IceCure presents hattrick of positive data from cryoablation device study

IceCure Medical has released data from three clinical trials showing the effectiveness of its ProSense cryotherapy device in treating breast cancer, amid declining financial results for the company.

The data, presented at the 32nd annual meeting of the Japanese Breast Cancer Society on July 12, 2024 in Miyagi, Japan, included two independent studies and an ongoing research study.

The ICE3 study results were the main presentations. IceCure says it is the largest controlled, multi-site study of cryoablation with liquid nitrogen for early-stage breast cancer. Over about six years, 389 breast cancer patients with small tumors were treated with ProSense. The ipsilateral breast tumor recurrence rate (IBTR) was 0.26%, giving a recurrence-free rate of 99.74%. It also highlighted data from an ongoing research study led by Professor Eisuke Fukuma of Kameda Medical Center.

Fukuma said, “The ProSense results continue to be excellent, which is why cryoablation is becoming a common procedure here. Patients are becoming more interested. They come in and ask to learn more about it.”

Professor Hisanori Kawamoto of St. Marianne University School of Medicine presented further data, which were published in Breast cancer, from a separate independent study. In that study, there was no local recurrence or distant spread of cancer in breast cancer patients five years after ProSense treatment. There were no serious adverse events in patients who were followed for an average of just over 44 months.

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

IceCure CEO Eyal Shamir said, “We expect Terumo Corporation to file for regulatory approval for ProSense for the treatment of breast cancer in Japan in the first quarter of 2025, and our goal is to make our cryoablation system more commercially available to physicians and patients in Japan.”

While cryoablation and thermal ablation devices maintain market dominance in many indications, the advent of pulsed field ablation (PFA) is poised to change that. In cardiovascular disease, for example, PFA is associated with improved safety compared to traditional counterparts. According to a GlobalData analysis, PFA will be used in 75% to 80% of electrophysiological ablation procedures by 2030.

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

The story continues

IceCure shares fell in 2021 as the company reported lower gross profit and lower gross margins, as well as a widening net loss compared to the prior year.

The company’s shares fell again last year when the U.S. Food and Drug Administration (FDA) declined to approve a new indication for ProSense in the treatment of breast cancer.

“IceCure Presents Three Positive Study Data for Cryoablation Device” was originally created and published by Medical Device Network, a GlobalData brand.

The information on this site is provided in good faith for information purposes only. It is not intended to constitute advice on which you should rely and we make no representations, warranties or assurances, express or implied, as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.