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PlasmaSure received FDA breakthrough device designation for low- to intermediate-risk non–muscle-invasive bladder cancer.
The FDA has granted breakthrough device designation to the PlasmaSure System for the treatment of patients with low- to intermediate-risk non–muscle-invasive bladder cancer (NMIBC).1
PlasmaSure is a minimally invasive, non-thermal plasma system intended to ablate solid tumors without harming healthy tissue. The system is designed to deliver non-thermal atmospheric plasma energy via working channels of standard minimally invasive tools in patients with solid tumors. For NMIBC, the energy is propelled through cystoscopes to allow for highly selective, tissue-preserving tumor ablation.
Findings from a study evaluating the efficacy and safety of PlasmaSure published in The Journal of Urology Open Plus demonstrated that among patients with low-grade, stage Ta bladder cancer (n = 30), investigators used PlasmaSure to treat 67 total tumors in 36 total procedures.2 Data showed that 83% of patients achieved a complete response (CR) per visual inspection. In the 5 patients who did not experience a CR, 2 had a partial response, and 3 patients had no response but did not have disease progression per subsequent biopsy. The lesion CR rate was 84%.
Regarding safety, 16 adverse effects (AEs) were reported in 11 patients; however, no AEs related to PlasmaSure occurred in any patients. Additionally, patient-reported outcomes (PROs) showed that patients experienced minimal pain following the procedure and had a rapid recovery.
“Receiving breakthrough device designation is a strong validation of the clinical need for a safer, more accessible solution for [patients with] NMIBC patients and of the differentiated potential of our PlasmaSure platform,” Ilan Uchitel, chief executive officer and co-founder of CAPS Medical, stated in a news release.1 “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.”
PlasmaSure was evaluated in a prospective, multicenter, open-label, first-in human study that enrolled patients 21 to 85 years of age with a history of low-grade NMIBC who experienced a recurrence of up to 7 small papillary tumors that were 3 cm or smaller.2 Patients also needed to have high-grade cells absent on urine cytology and a normal upper tract on imaging prior to treatment.
Investigators excluded patients with a history of carcinoma in situ; high-grade or MIBC; nonurothelial tumors; or treatment with an intravesical chemotherapeutic agent within 6 months of enrollment.
PlasmaSure was integrated into the routine care of NMIBC for the enrolled patient population. The system was used for 3 to 6 minutes per tumor; patients were divided into 3 groups to receive PlasmaSure at 3 minutes per tumor, 4.5 minutes per tumor, or 6 minutes per tumor. For tumors over 3 cm or located in locations with limited access for the PlasmaSure probe, patients underwent resection or fulguration. Patients underwent follow-up at 3 weeks and 3, 6, 9, and 12 months following the procedure.
Safety served as the primary end point of the study. Secondary end points included treatment duration and efficacy.
In the publication, study authors noted that the trial was limited by its small sample size. They also explained that PRO protocols were added during the study, which led to limited PRO data from the study population.
The device is expected to be investigated in a larger cohort of patients to further explore its safety and efficacy, and to gather additional PRO data.
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