Israeli medical device company IceCure Medical (TASE: ICCM) has announced that updated guidelines have been published by the American Society of Breast Surgeons (ASBS) to recommend that surgeons take part in clinical trials for treating malignant breast tumors. The ASBS is the leading US organization of breast surgeons, which among others things, sets guidelines for breast surgery practices, which support use of IceCure’s cryoablation technology in early stage malignant breast tumors.
The Israeli company has developed technology for treating breast and other benign and malignant cancer tumors by freezing the tumor during treatment in a clinic, without surgery. In May 2018, IceCure published positive results on 146 patients taking part in a trial that it had conducted. As part of the trial, the patients underwent a medical procedure of about 20-40 minutes in a clinic using the company’s IceSense3 system. The trial took place in 18 leading US hospitals and clinics including Mount Sinai Beth Israel and Columbia University Medical Center.
In its updated guidelines, the ASBS specifically mentions cryoablation technology and recommends taking part in clinical trials for treating malignant breast tumors and in registries, due to the publication of initial data regarding the effectiveness of cryoablation. The previous guidelines said that cryoablation was only for trials and not to be used outside of the clinical trial framework.
Registries, by which uniform data is collected from patients through observational studies, represent an important stage in the commercialization of technologies and are part of the required procedure for receiving remuneration from health insurance companies. IceCure’s share price rose 8.5% on the news earlier this week but has since fallen back somewhat, although the share price is up 51.9% in 2018.
Published by Globes, Israel business news – en.globes.co.il – on October 23, 2018
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