BiaCure Therapies, a Wisconsin-based medical technology company, has received a $2.6 million Small Business Innovation Research (SBIR) Phase I grant from the National Institutes of Health (NIH) to advance its innovative high-frequency energy (HFE) therapy system for onychomycosis. The three-year funding will support the development of BiaPulse™, a non-invasive therapeutic device designed to treat fungal nail infections that affect over 35 million Americans.
Onychomycosis, a chronic fungal infection of the nail, has traditionally been difficult to treat effectively. Current treatment options often involve oral antifungal medications that can cause systemic side effects and have limited efficacy. BiaCure's approach aims to address these limitations by delivering targeted high-frequency energy directly to the infected nail through a patient-friendly applicator.
"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."
Advancing Clinical Validation
The NIH funding will enable BiaCure to conduct critical clinical efficacy studies in collaboration with dermatology and podiatry experts. These studies will focus on measuring fungal eradication to establish the efficacy of high-frequency energy as a mycological cure platform.
The BiaPulse™ system is designed to achieve mycological cure through a short-course, non-invasive treatment regimen. This approach could represent a significant breakthrough for patients who have failed previous treatments or cannot tolerate traditional oral antifungal medications due to side effects or contraindications.
Rick Schefelker, Vice President of Engineering at BiaCure Therapies, emphasized the significance of this development: "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. Our team is deeply committed to advancing non-invasive solutions that not only demonstrate clinical efficacy but also improve the patient experience."
Addressing an Underserved Condition
Onychomycosis represents a substantial unmet medical need characterized by low cure rates and high risk of recurrence. The condition can significantly impact quality of life, causing pain, discomfort, and psychological distress for affected individuals.
Dr. Molly Hinshaw, Chief Medical Officer and Co-Founder of BiaCure Therapies, expressed enthusiasm about the project's potential: "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."
Beyond Onychomycosis
While the initial focus is on treating nail fungus, BiaCure's high-frequency energy technology platform may have broader applications. The clinical endpoints established through this research could help validate HFE as a mycological cure platform with potential applications beyond onychomycosis.
Founded by a team of experts in dermatology, engineering, and medical innovation, BiaCure Therapies is positioning itself as a pioneer in non-invasive medical technologies. The company's approach combines scientific rigor with patient-centered design to address conditions that have historically lacked effective treatment options.
As the project advances, healthcare providers and patients alike will be watching closely to see if BiaCure's high-frequency energy technology can deliver on its promise to transform the treatment landscape for fungal nail infections and potentially other related conditions.
