A recap of the November Monthly Hamilton Health Check-up with ToeFX

Each month the Synapse Life Science Consortium hosts a virtual session to bring the life science community together to share updates, explore collaboration opportunities and discuss the development and deployment of health innovations, called the Monthly Hamilton Health Checkup.

The latest Health Checkup featured ToeFX, a Hamilton-based company redefining how we diagnose and treat Onychomycosis, otherwise known as fungal nail infections. This persistent and common condition affects millions worldwide, causing pain, mobility challenges, and social stigma. ToeFX’s innovative light therapy solution is providing new hope for patients and setting a high standard for medtech innovation.

Tackling a Global Health Challenge

ToeFX specializes in non-invasive LED light therapy for treating fungal nail infections. Unlike traditional pharmaceutical approaches, their treatment uses light therapy combined with a photosensitive antifungal formulation. This method offers a drug-free alternative that has proven effective in transforming infected nails into healthy ones, with a 73% efficacy rate for clear nail results.

The condition impacts between 6% and 20% of the global population and up to 50% of seniors and is far more than a cosmetic issue. Patients often experience pain, difficulty walking, and an inability to wear standard footwear. Addressing this problem, ToeFX’s solutions have already reached patients in Canada, the U.S., the UK, Australia, and Israel, with more than 25,000 treatments delivered globally.

From Research to Commercialization

ToeFX’s journey started with a focus on science, working to create reliable, evidence-based treatments to improve outcomes for patients with fungal infections. They conducted the largest clinical study on light therapy for Onychomycosis, involving 217 patients. These studies, paired with approvals from Health Canada, the FDA, and other regulatory bodies, have allowed ToeFX to position itself as a leader in the market.

“We really focused on getting into the market quickly with something that worked,” shared Monika Yazdanian, CEO and co-founder of ToeFX. “The first version of the product amazed us with how well it was received, even as we continued to improve and iterate based on feedback.”

The company’s first product launched in 2020, and its next-generation device quickly followed. Both are compact, portable, and designed for use in clinical settings, ensuring professional oversight and consistent treatment protocols. This approach has earned the trust of clinicians and patients alike, with glowing testimonials from those who have seen life-changing results.

Innovations in Diagnostics

ToeFX is also addressing a critical gap in Onychomycosis care: diagnostics. Current diagnostic methods, such as culturing nail clippings, are outdated and prone to errors. ToeFX is collaborating with McMaster University on developing molecular diagnostic tools, including PCR testing, to provide faster and more accurate results.

The team also found that their proprietary formulation can preferentially bind to fungal infections directly on the nail, helping to improve diagnosis. This innovation underscores ToeFX’s focus on advancing the entire spectrum of care for fungal nail infections—from diagnosis to treatment and follow-up.

“Diagnostics for fungal infections have been surprisingly antiquated,” Yazdanian explained. “We’re aiming to modernize this with more precise and efficient methods that fit into clinicians’ existing workflows.”

Overcoming Challenges and Looking Ahead

Yazdanian combines scientific expertise with entrepreneurial drive. Her background in chemical physics, law, and photovoltaics research reflects a commitment to tackling complex problems. After leading The Forge incubator by McMaster University in Hamilton, Yazdanian co-founded ToeFX, shaping its growth and direction.

“Running the company efficiently has always been a priority,” said Yazdanian. “Our focus is on the mission and ensuring everything we do serves that purpose.”

The company’s lean approach—launching early products to gather feedback and improve—has been key to its success. Now, ToeFX is concentrating on scaling sales, particularly in the U.S., while remaining committed to clinician-administered care and maintaining rigorous treatment protocols.

ToeFX’s growth highlights the critical role of Hamilton’s life sciences and healthcare innovation ecosystem. Access to McMaster University’s R&D facilities and local mentorship has greatly supported the company’s development.

The impact of ToeFX’s work is most evident in patient stories. For individuals who lived with fungal nail infections for decades, the ability to walk pain-free and regain confidence has been transformative. “The small moments, like a patient saying they can walk normally again, make all the hard work worthwhile,” Yazdanian shared.

With plans to expand diagnostics and explore new therapeutic areas, ToeFX is poised to make an even greater impact on global health.

Interested in learning more about how Hamilton’s innovation ecosystem supports health start-ups? Connect with us to explore opportunities and resources to support your journey.