IceCure ProSense Device Allows Cancerous Tumors to be Frozen

IceCure aims to make the ProSense device it has developed, which allows cancerous tumors to be frozen and destroyed in a targeted manner and without damaging the surrounding healthy tissues, the preferred treatment alternative in the United States for early-stage breast cancer, saving many women the need for partial mastectomy. The company is now preparing to enter the US market in two ways: listing the company’s stock, which is currently traded in Tel Aviv, for trading on the NASDAQ and completing a major experiment that will allow it to apply to the FDA to expand the use of the device for breast cancer.

At the end of January, the company completed a $ 15 million fundraiser in preparation for the double listing on the Nasdaq. About half of the amount raised came from the controlling shareholder in the company, a Chinese businessman who has invested a total of $ 20 million in recent years. Voting at the company’s shareholders’ meeting in early March, and Icecure believes that listing on NASDAQ will take effect during the second quarter. In the past month, apparently due to the intention to join NASDAQ, the Icecore share doubled in value and the company traded at a market value of 230 a million shekels.

The company’s CEO, Eyal Shamir, explained in a conversation with Techtime that joining the Nasdaq is part of the strategy for entering the American market. “The United States is a very important market for us. Entering the NASDAQ will provide us with exposure to investors and strategic players and allow us to achieve pricing that more reflects the value of the company.”

At the clinical level, the company is currently conducting the multicenter trial at the end of which it will be able to request from the FDA approval for the use of a device for the treatment of early-stage breast cancer. The trial was conducted at 19 medical centers across the United States and involved about 200 women diagnosed with breast cancer. Icecure’s VP of Business Development, Tallit Bossi, explains that the uniqueness of the experiment is not just proving the device’s effectiveness, but also comparing the minimally invasive treatment with Icecure’s device with the surgical alternative of partial mastectomy.

Leap in device use in Europe at the height of the plague
IceCure, founded in 2006, has developed a system that works with a method called Cryoablation, in which the tumor is destroyed by freezing. IceCure’s system allows the procedure to be performed in a minimally invasive manner, by inserting a thin needle (protected by 11 patents) which the doctor navigates to the tumor using ultrasound guidance (or CT if it is a tumor in the liver, lungs and bones). Once the needle reaches the tumor, it freezes it by flowing liquid nitrogen to the tip of the needle where the tumor is located, without damaging the surrounding healthy tissue.

The treatment lasts about 15-25 minutes under partial anesthesia and does not have to be performed in an operating room. Most competing treatments are based on other gases such as argon and helium, which are more expensive and have a smaller radius of action, so they require more needles, which complicates navigation and also micromanages the procedure. It should be emphasized that the destruction of cancerous tumors in freezing is especially effective in tumors in the early stages, and therefore early diagnosis is critical to the success of treatment.

The most strategic market in which the company is active in the field of breast cancer is the East Asian countries. In the past year, the company has been able to obtain regulatory approvals in a number of key countries. IceCure operates in the region in collaboration with Terumo, the Japanese medical device giant that serves as the company’s exclusive distributor in Japan, Singapore and Thailand. In China, the company has received approval for the device but is still awaiting approval for needles. In 2020 the company reported sales of about $ 3.86 million, compared to $ 1.6 million in 2019, a 2.4-fold growth in the corona year.

 

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