BETA
Israeli clinical-stage developer of PlasmaSure, an investigational non-thermal plasma platform for minimally invasive tumor ablation.
CAPS Medical is developing PlasmaSure, a non-thermal atmospheric plasma system intended to deliver energy through standard minimally invasive instruments. Its initial human development focus is non-muscle-invasive bladder cancer, with additional solid-tumor applications described as preclinical programs.
The company reports completing first-in-human research and receiving FDA Breakthrough Device designation for low- to intermediate-risk bladder cancer in October 2025. Its website continues to identify the technology as investigational and not cleared for marketing; designation does not establish commercial availability.
The technology originated from work involving the Technion and Rambam Health Care Campus and was developed within MEDX Xelerator. A US$3.5 million Series A was announced in 2020. Current clinical evidence, further trial plans and eventual market access require separate evaluation.
PlasmaSure remains in clinical development for bladder-tumor ablation. CAPS reports Breakthrough Device designation for low- to intermediate-risk NMIBC, while its current site states investigational use only and no marketing clearance. [15][2][3][16][18]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [20][21]
Latest recorded source review: 2026-10-20.
No commercially marketed products established. Research participation is separate from customer adoption.
The sponsor describes preclinical work in lung, esophageal, gastric and prostate cancer, alongside the bladder program. These are investigational applications of the platform, not verified separate products or authorized indications. [7][8][9][2]
Investigational system delivering non-thermal atmospheric plasma through minimally invasive instrument channels. Initial human work focuses on recurrent low-grade non-muscle-invasive bladder tumors; other solid-tumor uses remain development objectives. [15][2][7][8]
Investigational / in developmentInvestigational use only. Company states not cleared for marketing in the U.S. or other markets.
A Journal of Surgical Case Reports publication describes one bladder-tumor treatment under local anesthesia. The single case supports further investigation, not a finding that routine office treatment is established. [9]
CAPS reported FDA designation for PlasmaSure in low- to intermediate-risk NMIBC. The announcement describes pivotal-study and U.S. expansion plans; designation is not clearance, approval or guaranteed reimbursement. [2][3]
The 2025 JU Open Plus paper reports a prospective multicenter open-label study involving 30 patients, 67 tumors and 36 procedures. Reported complete response was 83% of patients and 84% of tumors, with no device-related adverse events reported. The small, uncontrolled study does not establish comparative effectiveness or rule out uncommon harms. [7][8]
Round led by Chasing Value Asset Management and Israel Investment Fund Group, with other participants identified by MEDX. The announced amount supported clinical development; it is not current revenue or a verified lifetime funding total. [4][24]
MEDX reported that CAPS Medical, formerly Plasmed, won first place in the life-sciences pitch track; co-founder Jacob Cohen presented its plasma-based cancer-ablation technology. [5]
Accessed 10/29/2026