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spk00: Good morning, and thank you for standing by. Currently, all participants are in a listen-only mode. After management's 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 Pulliview. Please go ahead.
spk05: Thank you, Yoni, and welcome to iSecure Medical's conference call to review the financial results for the nine months ended September 30, 2023, 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 iSecure Medical CEO, Al Jameer, and company CFO and COO, Ronan Zimmerman. Before we begin, I will now take a moment to read a statement about a little constatement. This call and the question and answer session that follows it contains all of the statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as expects, anticipates, intends, plans, believes, seeks, estimates, and similar expressions or variations of such words are intended to identify public statements. For example, We are using political statements in this presentation when we discuss the achievements we expect to accomplish as we continue to advance our growth strategy, our position to make significant commercial advances in key markets, pursuit of regulatory approvals in various jurisdictions, including with respect to the appeal we filed requesting review of the de novo classification for process, expansion of clinical applications, release of results from our clinical trials, potential market adoption, and future sales of ice cures minimally invasive cryoablation technology, advancing regulatory, commercial strategies, strategic plans, and our belief that we are in position to meet our primary goals in 2024. Because such statements deal with future events and are based on ISECURE's current expectations, they are subject to various risks and uncertainties in actual results, performance, or achievements of ISECURE-credited material from those described in or implied by the statements during this call. The follow-up statements contained in the reply during this call are subject to other risks and uncertainties, many of which are beyond the control of the company, including those set forth in the risk factor section of the company's annual report on Form 20F, which will be year-ended December 31, 2022, filed with the Securities and Stages Commission on March 29, 2023, which is available on the SEC's website at www.sec.gov. The company disclaims any intention or obligation except by law to update or revise any following statements, whether because of new information, future events, or otherwise. This conference call contains science-sensitive information and speaks only as of the live broadcast today, November 15, 2023. I would now like to turn the call over to iSecure Medical's CEO, Eyal Shamir. Eyal, please go ahead.
spk03: Thanks, Michael, and hello, everyone, and thank you for joining us today to review our operating results for the nine months ended September 13, 2023. To begin, and on behalf of the entire ICO team, I want to thank those who have reached out to us over the past few weeks. We greatly appreciate your thoughts, well wishes, and concern. While our team and everyone in Israel is personally impacted by the war with Hamas and why it remains a difficult and challenging matter, I want to reiterate that I still remain laser-focused and we will continue to execute our plan of delivering our life-preserving technology to people around the world for improved healthcare outcomes. We will continue to push forward. And as reflected in several key developments that have achieved during the current quarter, we are also experiencing a heightened level of interest for our process system. We had some significant achievements on the regulatory front, including approval for process in Brazil and Canada. Additionally, we encourage with the vast number of independent studies being initiated, conducted, and published by doctors using process. Our cryoablation system was highlighted at several medical conferences, and commercial distribution continues to expand as our process systems and disposable probe cells continue to increase. Given the importance of this development, I have asked Shaila Vav, our Vice President of Regulatory Affairs, Quality Assurance, and Clinical Applications, and Lalit Busitelso, our Vice President of Business Development and Global Marketing, to provide some additional comments. Earlier today, we announced that we filed an appeal with the FDA requesting an additional review of IQ, the NOVA classification request. Shai will provide more specific about the appeal in addition to sharing our regulatory pathway. Lalit will also provide more insight into the impact of the independent study and how it helps our global commercial penetration. They will both be available to answer your questions during the Q&A session at the end of this call. Shai, let's begin with our prepared remarks. Please go ahead.
spk04: Thank you, Eyal. As most of you know, in October 2022, iSQ filed a de novo classification request with the FDA for process for treating patients with early-stage low-risk breast cancer. The filing included interim analysis from our i3 breast cancer study because we believe that the data demonstrated efficacy and safety. with a five-year estimate of 95.7% recurrence free rate and 100% doctor and patient satisfaction with cosmetic results. We saw this as an opportunity to make this minimally invasive cryoablation procedure available to women in the U.S. sooner. Following a nearly one-year review, which is typical, The FDA denied our de novo request in September 2023. We reviewed the FDA's comment letter in greater detail, and in consulting with our regulatory consultants, we have come to conclude that the FDA's response was largely due to the agency's choice of a comparator group against which the I3 interim results were evaluated. There is a large amount of data from published studies in the scientific literature, including meta-studies, that provide efficacy and safety numbers for women with early-stage low breast cancer with lymphoma. We included robust and published literature in the de novo filing request, and this is why we had been expecting a more favorable response from the FDA. It was consistent with our expectation based on the conversation we had with them during the review process. We decided to appeal because we believe a dialogue with the FDA will allow us to come to an agreement on a proper comparator, mainly due to the fact that the new published article that was not available at the time of the last material submission to the FDA was cited in the denial letter and incorporating this article into the meta-analysis is more appropriate for the patient population we seek to treat with process. We believe a subsequent analysis of the data may make the benefits of process more obvious and therefore lead to granting of the de novo submission and marketing authorization. We expect a response to our appeal from the FDA by the end of January 2024, and our goal is to work closely with FDA to come to agreements on the comparator and on the classification of process. Upon completing the review process with the FDA, We seek to finalize the qualification and the classification of process. Our I3 study remains on track and is expected to be completed in the first quarter of 2024, following the last patient's five-year follow-up exam, which has remained consistent throughout the trial. Furthermore, the FDA's decision regarding the de novo for breast cancer has no effect on process FDA cleared authorizations for other indications in the U.S., so patients and doctors continue to have access to and benefit from process in the U.S. Outside of the U.S., process is approved for early-stage low-risk breast cancer in numerous countries including European countries, Brazil, India, and China. I'll now take it over to Yael, who will share operating differences.
spk03: Thank you, Shai, for that thorough review. In this exact same indication, early stage low-risk breast cancer Two independent studies conducted in Spain and Italy were recently presented at the European Society of Breast Imaging annual scientific meeting by doctors who are using ProSense. This study produced data that are similar to our i3 results, adding to the growing body of evidence, pointing to ProSense as a minimally invasive alternative in this indication. While ICO is in the process of conducting two studies, I3 in early-stage low-risk breast cancer and ISECRET in kidney cancer, it is important to acknowledge that there are 17 additional independent, non-sponsored studies ongoing for process. This is in addition to the 12 studies that have have already been published in peer-reviewed journals and medical conferences. 13 of the published and ongoing studies are for breast cancer, again offering more confidence in our minimally invasive cryoablation authors. The remaining independent studies are focused on fibroadenoma, endometriosis, and malignant or benign tumors of the kidney, lung, musculoskeletal systems. Why would so many doctors who are using ProSense around the world for multiple indications be taking their own time to conduct and publish such studies? We believe it is because they see firsthand the benefit that ProSense provides for their patients. This gives us the greatest confidence in ProSense and ICU. We hope you agree. This growing body of data and our focused effective commercialization strategy and leading to a greater process uses globally as evidence in the increased cells of processing systems and disposable cryoprops. In the U.S., we recently appointed Mr. Shad Good, a talented healthcare sales executive with a solid track record in breast diagnostic and therapeutic devices. As our VP of sales for North America, this market represents a significant market opportunity for process, and I believe that upon a successful outcome of our trial and regulatory strategy, we'll be fully realized as Chad and his team will make a significant contribution towards the acceleration of process sales in the U.S. In Europe, we expanded distribution in Portugal with a new distributor, MC Medical, the largest distributor of a third-party medical devices in the country. In India, the first ever breast cancer cryoablation procedure in the country was performed using process. We believe as India adopt more early detection for breast cancer, migrating to a minimally invasive solution like ours will improve the lives of women by providing them with an alternative to lumpectomy. I will turn the call over now to Lalit, our Vice President of Business Development and Global Marketing, for further insight on how PROSENS is gaining increased recognition globally as an excellent minimally invasive alternative to surgery across multiple indications. Lalit?
spk01: Thank you, Eyal. As independent user data continues to grow and is shared at medical conferences and in journals, this is creating a growing momentum as more and more doctors and patients become aware of process as a minimally invasive option. We believe the independent study data is a major catalyst for process adoption, and our marketing team and distribution partners are very active at medical conferences speaking with doctors, answering questions, and providing non-financial support to those who are interested in conducting studies. We have various doctors who use the technology in our present and share experience at medical conferences. I participated in four conferences immediately after the conference. This time, I brought to you my professor, Yushu Okun. a breast surgeon in Japan, performed 600 breast cancer procedures, led a symposium with process. In India, at the 10th annual conference of the Breast Imaging Society of India, results from the iSCURE i3 study were presented by study's co-primary investigator, Dr. Kenneth R. Tomkovic. In Copenhagen, Denmark, at the Cardiovascular and Interventional Radiology Society of Europe for 2023. A tumor ablation hands-on device training with ProSense was conducted, and a symposium about cryoablation was conducted by two leading interventional radiologists who use ProSense, one of whom conducted a cryoablation endometriosis study, which was recently published. In Valencia, Spain, at the European Society of Imaging Annual Scientific Meeting, The two independent studies in early-stage low-risk breast cancer were presented, as previously mentioned by Eyal. Clearly, ProSense is gaining significant traction and momentum amongst doctors, and we believe this translates into more system and disposable demand globally. I'll now turn the call over to Ronen for a summary of the financial results. Ronen.
spk02: Thank you, Clalit. For the nine months ended September 30, 2023, percent systems and disposable probe sales increased by 11% to $1.7 million, compared to $1.5 million for the nine months ended September 30, 2022, driven by higher sales in the US and China. Total revenue for the nine months ended September 30, 2023, was approximately $2 million, compared to $2 million
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