Zero Candida Scales Production to 250 ISO 13485 Clinical-Grade Prototypes of ZC-001 Therapeutic Device

Rhea-AI Summary

Zero Candida Technologies (OTCQB: ZCTFF) scaled manufacturing to 250 ISO 13485 clinical‑grade prototypes of its ZC-001 therapeutic device, with completion expected within 90 days.

The production supports GLP preclinical testing and remains on track for a targeted Q4 2026 clinical study of at least 100 women, building on prior lab results showing 99.999% fungal eradication under controlled conditions.

Positive

• 250 clinical‑grade prototypes produced under ISO 13485 standards
• Supports GLP preclinical testing ahead of human studies
• Planned Q4 2026 clinical study of at least 100 women
• Prior lab results showed 99.999% fungal eradication
• Completion timeline: within 90 days

Negative

• None.

Supports GLP preclinical testing and planned Q4 2026 clinical study of at least 100 women

VANCOUVER, BC, Feb. 17, 2026 /PRNewswire/ -- Zero Candida Technologies, Inc. (TSXV: ZCT) (OTCQB: ZCTFF) (FSE: 9L2) (the "Company" or "ZCT"), a FemTech medical device company advancing next-generation solutions for women's health, today announced that it is scaling manufacturing to 250 clinical-grade prototypes of its ZC-001 therapeutic device under ISO 13485-certified quality standards.

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.

About Zero Candida Technologies, Inc.

Zero Candida Technologies, Inc. is a publicly traded FemTech company pioneering innovative solutions to address unmet needs in women's health. The Company is developing a SMART, tampon-like device that combines artificial intelligence and therapeutic blue light at a precise wavelength and intensity to effectively treat Vulvo-Vaginal Candidiasis (VVC) through personalized, at-home care. This condition affects approximately 75% of women worldwide, and recurrent cases (four or more episodes per year) are increasingly resistant to existing drug treatments, as the root cause remains poorly understood and inadequately addressed. With the VVC treatment market projected to exceed US $2B by 2030, Zero Candida is combining hybrid medicine and technology-based diagnostics to improve access for underserved populations and bring gynecology into the 21st century. To learn more, visit www.zero-candida.com 

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

Victoria Gamble
investors@zero-candida.com
(647) 874 3767

Logo: https://mma.prnewswire.com/media/2420533/4723164/ZERO_CANDIDA_Logo.jpg

View original content:https://www.prnewswire.com/news-releases/zero-candida-scales-production-to-250-iso-13485-clinical-grade-prototypes-of-zc-001-therapeutic-device-302689419.html

SOURCE Zero Candida

FAQ

What exactly did Zero Candida (ZCTFF) announce on February 17, 2026 about ZC-001 production?

They announced scaling to 250 ISO 13485 clinical‑grade prototypes of ZC-001, with completion expected within 90 days. According to the company, this step supports GLP preclinical testing and the clinical development timeline toward Q4 2026.

How does the 250‑unit production milestone affect ZCTFF's planned Q4 2026 clinical study?

The production supports readiness for human testing by supplying clinical‑grade prototypes for studies. According to the company, these units enable GLP preclinical work and keep the company on track for a targeted Q4 2026 study of at least 100 women.

What clinical evidence does Zero Candida cite for ZC-001's efficacy before the Q4 2026 trial?

The company cites prior laboratory testing demonstrating 99.999% fungal eradication under controlled conditions. According to the company, those lab results form the basis for advancing to GLP preclinical testing and human studies.

What features of ZC-001 did Zero Candida highlight in the February 17, 2026 announcement?

ZC-001 is described as a SMART, AI‑enabled therapeutic device integrating precision blue light therapy, targeted drug delivery, and wireless diagnostics. According to the company, it is designed for personalized at‑home treatment of recurrent VVC.

Will the ZC-001 production follow quality standards important to investors in ZCTFF?

Yes. The announcement states the prototypes are manufactured under ISO 13485 certified quality standards. According to the company, that certification supports medical‑grade production and regulatory readiness for clinical testing.

What is the timeline for completing the 250 ZC-001 clinical‑grade prototypes announced by ZCTFF?

Completion of the 250 units is expected within 90 days from the announcement date. According to the company, meeting this timeline helps transition from laboratory validation to planned human studies in 2026.