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The Problem
35M patients in the US are currently diagnosed with onychomycosis
Onychomycosis is a pervasive, disfiguring, and often painful infection of the nail, surface of the nail bed, and/or nail matrix caused by fungi that are ubiquitous in the environment (See image)
Over 35 million patients in the US suffer from this type of infection, including approximately 1 in 3 diabetic patients. Research demonstrates an increased risk of other foot disorders and amputations in diabetic patients with onychomycosis.
There are no current treatments that effectively treat this type of infection.
Existing Treatment Options
There are currently three categories of treatment options for onychomycosis:
Topical Therapies
Jublia (efinaconazole), Penlac (ciclopirox), Kerydin (tavaborole).
Topical therapies are ineffective, with complete cure rates of 5–17% depending upon the topical agent. Efficacy of amorolfine 5% lacquer and ciclopirox 8% lacquer is very low (13, 19). Efinconazole 10% solution (Jublia™) is the most recently FDA cleared topical therapy from 2014, yet when used daily for 48 weeks complete cure rates are less than 17%.
Topical medications have very low cure rates, attributed to the relatively impermeable nature of the nail plate.
Oral anti-fungals
Terbinafine, Itraconazole, Fluconazole, Griseofulvin (FDA Approved)
Specifically, terbinafine for mild to moderate disease (20–50% of nail affected) has a mycologic cure rate in toenails of 70% when taken for 3 months and poses significant risks including liver failure (1).
Oral medications require lab tests prior to starting the medication, often induce additional clinical visits and laboratory monitoring and have severe potential side effects, including liver failure.
Medical Devices
FDA cleared only for other skin disorders or for cosmetic improvements.
- ThermoMed: Utilizes Radio Frequency (RF) energy to treat skin disorders and improve the appearance of infected nails.
- Pinpoint Laser: FDA approved for the cosmetic indication of temporary improvement of clear nail.
Accure's Solution
Our Cure Onychomycosis
Our patented TherawaveTM 100 technology delivers a safe and effective High Frequency Energy (HFE) precisely to the infected nail plate and surface nail bed to eliminate the fungal infection while sparing surrounding tissue.
*The Therawave100 is under development and is not available for sale.
Features
The Accure TherawaveTM 100 will include a re-usable energy delivery source capable of treating two digits (toes) concurrently. The Energy Delivery Device will have a treatment protocol that includes a control mechanism to ensure the patient’s toe temperature remains within safe conditions and in accordance with FDA labeling
This product will have a custom applicator for each treated digit. Each applicator will be specifically customized and uniquely manufactured to the physical properties of the individual digit and nail taking into account nail size, thickness, topography and extent of the disease. These custom applicators will be manufactured using ultrasound scans acquired in the physician office, transformed into 3D custom files through a proprietary algorithm.
Transformed into 3D custom files through a proprietary AI algorithm.
Chief Executive Officer
Laura G King
Ms. King is a proven Founder and CEO of successful medical device companies. Ms. King has successfully raised over $80MM in venture capital funding.
As the Founder and CEO of Elucent Medical, Ms. King developed and commercialized the Revolutionary EnVisioTM Wireless Surgical Navigation system.
Prior to Elucent, Ms. King led NeuWave Medical, a Madison, WI-based start-up that developed and commercialized a device to ablate cancer tumors in liver, kidney, lung and bone. NeuWave had a successful exit, selling for $300MM in 2016 to J&J Ethicon. NeuWave continues to have leadership share in the ablation market.
Prior to joining the start-up world, Ms. King was a GE Company Officer and led the $1.2B Global Interventional Cardiology and Surgery business with over 5,000 employees globally. She is a graduate of UC Davis in Economics.
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Chief Medical Officer
Molly A. Hinshaw, MD
Molly A. Hinshaw MD, FAAD is driven by her passion for providing exceptional care tailored to each individual patient and their unique needs. She uses her expertise in the clinical, mycologic, andhistopathologic aspects of onychomycosis (fungal infection of the nail unit) in routine patient care and in informing discovery about this pervasive disease.
She has been an invited speaker for all aspects of onychomycosis from diagnosis to management and on all aspects of nail disorders internationally and across the United States including for the American Academy of Dermatology (AAD) and American Society of Dermatopathology, and Council for Nail Disorders (CND). In addition to her clinical work and teaching, Dr. Hinshaw has held leadership appointments within the AAD, ASDP, CND Wisconsin Dermatological Society, and Women’s Dermatologic Society including service as president of the latter two.
Dr. Hinshaw is dual board-certified in dermatology and dermatopathology, Professor of Dermatology and Affiliate Professor of Pathology and Laboratory Medicine at the University of Wisconsin School of Medicine and Public Health. Dr. Hinshaw founded the Nail Clinic at UWHealth in Madison, WI where she directs that Clinic and is the medical director of the Dermatopathology and Mohs laboratory.
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1. Gupta AK, Stec N, Summerbell RC, Shear NH, Piguet V, Tosti A, et al. Onychomycosis: a review. J Eur Acad Dermatol Venereol. 2020. Epub 2020/04/01. doi: 10.1111/jdv.16394. PubMed PMID: 32239567.