Zero Candida Scales Production to 250 ISO 13485 Clinical-Grade Prototypes of ZC-001 Therapeutic Device
MWN-AI** Summary
Zero Candida Technologies, Inc., a pioneering FemTech medical device company, has recently announced its significant step towards advancing women's health solutions with the production of 250 ISO 13485-certified clinical-grade prototypes of its ZC-001 therapeutic device. This initiative underscores the company's compliance with stringent quality standards and supports ongoing preclinical testing, which adheres to Good Laboratory Practice (GLP). The company is on track to initiate a targeted clinical study involving at least 100 women in Q4 2026, further investigating the efficacy of the device, which has previously demonstrated an impressive 99.999% success rate in eradicating fungal infections in laboratory conditions.
Eli Ben-Haroosh, CEO of Zero Candida, emphasized that scaling volume production is crucial for transitioning from laboratory testing to human studies efficiently. The ZC-001 device utilizes innovative technologies, combining precision blue light therapy with targeted drug delivery and wireless diagnostics for the at-home treatment of Vulvovaginal Candidiasis (VVC). This condition affects around 75% of women worldwide, with recurrent cases often resistant to existing treatments.
Completion of the initial 250 units is expected within 90 days, signaling Zero Candida's commitment to revolutionizing VVC treatment by enabling personalized care that minimizes the need for repeated clinic visits. As the VVC treatment market is anticipated to exceed $2 billion by 2030, the company aims to enhance access to effective treatments, particularly for underserved populations, ultimately modernizing gynecological healthcare.
Zero Candida is steadfast in its mission to address unmet health needs for women, leveraging a unique blend of hybrid medicine and technology-driven diagnostics to deliver next-generation healthcare solutions.
MWN-AI** Analysis
Zero Candida Technologies, Inc. (ZCT) is poised for significant growth as it approaches the production of 250 ISO 13485 clinical-grade prototypes of its ZC-001 therapeutic device. This development represents a strategic milestone that not only bolsters its credibility in the medical device sector but also shores up investor confidence during an ambitious regulatory and clinical testing phase.
ZCT's focus on women’s health, specifically the treatment of Vulvovaginal Candidiasis (VVC), targets a substantial market, projected to exceed $2 billion by 2030. The innovative ZC-001 device integrates AI, blue light therapy, and targeted drug delivery, addressing a pressing medical need for effective at-home treatment for recurrent infections, particularly in drug-resistant cases. This not only enhances patient access to care but also aligns with emerging trends advocating for hybrid medicine solutions that combine technology with therapeutic effectiveness.
From a market perspective, the current phase of scaled production indicates ZCT’s commitment to quality, adhering to ISO 13485 standards, which is crucial for long-term viability and regulatory approval. Analysts should pay close attention to the company's upcoming clinical study set for Q4 2026, involving at least 100 women. The success of this trial can significantly impact the company’s valuation and market perception.
Investors might consider positioning in ZCT given the growing emphasis on FemTech and the increasing recognition of women’s health issues. As ZCT transitions from laboratory validation to human trials, potential investors should remain attuned to updates regarding clinical efficacy results and regulatory feedback. While inherent risks exist in biotechnology ventures, the unique positioning and innovation of ZCT suggest a favorable long-term outlook for investors ready to engage with this transformative player in women's health.
In summary, Zero Candida is well-aligned to capitalize on a growing market with a groundbreaking therapeutic approach, making it a compelling consideration for investors focused on cutting-edge health technologies.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Canada NewsWire
Supports GLP preclinical testing and planned Q4 2026 clinical study of at least 100 women
VANCOUVER, BC, Feb. 17, 2026 /CNW/ -- 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
SOURCE Zero Candida
View original content: http://www.newswire.ca/en/releases/archive/February2026/17/c1755.html
FAQ**
How does Zero Candida Tec ZCTFF plan to ensure the quality and safety of the 250 ISO 13485 clinical-grade prototypes of the ZC-001 therapeutic device during the manufacturing process?
What specific metrics will Zero Candida Tec ZCTFF use to evaluate the efficacy of the ZC-001 device in the planned clinical study involving 100 women?
Can Zero Candida Tec ZCTFF share insights on the projected timeline for the regulatory approval process following the clinical study results for the ZC-001 device?
What strategies are in place to scale production further, should the clinical study with Zero Candida Tec ZCTFF be successful and demonstrate significant efficacy for the ZC-001?
**MWN-AI FAQ is based on asking OpenAI questions about Zero Candida Tec (OTC: ZCTFF).
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