Operator
Good morning, and thank you for standing by. Currently, all of the participants are in listen-only mode. After management discussion, there will be a question-and-answer session. Please be advised that today's conference call is being recorded. I would now like to turn the conference over to Michael Polyview. Please go ahead.
Thank you, Operator, and welcome to IceCare Medical's conference call to review the financial results as of and for the three months ended March 31, 2026, and provide an update on recent operational highlights. You may refer to the earnings press release that we issued earlier this morning. Participating on today's call are IceCare Medical's CEO, Al Shemir, the company's VP in sales, North America, Shadgood, and our guest, Dr. Richard Fine, a key opinion leader in the treatment of breast cancer, a breast surgeon, and ICE-3 investigator who has published and presented ICE-3 data and is active in hands-on trainings and symposia for cryoablation of the treatment of early stages. Before we begin, our contains overlooked statements within the meaning of the SEPAR www.scc.gov. The company exclaims any intention or obligation, except as required by law. encouraging start to 2026.
We reported revenue growth of 26% year-over-year for the first quarter of America by 31% of time. And since Chad and Dr. Fein will provide additional insight, I encourage you to our results clearly demonstrate high skills accelerating commercial momentum, particularly in the U.S. Continued conversion of our growing pipeline in your active customers and the expanding clinical and scientific validation supporting the first quarter from a revenue standpoint is rising to three customer sites. Growing and engaging customer types is a network in the world. Regional hospitals network and especially customers are integrating key advantage of of our system, and it does not require additional infrastructure in current activities, an important indicator for long-term adoption and recurring revenue potential. Turning to our U.S. commercial program last quarter is translating into a measurable growth. Prior to FDA approval, we had included some with several new accounts and reactivated others while waiting FDA clearance. Our active account space 219, encouraged by this level of growth, currently available information, we expected accounts due to customers' acquisition and growing confidence among existing institutions, many of which represent large additional system placements within our current customers network. While the U.S. remains our primary focus, it is important to the Americas, particularly event at international medical conferences, where we grow a number of physicians and researchers in adopting process and initiating new studies using mark approval in Europe for breast cancer for some time, the FDA clearance has had a visible impact on increased interest. This growing global engagement is a grindstone for our technology. I will now turn a call over to Shrad.
Training. I'm a radiologist. There is a growing recognition. Another important factor contributing to this interest is the increasing volume of independent clinical research. It is somewhat unusual to see such large numbers of investigator-initiated studies. The FDA clearance now in place for low-risk breast becoming a natural choice for researchers who are looking to study cryoablation in this setting. In addition, the updated 2026 resource guide. Thank you.
Operator
Ladies and gentlemen, at this time we will begin the question and answer session. If you have a question, please press star 1. If you wish to cancel your request, please press star 2. If you are using speaker equipment, kindly leave the answer before pressing the numbers. Your questions will be pulled in the order they received. Please stand by while we pull for your questions. The first question is from Anthony Mandetti of Maxine Group. Please go ahead.
I think, Ian, you mentioned there's 19 active sites right now.
Yes, Anthony, just to clarify, are you talking about commercial sites or are you referring to the post-market?
All the post-market study sites.
The FDA protocol that was approved in March.
I believe, Anthony, that we will be on schedule. That means that before September 5th, as the FDA approved the protocol by March 5th, We will have the first patient and we expect and plan to complete 80 patients before March 27th.
Okay, and then switching to HealthCat, you submitted in March, right, a decision from...
We received, you know, mainly, you know, some technical and informal questions which we replied. We believe that in the next few weeks, they will come back maybe with some questions, and we believe that before the end of the year, we expect to get the approval. And switching to Japan... I believe that maybe it would be... They had very positive discussions with the Japanese FDA, with the PMDA, during January. I think that they're supposed to have extremely soon the second call. I'm not sure yet if it will be end of June or early 7th quarter, but they are in full speed for the submission.
Okay, and I know obviously that there's the intense focus as the market.
Also in the past, Anthony, the U.S. will be focused on breast. in Europe and in other markets we are treating other organs as well. We of course the post-FDA and as we mentioned in the earning call or earning relief, we have a very nice activity to invest in Europe but we are treating regularly other organs as well in Europe and in Asia. And last November, if you all remember, Dr. Nomori published a new study regarding lung cancer. So we are putting all of them outside of the U.S.
Okay, great. Thanks for the caller. I appreciate it. I'll talk to you.
Operator
The next question is from Kent Bolivar of Brookline Capital. Please go ahead.
Thank you. Two questions. First is, how many of the active sites will be choice sites? And this is actually a question for Dr. Fine. And the question is, how do you expect to use, or at least what do you think your utilization of ProSense will be as you await the issuance of the CPT1 code? You know, I'm thinking commercially. I mean, certainly you're going to get reimbursed as part of the trial, but if you have other patients outside the trial, you know, does it make economic sense to be able to treat them? Can you do it?
Yes. What a lot of facilities have done and what we're planning to do commercially is we do this in an office post in the hospital. The pass-through code that was mentioned earlier won't work in the office space.
Does that answer your question? Yeah, well, just to build on that quickly, I mean, is it virtually all of your commercial patients say yes?
Say that those that we've done it on so far have all said yes. I haven't had any by decline.
Dr. Scott, thank you. You know, we, thanks to Dr. Fine, he's also led and leading the CPP code at the ASDRS and with the support of other societies, we believe that there is more as a process. We have all clinical evidence that the package is now in the final sharpening and shaping it and we are going to submit it in two to four weeks. And then it will be a process, some kind of a questionnaire to the physician, and we expect that during 27 we will be approved, and this CPT-1 could suppose to be effective January 1st, 2028.
Okay, great. Thank you for that color. And then I don't know about that cadence.
I still am not giving guidance to self-supplacement, but we expect to have a pretty good second quarter and we will continue to grow. Usually a third quarter is a bit slow because of the summer. First quarter is a good quarter, but we expect it to grow, we expect to see agreements with the study as well as being a commercial site or some of the sites as Shad mentioned will be commercial only and they will not participate in the post-market study because they don't at the facility to support some kind of a clinical process. Okay, Grant.
Yeah, yeah, I was going to add that now that we have the FDA approval, a lot of these accounts that we've been talking to.
Position yourself a little bit about.
Maybe you will answer, you know, to the first part, and Dr. Fein could answer what kind of clinical evidence we see as part of the PMS.
So to address the first part of your question in regards to volume, we have really good data sets.
Operator
There are no further questions at this time. I will turn the call over to Riyal Shamir for concluding remarks.
To conclude, we believe the first quarter of 2026 represents an important step forward for ISCO. We are seeing clear evidence that the foundation we have built over the past several years, including clinical data, regulatory milestone, and physician engagement, is now translating into a commercial growth, particularly in the U.S. The combination of FDA clearance, supporting clinical guidelines, expanding reimbursement, and increasing physician and patient's awareness is creating a strong environment for continued adoption of process. We are encouraged by the growth in our activities account base, the strength of our commercial pipeline, and the increasing level of engagement across the medical community. We look forward to continuing to build on this momentum throughout 2026. Thank you all for your time today.
Operator
This concludes the IFIL First Quarter 2026 Results Conference Call. Thank you for your participation. You may go ahead and disconnect.
