ProSense destroys tumour cells by freezing them via a minimally invasive approach. Image credit: Shutterstock / Katvic.

IceCure Medical has reported data from three clinical trials, showcasing the efficacy of its ProSense cryoablation device in the treatment of breast cancer, as the company battles poor financial performance.

The data, unveiled at the 32nd Annual Meeting of the Japanese Breast Cancer Society held on 12 July 2024 in Miyagi, Japan, involved two independent studies and an ongoing research study.

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Results from the ICE3 trial spearheaded the presentations. IceCure says it is the largest controlled multi-location trial for liquid nitrogen-based cryoablation of early-stage breast tumours. Over around six years, 389 breast cancer patients with small tumour lesions were treated with ProSense. The ipsilateral breast tumour recurrence rate (IBTR) was 0.26%, giving a recurrence-free rate of 99.74%. Data from an ongoing research study by Kameda Medical Center’s professor Eisuke Fukuma was also highlighted.

Fukuma said: “The results with ProSense continue to be excellent, and this is why cryoablation is becoming a common procedure here. Patients are becoming more interested. They are coming in and asking to learn more about it.”

St Marianna University School of Medicine’s professor Hisanori Kawamoto followed up with data, which was published in Breast Cancer, from a separate independent study. This trial found no local recurrence or distant cancer spreading in breast cancer patients five years following ProSense treatment. There were no serious adverse events reported in the patients, who were followed for an average of just over 44 months.

IceCure has an ongoing partnership with Terumo Corporation, Japan’s largest medical device company.

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IceCure’s CEO Eyal Shamir said: “We expect Terumo Corporation will file for regulatory approval of ProSense for breast cancer in Japan in the first quarter of 2025, with the aim of making our cryoablation system more commercially available to doctors and patients alike in Japan.”

Whilst cryoablation and thermal ablation devices have endured market dominance in many indications, the emergence of pulsed-field ablation (PFA) is poised to disrupt this. In cardiovascular disease, for example, PFA is associated with improved safety over its traditional counterparts. By 2030, PFA will be used in 75% to 80% of electrophysiology ablation procedures, according to an analysis by GlobalData.

IceCure announced its data on the same day it received a Nasdaq compliance notice after the company’s shares fell below the $1 threshold requirement. The Israeli company has until 14 January 2025, to achieve compliance and avoid delisting.

IceCure’s stock took a downturn in 2021 when it announced lower gross profit and smaller gross margins, along with an increase in net loss from the year before.

The company’s stock took another hit last year when the US Food and Drug Administration (FDA) denied a de novo approval for a breast cancer indication for ProSense.