AURORA, CO, UNITED STATES, March 10, 2026 /EINPresswire.com/ — OncoPatch, Inc., a medical device company developing targeted surface radiation therapy solutions, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Oncopatch Surface Brachytherapy System, indicated for the surface treatment of localized tumors. The system is designed to deliver targeted radiation therapy to superficial lesions and may be used as a primary treatment or for residual disease following 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,” said David Westerly, PhD, Co-founder and Chief Executive Officer of OncoPatch. “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 cancer in the United States, with approximately 9,500 new cases diagnosed each day. Basal cell carcinoma and squamous cell carcinoma account for the majority of cases, with an estimated 5.4 million lesions treated annually, underscoring the need for effective treatment options.¹
“Oncopatch represents a meaningful addition to the treatment landscape for skin cancer,” said Patricia S. Walker, MD, PhD, 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 received FDA 510(k) clearance on December 5, 2025, and will initiate a controlled commercial launch with a limited number of selected sites in Colorado in 2026, followed by broader U.S. expansion planned for 2027.
About OncoPatch, Inc.
OncoPatch, Inc. is a Colorado-based medical device company developing non-invasive, surface-based radiation therapy for the treatment of skin cancer and other superficial lesions. The 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 just 1-5 sessions, OncoPatch aims to expand treatment options while supporting patient convenience and cosmetic outcomes.
Citations:
1. American Academy of Dermatology Association. Skin cancer statistics.
https://www.aad.org/media/stats-skin-cancer
Sophia Saanz
Purple Crayon Brand
sophia@purplecrayonbrand.com
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