with clinicians in the U.S. to enhance distribution strategies for the revyve product line [2] - Cost reduction initiatives have been implemented to lower monthly operating costs, including a reduction in overhead [6] - The company has decided to delay the clinical study of its DispersinB Acne Cleanser to 2026 [6] - The binding term sheet with FB Dermatology S.R.L. has been terminated, and the acquisition will not proceed [7] Leadership Changes - Marc Edwards is no longer with the company as President and CEO, with Dr. Robert Huizinga appointed as interim CEO [5] - Dr. Huizinga has a background in clinical development and will resign from his position as Executive Chair at the upcoming annual meeting in June 2025 [5] Funding and Investment - Two insiders have agreed to subscribe for 12 million common shares at $0.10 per share, raising net proceeds of $1.2 million through a private placement [8] - An insider has also agreed to provide an unsecured loan of $1,000,000, repayable on demand, to support the company's operations [8] - These transactions are classified as related party transactions under Multilateral Instrument 61-101, with exemptions from formal valuation and minority approval requirements [10]