Zero Candida Scales Production to 250 ISO 13485 Clinical-Grade Prototypes of ZC-001 Therapeutic Device
Supports GLP preclinical testing and planned Q4 2026 clinical study of at least 100 women
This production milestone is a strategic step forward in the Company's regulatory roadmap, supporting further preclinical testing under Good Laboratory Practice (GLP) standards and remaining on track to initiate a targeted clinical study involving at least 100 women in Q4 2026. The planned study will further evaluate efficacy, building upon prior laboratory testing demonstrating 99.999% fungal eradication under controlled conditions.
Completion of the 250 units is expected within 90 days.
"Scaling volume helps us transition from laboratory validation to human studies more efficiently and demonstrates our commitment to medical-grade excellence," said Eli Ben-Haroosh, Chief Executive Officer of Zero Candida. "We look forward to sharing updates as we advance on our 2026 roadmap to bring innovative solutions to women worldwide living with recurrent VVC."
ZC-001 is a SMART, AI-enabled therapeutic device integrating precision blue light therapy, targeted drug delivery, and wireless diagnostics for personalized at-home treatment of Vulvovaginal Candidiasis (VVC). The device is designed to improve outcomes in recurrent and drug-resistant infections while reducing the need for repeated in-clinic visits. Its underlying technology may support future applications across other areas of women's health.
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Forward-Looking Statements
This news release includes certain statements and information that constitute forward-looking information within the meaning of applicable Canadian securities laws. All statements in this news release, other than statements of historical facts, are forward-looking statements. The Company provides no assurance that forward-looking statements and information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements or information. Accordingly, readers should not place undue reliance on forward-looking statements or information. The Company does not undertake to update any forward-looking statements, other than as required by law. More detailed information about potential factors that could affect financial results is included in the documents filed from time to time with the Canadian securities regulatory authorities by Zero Candida. Readers are cautioned not to place undue reliance on forward-looking statements.
Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Company Contacts:
Eli Ben Haroosh
CEO & Founder
info@zero-candida.com
investors@zero-candida.com
(647) 874 3767
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SOURCE Zero Candida