Zero Candida Announces Plans to Complete Preclinical Studies for FDA Submission by Q3 2025

VANCOUVER, BC, Jan. 6, 2025 /PRNewswire/ -- Zero Candida Technologies, Inc. (TSXV: ZCT), (FSE: 9L2) (the "Company" or "ZCT"), an Israeli FemTech medical device company focused on revolutionizing women's health, announces plans to complete preclinical studies for FDA submission by Q3 2025. In accordance with FDA requirements, the company is preparing to conduct a full preclinical study of its final human-use device in up to 24 additional sheep.

The company has successfully completed a two sheep protocol pilot trial in November 2023, and is now preparing to expand the study. The ZC-1-A device was confirmed as 100% safe for use, with findings concluded from the Shamir Medical Center.  

Conclusions from the Shamir Medical Center: two healthy, naïve sheep were exposed to intravaginal pulsating blue light for 3 hours using the Zero Candida ZC-1-A device. After the illumination procedure, both animals were examined postmortem and autopsy showed no abnormal findings. Pathological evaluation of the relevant harvested organs showed no signs of thermal lesions or other pathological changes. The pathology laboratory declared the Zero Candida ZC-1-A blue light illumination device safe to use.

The ZC-1-A device combines a therapeutic light source with a selected wave-length and intensity to not only destroy Vulvo-Vaginal Candidiasis ("VVC") at record speed, but is also AI-driven to transmit data in real-time to the attending physician for hybrid medicine and personalized treatment consulting. More commonly known as yeast infections, VVC affects 3 out of 4 women globally, and ZCT is providing a solution that addresses the root cause, without chemicals or side effects, breaking down barriers in this space. Zero-Candida technology (ZCT) is FemTech developing an AI smart tampon-like device based on therapeutic light source with a selected wave-length and intensity that can treat the Candida fungus successfully of 99.999% an POC overnight. Vulvo-Vaginal Candidiasis ("VVC") affects about 75% of women globally, ZCT device is a Game changer that has the potential to change the treatment of women and the FemTech industry in the world. The first of its kind technology using a controlled "Blue Light," destroys the vagina fungus at record speed and without side effects. The treatment is Safety & carried out by a tampon-like medical device which, according to medical experts, provides an optimal solution for removing the fungus altogether and preventing the recurrence of the disease.

Zero Candida is working on creating a technology to enable the hybrid medicine services to be provided by gynecologists to populations that until now received no treatment at all, including, among others, in the developing countries. The ZCT device is Collect and transmits treatment data to the attending physician in real time, for assessment, treatment personalization and monitoring. Seamless data transfer through Wi-Fi chip and VoIP, allows for the convenience of remote care and treatment consulting.  Another significant advantage of the Zero Candida device is treatment without side effects, supporting growing demand from women to improve their health without the use of chemicals.

Eli Ben Haroosh, Founder & CEO stated: "Zero Candida is a groundbreaking and game-changing company in the world of women's medicine & women's health and non-drug treatments technology, I believe that in 2025 we will present to investors the completion of the sheep animal study with full success. From there, the path to clinical research in women will be very close".

Dr. Asher Holzer CTO & Director added: "As the company's chief scientist, Zero Candida is a world leader in technology that includes hybrid medicine, we are a team of highly senior researchers leading unique research into a solution and remedy for hundreds of millions of women around the world who suffer from vaginal yeast infection".

About Zero Candida:

Zero Candida (ZCT) is a publicly traded FemTech company pioneering innovative solutions in women's health. The company is developing an AI-driven, tampon-like device that uses a therapeutic light source with a selected wave-length and intensity to effectively treat the Candida fungus with a demonstrated 99.999% success rate in POC.  Vulvo-Vaginal Candidiasis ("VVC") affects about 75% of women globally, with 138witheach year 138 million women are affected world-wide and 492 million over their lifetime. Recurrent VVC (4 or more episodes per year) is increasingly documented to become drug resistant to existing treatments, since the root cause is poorly understood and addressed.  ZCT has successfully completed a safety trial using its pre-clinical device in large animals (sheep), and is finalizing their device for human use in preparation for an upcoming clinical trial, that they secured both funding and agreements with leading hospitals in Israel and Europe for. The Company continues to grow it's global patent portfolio with applications filed in the United States, Brazil and Europe, and was recently granted a final patent in South Africa. With hybrid medicine and technology-based diagnostics, ZCT is addressing unmet needs in women's healthcare and expanding access to underserved populations, bringing the field of gynecology into the 21st century. To learn more visit www.zero-candida.com

ZCT has signed pre-clinical agreements with hospitals in Israel and Europe and the company has successfully completed a safety trial for the use of a pre-clinical device in large animals (sheep) ZCT continues the development of the final product for human use in preparation for a clinical trial that will take place in June 2025.

Zero Candida's device will bring the field of gynecology into the 21st century with hybrid medicine and technology-based diagnostics. At the same time as developing the treatment procedure, Zero Candida is working on creating a technology to enable the hybrid medicine services to be provided by gynecologists to populations that until now received no treatment at all, including, among others, in the developing countries.

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.

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.

Contacts:
Victoria Gamble
[email protected]
(647) 874 3767   

Eli Ben Haroosh    
CEO & Founder
[email protected]

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SOURCE Zero Candida