CAPS Medical's PlasmaSure System Receives FDA Breakthrough Device Designation for Non-Muscle Invasive Bladder Cancer Treatment
Key Insights
CAPS Medical (search)'s PlasmaSure (search) System has received FDA Breakthrough Device Designation for treating low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC).
The company completed its first-in-human clinical study treating approximately 70 tumors with durable complete response rates and no adverse events.
The non-thermal atmospheric plasma technology aims to replace traditional TURBT procedures with simple, office-based treatments without general anesthesia.
CAPS Medical (search), a clinical-stage MedTech company, announced that its PlasmaSure (search)™ System has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC). The designation supports the company's mission to transform tumor ablation into a simple, selective, and in-office procedure.
Revolutionary Plasma Technology for Bladder Cancer
The PlasmaSure (search)™ platform delivers non-thermal atmospheric plasma energy through the working channels of standard minimally invasive tools, specifically through cystoscopes for NMIBC treatment. This approach enables highly selective, tissue-preserving tumor ablation that could fundamentally change how bladder cancer is treated.
CAPS Medical (search) has successfully completed its first-in-human clinical study, treating approximately 70 tumors and demonstrating durable complete response rates across both short and long-term follow-up periods. The study revealed an improved safety profile with no adverse events, no damage to surrounding healthy tissue, and excellent patient tolerance, including procedures performed without general anesthesia.
Transforming Standard of Care
The company's goal is to replace traditional transurethral resection of bladder tumors (TURBT), hospitalization, and general anesthesia with a simple, office-based procedure. This transformation would allow patients to be treated earlier, with less risk, faster recovery, and lower cost compared to current standard treatments.
Ilan Uchitel, CEO & Co-Founder of CAPS Medical (search), commented: "Receiving Breakthrough Device Designation is a strong validation of the clinical need for a safer, more accessible solution for NMIBC patients and of the differentiated potential of our PlasmaSure (search)™ platform. This designation provides priority review and interactive communication with the FDA, more flexible clinical study design, and promising potential eligibility for CMS's Transitional Coverage for Emerging Technologies pathway, supporting earlier and more predictable reimbursement. Our team is committed to turning this innovation into a new standard of care."
Strategic Development and Expansion Plans
This milestone marks the beginning of the next growth phase for CAPS Medical (search) as the company prepares for pivotal trials, U.S. market entry, and global expansion. To support its next stage of development, CAPS Medical is establishing a U.S. headquarters and preparing for its pivotal study and subsequent commercialization efforts, enabling closer engagement with clinical partners, regulators, and payors in the U.S. market.
Multi-Indication Oncology Platform
Building on its clinical success in NMIBC, CAPS Medical (search) is advancing pre-clinical programs in lung, esophageal, gastric, and prostate cancer, among others. Early data from these studies show promising tumor ablation results, reinforcing the potential for the platform to become a multi-indication oncology solution.
The Breakthrough Device Designation provides several advantages including priority review and interactive communication with the FDA, more flexible clinical study design, and potential eligibility for CMS's Transitional Coverage for Emerging Technologies pathway, which could support earlier and more predictable reimbursement pathways.