OncoPatch: Frequently Asked Questions for Dermatologists
OncoPatch: Frequently Asked Questions for Dermatologists
Skin cancer remains the most commonly diagnosed cancer worldwide, with basal cell carcinoma and squamous cell carcinoma accounting for the vast majority of cases. While excision, Mohs surgery, ED&C, topicals, and conventional radiation therapy remain well-established treatment options, the field continues to evolve as new device-based approaches reach clinical practice.
OncoPatch is a surface brachytherapy system that received FDA 510(k) clearance in December 2025. It delivers beta radiation to non-melanoma skin cancers through a self-shielded, patch-based applicator designed for use in a physician’s office.
This FAQ is written for dermatologists, Mohs surgeons, dermatologic oncologists, and radiation oncologists who want to understand the device, its mechanism, and how it fits within the current treatment landscape.
The Device
What is OncoPatch?
OncoPatch is a surface brachytherapy system that delivers beta radiation directly to a skin lesion via a patch-based applicator. The device contains a yttrium-90 (Y-90) source housed in a shielded container. During treatment, the patch is positioned over the lesion and delivers a prescribed dose of beta radiation to the target tissue. A surface collimator is used to limit the areal extent of the treated region to the target lesion and a surrounding margin.
The device is designed for in-office use and does not require a linear accelerator, dedicated radiation vault, or external room shielding.
What does FDA 510(k) clearance mean?
A 510(k) clearance means the FDA has reviewed the device and determined it is substantially equivalent to another legally marketed device in terms of safety and effectiveness and intended use. This is the regulatory pathway for many medical devices in the United States. It authorizes the manufacturer to market the device for its cleared indications.
510(k) clearance is distinct from FDA approval, which applies to higher-risk devices that go through the more rigorous premarket approval (PMA) process. For context, many radiation therapy devices and brachytherapy sources used in dermatologic oncology have entered the market through the 510(k) pathway.
What types of skin cancer is OncoPatch designed to treat?
OncoPatch is designed for use in the treatment of non-melanoma skin cancers, including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). These are the two most commonly diagnosed forms of skin cancer and originate in the outer layers of the skin.
Mechanism of Action
How does OncoPatch deliver treatment?
The device uses a Y-90 beta-emitting source configured as a foil array within the patch applicator. When the patch is placed over the lesion, beta particles penetrate the superficial layers of the skin, delivering a targeted dose of radiation that destroys cancer cells in the treated area.
Beta particles from Y-90 have a maximum penetration depth of approximately 11 mm in tissue, with the majority of the dose being deposited within the first few millimeters. This physical characteristic makes beta radiation well-suited for treating lesions confined to the more superficial layers of the skin, as the dose falls off rapidly with depth and spares deeper structures.
How is this different from external beam radiation therapy?
External beam radiation therapy (EBRT) for skin cancer typically uses superficial X-ray units or electron beams from a linear accelerator, requiring multiple fractions delivered over several weeks in a radiation facility or shielded dermatologist’s office.
OncoPatch delivers radiation through placement of the Y-90 source over the lesion. A surface collimator limits the areal extent of the radiation to the lesion and a surrounding margin. Treatment protocols for surface brachytherapy generally involve fewer fractions than external beam approaches, with courses ranging from 1 to 5 fractions. The device uses low-energy beta emissions from the radioisotope Y-90 and is self-shielded, which makes it possible to use in a physician’s office rather than a shielded radiation therapy facility.
What is yttrium-90?
Yttrium-90 (Y-90) is a radioactive isotope that decays by pure beta emission with a half-life of approximately 64 hours. It is widely used in medicine, including in radioimmunotherapy, liver-directed radioembolization, and radiation synovectomy. Because Y-90 is a pure beta emitter with no primary gamma component, shielding requirements are minimal compared to gamma-emitting sources, which simplifies its use in an office-based setting.
Clinical Considerations
Who might be considered for treatment with OncoPatch?
Treatment decisions are always made by the physician based on individual clinical circumstances. Factors that dermatologists and radiation oncologists typically consider when evaluating localized radiation therapy for NMSC include the histologic type and grade of the lesion, its anatomic location, the patient’s surgical candidacy and medical history, prior treatments, cosmetic considerations, and patient preference.
Beta therapy may be of particular interest for lesions in anatomically challenging locations where surgical excision could result in functional or cosmetic compromise, or for patients who are poor surgical candidates.
Is OncoPatch a surgical procedure?
No. OncoPatch is a non-surgical, non-invasive treatment. The patch is applied to the surface of the skin and does not involve an incision, tissue removal, or wound closure.
How long does the treatment take?
Treatment duration depends on the prescribed dose and the size and depth of the lesion. Because the treatment is delivered during an office visit through direct application of the patch, treatments are designed to fit within a standard clinical appointment window. Physicians should consult the device’s instructions for use for detailed treatment planning guidance.
What does the clinical workflow look like for the dermatologist?
OncoPatch is built around an integrated care model that pairs the dermatologist’s clinical expertise in skin cancer with a radiation oncologist’s expertise in therapeutic radiation planning and delivery. In practice, the treating dermatologist identifies appropriate patients, performs the clinical evaluation, and initiates the OncoPatch treatment process. The radiation oncologist provides treatment planning as well as regulatory oversight of the treatment and the radiation safety program. A trained OncoPatch clinical specialist handles the logistics of transporting the radioactive patch to the dermatology office and assists with treatment administration on-site. The treatment takes place in the dermatology office environment, and the patient remains within the dermatologist’s practice for ongoing follow-up and surveillance.
Within the Treatment Landscape
How does OncoPatch fit alongside existing NMSC treatments?
The current standard of care for non-melanoma skin cancer includes a range of modalities: surgical excision, Mohs micrographic surgery, curettage and electrodesiccation (ED&C), topical agents (such as 5-fluorouracil and imiquimod), photodynamic therapy, and radiation therapy. Each has its own clinical profile, and treatment selection depends on lesion characteristics, patient factors, and clinical judgment.
OncoPatch adds a device-based option within the radiation therapy category, specifically as a localized beta therapy approach that can be administered in a physician’s office without expensive capital equipment. It is not positioned as a replacement for any existing standard of care, but rather as an additional tool available to physicians based on clinical appropriateness.
Practical and Regulatory Considerations
What are the radiation safety considerations?
Y-90 is a pure beta emitter, which means it does not produce the penetrating gamma radiation associated with many other radioactive medical sources. Beta particles are effectively shielded by the device housing, which simplifies the radiation safety requirements for office-based use. The use of radioactive materials in clinical practice is subject to applicable federal and state regulations. OncoPatch’s integrated care model, which includes regulatory oversight by a radiation oncologist and on-site support from a trained OncoPatch clinical specialist, is designed to handle these requirements so that dermatologists can focus on patient care.
Learning More
Where can I learn more about OncoPatch?
Physicians interested in learning more about the device are welcome to visit oncopatch.com or contact the OncoPatch team directly. The company is based in Aurora, Colorado, and welcomes conversations with dermatologists, Mohs surgeons, dermatologic oncologists, and radiation oncologists who treat non-melanoma skin cancer.
Will OncoPatch be at AAD 2026 in Denver?
Yes. The OncoPatch team will be hosting product demonstrations in a private suite at the Hyatt Regency Convention Center during AAD 2026 on Saturday, March 29 and Sunday, March 30 from 4:00 PM to 7:00 PM. Dermatologists attending the conference are welcome to stop by to see the device, ask questions, and meet the founders. No RSVP is required.