BiaCure Therapies

What BiaCure Therapies does

BiaCure Therapies is a privately held, early-stage medical device company developing the patented BiaPulse™ system for the treatment of onychomycosis (toenail fungal infection). The company targets the approximately 35 million diagnosed U.S. patients with the condition, including roughly one in three diabetic patients who face elevated risk of foot disorders and amputations, and is positioned as a physician office-administered alternative to topical therapies (5-17% cure rates) and oral antifungals (~70% mycologic cure but with liver failure risk).

The BiaPulse™ platform is built on patented High Frequency Energy (HFE) technology designed to deliver energy precisely to the infected nail plate and surface nail bed while sparing surrounding tissue. The system combines a reusable energy delivery source capable of treating two digits concurrently with integrated temperature control, paired with custom applicators manufactured individually for each treated digit. Applicators are produced using ultrasound scans acquired in the physician office and converted to 3D files through a proprietary AI algorithm that captures nail size, thickness, topography, and disease extent. The product remains under development and is not available for sale.

The anticipated business model combines upfront hardware sales of the energy delivery device into physician offices and clinical settings with recurring revenue from per-treatment custom applicator consumption, distributed through a direct enterprise sales motion targeting healthcare providers. The company is incorporated in Wisconsin, headquartered in Pewaukee, and led by CEO Laura G. King (former GE Company Officer who led NeuWave Medical's $300M sale to J&J Ethicon), CMO Dr. Molly A. Hinshaw (dual board-certified dermatologist and founder of the UW Health Nail Clinic), and VP R&D Rick Schefelker (NeuWave veteran with multiple medical device patents). Capital formation to date has been led by non-dilutive grant funding rather than disclosed venture equity rounds.

Name

BiaCure Therapies

Legal name

BiaCure Therapies

Website

https://accuremedical.com

Company type

Private

Founded year

2023

Operating status

Operating

Headcount range

1–10 employees

Short description

BiaCure Therapies is an early-stage medical device company developing the patented BiaPulse™ system, which combines proprietary High Frequency Energy and AI-driven custom applicators to treat onychomycosis in physician offices for the 35 million U.S. patients lacking effective treatment options.

Ownership category

akta.pro rank

Product category

Dermatology Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Energy-Based Surgical Devices (Electrosurgery, RF, Ultrasonic, Laser) (HLAHADAC)

Keywords

• Medical device development
• Onychomycosis treatment
• Dermatology devices
• High frequency energy therapy
• Custom applicator manufacturing

Headquarters

HQ city

Milwaukee

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Supply Chain, Operations, Infrastructure

Revenue model

1. Medical Device Sales: The company is developing a medical device (BiaPulse™) for treating onychomycosis. The product includes a reusable energy delivery source and custom applicators for each treated digit. Revenue would be generated from device sales and custom applicators to healthcare providers. The product is under development and not yet available for sale.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

BiaCure Therapies develops the BiaPulse™ medical device, a patented High Frequency Energy (HFE) system designed to cure onychomycosis (toe nail fungus). The system includes a reusable energy delivery source that treats two toes concurrently with temperature monitoring, paired with patient-specific custom applicators manufactured from ultrasound scans processed through a proprietary AI algorithm into 3D files. The product is currently under development and not yet available for sale.

Product overview

BiaCure™ Therapies is developing the BiaPulse™ device — a single core medical device product with patented High Frequency Energy (HFE) technology for treating Onychomycosis (toe fungus). The BiaPulse™ system consists of a reusable energy delivery source (treats two toes concurrently) paired with custom applicators manufactured individually for each patient from ultrasound scans processed into 3D files through a proprietary AI algorithm. The device is under development and not yet available for sale.

Differentiator

Problem solved

Functional benefit

Brands

• BiaPulse™: Patented High Frequency Energy (HFE) technology device under development for treating Onychomycosis (toe fungus). The device delivers energy precisely to the infected nail plate and nail bed to eliminate fungal infection while sparing surrounding tissue.

Products and services

• BiaPulse™ Medical Device System

Quantifiable outcome

• Topical therapies have 5-17% complete cure rates; BiaPulse™ aims to provide effective cure
• +1 more outcomes

Segments2 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature3 records

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Aerolase: Aerolase manufactures the PinPoint Laser, which is explicitly cited on BiaCure's own materials as an FDA-cleared laser for cosmetic nail improvement in onychomycosis — the closest direct functional alternative to BiaPulse.
• Erchonia Corporation: Erchonia makes the Lunula Low-Level Laser, a non-thermal cold laser device FDA-marketed specifically for onychomycosis treatment; the most direct competitive medical-device alternative to BiaCure's energy-based therapy.

Broad incumbents

• Cutera: Cutera is an established energy-based aesthetic and dermatology device company whose laser platforms overlap with the energy-based therapeutic approach BiaPulse takes; useful comparable for device commercialization in physician offices.
• Cynosure: Cynosure (a Hologic company) is a broad-line medical aesthetic laser and energy-based device incumbent with strong dermatology distribution; comparable as a likely strategic acquirer or channel reference for BiaCure's energy-based device category.
• InMode: InMode develops RF, laser, and energy-based platforms for medical aesthetics and is a listed comparable in energy-based physician-office devices; relevant for both channel dynamics and competitive benchmarking.
• Sciton: Sciton manufactures laser and light-based platforms marketed through dermatology and plastic-surgery physician channels; comparable to BiaCure as a physician-office energy-device incumbent with overlapping go-to-market motion.

Emerging players

• Moberg Pharma: Moberg Pharma is a dermatology-focused company developing topical therapies for onychomycosis (e.g., MOB-015), targeting the same clinical indication as BiaPulse via a different (topical) modality; useful as an onychomycosis-pure-play benchmark.
• Tarsus Pharmaceuticals: Tarsus is an emerging dermatology therapeutics company with a novel commercial model in physician-administered dermatology; relevant as a comparable for an early-stage company seeking to commercialize in dermatology channels serving similar specialists.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights5 records

Customer concentration

• LinkedInlinkedin.com/company/biacure

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds3 records

Investors3 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 BiaCure Therapies