BiaCure Therapies Awarded SBIR Phase I Grant to Advance Development of High-Frequency Energy Technology for the Treatment of Onychomycosis

PEWAUKEE, Wis., May 15, 2025 /PRNewswire/ -- BiaCure Therapies, an emerging innovator in non-invasive medical technology, today announced it has been awarded a Small Business Innovation Research (SBIR) Phase I grant from the National Institutes of Health (NIH) in the amount of $2.6M over three years to support the development of its proprietary high-frequency energy (HFE) therapy system for the treatment of onychomycosis, a chronic and stubborn fungal infection of the nail.

The funding will be used to further develop and validate BiaPulse™, BiaCure's therapeutic device designed to deliver targeted HFE through a patient-friendly applicator. The system aims to achieve mycological cure through a short-course, non-invasive treatment, offering a potential breakthrough for patients who have failed or cannot tolerate traditional oral antifungal medications.

"This SBIR grant is a strong validation of our science and approach," said Laura King, CEO of BiaCure Therapies. "Onychomycosis affects over 35 million Americans, yet treatment options are limited, slow, and often ineffective. Our mission is to deliver a faster, safer, and more effective therapy that works beneath the surface of the nail—without systemic side effects."

The award will enable BiaCure to conduct clinical efficacy studies in collaboration with dermatology and podiatry experts, measuring fungal eradication. These clinical endpoints will help establish the efficacy of HFE as a mycological cure platform with potential applications beyond nail fungus.

"This milestone represents a pivotal step in BiaCure's mission to redefine the standard of care for fungal nail infections through the intelligent application of high-frequency energy." said Rick Schefelker, Vice President of Engineering at BiaCure Therapies. "Our team is deeply committed to advancing non-invasive solutions that not only demonstrate clinical efficacy, but also improve the patient experience. This work moves us closer to delivering a truly effective therapy for a condition that has long lacked meaningful innovation."

"We are excited to advance our clinical collaboration with leading scientific partners as we validate the BiaPulse™ solution for this substantially underserved condition marked by low cure rates and high risk of recurrence," said Dr. Molly Hinshaw, Chief Medical Officer and Co-Founder of BiaCure Therapies.

About BiaCure Therapies
BiaCure Therapies is a Wisconsin-based medical technology company focused on delivering science-driven, non-invasive therapies. Founded by a team of experts in dermatology, engineering, and medical innovation, serial entrepreneurs. BiaCure is pioneering new Hight-Frequency Energy-based solutions for onychomycosis and beyond.

Media Contact:
Ginger Sands
Redfire Medical Consulting
ginger.sands@biacure.com
www.biacure.com

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SOURCE BiaCure Therapies