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Nice movement today. I hope this means good news is soon to come.
IceCure Medical to Review Recent Progress at Maxim Group's Virtual Healthcare Conference
https://finance.yahoo.com/news/icecure-medical-review-recent-progress-120000674.html
IceCure CEO, Eyal Shamir, to present and conduct Q&A on Wednesday, June 21st at 11:00 AM Eastern Time on Track 2
CAESAREA, Israel, June 13, 2023 /PRNewswire/ -- IceCure Medical LTD. (Nasdaq: ICCM) (TASE: ICCM), (the "Company" or "IceCure"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, will participate in the Maxim Group LLC's ("Maxim") Healthcare Virtual Conference (the "Conference"), held from Tuesday, June 20th through Thursday, June 22nd.
The Company's Chief Executive Officer, Eyal Shamir, will present on the unique advantages of the liquid nitrogen-based ProSense Cryoablation System ("ProSense") and discuss the previously disclosed promising interim results from the Company's ICE3 clinical trial for the indication of early-stage (Luminal A T1 invasive) low-risk breast cancer in patients who are at high risk to surgery (not suitable for surgical alternatives). In the largest study of its kind, 96.91% of patients were recurrence-free and 100% of patients and physicians reported satisfaction with the cosmetic results. No scarring or change to the shape or size of the breast resulted due to the procedure. The brief presentation, followed by a Q&A with Maxim's research analyst, will take place on Wednesday, June 21st at 11:00 AM Eastern Time on Track 2.
ProSense serves the global tumor ablation market projected to reach $2.4 billion by 2028. An estimated 288,000 new cases of invasive breast cancer were diagnosed among U.S. women in 2022. ProSense has regulatory approvals in over 15 markets, a growing number of distribution agreements, and approximately 30 patents for its advanced liquid nitrogen cryoablation technology.
The Conference is being hosted by M-Vest, a division of Maxim, and investors should contact their sales representatives at Maxim Group to schedule a virtual meeting with IceCure Medical's management team.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) (TASE: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.
Forward looking Statements:
This press release contains forward looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other federal and Israeli securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward looking statements. For example, IceCure is using forward looking statement in this press release when it discusses the upcoming presentation at the Conference and the growing number of the Company's global distribution agreements. Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties and actual results, performance, or achievements of IceCure could differ materially from those described in or implied by the statements in this press release. The forward looking statements contained or implied in this press release are subject to other risks and uncertainties, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2022 filed with the SEC on March 29, 2023, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
IR Contacts:
Michael Polyviou
732.232.6914
Email: mpolyviou@evcgroup.com
Todd Kerhli
310.625.4462
Email: tkehrli@evcgroup.com
Logo - https://mma.prnewswire.com/media/1941429/IceCure_Logo.jpg
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/icecure-medical-to-review-recent-progress-at-maxim-groups-virtual-healthcare-conference-301849410.html
SOURCE IceCure Medical
Analysts Reaffirm Buy Rating and Predict Significant Upside for Icecure Medical ICCM
https://beststocks.com/analysts-reaffirm-buy-rating-and-predict-sign/
Yasmim Mendonça by Yasmim Mendonça
On June 1, 2023, HC Wainwright & Co. analyst Yi Chen reaffirmed their Buy rating on Icecure Medical (NASDAQ:ICCM) and maintained a $3 price target. In the past three months, two Wall Street analysts have issued 12-month price targets, resulting in an average price target of $3.50 for ICCM. With analysts’ consensus price target of $3.00, ICCM is expected to experience an upside of 180.4% from its current price of $1.07. The average 12-month stock price forecast for ICCM is $3.00, indicating a potential increase of 153.16%.
IceCure's ProSense Installation in India is the First to Offer Cryoablation for the Treatment of Breast Cancer in the Country
https://finance.yahoo.com/news/icecures-prosense-installation-india-first-120000740.html
Latest system installation in IceCure's global commercial rollout of ProSense
CAESAREA, Israel, May 31, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced that ProSense was recently installed and inaugurated at Kovai Medical Center and Hospital ("KMCH") in Coimbatore, India. This development, to the Company's knowledge, constitutes the first instance of cryoablation for breast cancer treatment being offered in the country. KMCH, a leading hospital in southern India, is an innovator that has had numerous technology firsts in the region.
IceCure’s ProSense® System was installed at Kovai Medical Center and Hospital KMCH) in Coimbatore, India. The event was attended by Tammy Ben Haim, Consulate General of Israel, and several executives and doctors from KMCH. (PRNewsfoto/IceCure Medical)
IceCure’s ProSense® System was installed at Kovai Medical Center and Hospital KMCH) in Coimbatore, India. The event was attended by Tammy Ben Haim, Consulate General of Israel, and several executives and doctors from KMCH. (PRNewsfoto/IceCure Medical)
The installation of ProSense was unveiled, at a well-attended ceremony, by Tammy Ben Haim, Consulate General of Israel, along with executives and doctors from KMCH such as Dr. Nalla G Palaniswami (Chairman), Dr. Arun N Palaniswami (Executive Director), Dr. Mathew Cherian (Chief of Radiology Services) Dr. Murugan (Medical Director), Dr. Subramaniam (Consultant Radiation Oncologist), and Dr. Rupa Renganathan (Lead Consultant in Breast Center of KMCH).
Dr. Subramaniam described ProSense during the welcome address, stating: "It is futuristic, and we help patients, especially those with early-stage cancer. The primary aim of using this innovative technology is mainly to make the journey of patients with tumors more dignified."
In her public statement at the inauguration Ms. Ben Haim said: "With this innovative Israeli technology, IceCure's ProSense mission is to make cancer treatment safer and more effective by providing minimally invasive solutions for patients around the world. Although ProSense's capability spans the treatment of different types of tumors, here in India its first application will be in the fight against breast cancer."
"We are pleased that women in India now can choose a minimally invasive procedure that has shown high efficacy in interim study results. This installation is the latest in our global commercial rollout," stated Tlalit Bussi Tel Tzure, IceCure's VP of Marketing. "We have a productive relationship with our in-country distributor in India, which is a significant market for us, and we look forward to participating in the 10th Annual Conference of the Breast Imaging Society of India later this year."
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) (TASE: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal and Israeli securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statement in this press release when it discusses: the objectives of ProSense for breast cancer patients in India; ProSense's mission is to make cancer treatment safer and more effective by providing minimally invasive solutions for patients around the world; and IceCure's anticipated participation in the 10th Annual Conference of the Breast Imaging Society of India. Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties and actual results, performance, or achievements of IceCure could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2022 filed with the SEC on March 29, 2023, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
IR Contact:
Michael Polyviou
732.232.6914
Email: mpolyviou@evcgroup.com
Todd Kehrli
310.625.4462
Email: tkehrli@evcgroup.com
Photo - https://mma.prnewswire.com/media/2089412/IceCure_ProSense.jpg
Logo - https://mma.prnewswire.com/media/1941429/IceCure_Logo.jpg
(PRNewsfoto/IceCure Medical)
(PRNewsfoto/IceCure Medical)
Cision
Cision
View original content to download multimedia:https://www.prnewswire.com/news-releases/icecures-prosense-installation-in-india-is-the-first-to-offer-cryoablation-for-the-treatment-of-breast-cancer-in-the-country-301838533.html
SOURCE IceCure Medical
Cryoablation Takes Center Stage at American Society of Breast Surgeons' 24th Annual Meeting
https://finance.yahoo.com/news/cryoablation-takes-center-stage-american-120000926.html
IceCure's ProSense was the cryoablation system used in first-of-its-kind cryotherapy continuing medical education (CME) course.
High level of interest expressed in cryoablation from attending surgeons and from American Society of Breast Surgeons (ASBrS) leadership.
Plan presented for a proposed ASBrS Cryoablation trial during CME course
CAESAREA, Israel, May 1, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced that its participation in the American Society of Breast Surgeons' (ASBrS) 24th Annual Meeting, which took place in Boston on April 26-30, 2023, resulted in high levels of interest in ProSense. Cryoablation, a promising surgical tool and minimally invasive alternative to breast surgery for selected patient populations, was favorably mentioned several times during a keynote speech by ASBrS leadership and was the focus of the ASBrS' first-ever cryoablation CME course.
A plan for a proposed ASBrS Cryoablation trial was presented at the very well-attended CME course titled "Cryotherapy: An Introductory Course for the Ultrasound-Experienced Surgeon" taught by cryoablation thought leaders who demonstrated using ProSense during the hands-on course. The cryotherapy trial plan presented during the course indicated inclusion criteria of women between the ages of 55 to 85. IceCure's ICE3 trial interim results for cryotherapy in the treatment of early stage breast cancer were also presented during the course as well as mentioned several times in other settings during the 5-day conference.
Attending surgeons heard a keynote speech, the "Presidential Address", by the outgoing ASBrS president, Dr. Nathalie Johnson, who spoke favorably of cryoablation as a minimally invasive approach to treating breast cancer that breast surgeons ought to provide. IceCure welcomed a large number of breast surgeons at its exhibition booth where doctors gained knowledge and hands-on experience with ProSense.
"Our cryoablation system received the highest level of interest we've seen to date from the medical community. Numerous breast surgeons indicated their interest in using ProSense in their clinics. The interest and support that cryoablation received from ASBrS leadership indicate to us that the ASBrS may indeed proceed with a trial, which would be a significant turning point toward the adoption of this minimally invasive method for early stage breast cancer patients," stated Eyal Shamir, IceCure's Chief Executive Officer.
About ASBrS
The American Society of Breast Surgeons, the primary leadership organization for general surgeons who treat patients with breast disease, is committed to continually improving the practice of breast surgery by serving as an advocate for surgeons who seek excellence in the care of breast patients. This mission is accomplished by providing a forum for the exchange of ideas and by promoting education, research, and the development of advanced surgical techniques.
IceCure Medical to Provide Educational Support in a First-of-its-Kind Cryotherapy Course at the American Society of Breast Surgeons' 24th Annual Meeting
https://finance.yahoo.com/news/icecure-medical-educational-support-first-120000210.html
Physicians Attending the CME Course to Demo ProSense, Learn More About Breast Cryoablation, and Receive Hands-on Training
Previously Published ICE3 Trial Interim Results will be Highlighted to Further Raise Awareness of Breast Cryoablation
CAESAREA, Israel, April 24, 2023 IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced its educational support for a continuing medical education (CME) course on cryotherapy at the American Society of Breast Surgeons' (ASBrS) 24th Annual Meeting to be held in Boston, Massachusetts on April 26-30, 2023. This marks the ASBrS's first cryoablation CME course offered at its annual meetings, and ProSense will be the cryoablation system to be used in this year's course for hands-on training.
The course, titled "Cryotherapy: An Introductory Course for the Ultrasound-Experienced Surgeon" is scheduled for Thursday, April 27 from 7:30 am – 11:30 am ET. Course moderators and faculty include cryoablation thought leaders:
Richard Fine, MD, FACS, an ICE3 trial investigator who serves as Program Director of the Breast Surgical Oncology Fellowship and as Director of Research and Education at the West Comprehensive Breast Center in Germantown, Tennessee
Michael Berry, MD, breast surgeon at the West Comprehensive Breast Center in Germantown, Tennessee
Rache Simmons, MD, MBA, MS, FACS, breast surgeon at Weill Cornell Medicine in New York City
Dennis Holmes, MD, FACS, breast cancer surgeon at several Los Angeles hospitals and cancer researcher
The "Recent and Proposed Studies of Cryoablation without Surgery" segment of the course will include the previously published interim results from IceCure's ICE3 trial. Interim analysis completed in July 2022 demonstrated that following treatment with ProSense, only 3.09% of patients (6 out of 194 eligible trial patients) experienced cancer recurrence. ICE3 is the largest US-based controlled multicenter clinical trial ever performed for liquid nitrogen-based cryoablation of small, low-risk, early-stage malignant breast tumors as an alternative to surgery. In October 2022, the Company submitted a regulatory filing (De Novo Classification Request) with the U.S. Food and Drug Administration ("FDA") for marketing authorization and it is currently in the review process.
Dr. Fine commented, "Cryoablation potentially represents a dramatic improvement in care for appropriate low-risk patients. The non-invasive procedure is fast, painless, and can be delivered under local anesthesia in a doctor's office. Recovery time is minimal and cosmetic outcomes are excellent with little loss of breast tissue and no scarring."
"As we await a response from the FDA on our submission of ProSense in early-stage breast cancer, we are encouraged to see the high level of interest from breast surgeons in cryoablation CME courses," stated Eyal Shamir, IceCure's Chief Executive Officer. "We believe the strong interim ICE3 data, combined with physician education and training in cryoablation, will enable the accelerated adoption of ProSense and provide non-surgical options for women with early-stage breast cancer who are at high risk to surgery."
IceCure will be exhibiting and demonstrating ProSense at booth #816 and encourages physicians and other interested parties to visit the booth and/or contact info@icecure-medical.com to schedule a meeting.
About ASBrS
The American Society of Breast Surgeons, the primary leadership organization for general surgeons who treat patients with breast disease, is committed to continually improving the practice of breast surgery by serving as an advocate for surgeons who seek excellence in the care of breast patients. This mission is accomplished by providing a forum for the exchange of ideas and by promoting education, research, and the development of advanced surgical techniques.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) (TASE: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared to-date by the FDA and approved in Europe with the CE Mark.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal and Israeli securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statement in this press release when it discusses the presentation of its cryoablation system at the ASBrS' 24th Annual Meeting, its regulatory strategy, the potential benefits of its products and technologies, and awaiting the FDA's response to the Company's regulatory requests for clearance for ProSense in early-stage breast cancer.. Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties and actual results, performance, or achievements of IceCure could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2022 filed with the SEC on March 29, 2023, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
IR Contact:
Michael Polyviou
732.232.6914
Email: mpolyviou@evcgroup.com
Todd Kehrli
310.625.4462
Email: tkehrli@evcgroup.com
Logo - https://mma.prnewswire.com/media/1941429/IceCure_Logo.jpg
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/icecure-medical-to-provide-educational-support-in-a-first-of-its-kind-cryotherapy-course-at-the-american-society-of-breast-surgeons-24th-annual-meeting-301805302.html
SOURCE IceCure Medical
IceCure's ProSense System Used in Endometriosis Cryoablation Study That Demonstrated Efficacy Rate of 92.8% to Avoid Secondary Surgery
https://finance.yahoo.com/news/icecures-prosense-system-used-endometriosis-120000133.html
ProSense System among the two types of systems used in the study
Pain-free survival rates of 93.75% at 6 months and 82.72% at 36 months post-procedure
190 million women globally live with endometriosis, for which there is no cure; current treatments aim to control symptoms
Data presented at Society of Interventional Radiology 2023 Annual Scientific Meeting by lead investigator Francois H. Cornelis, MD, PhD
CAESAREA, Israel, April 20, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) developer of minimally-invasive cryoablation technology, the ProSense® System, that destroys tumors by freezing as an alternative to surgical tumor removal, today announced that its ProSense system was used in a single-site study conducted at the Sorbonne University Department of Interventional Radiology and Oncology, Tenon Hospital in Paris, France by lead investigator Francois H. Cornelis, MD, PhD and a team of doctors. The study titled "Pain-Free Survival After Percutaneous Image-Guided Cryoablation of Extraperitoneal Endometriosis" was published in the Journal of Vascular and Interventional Radiology. The independent study and published paper were not sponsored by IceCure. Dr. Cornelis presented the study data at the Society of Interventional Radiology 2023 Annual Scientific Meeting on March 8, 2023.
Cryoprobes used in the study were of two types: IceCure's ProSense cryoprobe and Varian's V-probe. The purpose of the study was to retrospectively evaluate the pain-free survival of percutaneous (minimally invasive, through the skin) image-guided cryoablation of symptomatic extraperitoneal endometriosis ("EE"). 42 patients with a total of 47 lesions were treated. Patients were made aware that cryoablation was offered as a minimally invasive alternative to surgery, and that a surgical procedure may be performed if cryoablation failed. According to the published study, the therapeutic options thus far to avoid the progression of endometriosis and reduce symptoms have been limited to hormonal agents and wide surgical excision. During the last decades, minimally invasive techniques such as cryoablation have been suggested as a promising option to treat abdominal wall endometriosis with satisfactory outcomes and low morbidity.
Based on the following study outcome data, the study concluded that percutaneous cryoablation is a safe and effective procedure that significantly reduces pain and obtains local control of EE. The median follow-up was 13.5 months after cryoablation. The study's conclusions included:
Efficacy rate of cryoablation to avoid secondary surgery was 92.8% per patient and 93.6% per nodule treated
Median pain-free survival rates were 93.75% at 6 months and 82.72% after 12 months, 24 months, and 36 months
Pain decreased from a median of 8/10 on the visual analogue scale to 0/10 at the last follow-up (P < 0.0001)
4 patients had an adverse event in the days following the procedure, 1 patient had a severe adverse event.
"We are grateful to Dr. Cornelis and the team of doctors at Sorbonne University and Tenon Hospital, where the data was collected, for having used our ProSense system, in addition to those from another company, as part of this independent study. Tenon Hospital institution is highly regarded in the field of gynecology and interventional radiology. We believe that the independent study has demonstrated the value of cryoablation in treating endometriosis, a chronic and painful condition in dire need of an effective minimally invasive treatment," stated Eyal Shamir, IceCure's Chief Executive Officer. "The ProSense system has regulatory approval in several countries, including FDA clearance for use as a cryosurgical tool in gynecology, and we are pleased that doctors now have more evidence of cryoablation's efficacy in patients with extraperitoneal endometriosis."
According to the World Health Organization, endometriosis affects about 10% of women who are at reproductive age globally, or 190 million people. Endometriosis is a chronic disease associated with severe, life-impacting symptoms. Many individuals suffering from it have limited awareness of the condition causing a lengthy delay between onset of symptoms and diagnosis. Current treatments are aimed at controlling symptoms. EE may be observed incidentally but more often on surgical scars in women with or without a history of endometriosis.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) (TASE: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.
Logo - https://mma.prnewswire.com/media/1941429/IceCure_Logo.jpg
IR Contact:
Michael Polyviou
Email: mpolyviou@evcgroup.com
732.232.6914
Todd Kehrli
Email: tkehrli@evcgroup.com
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/icecures-prosense-system-used-in-endometriosis-cryoablation-study-that-demonstrated--efficacy-rate-of-92-8-to-avoid-secondary-surgery-301802896.html
SOURCE IceCure Medical
I concur, this is a positive move.
that should save them some money, plus US investors won't have to pay fees, that's a good thing
IceCure Medical Ordinary Shares to Trade Exclusively on Nasdaq: Company to Voluntarily Delist Shares from Trading on the Tel Aviv Stock Exchange
https://finance.yahoo.com/news/icecure-medical-ordinary-shares-trade-120000686.html
CAESAREA, Israel , April 19, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System, that destroys tumors by freezing as an alternative to surgical tumor removal, today announces that it has initiated a process to voluntarily delist its ordinary shares, no par value per share (the "Ordinary Shares"), from the Tel Aviv Stock Exchange (the "TASE").
In accordance with applicable Israeli law and the rules of the TASE, the last day the Ordinary Shares will trade on the TASE will be July 20, 2023 and the Ordinary Shares will be delisted from the TASE on July 24, 2023. Until the last day of trading on the TASE, shareholders will be able to continue to buy and sell Ordinary Shares in the same manner as has been the case to date.
The Company's Ordinary Shares will continue to be traded on the Nasdaq Capital Market ("Nasdaq") under the symbol "ICCM," and the Company will continue to file public reports and make public disclosures in accordance with the rules of the U.S. Securities and Exchange Commission (the "SEC") and Nasdaq. The delisting in Israel will not affect the Company's continued listing on Nasdaq in the United States and all Ordinary Shares now traded on the TASE may be transferred to Nasdaq.
"We believe it is in the best interest of the company and its shareholders to focus on our efforts in the U.S. capital markets with our Ordinary Shares trading exclusively on Nasdaq," said Ron Mayron, Chairman of the Board of Directors. "From an operational, developmental, and strategic perspective, Israel remains of vital importance to IceCure, while delisting from the TASE will reduce redundant listing costs. This decision underscores our commitment to our U.S. investors and to the U.S. healthcare market, where we believe our unique cryoablation technologies have the greatest potential to provide physicians with medical solutions that achieve enhanced patient outcomes and, as a result, will potentially build shareholder value. We value all our TASE investors and thank them for their ongoing support."
IceCure Medical Ltd (NASDAQ:ICCM) Q4 2022 Earnings Call Transcript
IceCure Medical Ltd (NASDAQ:ICCM) Q4 2022 Earnings Call Transcript March 29, 2023
Operator: Good morning, and thank you for standing by. . I would now like to turn the conference over to Todd Kehrli. Please go ahead.
Todd Kehrli: Thank you, Operator, and welcome to IceCure Medical's conference call to review the financial results for the 12 months ended December 31, 2022, and to provide an update on recent operational highlights. We ask that you refer to this morning's press release and 20-F to review the audited 2022 year-end financial results. Participating on the call are IceCure Medical's CEO, Eyal Shamir; and CFO & COO, Ronen Tsimerman. After the prepared comments, Eyal and Ronen will be available to address your questions. Before we begin, I will take a moment to read a statement about forward-looking statements. This call and the question-and-answer session that follow it, contain forward-looking 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 forward-looking statements. For example, we are using forward-looking statement in this presentation when we discuss the achievements we expect to accomplish as we continue to advance our growth strategy, our positioning to make significant commercial advances in key markets, pursuit of regulatory approvals in various jurisdictions, expansion of clinical applications, release of results from our clinical trials, potential market adoption and future sales of IceCure's minimally-invasive cryoablation technology, advancing regulatory and commercial strategies, strategic plans, and our belief that we are well-capitalized to execute on commercial opportunities to increase shareholder value.
Surgery, Medicine, Health
Surgery, Medicine, Health
Photo by National Cancer Institute on Unsplash
Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of IceCure could differ materially from those described in or implied by statements in this presentation. The forward-looking statements contained or implied in this presentation are subject to other risks and uncertainties, many of which are beyond the control of the company, including those set forth in the Risk Factors section of the company's Annual Report on Form 20-F for the year ended December 31, 2022, filed with the SEC on March 29, 2023, which is available on the SEC's website, www.sec.gov. The company undertakes no obligation to update these statements or revisions or changes after the date of this release, except as required by law.
I will now turn the call over to IceCure Medical's CEO, Eyal Shamir. Eyal, please go ahead.
Eyal Shamir: Thank you, Todd, and welcome, everyone. My comments will be brief and will focus on the significant achievements we accomplished during the year, as well as those we expect over the coming months as we continue to advance our growth strategy. I will begin with yesterday development, the receipt of regulatory approval in China for our disposable cryoprobes. The latest approval allow us to use the IceSense3 disposable cryoprobes in combination with our previously approved IceSense3 console. This is exciting catalyst, and we believe that this will generate increased commercial activities in China. This will be driven by our exclusive distributor agreement in China with Shanghai Medtronic Zhikang Medical Devices Co. Ltd, an affiliates of Medtronic PLC, and Beijing Turing Medical Technology Co. Ltd.
If you recall, the initial three years period of this agreement includes minimum purchase targets of $3.5 million. In the US market, which we believe represents the sizable addressable market, the revenue trend we are currently experiencing are encouraging and consumable sales represented 20% of our 2022 revenues, almost double the 11% reported in 2021. Globally, our consumable sales accounted for 43% of our 2022 revenue, up from 29% in 2021, indicating increased physician awareness of our system. On the regulatory front, we are waiting the US FDA response to our regulatory filing for ProSense in treatment of early stage breast cancer. We believe, based on our data emerging from our ICE3 trial, ProSense is highly beneficial, invasive option for physicians treating breast cancer to address the initial indication market of 43,000 women in the US annually.
Moreover, last year we received an initial reimbursement code from the Center for Medicare and Medicaid Services, to help offset some of the cost for the treatment with respect to the facility fee. Globally, we're expecting responses to applications filed in several other countries, including Brazil, Vietnam, and Canada. On the clinical front, we reported positive interval results from the ICE Secret study, which continues to validate that ProSense is safe and effective in treating kidney cancer tumors, with an 89.5% recurrence-free rate. In summary, our results demonstrate that we are a results-oriented company, and I believe we are well-capitalized to execute on commercial opportunities in the US and globally to increase shareholder value.
With that, Ronen and I are ready to take your questions. Operator, we would like to open the call for questions.
Operator: The first question is from Kemp Dolliver of Brookline Capital Markets. Please go ahead.
Kemp Dolliver: Hi. Thank you and good morning. I’ll ask a couple of questions and go back into the queue. Now that you have the approval in China, how will the rollout proceed? And some of these decisions, I acknowledge, may be in the hands of your partners, but I’m assuming they’ll – I mean, are they contemplating pursuing government reimbursement at some point, or strictly focused on the cash pay market? I’ll start with that.
Eyal Shamir: Thank you, Kemp. We are very excited about the opportunity in China. We always believe China will be a growth market for IceCure. Our partner in China, which is both mainly Shanghai Medtronic Zhikang, and together with Turing Medical, they will approach public hospitals mainly at the beginning, because most of those cases will be done in hospitals, and later they will go for private clinics. Even in public hospitals, they will be able to start with some co-payment by the patients, and in parallel, they will pursue for reimbursement in China.
Kemp Dolliver: Okay, very good. Thank you. And just switching to the US, you have been evaluating partnering versus self-distribution. How’s that thought process evolving over the last few months?
Eyal Shamir: Yes, we are still in process on that. I think that it might be a combination of a direct sales team with some partners, but this is still under evaluation as we did a strategic market approach and market plan in order to enter the market. But it might be some level of combination.
Kemp Dolliver: Would that be by geography or some other criterion?
Kemp Dolliver: It’ll be by geography, but also by some other partnering that will have some benefits with specific organizations, DNAs, and other aspects that will help us to make the market penetration.
Kemp Dolliver: Okay. Very good. Thank you. I’ll go back in the queue.
Operator: The next question is from Yi Chen of H.C. Wainwright. Please go ahead.
Chaitanya G.: Hey, everyone. This is Chait on behalf of Yi. And I’m sorry if I missed some of the information in your prepared remarks. My call was in and out, but any guidance on the anticipated sales of – in China this year or even next year would be helpful. And also again, please bear with me if I’ve missed it. Any guidance for 2023, topline guidance for 2023. And also, on ICE Secret and other – any other indications? Are there any future data presentations that may happen this year? Would be very helpful. Thank you.
Eyal Shamir: So, thank you very much. On China, we are not giving a specific guideline on specific sales every year. The minimum quantity agreement that we signed, the triangle agreement with Shanghai Medtronic Zhikang, and with Turing Medical, is a minimum of $3.5 million for the next three years. Other than that, we are not giving a specific guideline on sales every year. IceCure is running two sponsor trials. One of them is the ICE3 breast cancer cryoablation trial that we did the file, that we filed on October last year. And we have the interim results on the kidney that we published on last December. At this stage, we don’t have other sponsored study. There are some other studies that they are investigational studies, and they will make their publication and results according their own study and time.
Chaitanya G.: Thank you. And if I may sneak in one more quick question, also could you provide some color or elaborate on the impact that the CPT Category III code that was assigned to you by the CMS in November, 2022? How has that impacted your marketing efforts or the uptake or adoption that you’ve seen in the US? Any trends would be very helpful after you’ve received the CPT code.
Operator: The first question is from Kemp Dolliver of Brookline Capital Markets. Please go ahead.
Kemp Dolliver: Hi. Thank you and good morning. I’ll ask a couple of questions and go back into the queue. Now that you have the approval in China, how will the rollout proceed? And some of these decisions, I acknowledge, may be in the hands of your partners, but I’m assuming they’ll – I mean, are they contemplating pursuing government reimbursement at some point, or strictly focused on the cash pay market? I’ll start with that.
Eyal Shamir: Thank you, Kemp. We are very excited about the opportunity in China. We always believe China will be a growth market for IceCure. Our partner in China, which is both mainly Shanghai Medtronic Zhikang, and together with Turing Medical, they will approach public hospitals mainly at the beginning, because most of those cases will be done in hospitals, and later they will go for private clinics. Even in public hospitals, they will be able to start with some co-payment by the patients, and in parallel, they will pursue for reimbursement in China.
Kemp Dolliver: Okay, very good. Thank you. And just switching to the US, you have been evaluating partnering versus self-distribution. How’s that thought process evolving over the last few months?
Eyal Shamir: Yes, we are still in process on that. I think that it might be a combination of a direct sales team with some partners, but this is still under evaluation as we did a strategic market approach and market plan in order to enter the market. But it might be some level of combination.
Kemp Dolliver: Would that be by geography or some other criterion?
Kemp Dolliver: It’ll be by geography, but also by some other partnering that will have some benefits with specific organizations, DNAs, and other aspects that will help us to make the market penetration.
Kemp Dolliver: Okay. Very good. Thank you. I’ll go back in the queue.
Operator: The next question is from Yi Chen of H.C. Wainwright. Please go ahead.
Chaitanya G.: Hey, everyone. This is Chait on behalf of Yi. And I’m sorry if I missed some of the information in your prepared remarks. My call was in and out, but any guidance on the anticipated sales of – in China this year or even next year would be helpful. And also again, please bear with me if I’ve missed it. Any guidance for 2023, topline guidance for 2023. And also, on ICE Secret and other – any other indications? Are there any future data presentations that may happen this year? Would be very helpful. Thank you.
Eyal Shamir: So, thank you very much. On China, we are not giving a specific guideline on specific sales every year. The minimum quantity agreement that we signed, the triangle agreement with Shanghai Medtronic Zhikang, and with Turing Medical, is a minimum of $3.5 million for the next three years. Other than that, we are not giving a specific guideline on sales every year. IceCure is running two sponsor trials. One of them is the ICE3 breast cancer cryoablation trial that we did the file, that we filed on October last year. And we have the interim results on the kidney that we published on last December. At this stage, we don’t have other sponsored study. There are some other studies that they are investigational studies, and they will make their publication and results according their own study and time.
Chaitanya G.: Thank you. And if I may sneak in one more quick question, also could you provide some color or elaborate on the impact that the CPT Category III code that was assigned to you by the CMS in November, 2022? How has that impacted your marketing efforts or the uptake or adoption that you’ve seen in the US? Any trends would be very helpful after you’ve received the CPT code.
Ben Haynor: Okay, got it. Okay, that makes sense.
Eyal Shamir: This is the minimum for the next first three years.
IceCure Medical Reports 2022 Full Year Financial Results & Recent Corporate Developments;
Milestone Achievements Expected to Drive Revenue Growth in 2023
https://finance.yahoo.com/news/icecure-medical-reports-2022-full-120000566.html
Rising Utilization of ProSense in the U.S. Market Generates Year-over-Year Consumable Revenue Growth
Physician Adoption Continues to Grow Ahead of the FDA's Response to the Company's Application for Marketing Approval in Breast Cancer Indication
Regulatory Approval Received in China for Commercial Use of IceSense3 Disposable Cryoprobes, to be Used in Combination with its IceSense3 Cryoablation System Console, Which was Previously Approved in China
Cryoablation System and Cryoprobes to be Sold in China Through Exclusive Distribution Partnership
Conference Call to be Held Today at 10:00 am Eastern Time
CAESAREA, Israel, March 29, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) developer of the ProSense System of minimally-invasive cryoablation technology that destroys tumors by freezing, today reported audited financial results as of and for the twelve months ended December 31, 2022.
"Our success throughout 2022 and the trends we are currently experiencing position us to make significant commercial advances in key markets, including in the U.S., for the ProSense platform for early-stage breast cancer and in China where our cryoprobes recently received approval for commercial use in combination with our cryoablation system console, which was previously approved. Commercialization in China is driven by our exclusive distribution agreement with Shanghai Medtronic Zhikang Medical Devices Co. Ltd., an affiliate of Medtronic ("Shanghai Medtronic Zhikang"), the world's largest medical device company, which includes minimum purchase targets," stated Eyal Shamir, IceCure's Chief Executive Officer. "We believe that our achievements in 2022, which included regulatory, reimbursement, clinical, and commercial milestones, provide us with a solid foundation to execute our growth strategy to drive revenues in the years to come.
"Our rising confidence is bolstered by accelerated sales of our disposable cryoprobes in the U.S., demonstrating that the previously installed ProSense systems are increasingly being utilized by physicians. We also believe our strengthened balance sheet, which includes the $14.5 million we raised in December 2022, allows us to expand our global marketing footprint. The capital resources we have will enable us to execute on our commercialization plans throughout 2023 and beyond while ensuring we can also invest in future generations of our novel technology."
Significant Operating, Clinical, Regulatory & Commercial Highlights
Rising Awareness and Utilization of ProSense System: System and disposables sales in the U.S. represented 20% of 2022 revenues, up from 11% in 2021, as increased utilization of systems generated a 28% year-over-year increase in U.S. sales. Worldwide, disposable sales accounted for 43% of 2022 revenue, up from 29% in 2021.
Filed for FDA Marketing Authorization of ProSense for Breast Cancer: The Company submitted a De Novo Classification Request regulatory filing with the U.S. Food and Drug Administration ("FDA") for marketing authorization based on ICE3 clinical trial ("ICE3") interim analysis for the indication of early-stage (Luminal A T1 invasive) low-risk breast cancer in patients who are at high risk to surgery (not suitable for surgical alternatives). This indication alone represents approximately 43,000 women in the U.S. annually.
Initial Medicare Reimbursement Code for ProSense Established: The Centers for Medicare & Medicaid Services ("CMS") assigned ProSense breast cancer cryoablation procedures with a CPT Category III reimbursement code setting the facility fee at $3,400 per procedure. Additional reimbursement coverage, including payment for the physician, is expected upon CMS establishing the permanent CPT Category I code, which is conditioned on several factors, particularly the Company's receipt of FDA marketing authorization of ProSense for breast cancer.
Received Regulatory Approval in China for Commercial Use of Cryoprobes in 2023: The National Medical Products Administration ("NMPA") of China approved the IceSense3 (ProSense's brand name in China) disposable cryoprobes for commercial use, to be used in combination with the Company's IceSense3 system console, which was previously approved by the NMPA.
Signed China Distribution Agreement with Shanghai Medtronic Zhikang Medical Devices Co. Ltd.: IceCure's wholly-owned subsidiary, IceCure (Shanghai) MedTech Co., Ltd. ("IceCure Shanghai"), signed an exclusive distribution agreement for IceSense3 cryoablation systems with Shanghai Medtronic Zhikang and Beijing Turing Medical Technology Co. Ltd. ("Turing"), to be the exclusive distributors of the IceSense3 and its disposable probes in mainland China for an initial period of three years, with minimum purchase targets of $3.5 million for this period.
Patents Granted in U.S. and Japan: IceCure received patents in the U.S. and Japan for its novel cryogenic pump, potentially broadening the clinical indications addressed by the Company's platform technology.
Achieved Regulatory Milestones in Major Global Markets—Additional Responses Expected in 2023: ProSense cryoprobes and introducers received regulatory approval in Brazil for several indications, including breast and other cancers, benign tumors, and palliative intervention. Approval for the ProSense system is currently pending in Brazil, and a response from the Brazilian Health Regulatory Agency ("ANVISA") is expected in 2023. Applications for regulatory approval of ProSense and its accessories were filed in Canada and Vietnam.
Presented Interim Study Results Showing ProSense is Safe and Effective in Treating Kidney Tumors with 89.5% Recurrence-Free Rate: At the Urological Association Conference in Israel, the Company presented interim findings from its ICESECRET study for the treatment of patients with small renal masses ("SRM") who cannot be offered kidney-preserving surgery. ProSense was found to be a safe and effective treatment method for renal lesions smaller than 5 cm in patients not suitable for kidney-preserving surgery. In a subgroup of patients with no previous history of kidney cancer on the same kidney and a lesion ≤3 cm, an 89.5% recurrence-free rate was observed at a mean follow-up time of 22.2 months when the procedure protocol was followed. ProSense is approved for the treatment of benign and malignant kidney tumors in the U.S., Europe, and numerous other countries.
Strengthened Balance Sheet
As of December 31, 2022, the Company had cash and cash equivalents including short-term deposits of approximately $23.7 million, compared to approximately $25.6 million as of December 31, 2021. The Company will use its resources to execute its global business strategy and continue to raise awareness of the clinical and economic benefits of its ProSense system.
Financial Results for the Twelve Months Ended December 31, 2022
For the twelve months ended December 31, 2022, the Company reported revenue of $3.1 million compared to revenue of $4.1 million for the twelve months ended December 31, 2021. As previously disclosed on February 9, 2023, the year-over-year decline was due to lower revenue recognition of approximately $0.6 million from the distribution agreements with Terumo Corporation and a decrease in sales of new systems, mostly in Thailand. This was partially offset by higher revenue from sales of the Company's disposable probes, as previously sold and installed systems were utilized for procedures in clinical settings, as well as higher sales in the U.S. compared to the prior year period.
Gross profit was approximately $1.4 million for the twelve months ended December 31, 2022, compared to approximately $2.1 million for the twelve months ended December 31, 2021. Gross margin was approximately 47% for the twelve months ended December 31, 2022, compared to approximately 53% for the twelve months ended December 31, 2021. The decrease in gross margin compared to the same period last year was attributable to the decrease in revenue recognition from the Terumo distribution agreements.
Research and development expenses for the twelve months ended December 31, 2022, were approximately $9.1 million compared to approximately $5.9 million for the twelve months ended December 31, 2021. The increase was primarily due to the development of IceCure's next-generation single-probe system, along with increased clinical and regulatory activities, including the FDA and NMPA submissions.
Sales and marketing expenses for the twelve months ended December 31, 2022 were approximately $3.2 million, compared to approximately $1.9 million for the twelve months ended December 31, 2021. The increase was attributed to the Company's expanding commercialization efforts in the U.S. and other territories.
General and administrative expenses for the twelve months ended December 31, 2022 were approximately $5.9 million, compared to approximately $4.1 million for the twelve months ended December 31, 2021. The increase was attributed to the Company's increased Nasdaq listing-related expenses.
Total operating expenses for the twelve months ended December 31, 2022 were approximately $18.2 million, compared to approximately $11.9 million for the twelve months ended December 31, 2021. The increase in operating expenses was primarily attributable to increased development, commercialization, and Nasdaq listing-related activities. As a result of lower revenue and increased operating activities, net loss reported for the twelve months ended December 31, 2022 increased to approximately $17.0 million, or $0.46 per share, compared with a net loss of approximately $9.9 million, or $0.35 per share, for the same period last year.
Conference call information:
The Company will discuss its results today via teleconference at 10:00 a.m. Eastern Time. To access the live call, dial 1-888-642-5032 (U.S. toll-free) or +972-3-9180609 (International) and ask to join the IceCure earnings call. An archived recording of the call will also be accessible on the "Investors" section of our website at www.icecure-medical.com.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) (TASE: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared to-date by the FDA and approved in Europe with the CE Mark.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal and Israeli securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statement in this press release when it discusses its positioning to make significant commercial advances in key markets, its ability to execute its growth strategy and drive revenues, expected financial results and continued growth, the belief that the Company's achievements provide it with a solid foundation to execute its growth strategy to drive revenues in the years to come, its ability to expand its global marketing footprint and execute its commercialization plans, anticipating the FDA's response to regulatory requests for approvals, the continued commercial rollout and commercial growth of its products, pursuit of and timing for regulatory approvals in various jurisdictions, its strategic plans, and expansion of clinical applications and potential market adoption of its minimally-invasive cryoablation technology. Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties and actual results, performance, or achievements of IceCure could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2022 filed with the SEC on April 1, 2022, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
IR Contact:
Michael Polyviou
Email: mpolyviou@evcgroup.com
Todd Kehrli
Email: Tkehrli@evcgroup.com
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data and per share data)
As of
December 31,
As of
December 31,
2022
2021
ASSETS
CURRENT ASSETS
Cash and cash equivalents
23,659
25,621
Restricted deposit
296
-
Trade accounts receivable
78
456
Inventory
2,857
1,955
Prepaid expenses and other receivables
1,240
2,290
Total current assets
28,130
30,322
NON-CURRENT ASSETS
Right of use assets
668
913
Property and equipment, net
1,356
713
Prepaid expenses and other long-term assets
34
333
Total non-current assets
2,058
1,959
TOTAL ASSETS
30,188
32,281
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES
Trade accounts payable
714
881
Lease liabilities
167
224
Other current liabilities
3,455
2,915
Total current liabilities
4,336
4,020
NON-CURRENT LIABILITIES
Long term lease liabilities
430
685
Other long-term liabilities
-
618
Total non-current liabilities
430
1,303
Commitments and contingencies
SHAREHOLDERS' EQUITY
Ordinary shares, No par value; Authorized
2,500,000,000 shares; Issued and outstanding: 45,623,434 shares and 35,780,335 shares as of December 31, 2022 and December 31, 2021, respectively
-
-
Pre-funded warrants to ordinary shares, Issued and outstanding: zero Pre-funded warrants and 1,034,000 Pre-funded warrants as of December 31, 2022 and December 31, 2021, respectively
-
-
Additional paid-in capital
100,831
85,389
Accumulated deficit
(75,409)
(58,431)
Total shareholders' equity
25,422
26,958
TOTAL LIABILITIES AND
SHAREHOLDERS' EQUITY
30,188
32,281
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(U.S. dollars in thousands, except share data and per share data)
Year ended
December 31,
Year ended
December 31,
2022
2021
Revenues
3,085
4,138
Cost of revenues
1,640
1,943
Gross profit
1,445
2,195
Research and development expenses
9,123
5,877
Sales and marketing expenses
3,204
1,917
General and administrative expenses
5,857
4,125
Operating loss
16,739
9,724
Financial expenses (income), net
239
171
Net loss and comprehensive loss
16,978
9,895
Basic and diluted net loss per share
0.46
0.35
Weighted average number of shares
outstanding used in computing basic and diluted net loss per share
37,016,631
28,548,676
CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands, except share data and per share data)
Year ended
December 31,
Year ended
December 31,
2022
2021
Cash flows from operating activities:
Net loss
(16,978)
(9,895)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation
248
127
Share-based compensation
1,865
316
Exchange rate changes in cash and
cash equivalents and deposit
359
5
Changes in assets and liabilities:
Decrease (increase) in trade
accounts receivable
378
(362)
Increase in inventory
(902)
(891)
Decrease (increase) in prepaid
expenses and other receivables
1,050
(2,030)
Decrease in prepaid expenses ~
and other long- term assets
-
-
Decrease (increase) in right of use assets
245
(607)
Increase (decrease) in trade accounts payable
(167)
236
Increase (decrease) in lease liabilities
(312)
577
Increase (decrease) in other current liabilities
540
60
Increase (decrease) in other long-term liabilities
(618)
(141)
Net cash used in operating activities
(14,292)
(12,605)
Cash flows from investing activities:
Realization of (Investment in) deposits
-
4,621
Investment of restricted deposits
-
(296)
Purchase of property and equipment
(891)
(533)
Net cash provided by (used in)
investing activities
(891)
3,792
Cash flows from financing activities:
Issuance of ordinary shares,
net of issuance costs
13,569
14,586
Issuance of restricted ordinary shares
6
-
Issuance of ordinary shares and
pre- funded warrants, net of issuance costs
-
15,966
Exercise of pre- funded warrants
1
-
Exercise of options to ordinary shares
1
337
Net cash provided by financing activities
13,577
30,889
Increase (decrease) in cash
and cash equivalents
(1,606)
22,076
Cash and cash equivalents
beginning of the year
25,621
3,502
Effect of foreign exchange
rate on cash and cash equivalents
(356)
43
Cash and cash equivalents
end of the year
23,659
25,621
Cision
Cision
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SOURCE IceCure Medical
IceCure Medical Receives Regulatory Approval in China for Commercial Use of its IceSense3 Disposable Cryoprobes
https://finance.yahoo.com/news/icecure-medical-receives-regulatory-approval-120000696.html
This approval allows the use of the IceSense3 disposable cryoprobes in combination with the Company's IceSense3 console, which was previously approved by the NMPA
Products to be distributed in China through agreement with Shanghai Medtronic Zhikang Medical Devices Co. Ltd., an affiliate of Medtronic plc, and Beijing Turing Medical Technology Co. Ltd.
Ongoing physician awareness and education efforts will potentially accelerate market acceptance for novel technology and deliver better patient outcomes for those suffering from malignant and benign tissue of the breast, lung, bone, liver, and kidneys, as well as palliative interventions
CAESAREA, Israel, March 28, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System (marketed under the brand name IceSense3 in China), that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the National Medical Products Administration ("NMPA") of China approved the Company's IceSense3 disposable cryoprobes for commercial use, to be used in combination with the Company's IceSense3 console, which was previously approved by the NMPA.
With this latest approval, the Company and its partners in China can address a significant market with its novel and proven technology to treat malignant and benign tissue of the breast, lung, bone, liver, and kidneys, as well as palliative interventions.
"With approximately 430,000 new breast cancer cases in 2022 alone, and a healthcare system readily adopting new technologies that produce improved outcomes, we see China as a prime market for our cryoablation system," stated Eyal Shamir, IceCure's Chief Executive Officer. "Having received regulatory approval for commercial sales of both our console and cryoprobes, we expect to effectively monetize our distribution agreement in the Chinese market."
IceCure Medical Ltd (NASDAQ:ICCM) to Post FY2022 Earnings of ($0.45) Per Share, HC Wainwright Forecasts
https://www.defenseworld.net/2023/03/23/icecure-medical-ltd-nasdaqiccm-to-post-fy2022-earnings-of-0-45-per-share-hc-wainwright-forecasts.html
Posted by Defense World Staff on Mar 23rd, 2023
IceCure Medical Ltd (NASDAQ:ICCM – Get Rating) – Analysts at HC Wainwright issued their FY2022 EPS estimates for shares of IceCure Medical in a report released on Monday, March 20th. HC Wainwright analyst Y. Chen expects that the company will earn ($0.45) per share for the year. HC Wainwright currently has a “Buy” rating on the stock. The consensus estimate for IceCure Medical’s current full-year earnings is ($0.42) per share. HC Wainwright also issued estimates for IceCure Medical’s Q4 2022 earnings at ($0.09) EPS, Q1 2023 earnings at ($0.08) EPS, Q2 2023 earnings at ($0.08) EPS, Q3 2023 earnings at ($0.08) EPS, Q4 2023 earnings at ($0.08) EPS and FY2023 earnings at ($0.34) EPS.
IceCure Medical to Report 2022 Full Year Financial & Operational Results on March 29, 2023
https://finance.yahoo.com/news/icecure-medical-report-2022-full-120000726.html
CAESAREA, Israel, March 20, 2023 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System, that destroys tumors by freezing as an alternative to surgical tumor removal, announced that it will release its full year financial and operational results for the twelve months ended December 31, 2022, prior to the market open on Wednesday, March 29, 2023, and will host a conference call at 10:00 a.m. ET to discuss the results and corporate developments.
Conference call:
March 29, 2023 at 10:00 am ET
US: 1-888-642-5032
Israel/International: +972-3-9180609
About IceCure Medical Ltd.
IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared to-date by the FDA and approved in Europe with the CE Mark.
On March 5, 2023, the motion to certify a claim as a class action lawsuit that was filed by Shalom Benamo against IceCure Medical Ltd. (the “Company” and the “motion”, respectively) and other publicly listed companies on the Tel Aviv Stock Exchange (“TASE”), at the time the motions to certify as class actions were submitted, were dismissed by the Tel-Aviv Jaffa District Court. The plaintiff had claimed in the motion that the Company’s reports filed on the TASE’s electronic filing site (the MAYA) and on the Israel Securities Authority’s electronic filing site (the MAGNA) were not in compliance with applicable accessibility guidelines. The plaintiff had sought damages against the Company in a total amount of NIS 5,000,000.
IceCure Medical Announces Preliminary Unaudited 2022 Year-End Financial Results & Recent Operational Highlights
https://finance.yahoo.com/news/icecure-medical-announces-preliminary-unaudited-130000691.html
- Significant regulatory and reimbursement milestones achieved
- Positive interim clinical results for ProSense in the treatment of kidney tumors and breast cancer
- Fortified balance sheet with $23.6 million in cash and cash equivalents including short-term deposits as of December 31, 2022
- ProSense System and disposable cryoprobe sales continue to increase in the U.S.
CAESAREA, Israel, Feb. 9, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System, that destroys tumors by freezing as an alternative to surgical tumor removal ("ProSense"), today announced preliminary unaudited year-end financial results for the twelve months ended December 31, 2022.
Revenues decreased to $3.1 million in 2022, compared to $4.1 million in 2021.This is due to decreased revenue recognition of approximately $0.6 million from the distribution agreement with Terumo Corporation and a decrease of sales in most territories by 25%, which was partially offset by a 28% increase in U.S sales, and higher sales of disposable probes, as previously sold and installed systems were increasingly utilized for procedures in clinical settings. IceCure expects revenues may continue to fluctuate in the near future while the Company awaits a response from the U.S. Food and Drug Administration ("FDA") on regulatory clearance for ProSense in early-stage breast cancer.
As of December 31, 2022, the Company's cash and cash equivalents, including short-term deposits, totaled $23.6 million, compared to $25.6 million on December 31, 2021. In December 2022, IceCure raised $14.5 million in an equity financing funding priced at-the-market under Nasdaq rules with no warrants.
"In 2022 we delivered across the board on our goals from regulatory achievements and making progress with respect to obtaining the CPT Category III code for insurance reimbursements, to interim clinical results, to traction in the medical and scientific communities, and commercialization. Our team has worked extremely hard, and we thank the patients who have enrolled in our trials, as well as the increasing number of doctors using ProSense across the world," stated Eyal Shamir, IceCure's Chief Executive Officer. "We are well funded to continue to execute on an enormous opportunity to expand the use of cryoablation, delivering better treatment of numerous indications. We believe our recent fund raise, which was completed on very favorable terms given current market conditions, is a testament to IceCure's technology and our ability to deliver."
"On the regulatory front, we filed a De Novo classification request with the FDA for Marketing Authorization of our ProSense System with Breakthrough Indication for early-stage, low-risk, breast cancer patients at high risk to surgery. Elsewhere, we filed for approvals in Canada and Vietnam and received approval in Brazil for our cryoprobes."
"As we await a response from the FDA on our regulatory filing, reimbursement and affordability for patients is critical. We were very pleased to receive the assignment of a $3,400 CPT Category III code from the Centers for Medicare & Medicaid Services ("CMS") for breast cancer cryoablation procedure facility fees. Concurrent with potential regulatory clearance, we will continue working with CMS to refine reimbursement codes to include payment for the physician, thereby enabling greater availability and affordability of the ProSense System for breast cancer."
"The body of clinical data on ProSense continues to grow. Interim results from ICESECRET were recently presented at the Urological Association Conference in Israel which demonstrated ProSense is safe and effective in treating kidney tumors with an 89.5% recurrence-free rate. When filing our De Novo application with the FDA, we submitted the most recent interim ICE3 trial results, which showed there were six cases of ipsilateral breast tumor recurrence ("IBTR") out of 194 patients, or 3.09%. Our commercial and scientific team, including principal investigators of our trials, have been very active presenting, training, and demonstrating ProSense at medical conferences. The high level of interest in ProSense from patients and the medical community is highly encouraging."
"IceCure is committed to leading cryoablation technology. We've recently received patent allowances for technologies that enable our next generation of systems. We expect our commercial momentum will continue to build in 2023."
IceCure plans to report full 2022 audited financial results upon filing its annual report on Form 20-F with the U.S. Securities and Exchange Commission ("SEC").
The above information reflects preliminary, unaudited estimates with respect to certain results of IceCure for the full year ended December 31, 2022, based on currently available information. Because the audit for 2022 is not yet complete, IceCure's final results may vary from the preliminary estimates.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) (TASE: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared to-date by the FDA and approved in Europe with the CE Mark.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal and Israeli securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statement in this press release when it discusses: its expected financial results and continued growth; the expectation that revenues may fluctuate in the near future; the belief that the Company is well funded to continue to execute on expending the use of cryoablation and delivering better treatment; the Company will continue working with CMS to refine reimbursement codes to include payment for physicians, enabling greater availability and affordability of ProSense; expecting commercial momentum to continue to build in 2023; and awaiting the FDA's response to the Company's regulatory requests for clearance for ProSense in early-stage breast cancer; . Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties and actual results, performance, or achievements of IceCure could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2021 filed with the SEC on April 1, 2022, as amended, which is available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
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IR contact:
Ronen Tsimerman
ronent@icecure-medical.com
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SOURCE IceCure Medical
World Cancer Day: How Minimally Invasive Treatments Can Be Leveraged To Reach Underserved Populations
https://www.forbes.com/sites/forbesbusinessdevelopmentcouncil/2023/02/03/world-cancer-day-how-minimally-invasive-treatments-can-be-leveraged-to-help-reach-underserved-populations/?sh=379e4d4955ac
Over the last decade, minimally invasive cancer treatments have been transforming how we give and receive care. As a disclosure, my company IceCure Medical is a provider of minially invastive medical devices. Advanced tech solutions now enable much safer and more accessible therapy options for cancer patients while enabling treatment where often no solution previously existed.
At this current level, risk is minimal.
Picked up some shares, May be ready for a big move
IceCure's ProSense Featured in Breast Session at the Society of Interventional Oncology's Annual Scientific Meeting in Washington, D.C.
https://finance.yahoo.com/news/icecures-prosense-featured-breast-session-130000789.html
Panel discussion included doctors currently using the ProSense cryoablation system
Live ProSense demonstrations conducted at IceCure's booth
CAESAREA, Israel, Jan. 26, 2023 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing, today announced its participation in the Society of Interventional Oncology's Annual Scientific Meeting ("SIO2023") in Washington, D.C. on January 19 - 23, 2023. ProSense was demonstrated throughout the duration of the conference at IceCure's booth. Separately, in a breast session organized by SIO2023, ProSense was featured in a panel discussion on January 21st led by Dr. Kenneth Tomkovich and included Dr. Robert Ward, both ProSense users. The discussion included cryoablation as a treatment option as well as a mention of ICE3 interim trial results.
Dr. Tomkovich, Diagnostic and Interventional Radiologist with Princeton Radiology and Director of Breast Imaging and Interventions at CentraState Medical Center, is Co-lead Investigator of IceCure's landmark ICE3 study for the treatment of small, low-risk, early-stage malignant breast tumors. Dr. Ward, Assistant Professor of Diagnostic Imaging at the Warren Alpert Medical School of Brown University, Program Director for the Breast Imaging Fellowship, Associate Chief of Diagnostic Imaging at Women & Infants Hospital, specializes in women's imaging and breast tumor cryoablation.
Commenting on the growing interest in ProSense, Dr. Tomkovich stated, "we are seeing increasing interest from interventional radiologists and interventional oncologists, many of whom are practitioners who previously were not treating breast cancer patients. Their interest appears to be driven by the encouraging ICE3 interim results, which can drive the development of new patient markets for practitioners while making the minimally invasive procedure more accessible to patients." About IceCure Medical Ltd.
IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared to-date by the U.S. Food and Drug Administration and approved in European with the CE Mark.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other U.S. federal securities laws and Israeli securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statement in this press release when it discusses: the increasing interest in its products amongst practitioners and the potential for its products to drive development of new patient markets while making minimally invasive procedures more accessible to patients. Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of IceCure could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2021, filed with the Securities and Exchange Commission (the "SEC") on April 1, 2022, as amended, which is available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. The Company is not responsible for the contents of third-party websites.
IR Contact:
Ronen Tsimerman
ronent@icecure-medical.com
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SOURCE IceCure Medical
IceCure's ProSense Presented in Hands-On Training Course at The American Society of Breast Surgeons Breast Follows Ultrasound Course
https://finance.yahoo.com/news/icecures-prosense-presented-hands-training-130000192.html
Professional training courses are well-timed following IceCure's FDA filing for marketing authorization of ProSense with breakthrough indication
CAESAREA, Israel, Jan. 25, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing, today announced that on January 13-14, 2023, the Company participated in the American Society of Breast Surgeons ("ASBrS") Breast Fellows Ultrasound Course in Cincinnati, Ohio. The diagnostic and interventional breast ultrasound course was organized by ASBrS.
The course was moderated by Dr. Michael Berry and Dr. Richard Fine of the West Cancer Center in Germantown, Tennessee, both investigators in IceCure's ICE3 ProSense trial in early-stage, low-risk breast cancer in patients who are at high risk to surgery. Dr. Fine led a session of the course on cryoablation of breast tumors with ProSense and conducted a hands-on workshop and demonstration.
"ProSense was very well received by course participants who got hands-on training with our cryoablation system," stated Eyal Shamir, IceCure's Chief Executive Officer. "We welcome the ASBrS's role in addressing the need to provide more training in ultrasound for breast surgeons, as it is a key skill necessary for performing minimally invasive treatments like cryoablation. Clinician training is an important component of IceCure's multifaceted cooperation with the ASBrS with the aim of advancing the standard of care for breast cancer. As we look forward to the FDA's response to our recent regulatory filing for marketing authorization, conducting awareness and training around cryoablation for breast procedures supports our commercial rollout."
U.S. Patent Office Grants Notice of Allowance to IceCure for Novel Cryogenic Pump for Next-Generation Cryoablation Systems
https://finance.yahoo.com/news/u-patent-office-grants-notice-130000577.html
Patent has also been granted or allowed in major markets, including the European Union and Japan
Cryogenic pump potentially broadens clinical indications for IceCure's cryoablation platform technology
CAESAREA, Israel, Jan. 23, 2023 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing, today announced it has received a Notice of Allowance from the U.S. Patent and Trademark Office for its patent application titled "Cryogen Pump". The patent will be in effect until February 2040 and was recently granted in the European Union and allowed in Japan.
"ProSense is gaining increasing commercial traction in the U.S. in the indications for which it already has regulatory approval and reimbursement, as well as increased visibility in breast cancer following our October 2022 regulatory filing with the FDA. This Notice of Allowance in the U.S. is very well timed to protect our intellectual property as we develop the next generation of cryoablation systems to perform minimally invasive procedures for new indications," stated Eyal Shamir, IceCure's Chief Executive Officer.
The novel cryogenic pump enables IceCure to bring to market a new generation of cryoablation systems with a small footprint for a wide range of clinical applications. Moreover, this pump expands IceCure's portfolio of products with a broader range of thinner cryoprobes and catheters.
IceCure's novel cryogenic pump is submersible in liquid nitrogen, works in a closed circuit, enables temperature control of the cryoprobe, improves the cooling rate during a procedure, and is designed to be used for multiple procedures or longer duration procedures without the need to refill liquid nitrogen.
IceCure Receives Notice of Patent Allowance in Japan for a Novel Cryogenic Pump for its Next-Generation Cryoablation Systems
https://finance.yahoo.com/news/icecure-receives-notice-patent-allowance-130000027.html
Innovating as a global leader in cryoablation technologies, with 29 patents issued and allowed
Cryogenic pump enables multiple and longer duration procedures without the need to refill liquid nitrogen, potentially expanding clinical indications
CAESAREA, Israel, Jan. 18, 2023 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing, today announced it has received a Notice of Allowance from the Japan Patent Office (the "JPO") for IceCure's patent application titled "Cryogen Pump". The patent will be in effect until 2041. A patent for this invention has been issued in the European Union and is pending in other major markets, including the U.S.
IceCure's novel cryogenic pump is submersible in liquid nitrogen, works in a closed circuit, improves the cooling rate during a procedure, and is designed to be used for multiple procedures or longer duration procedures without the need to refill liquid nitrogen. Moreover, this pump enables temperature control of the cryoprobe, as well as the use of a wider range of cryoprobes and catheters.
"With this Notice of Allowance from the JPO, IceCure continues to build upon its leadership position in cryoablation procedures worldwide. We believe the cryogen pump will be instrumental in enabling practitioners to perform longer-term and multiple procedures more efficiently, as well as allowing for the expansion of cryoablation treatment to more clinical applications in the future," stated Eyal Shamir, IceCure's Chief Executive Officer. "This additional IP in Japan supports our distribution agreement with Terumo for our cryoablation systems in Japan."
At current share price, methinks
it is a good entry point, especially
now that they raised $14.5 million
@$1.65 a short while ago
Sounds pretty good to me !!
IceCure Medical CEO Issues Letter to Shareholders
https://finance.yahoo.com/news/icecure-medical-ceo-issues-letter-130000566.html
CAESAREA, Israel, Jan. 4, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing, today released the following letter to shareholders from its Chief Executive Officer, Eyal Shamir.
Dear Shareholders,
In 2022, we built a strong foundation for the road ahead. IceCure is creating the new standard in tumor therapy, freezing tumors in their tracks through a minimally invasive outpatient procedure that doesn't disrupt lives and aims to eliminate recurrence. We've reported solid data in breast and kidney cancer this year with investigator-initiated studies in several other indications ongoing. Throughout 2022, we've delivered on stated goals by bolstering current customer relationships, developing new partnerships, and innovating the next generation of our cryoablation technology.
2022 Key Achievements
Fortified Balance Sheet: Under very challenging market conditions, we successfully closed a $14.5 million equity financing priced 'at the market' under Nasdaq rules and without warrants. Several of our long-term institutional shareholders participated in the transaction. We believe that our ability to execute this kind of fundraise in the current market is a testament to investors' confidence in our technology, market strategy, and management team. With the net proceeds of this financing plus our cash balance of $14.2 million as of the end of the third quarter 2022, we believe we are well funded to continue to execute on the global rollout of ProSense across a broad number of indications.
Submitted for Regulatory Approvals: We achieved several significant milestones with submission for regulatory approvals in Canada, Vietnam, and our filing of a De Novo classification request with the U.S. Food and Drug Administration ("FDA") for Marketing Authorization of our ProSense System with Breakthrough Indication for early-stage, low-risk, breast cancer patients at high risk to surgery representing an estimated $80 million annual addressable market in the U.S.
Received Regulatory Approval: Our cryoprobes and introducers received regulatory approval in Brazil, a key step towards opening the largest market in Latin America.
Achieved Reimbursement Milestone in the U.S.: Our U.S. commercialization efforts made a major move forward with respect to insurance reimbursement when we received the assignment of a $3,400 CPT Category III code from the Centers for Medicare & Medicaid Services ("CMS") for breast cancer cryoablation procedures for facility fees.
Continued to Execute on Global Commercial Rollout: In China, we entered into an exclusive distribution agreement with Shanghai Medtronic Zhikang Medical Devices Co. Ltd., an affiliate of Medtronic plc (NYSE:MDT) and Beijing Turing Medical Technology Co. Ltd. ProSense has been installed at numerous new sites in 2022, about half of which were in the U.S., with others in Europe and Southeast Asia. We are highly encouraged by the increasing usage across these sites and sites that were installed previously.
Clinical Data Presented & Published: In the most up-to-date interim data available from our ICE3 study, there were six cases of ipsilateral breast tumor recurrence ("IBTR") out of 194 patients, or 3.09%. Interim analysis from our ICESECRET study found that ProSense was safe and effective in treating kidney tumos with an 89.5% recurrence-free rate. Additionally, ProSense for breast cancer was featured in a poster presentation at the Radiological Society of North America's Annual Meeting. Two articles featuring ProSense were published in medical journals; one article published in Cancers studied the feasibility and safety of ProSense for kidney, bone, liver, lung, and soft tissue and the other article from Clinics in Oncology studied the use of liquid nitrogen based cryoablation with ProSense in the treatment of metastatic lung cancer.
Raised ProSense's Visibility Worldwide: We were extremely active exhibiting and conducting live ProSense webinars and demos at medical conferences worldwide including the Society of Interventional Radiology Annual Scientific Meeting and the European Conference on Interventional Oncology. We launched our breast cancer cryoablation awareness campaign #FreezeCancerNotYourLife during Breast Cancer Awareness Month. Raising awareness among the patient population and educating clinicians will drive demand for our ProSense procedures.
2023 Objectives
We await the FDA's response to our regulatory filing, which included efficacy and safety data, for early-stage, low-risk, breast cancer patients at high risk to surgery. Concurrent with potential regulatory clearance, we will continue work with CMS to refine reimbursement codes to enable greater availability and affordability of the ProSense System for breast cancer.
Ahead of potential FDA clearance, we are increasing commercialization efforts in the U.S. with a focus on breast cancer to address the initial indication market of 43,000 women in the U.S. annually.
In Europe, we also are increasing our focus on breast cancer and plan to conduct studies in cooperation with our distributors and healthcare providers to collect clinical data and support commercialization. We believe that the regulatory environment in Europe offers our liquid nitrogen-based cryoablation system clear technological and market advantages and we will seek to leverage these benefits in the coming year.
Globally, we expect continued commercial rollout, regulatory filings, and approvals. As we continue discussions with potential distribution partners in new territories, we are working closely with our current strategic partners Shanghai Medtronic Zhikang Medical Devices Co. Ltd. in Mainland China, Terumo Corporation in Japan and Thailand, and numerous others throughout Europe, Asia, and the Americas to make ProSense procedures widely available across numerous indications.
We are also continuing to explore cooperations with various strategic players in the industry to optimize the commercial development and rollout of our ProSense technology.
With many accomplishments achieved this past year, IceCure looks forward to a bright and exciting future in 2023. Stay tuned! We wish you all a healthy and prosperous new year.
Sincerely,
Eyal Shamir, CEO
IceCure Medical
About IceCure Medical Ltd.
IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared to-date by the FDA and approved in Europe with the CE Mark.
IR Contact:
Ronen Tsimerman
email: ronent@icecure-medical.com
Logo - https://mma.prnewswire.com/media/1941429/IceCure_Logo.jpg
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View original content:https://www.prnewswire.com/news-releases/icecure-medical-ceo-issues-letter-to-shareholders-301713316.html
SOURCE IceCure Medical
IceCure Medical Ltd. Announces Closing of $14.5 Million Public Offering Priced At-The-Market Under Nasdaq Rules
https://finance.yahoo.com/news/icecure-medical-ltd-announces-closing-210000569.html
Fri, December 23, 2022 at 11:00 PM GMT+2
CAESAREA, Israel, Dec. 23, 2022 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing, today announced the closing of its previously announced "best efforts" public offering of 8,787,880 shares of the Company's ordinary shares (the "Ordinary Shares") priced at-the-market under Nasdaq rules at a price to the public of $1.65 per share. The gross proceeds of the offering to the Company were approximately $14.5 million, before deducting placement agent fees, commissions, and other estimated offering expenses.
A.G.P./Alliance Global Partners acted as lead placement agent for the offering on a best efforts basis. Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as a co-placement agent for the offering.
The Company intends to use the net proceeds from the offering to fund the development of its next generation single Probe and MultiSense systems, collecting clinical data and adding regulatory approvals in new territories and indications, business development, marketing and selling activities as well as for working capital and general corporate purposes.
This offering of the Ordinary Shares is being made pursuant to an effective shelf registration statement on Form F-3 (File No. 333-267272) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). The offering was made by means of a prospectus supplement and accompanying base prospectus. The final prospectus supplement and accompanying prospectus have been filed with the SEC, and are available on the SEC's website located at http://www.sec.gov. Electronic copies of the final prospectus supplement may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at prospectus@allianceg.com.
https://ih.advfn.com/stock-market/NASDAQ/icecure-medical-ICCM/stock-news/89812573/icecures-prosense-safe-and-effective-in-treating-k
that's what important ! Yesterday and the day before yesterday the investors thought that the announcement was worth buying at 4-11 dollars, so because the company needs liquidity, then suddenly the announcement is not important?
I would not be surprised if it was pulled down below $1.00 to close the gap!
If they had done it at a lower price they would've just had to sell more shares. Which is worse?
That's what all small biotechs do in the beginning out of necessity. If they need the money to finance a new treatment then it's justified. Sorry for those that bought at a higher price recently but the price will come back. Just hold on. Anyway I got in at 1.5 this morning. Looks like a good entry point or time to average down.
This is what small cap pharma/biotech firms do, they have positive product news they sell shares. You do not buy into the news new buy after the offering:
https://icecure-medical.com/investor-media/news/
im not in but I feel for those innocent folks who got caught in this mess
right before the holidaze
Suspended until final details of
the offering are disclosed.
you cursed the trading, now suspended lol
no like i said, i wanted 2.22 and only went 2.26 and i didnt slap da ask. over now though. offering
Never seen a halt for that in any orher stocks. Have u?
IceCure Medical Files Shelf Registration For Up To $100M
BENZINGA 3:24 PM ET 12/20/2022
-SEC Filing
Probably to figure out PO pricing which came out 20 mins ago
Just a guess…
O never mind I see they just did one. Lots of medical stocks do this I’ve noticed after any big news. Should be outlawed
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