ToeFX

What ToeFX does

ToeFX is a privately held Canadian medical device company, headquartered at McMaster Innovation Park in Hamilton, Ontario, that develops and commercializes a clinically validated phototherapy system for treating onychomycosis (toenail fungus). Founded in 2016 by scientists including CEO Monika Yazdanian and founder/CTO Irit Van Ham, the company targets foot care clinicians — podiatrists, foot care nurses, and chiropodists — through a B2B partner-clinic model rather than selling directly to patients. Its product portfolio centers on two light-therapy devices, the dual-wavelength LT2000 (405nm + 660nm) and the single-wavelength TFX1000N ClearToe (660nm), which pair with a proprietary ToeFX Serum (a photosensitive formulation in single-use disposable pens) to generate reactive oxygen species (ROS) that disrupt fungal cell walls. A complementary diagnostic line — the ToeFX PCR Test (FungiCheck and FungiPanel Advanced at $54.99-$150 per test) — provides species-level identification of dermatophytes, yeasts, non-dermatophytes, and bacteria with claimed 95-99% accuracy and 5-business-day turnaround. The system is completed by an online certification training program ($199-$350 per clinician) and is supported by an 18-month, 165-nail longitudinal clinical study accepted for publication in the Journal of the American Podiatric Medical Association (March 2026) reporting 73% efficacy and zero recorded side effects. The platform is ISO 13485-certified under manufacturing partner Interktek, and the devices are cleared across five jurisdictions (FDA, Health Canada, MHRA, Australian TGA, Israel MOH). ToeFX monetizes through one-time hardware sales (quote-based via distributors), recurring consumable sales (serum pens, PCR kits), and professional services revenue from clinician certification training. Revenue is not publicly disclosed and the company has raised only $40,000 in disclosed external capital (a 2019 Accelerator Centre/FedDev seed round). ToeFX has scaled from 100 certified Canadian clinics in June 2022 to 600+ partner clinics globally across Canada, the United States, the United Kingdom, Israel, and Australia via an authorized distributor network (Pedicare, Rotatool, Gill Podiatry, Royal Dent, Only Footcare, DBS). An upcoming product, NailFX — a topical post-treatment formulation — is positioned to extend the business model into maintenance-stage, patient-direct use.

Name

ToeFX

Legal name

ToeFX Inc.

Website

https://toefx.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

ToeFX is a privately held Canadian medical device company that develops and sells a clinically validated phototherapy system (light devices, proprietary serum, and PCR diagnostics) to a global network of 600+ certified foot care clinics for treating onychomycosis (toenail fungus).

Ownership category

akta.pro rank

Product category

Medical Phototherapy Devices

NAICS

Medical and Diagnostic Laboratories (62151)

SIC

Surgical & Medical Instruments & Apparatus (3841), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Medical/Clinical Nail Care (e.g., diabetic foot, podiatry-adjacent) (HSALACAJ)

Keywords

• Phototherapy medical devices
• Onychomycosis treatment
• Medical light therapy
• Fungal PCR diagnostics
• Podiatry medical equipment

Headquarters

HQ city

Hamilton

HQ country

Canada

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Supply Chain, Operations, Marketing or Sales

Revenue model

1. Therapy Light Devices: Sale of medical-grade phototherapy devices (LT2000 and TFX1000N ClearToe) to partner clinics. Devices are one-time purchases with lifetime customer support. Treatment sessions every 2 weeks for 10-12 sessions per patient course.
2. ToeFX Serum: Sale of proprietary serum formulation in single-use disposable applicator pens (10 per package). One package typically covers a full treatment course for one patient (6-10 sessions).
3. PCR Diagnostic Tests: Sale of PCR test kits for toenail fungus identification. Available in single-test and 10-pack configurations. Provides fungal DNA detection with species identification and treatment recommendations.
4. Clinical Training Programs: Online certification training for clinicians on ToeFX protocol. Part 1 is free; Part 2 (hands-on training) is priced at $199-350 depending on course. Certification enables clinicians to deliver treatments effectively.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels9 records

Core offering

ToeFX designs, manufactures, and sells clinically validated phototherapy medical devices (the dual-wavelength LT2000 Therapy Light and the single-wavelength TFX1000N ClearToe Therapy Light), a proprietary photosensitizing serum, and PCR-based fungal diagnostic tests for the treatment of onychomycosis (toenail fungus). The company sells exclusively through certified partner clinics and authorized regional distributors across Canada, the United States, the United Kingdom, Australia, and Israel.

Product overview

ToeFX offers a suite of clinically tested phototherapy products for treating onychomycosis (toenail fungus). The core portfolio consists of two therapy light devices—the dual-wavelength LT2000 (available in USA and Canada) and the single-spectrum TFX1000N ClearToe (not available in USA)—which use light-activated reactive oxygen species to destroy fungal cells. These are paired with a proprietary ToeFX Serum (photosensitizing formulation) and supported by advanced PCR diagnostic tests (FungiPanel and FungiCheck) for accurate pathogen identification. A new NailFX topical product is launching soon for post-treatment maintenance. All devices require clinician training certification through ToeFX's online training programs. The company operates exclusively through a B2B partner clinic model with 600+ certified clinics globally.

Differentiator

Problem solved

Functional benefit

Brands

• ClearToe: ClearToe Therapy Light - a phototherapy system designed to deliver consistent, clinically optimized red light exposure to affected nails using single-spectrum architecture. Available outside USA.
• FungiPanel
• FungiCheck

Products and services

• ToeFX Therapy Light (LT2000) Dual-wavelength (405nm blue + 660nm red) phototherapy medical device for treating onychomycosis in clinical settings. The 405nm wavelength produces reactive oxygen species (ROS) targeting fungal cells while the 660nm wavelength supports blood flow and healing. Features a 12-minute built-in timer, treats all five toes simultaneously, and operates without heat, pain, or pharmaceuticals.
• ClearToe Therapy Light (TFX1000N) Single-wavelength (660nm red) phototherapy medical device for treating onychomycosis. Delivers consistent, clinically optimized red light exposure using single-spectrum architecture with a 15-minute built-in timer. Treats all five toes simultaneously. Not available in USA.
• FungiPanel Advanced PCR Test Comprehensive PCR-based molecular diagnostic test that identifies specific fungi causing onychomycosis, including dermatophytes (T. rubrum), yeast (Candida genus), non-dermatophytes, and bacteria (Pseudomonas aeruginosa). Provides species identification, fungal load measurement, and treatment options with 95-99% accuracy and results within 5 business days.
• FungiCheck PCR Test PCR-based diagnostic test providing a simple, clear positive or negative report for fungal infection in toenails. Designed for routine screening use by foot care clinicians.
• ToeFX Serum Proprietary, non-toxic photosensitive formulation designed for use with ToeFX Therapy Lights. Available in single-use disposable applicator pens (10 per package); one package typically covers a full treatment course for one patient. Contains blue dye that visualizes affected nail surfaces and enhances light absorption for effective reactive oxygen species (ROS) generation.
• ToeFX Clinician Training & Certification Program Online certification training program for foot care clinicians on the ToeFX protocol. Part 1 is free and covers onychomycosis theory and ToeFX science; Part 2 (hands-on training) is paid ($199-$350) and covers device usage, patient assessment, debridement, case studies, and certification. Required for partner clinics to deliver ToeFX treatments.

Quantifiable outcome

• 73% of nails achieved full clearance or ≥3mm of healthy new nail growth in clinical study of 165 nails
• +4 more outcomes

Named customers7 records

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Twelve partnerships are on record, tiered primary, core and minor.

• PedicareprimaryChannel Partner/ Reseller/ DistributorAuthorized Canadian distributor for ToeFX products including therapy lights and serum. Part of the 600+ partner clinic network serving foot care clinicians across Canada.
• RotatoolprimaryChannel Partner/ Reseller/ DistributorAuthorized USA distributor for ToeFX products. Supporting the growing network of American foot care clinicians with product distribution and local support.
• Gill PodiatryprimaryChannel Partner/ Reseller/ DistributorAuthorized USA distributor for ToeFX products. Expanding distribution reach for therapy lights and diagnostic tests in the American market.
• DBSprimaryChannel Partner/ Reseller/ DistributorAuthorized Australian distributor for ToeFX products. Supporting Australian foot care clinicians with access to phototherapy treatment technology.
• Royal DentprimaryChannel Partner/ Reseller/ DistributorAuthorized Israeli distributor for ToeFX products. Part of global network bringing non-invasive toenail fungus treatment to clinicians in Israel.
• Only FootcareprimaryChannel Partner/ Reseller/ DistributorAuthorized UK distributor for ToeFX products. Serving foot care professionals across the United Kingdom with phototherapy solutions.
• McMaster UniversitycoreStrategic or Co-development PartnerFounding scientific partner. Co-founder Dr. Irit Van-Ham affiliated with McMaster. Multiple scientific advisory team members trained at McMaster including Dr. Judy Wismer (Dermatology) and Dr. Alexander Rabinovich (Orthopaedics).
• Innovation FactorycoreStrategic or Co-development PartnerOntario's Regional Innovation Centre supporting life science companies. Hosted Synapse Life Science Competition where ToeFX won Grand Prize in 2021.
• OBIO (Ontario Bioscience Innovation Organization)coreStrategic or Co-development PartnerOntario health science industry organization supporting innovation. Featured ToeFX in WiHI Seed Program and Leadership Awards. OBIO EAHN spotlight highlighting ToeFX for senior foot care applications.
• Synapse Life Science ConsortiumminorStrategic or Co-development PartnerOntario life science network. Featured ToeFX milestone of 100 clinics across Canada in June 2022, recognizing rapid growth and adoption.
• ForgeminorOthersMcMaster-affiliated entrepreneurship support organization. Part of Ontario innovation ecosystem supporting ToeFX development.
• InterktekcoreTechnology or IntegrationISO 13485-certified manufacturer operating under ToeFX's Quality Management System. Supports regulatory compliance and product manufacturing for medical devices.

Scale indicators9 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Pfizer (Anacor / Kerydin):
• Cynosure (Hologic): Cynosure, owned by Hologic, is a global aesthetic and medical laser leader serving dermatologists, plastic surgeons, and podiatrists with broad device portfolios. While not focused exclusively on onychomycosis, its podiatry-channel presence and clinical-laser expertise make it a meaningful adjacent incumbent.
• Bausch Health (Valeant): Bausch Health markets Jublia (efinaconazole), a leading topical onychomycosis treatment, and other antifungal brands. While pharmaceutical rather than device-based, it competes for the same prescriber and patient relationships in the toenail fungus treatment market.

Direct peers

• CoolTouch (New Star Lasers): CoolTouch develops medical laser and light-based devices used in podiatry, dermatology, and aesthetics. Their focus on non-ablative, light-based clinical treatments and podiatric indication overlap directly with ToeFX's phototherapy modality.
• Nomir Medical Technologies: Nomir developed Noveon, a light-based onychomycosis treatment system using photo-inactivation. Although its commercial footprint has fluctuated, its phototherapy mechanism and podiatry-channel strategy directly parallel ToeFX's positioning.
• Erchonia Corporation: Erchonia manufactures FDA-cleared low-level laser therapy (LLLT) devices with multiple clinical applications, including podiatric and dermatological indications. Its portfolio overlaps ToeFX's light-based, non-thermal therapeutic approach and clinician-channel GTM.
• Cutera (PinPointe FootLaser): Cutera acquired PinPointe FootLaser, the most established laser-based onychomycosis treatment, and markets it to podiatry and dermatology clinics globally. It is the closest direct competitor in the device-based, clinic-administered toenail fungus treatment category.

Emerging players

• Emblation Limited: Emblation develops clinical microwave and light-based therapeutic devices, including podiatry applications. As a UK-based medical device company targeting foot care clinicians, it represents an emerging competitor with adjacent phototherapy/energy-based modality expertise.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@toefx-showoffyourtoenails9128
• Facebookfacebook.com/toefx
• LinkedInlinkedin.com/company/toefx
• Instagraminstagram.com/toefxofficial

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds2 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about ToeFX