Zero Candida Ltd (TSX-V:ZCT) has revealed plans to complete preclinical studies for its ZC-1-A device by the third quarter of 2025, paving the way for FDA submission.
The company aims to address Vulvo-Vaginal Candidiasis (VVC) with an AI-driven light therapy device that offers chemical-free treatment and real-time data transmission for personalized care.
Building on the success of a two-sheep pilot trial conducted in November 2023, the company will expand its study to include up to 24 sheep to meet FDA requirements.
The pilot trial, conducted at Shamir Medical Center, demonstrated the safety of the ZC-1-A device.
Postmortem evaluations revealed no abnormal findings, with pathological analyses confirming the absence of thermal lesions or other pathological changes.
The ZC-1-A device combines therapeutic blue light with a specific wavelength and intensity to target and eliminate the Candida fungus, which causes VVC. The device achieved a 99.999% success rate in point-of-care trials.
Equipped with AI capabilities, the tampon-like device transmits real-time treatment data to attending physicians via Wi-Fi and VoIP technology, enabling hybrid medicine and personalized treatment consulting.
CEO Eli Ben Haroosh told shareholders that the company is poised to complete the sheep animal study in 2025 “with full success.”
“From there, the path to clinical research in women will be very close,” Ben Haroosh added.
Dr Asher Holzer, the company’s chief technology officer, highlighted the device’s potential to revolutionize treatment, describing it as a "game-changer" for the FemTech industry.