IceCure Medical Ltd (NASDAQ:ICCM) Q3 2022 Earnings Call Transcript

Ben Haynor: Okay. That’s fair enough. I’m just got a try. And then congrats again on the FDA submission. Have you guys had any conversations with the FDA post the submission and anything you can share on that process?

Eyal Shamir: We have a continuous discussion with them after we had the submission on October 18. We don’t have anything yet to report, but we are sharing information with the agency in order to get the clearance.

Ben Haynor: Okay. So there’s no surprises or show stoppers on that point.

Eyal Shamir: Not at this stage. We have continued good discussion.

Ben Haynor: Okay. Well, thank you guys for taking the questions and congrats on all the progress.

Eyal Shamir: Thank you very much.

Operator: The next question is from Anthony Vendetti of Maxim Group. Please go ahead.

Anthony Vendetti: Thank you. I’ll start with Dr. Bednarski. So that was really helpful. Thank you so much for sharing your experience with patients and your expertise. I was just wondering on tumor size, with the ProSense system, is there — do you feel that there’s a limit to the size or is that just a limit right now based on the way the system set up and the consumable? And do you believe it could be used for larger tumors?

Hania Bednarski: Thank you for the question. So the way that the probes are currently manufactured, each probe for breast cancer, we’re talking about breast cancer here, we’ll be able to manage a two centimeter tumor, maybe 2.2 centimeters. We really don’t like to go much bigger than that because we want to make sure to cover the entire tumor with a one centimeter margin all the way around. That said, hypothetically, there’s nothing to say that you can’t place multiple probes within a tumor. So if a tumor is larger, you could potentially have overlapping ice balls and overlapping pro positioning to cover a larger tumor size.

Anthony Vendetti: Okay. That’s helpful. And then, in terms of the stages, right now, it’s for early stage breast cancer. Do you see that evolving to be able to treat later stage or once it gets later stage that’s when you talk about different options?

Hania Bednarski: Well, I think that some of both is available. So yes, I do see the system being able to be used for larger tumors, later stages. So right now, stay one is what it’s being used for, which essentially is defined as a tumor less than two centimeters. Tumors two to five centimeters that automatically bumps them into a stage two breast cancer. So yes, I definitely see it being potentially useful for larger tumors. At the same time, there are some breast cancers that simply would not be treatable by cryoablation, no matter what. So things like inflammatory breast cancer should not be treated by cryoablation. Tumors that actually infiltrate the nipple itself, that’s something that should not be treated with cryoablation. So there are certainly limitations, but generally, I think that this system can be used quite extensively for many different applications in breast cancer.

Anthony Vendetti: Okay. That’s very helpful. And since Dr. Bednarski, you’ve been doing this since 2014, just if you can give us a little more color on the competitive cryoablation systems out there. I know you said you came back to the ProSense system. Just in terms of what other systems are out there? Was it just the liquid nitrogen or anything else specifically about the ProSense system that you said this is clearly the best system out there, a little more color on that would be very helpful. Thank you so much.

Hania Bednarski: Sure. Thank you. So one thing that I’ll mention, I believe, I mentioned it earlier, is the support from IceCure. I think that that is a huge aspect of why I came back to the system. That said, yes, there are some competing systems on the market, mainly organ based. And I feel that organ based systems are subpar, quite honestly, for breast cancer use at least. Certainly, maybe for other cancers, they can be used more facily, but for breast cancer, I feel that the probes are much smaller. The tissue does not get as cold. It really is not as effective from my experience and my reviews of the literature. As far as liquid nitrogen’s competitors, I don’t know that there are any right now. There were some in the past and I believe I’ve heard some talk that there are some trying to facilitate themselves. But right this minute, I believe that IceCure is the only liquid nitrogen based cryoablation system on the market.

Anthony Vendetti: Okay, great. That’s very helpful. And then just one question for Eyal. I know you received approval or you — regulatory approval in Brazil and you submitted approvals in Canada and Vietnam, you submitted for those. Just any update on expectations. Is that on schedule in Canada and Vietnam? And then, now that you have approval in Brazil, can you talk about a little bit about the commercialization there? Thank you.