SkinCure Oncology Submits GentleBeam™ for FDA Clearance, Expanding Noninvasive Skin Cancer Treatment

 SkinCure Oncology, the world leader in providing a comprehensive model for the delivery of Image-Guided Superficial Radiation Therapy (Image-Guided SRT or IGSRT) for the treatment of nonmelanoma skin cancer, presented to dermatology patients as the GentleCure Experience^™,  announced the submission of its GentleBeam^™ technology to the U.S. Food and Drug Administration (FDA) for 510(k) clearance.

GentleBeam is designed to deliver Image-Guided SRT, a noninvasive treatment option that uses imaging to help clinicians direct low-level x-rays to targeted areas of the skin.

The submission marks a key step in SkinCure Oncology's ongoing commitment to advancing technologies that support patient-centered care and physician-driven treatment protocols. GentleBeam is designed to offer a gentle, targeted approach to treating nonmelanoma skin cancers, expanding nonsurgical options for both patients and healthcare providers.

"We are thrilled to take this important step toward regulatory review of GentleBeam," said Kerwin Brandt, Chief Executive Officer of SkinCure Oncology. "Our more than 400 practice partners have used GentleCure Image-Guided SRT over the years to successfully and safely treat nearly 100,000 patients across the country who have sought out less invasive options. Today's announcement represents our commitment to patients and their families and our unyielding fidelity to lead the state of the art in skin cancer treatment. For us, it's first and always about the patient."

The FDA's review process for 510(k) clearance is designed to evaluate whether a new device is substantially equivalent to a legally marketed predicate device. If cleared, GentleBeam would become part of SkinCure Oncology's portfolio of solutions focused on delivering personalized, effective treatment options for patients with nonmelanoma skin cancers.

GentleBeam is not yet cleared by the FDA and is not available for commercial distribution in the United States.