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Cryoablation System Gets Approved in Brazil

Source: Dr. Yi Chen

September 8, 2023 ( Newswire) The product developer expects to generate US$6.6 million in sales of this medical device in Brazil over the next five years, noted an H.C. Wainwright & Co. report.

IceCure Medical Ltd.'s (ICCM:NASDAQ) ProSense system, used to deliver precise and targeted cryoablation treatments, was approved in Brazil as a Class III device for oncological conditions, reported H.C. Wainwright & Co. analyst Dr. Yi Chen in a September 6 research note.

"The cost-effective and minimally invasive cryoablation procedure should drive physician and patient adoption compared to traditional surgical intervention," Chen commented.

Notable Return Potential

On this news, H.C. Wainwright reiterated its US$3 per share target price on the Israeli medical device firm, now trading at about US$1.12 per share, noted Chen.

The difference between the current and target prices reflects a potential return on investment that is significant: 168%.

IceCure is a Buy.

Regulatory Approval Specifics

The Brazilian Health Regulatory Agency, Anvisa, approved IceCure's ProSense for the ablation of benign and malignant tissues in the breast, prostate, kidney, lung, liver, musculoskeletal system, and skin. With the approval, Ktrfios, IceCure's distributor in Brazil, may market and sell ProSense along with the disposable probes and introducers needed for its use.

Chen highlighted that IceCure's management expects to generate US$6.6 million in ProSense-related sales in Brazil over the next five years based on guarantees outlined in the distribution agreement.

As part of the recent approval, Anvisa requested the ProSense probes be transitioned to a Class III device, as is the overall system. Ktrfios will apply for Class III approval of these, which it expects to obtain by the end of Q1/24. The introducers, however, will remain a Class II device.

Further Approval Pending

In other news, IceCure used interim data from the ICE3 clinical trial to support a de novo application of ProSense in the U.S. for the indication of early-stage, low-risk breast cancer in patients deemed unsuitable for surgical alternatives, Chen reported.

Five-year results of the ICE3 study, still in progress, are due out in H1/24. H.C. Wainwright expects them to be positive.

"If approved, the U.S. would have the company's largest commercial footprint for ProSense," Chen added.

More Info: Newswire

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