IceCure wins FDA breakthrough status for tumor freezing

Eyal Shamir / Photo: IceCure

The Israeli company's ProSense treats early stage, low risk breast cancer.

Israeli medical device company IceCure Ltd. (TASE: ICCM) saw its share price rise 35% today, on a high trading turnover, after the company announced that the US Food and Drug Administration (FDA) had awarded breakthrough status for its ProSense system, for treating cancerous tumors by freezing them. ProSense solutions for removing breast cancer growths through freezing are far less intrusive than current surgical procedures.

As part of the FDA's 'breakthrough device' program, IceCure's treatment was fast tracked by the US regulator.

IceCure CEO Eyal Shamir said, "We are delighted about the FDA's recognition of our innovative cryoablation (freezing) technology as a breakthrough device, which meets the major needs for treating benign and cancerous tumors for a range of indications including early stage and low risk breast cancer. Receiving breakthrough device status allows the company direct access to the FDA team examining the product, thus shortening the process for requesting approval of the product."

Published by Globes, Israel business news - en.globes.co.il - on April 4, 2021

© Copyright of Globes Publisher Itonut (1983) Ltd. 2021

Eyal Shamir / Photo: IceCure
Eyal Shamir / Photo: IceCure
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