Zero Candida Ltd (TSX-V:ZCT), a company pioneering a non-drug treatment for Candida infections, has provided investors with an update on its groundbreaking technology and plans for 2025.
Key milestones on the horizon include finalizing the human-use prototype of its AI-powered, blue-light therapy device by the second quarter, achieving US patent approval, and completing preclinical safety and human clinical trials by year-end.
During a recent investor presentation, Zero Candida’s leadership team highlighted the unique nature of its tampon-sized device, which targets Candida infections without chemicals or side effects.
Candida infections, which impact 75% of women, are poorly understood and increasingly drug-resistant.
“What we have developed is something very unique. We are not aware of things like that in the market,” Dr Asher Hozler, Zero Candida's founder and director, told investors.
Preclinical trials demonstrated a 99.999% eradication rate of the fungus overnight, within just three hours.
Upcoming human trials
At the request of the US Food and Drug Administration (FDA), Zero Candida’s device will undergo additional preclinical animal studies in Q3 2025 with human trials to follow immediately after.
These trials, which are fully funded, will take place in hospitals in Israel and Europe. They are designed to evaluate safety and efficacy for an FDA submission.
“It’s going to look like a very straightforward trial type of pathway with the FDA, so we don’t expect any special challenges,” Dr Hozler said.
CEO Eli Ben Haroosh highlighted the company’s strong financial position, noting that it is fully funded to finish all of its planned clinical studies.
“When we go to the market, we will need to first bench 10,000, 20,000 units,” Ben Haroosh said. “At the moment, we have enough money to run the company as a public, research company.”
Patents and market entry
The company has secured a final patent in Africa and expects to receive a US patent by mid-to-late 2025, followed by European patents in 2026.
Zero Candida plans an initial business-to-business (B2B) model, distributing the device through clinical channels before expanding to over-the-counter (OTC) sales.
“We will start to do it with restrictions, and then we move to OTC inside the pharmacies. So, it’s going to be B2B at the moment,” Ben Haroosh said.
The device is priced at approximately US$199 and is designed to be used multiple times.
While the company is currently focused on Candida infections, it aims to expand within the FemTech space in the future.
“Zero Candida will not stop in Candida,” Ben Haroosh said. “Zero Candida will expand and is already open-minded about research in our laboratory above Candida treatment.”