Israel-based IceCure Medical has secured the US Food and Drug Administration (FDA) Breakthrough Device Designation for its ProSense Cryoablation System.

ProSense is a liquid-nitrogen-based cryoablation system, designed to enable minimally-invasive, treatment of cancer tumours.

The US regulator indicated ProSense for the treatment of patients with T1 invasive breast cancer and patients who are not eligible for surgical alternatives for breast cancer treatment.

IceCure CEO Eyal Shamir said: “We are thrilled to receive the Breakthrough Device Designation from the FDA for our lead asset, ProSense, based on promising clinical outcomes in multiple clinical studies to date.

“ProSense has successfully demonstrated the potential to be an exceptionally safe and effective minimally-invasive cryoablation approach to tumour destruction.

“We believe receipt of this designation is a testimony to the potential of ProSense to become the new gold standard for cryoablation tumour therapy. The addition of the Breakthrough Device Designation builds on a series of successful regulatory milestones.”

Established in 2006, IceCure is engaged in developing the next-generation cryoablation technology that destroys tumours by freezing, with a primary focus on breast, kidney, bone and lung cancer.

The minimally-invasive technology is safe and effective surgical alternative to tumour removal, and can be easily performed in a relatively short procedure, said the company.

IceCure intends to advance its collaborative dialogue with the FDA for the commercialisation of ProSense for the treatment of benign and malignant tumours.

The company intends to commercialise the cryoablation system worldwide, after receiving regulatory approvals from the US FDA and CE.

Shamir added: “ProSense has already received FDA approval for general minimally-invasive cryoablation applications, including for kidney, liver, and benign breast tumours.

“IceCure is further pursuing FDA-specific approval for breast cancer with its ongoing ICE3 clinical trial, the largest controlled multi-location clinical trial in the US for liquid nitrogen-based cryoablation of small, low-risk, early-stage malignant breast tumours.

“We are excited to have updated interim results of the ICE3 trial presented at the upcoming American Society of Breast Surgeons Annual Meeting on April 30.”