IceCure Medical Ltd. reported growing commercial adoption of its ProSense cryoablation system in Brazil following a recent U.S. FDA marketing authorization for early-stage, low-risk breast cancer. The company highlighted this expansion at the SOBRICE Onco 2026 congress, noting that the FDA clearance has significantly boosted awareness among Brazilian physicians and institutions. IceCure CEO Eyal Shamir stated that commercial procedures are already being performed for breast, lung, kidney cancer, and musculoskeletal tumors in the country.

The ProSense system holds Agência Nacional de Vigilância Sanitária (ANVISA) regulatory approval in Brazil. IceCure believes the U.S. FDA authorization has provided a tailwind for market penetration in Brazil's interventional oncology sector. The company is working with KTR Medical, its exclusive distributor in Brazil, to expand access to the technology through clinical education and strategic partnerships.

Clinical validation efforts are accelerating with large-scale independent studies. Dr. Vanessa Sanvido, a breast surgeon at HCor Hospital in São Paulo, is leading a study involving 750 patients across Brazil. In France, Dr. Toulsie Ramtohul of Institut Curie is planning a two-arm study with 900 patients to evaluate cryoablation against the current standard of care. Dr. Ramtohul also conducted master classes at Albert Einstein hospital in São Paulo to share clinical expertise.

Clinical Studies Overview

Key medical centers in Brazil are adopting the technology, advocated by experts such as Dr. José Hugo Luz of the Instituto Nacional De Câncer. IceCure positions ProSense as a minimally invasive alternative to surgery, offering shorter recovery times and improved quality of life for patients.

IceCure Medical Ltd. has regained compliance with the minimum bid price requirement mandated by the Nasdaq Stock Market LLC, securing the continued listing of its securities. The company received written notification on June 18, 2026, confirming that its stock now meets the $1.00 per share threshold required under Nasdaq Listing Rule 5550(a)(2).

The compliance status addresses a critical regulatory requirement for the developer of minimally-invasive cryoablation technology, which destroys tumors by freezing as an alternative to surgical removal. Nasdaq staff determined compliance after the closing bid price of the company's ordinary shares was $1.00 or greater for 10 consecutive business days from June 4 to June 17, 2026. Consequently, Nasdaq considers the bid price deficiency matter now closed.

Compliance Details

The following table outlines the key compliance parameters met by IceCure Medical:

IceCure Medical develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors by freezing. Its primary focus areas include breast, kidney, bone, and lung cancer. The company's flagship ProSense system is marketed and sold worldwide for indications cleared and approved to date, including in the U.S., Europe, and Asia. The company's common stock trades on the Nasdaq market under the ticker symbol ICCM.