CAPS Medical, a clinical-stage MedTech company, has received Breakthrough Device Designation from the U.S. FDA for its PlasmaSure™ System, aimed at treating low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC).
The PlasmaSure™ platform delivers non-thermal plasma energy through standard minimally invasive tools, enabling precise tumour removal while protecting healthy tissue.
In a first-in-human study, approximately 70 tumours were treated with durable results, no adverse events, and procedures performed without general anaesthesia.
The approach aims to replace traditional surgery, offering a faster, safer, and lower-cost option in an office setting.
Building on this success, CAPS Medical is advancing pre-clinical studies in lung, oesophageal, gastric, and prostate cancers, indicating the platform’s potential for multiple tumour types.
To support its next phase, the company is establishing a U.S. base and preparing pivotal trials, paving the way for future commercialisation and global growth.
