FDA Clears Surface Radiation Therapy Solution

OncoPatch Inc. is readying its Oncopatch Surface Brachytherapy System for a limited market release after securing U.S. Food and Drug Administration (FDA) 510(k) clearance for the product.

The system delivers targeted radiation therapy to superficial lesions and may be used as a primary treatment or for residual disease after the excision of primary or recurrent skin tumors. Oncopatch introduces a distinct, patch-based approach to delivering beta radiation directly to skin cancers and other superficial lesions, enabling precise surface treatment while minimizing exposure to underlying healthy tissue.

“Oncopatch was developed by physicists and radiation oncology researchers with the explicit goal of bringing a precise, isotope-based radiation therapy option into dermatology practice,” OncoPatch Co-Founder/CEO David Westerly, Ph.D., said. “This FDA clearance reflects years of work in radiation physics, clinical care, and collaboration across academic institutions. Our focus now is on a disciplined rollout that ensures this technology is implemented thoughtfully and delivers meaningful value for patients with skin cancer.”

Skin cancer is the most commonly diagnosed U.S. cancer, with approximately 9,500 new cases diagnosed daily. Basal cell carcinoma and squamous cell carcinoma account for most cases; the estimated 5.4 million lesions treated annually demonstrate the need for effective treatment options.¹

“Oncopatch represents a meaningful addition to the treatment landscape for skin cancer,” stated Patricia S. Walker, M.D., Ph.D., a board-certified dermatologist. “A non-invasive, surface brachytherapy system that can be integrated into dermatology workflows gives clinicians additional flexibility when managing appropriately selected patients, particularly in situations where tissue preservation and patient experience are important considerations.”

OncoPatch will begin a controlled commercial rollout of its therapeutic product at a select number of Colorado sites before expanding it across the United States next year.

OncoPatch Inc. is a medical device company developing non-invasive, surface-based radiation therapy for treating skin cancer and other superficial lesions. The Aurora, Colo., company’s patch-based technology delivers beta radiation directly to localized tumors and is designed for use in dermatology settings with appropriate authorized user oversight. By providing an effective surface treatment option that can be delivered in a short course of one to five sessions, OncoPatch aims to expand treatment options while supporting patient convenience and cosmetic outcomes.

Reference
¹ American Academy of Dermatology Association. Skin cancer statistics.
https://www.aad.org/media/stats-skin-cancer