US Market News
3週前
IceCure Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid RequirementMay 13, 2026 4:30 PM
PR Newswire (US) No Immediate Effect on Nasdaq Listing or Trading of the Company's Ordinary SharesCAESAREA, Israel, May 13, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that it has received a notification letter from Nasdaq Stock Market LLC ("Nasdaq") that the Company has been granted an additional 180-day compliance period, or until November 9, 2026 to regain compliance with Nasdaq's minimum bid price rule. Nasdaq's determination is based on the Company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on the Nasdaq Capital Market, with the exception of the bid price requirement, and the Company's written notice of its intention to cure the deficiency during the second compliance period and if necessary, by effecting a reverse share split.In a notification letter dated November 12, 2025, Nasdaq had first informed the Company that, based on the previous 30 consecutive business days, the Company's ordinary shares no longer met the minimum $1.00 bid price per share requirement and in accordance with Nasdaq's Listing Rules, the Company was provided 180 calendar days, or until May 11, 2026, to regain compliance. The Company did not regain compliance with the minimum $1.00 bid price per share requirement during the first 180-calendar-day compliance period and submitted a written request to the Nasdaq's staff to afford it an additional 180-day compliance period to cure the deficiency, which it was granted in a notification letter dated May 12, 2026.If at any time before November 9, 2026, the closing bid price of the Company's ordinary shares is at least $1.00 per share for a minimum of 10 consecutive business days, the Company will regain compliance with this Nasdaq rule and this matter will be closed. However, Nasdaq may, in its discretion, require the Company's ordinary shares to maintain a bid price of at least $1.00 for a period in excess of ten consecutive business days, but generally no more than 20 consecutive business days, before determining that the Company has demonstrated an ability to maintain long-term compliance.This current notification from Nasdaq has no immediate effect on the listing or trading of the Company's ordinary shares, which will continue to trade on the Nasdaq Capital Market under the symbol "ICCM."About IceCure MedicalIceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction 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 option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe and Asia. 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 securities laws. For example, IceCure is using forward-looking statements when it discusses regaining compliance with Nasdaq's continued listing requirements, and the timing and effect thereof as well as potentially effecting a reverse share split. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. 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, including those discussed under the heading "Risk Factors" in IceCure's Annual Report on Form 20-F filed with the SEC on March 17, 2026, and in subsequent filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, IceCure disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.Investor Contact:Email: investors @Reidman-6914Logo - https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg View original content:https://www.prnewswire.com/news-releases/icecure-granted-180-day-extension-by-nasdaq-to-regain-compliance-with-minimum-bid-requirement-302771474.htmlSOURCE IceCure Medical Original: IceCure Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid Requirement
US Market News
1月前
IceCure Medical to Report First Quarter 2026 Financial and Operating Results on May 12, 2026May 6, 2026 8:30 AM
PR Newswire (US) CAESAREA, Israel, May 6, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that it will issue a press release with its financial and operational results as of and for the three months ended March 31, 2026 before the Nasdaq Stock Market opens on Tuesday, May 12, 2026. The Company will also discuss such results and other corporate developments on a conference call at 11:00 a.m. EDT on the same day. Conference call & webcast info:
Tuesday, May 12, 2026, at 11:00 am EDT
US: 1-888-407-2553
Israel/International: +972-3-918-0696
A live webcast will be available at: https://www.veidan-conferencing.com/icecure-investors
A recording of the webcast will be available at: ir.icecure-medical.comAbout IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction 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 option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the United States, Europe and Asia.Forward Looking Statement
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 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 statements in this press release when it discusses: the timing for announcing its financial and operating results for the three month ended March 31, 2026 and the related conference call. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission ("SEC") on March 17, 2026, 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:Email: investors @Reidman-6914Logo - https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg View original content:https://www.prnewswire.com/news-releases/icecure-medical-to-report-first-quarter-2026-financial-and-operating-results-on-may-12-2026-302764075.htmlSOURCE IceCure Medical Original: IceCure Medical to Report First Quarter 2026 Financial and Operating Results on May 12, 2026
US Market News
2月前
IceCure Participates in Society of Breast Imaging Symposium 2026 as U.S. ProSense® Revenue Increases by 30%+ in First Quarter of 2026 Compared to First Quarter of 2025April 21, 2026 8:30 AM
PR Newswire (US)
The Company's participation at the Society of Breast Imaging Symposium and other upcoming medical conferences are timely as commercial momentum acceleratesCryoablation cost analysis study from Massachusetts General Hospital featuring ProSense® demonstrated 50% reduction in cost vs. lumpectomy won SBI 2026 Abstract AwardCAESAREA, Israel, April 21, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that it expects to report U.S. revenue of ProSense® systems and cryoprobes increased more than 30% in the first quarter of 2026 compared the same period last year, based on preliminary, unaudited estimates.
The performance in the U.S. represents the adoption of ProSense® immediately following the U.S. Food and Drug Administration's ("FDA") clearance of ProSense® for the local treatment of low-risk breast cancer in women aged 70 and above in October 2025. The Company experienced this rising enthusiasm at the Society of Breast Imaging ("SBI") 2026 Symposium ("SBI 2026"), which was held in Seattle, Washington from April 16 to 19, 2026. IceCure exhibited ProSense® cryoablation technology and participated in a hands-on physician training workshop.Following the FDA's clearance of ProSense® for early-stage breast cancer, IceCure continues to expand its installed base of ProSense® systems in the U.S., including placements at leading academic and research hospitals, supported by a robust and expanding pipeline of prospective customers, which the Company expects to close with new system sales in the second quarter of 2026."IceCure is seeing a meaningful shift in the treatment landscape for early-stage breast cancer, with cryoablation gaining increasing attention from physicians, healthcare systems, and patients," said Eyal Shamir, Chief Executive Officer of IceCure. "We believe this growing momentum is reflected in our strong commercial performance in the U.S., as well as in the expanding number of systems installed at some of the most prestigious teaching and research hospitals in the U.S. Additionally, we believe the high level of engagement at SBI 2026, combined with independent, award-winning data demonstrating the significant cost benefits of cryoablation, further supports our view that this technology is advancing toward becoming a standard-of-care option for indicated patients."Award Winning AbstractAt SBI 2026, an award-winning abstract titled "Cost Analysis of Percutaneous Cryoablation versus Breast Conserving Surgery for the Treatment of Breast Cancer: Implication for Cost Efficacy-based Treatment Strategy" was presented by Matt Hoyer, M.D., of Massachusetts General Hospital. The study received the Wendell Scott Research Award, which recognizes the most outstanding abstract submitted by a breast imaging fellow. The analysis, which evaluated ProSense® as one of two liquid nitrogen-based cryoablation systems, demonstrated that cryoablation may reduce total treatment costs by more than 50% compared to breast-conserving surgery. The findings also highlighted cryoablation as a viable alternative for well-selected, low-risk early-stage breast cancer patients, building on promising treatment outcomes demonstrated in prior studies, including IceCure's ICE3 trial. In addition to highlighting optimized outpatient treatment, faster recovery, and improved patient quality of life, the abstract emphasized cryoablation's alignment with value-based low cost care and its potential to expand the role of radiologists in multidisciplinary cancer treatment.How-To Cryoablation Workshop
Part of SBI 2026's scientific programming included the workshop, "How I Do It – Cryoablation: Working It Up and Freezing it Out," led by Luz A. Venta, M.D., FACR, FSBI, of Weill Cornell Medical College, and Robert C. Ward, M.D., of the Warren Alpert Medical School of Brown University. The session provided practical, real-world guidance on integrating cryoablation into clinical practice. Dr. Venta's portion focused on optimizing diagnostic imaging workups prior to cryoablation, including protocols for evaluating masses, calcifications, asymmetries, and associated findings. Dr. Ward, who will be the co-primary investigator of IceCure's upcoming post-market surveillance study, the ChoICE trial, reviewed procedural techniques, clinical indications, and supporting data for cryoablation, as well as strategies to maximize benefits while minimizing risks and addressing potential barriers to broader adoption. The session concluded with an interactive Q&A, offering attendees deeper insight into implementation and best practices.The Company expects to report its full operating and financial results for the first quarter of 2026 on Thursday, May 14, 2026. Details for the conference call and webcast will be provided in a separate press release in early May. The preliminary financial information above regarding an increase in the Company's U.S. revenue of ProSense ® systems and cryoprobes for the first quarter of 2026 has been prepared solely on the basis of information that is currently available to, and that is the responsibility of, management and is based upon Company estimates and remains subject to, among other things, the completion of IceCure's quarterly financial closing procedures and final adjustments, which may impact the results and expectations set forth above.About ProSense®
The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company's website.ProSense® is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens the door to fast and convenient office-based procedures for breast tumors.About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction 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 option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe and Asia.Forward Looking StatementThis 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 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 statements in this press release when it discusses: the expected increase in U.S. revenue of ProSense® systems and cryoprobes in the first quarter of 2026 compared to the first quarter of 2025, which are subject to, among other things, the completion of IceCure's quarterly financial closing procedures and final adjustments, which may impact the results and expectations set forth above; the Company's expectations regarding closing new system sales in the second quarter of 2026; the Company's belief that commercial momentum reflects a meaningful shift in the treatment landscape for early-stage breast cancer; the potential for cryoablation to become a standard-of-care option for indicated patients; and the Company's expectations regarding the timing of reporting its full operating and financial results for the first quarter of 2026. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on March 17, 2026, 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:E-mail: investors @Reidman-6914Logo - https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/icecure-participates-in-society-of-breast-imaging-symposium-2026-as-us-prosense-revenue-increases-by-30-in-first-quarter-of-2026-compared-to-first-quarter-of-2025-302747230.htmlSOURCE IceCure Medical
Original: IceCure Participates in Society of Breast Imaging Symposium 2026 as U.S. ProSense® Revenue Increases by 30%+ in First Quarter of 2026 Compared to First Quarter of 2025
US Market News
3月前
American Society of Breast Surgeons (ASBrS) Resource Guide Update Recommends Cryoablation for Low-Risk Breast CancerMarch 9, 2026 8:30 AM
PR Newswire (US)
IceCure's ICE3 study and the FDA Advisory Panel's favorable vote on ProSense® cryoablation's benefit-risk profile for low-risk breast cancer played a key role in the ASBrS 2026 Resource Guide updateNew medical society guidance expected to further accelerate commercial adoption of ProSense® following FDA-clearance for low-risk breast cancer in October 2025CAESAREA, Israel, March 9, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), a developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that the American Society of Breast Surgeons' ("ASBrS") updated 2026 "Resource Guide on the Use of Transcutaneous and Percutaneous Ablation for the Treatment of Benign and Malignant Tumors of the Breast" recommends cryoablation as an option for selected patients with biologically low-risk early-stage breast cancer. The updated guidance represents an important step toward broader clinical adoption of IceCure's ProSense® cryoablation system, which received U.S. Food and Drug Administration ("FDA") marketing clearance in October 2025 for the treatment of low-risk breast cancer in patients aged ≥70 years, with tumors measuring ≤1.5 cm, who are treated with adjuvant endocrine therapy. ProSense® is the first and only FDA cleared medical device for the treatment of breast cancer.
"We believe this recognition by the ASBrS, a leading professional society, further validates cryoablation's role in modern breast cancer care and positions ProSense® as an option that prioritizes outcomes, cosmetic results, and patient choice," said Eyal Shamir, IceCure's Chief Executive Officer. "The ASBrS Resource Guide on percutaneous ablation compliments their recent guidance for breast-conserving treatment, emphasizing preservation, de-escalation, and individualized care. Cryoablation aligns naturally with these principles by providing minimally invasive, breast-preserving local tumor control without surgical excision."IceCure's Vice President of Sales for North America, Shad Good, added, "We believe ASBrS's new guidance will further raise awareness of and confidence in cryoablation among patients and breast surgeons, who develop and oversee breast cancer patients' treatment plans. We expect these developments, as well as the established CPT III reimbursement code, will help further accelerate commercial adoption and drive continued momentum in ProSense® system placements and procedure volumes."The ASBrS 2026 Resource Guide continues to recognize cryoablation as a validated, cosmetically favorable treatment for benign fibroadenomas and now identifies it as a carefully selected, FDA-approved option to surgery for biologically low-risk early-stage breast cancer in older patients. The guide indicates that cryoablation must be considered in the context of a comprehensive treatment plan with input from a multidisciplinary team. The ASBrS recommendations align clinical evidence, FDA authorization, and multidisciplinary care principles into a unified framework for the use of breast cryoablation.Based on data from the American Cancer Society, ProSense® addresses a U.S. breast cryoablation patient population of approximately 200,000 women annually, including an estimated 47,245 early-stage, low-risk breast cancer patients aged 70 and over, approximately 90,300 patients who are not candidates for breast cancer surgery, and roughly 63,200 patients with fibroadenomas who opt for excision.About ProSense®The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company's website.ProSense® is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens the door to fast and convenient office-based procedures for breast tumors.About IceCure MedicalIceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction 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 option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and Asia.Forward Looking StatementThis 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 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 statements in this press release when it discusses: the expected impact of the of the ASBrS 2026 Resource Guide update on physician adoption, patient access, reimbursement coverage, and commercial adoption of ProSense®; the Company's belief that ProSense® is positioned as a treatment option that prioritizes outcomes, cosmetic results, and patient choice; that the ASBrS guidance is expected to further accelerate commercial adoption of ProSense® following FDA-clearance for low-risk breast cancer in October 2025; and the Company's expectations regarding the role of cryoablation as a minimally invasive treatment option for appropriately selected breast cancer patients. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024 filed with the SEC on March 27, 2025, 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:Email: investors @Reidman-6914Logo - https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/american-society-of-breast-surgeons-asbrs-resource-guide-update-recommends-cryoablation-for-low-risk-breast-cancer-302708105.htmlSOURCE IceCure Medical
Original: American Society of Breast Surgeons (ASBrS) Resource Guide Update Recommends Cryoablation for Low-Risk Breast Cancer
US Market News
3月前
IceCure Medical Reports Independent Study Published in PLOS One Demonstrating ProSense® Cryoablation Safe and Effective in Treatment of Breast FibroadenomasMarch 2, 2026 8:30 AM
PR Newswire (US)
Treatment with ProSense® resulted in 92.9% volume reduction of fibroadenoma one-year post-cryoablationFindings may impact treatment guidelines issued by medical societies for large non-cancerous breast tumors; study is believed to be the first to evaluate larger lesions and use multiple cryoprobe relocationsProSense® Cryoablation has FDA-clearance for fibroadenomasCAESAREA, Israel, March 2, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced the publication of an independent, investigator-initiated study evaluating ProSense® for the treatment of non-cancerous breast tumors, or fibroadenomas. The study, titled "Cryoablation for fibroadenoma with liquid nitrogen-based system: A retrospective analysis of prospectively collected data," was published in the peer-reviewed journal PLOS One.
Fibroadenoma is the most common benign breast lesion identified through core needle biopsy. Up to 10% of women will have a fibroadenoma at some point in their lives, according to the Cleveland Clinic. Surgical excision is currently the standard of care for many fibroadenomas, particularly for larger lesions or those causing discomfort. IceCure estimates that cryoablation could address approximately 63,000 cases of fibroadenoma excision in the U.S. annually. "We believe this publication is very significant because it reinforces the safety and effectiveness of ProSense® cryoablation for fibroadenomas and may contribute to updates in treatment guidelines for non-cancerous breast tumors issued by medical societies in key markets where ProSense® is used, including the American Society of Breast Surgeons," said Eyal Shamir, IceCure's Chief Executive Officer. "Previous studies supporting cryoablation for fibroadenomas were often limited to lesions 4 centimeters or smaller, and many were published more than a decade ago. This study is unique in that it includes a large patient cohort and evaluates larger lesions using multiple cryoprobe relocations. We are grateful to the study's investigators for their pursuit of improved outcomes for patients and their use of ProSense® for their study."The study was conducted at the Premier Med Healthcare, Training, and Research Institute in Hungary and led by Dr. Teodora Filipov and Dr. Pál Ákos Deák. The investigators concluded that cryoablation with a liquid nitrogen system, specifically ProSense®, proved safe and effective, demonstrating a median volume reduction of 80.6% at approximately six months and 92.9% at one-year post-treatment. The study further found that sequential cryoprobe relocations preserve safety and efficacy. ProSense® cryoprobes can be relocated up to three times per patient, per procedure enabling physicians to fully treat large or multifocal lesions through complete ablation coverage.IceCure believes these findings further support the growing clinical adoption of minimally invasive cryoablation as an alternative to surgical excision for benign breast tumors, particularly for women seeking minimal scarring and short procedure times.About ProSense®The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company's website.ProSense® is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens the door to fast and convenient office-based procedures for breast tumors.About IceCure MedicalIceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction 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 option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the United States, Europe and Asia.Forward Looking StatementThis 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 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 statements in this press release when it discusses: the potential number of cases of fibroadenoma excision that cryoablation could address in the U.S. annually; the potential impact of the study's findings on future treatment guidelines for non-cancerous breast tumors; the possibility that the results may contribute to updates by medical societies such as the American Society of Breast Surgeons; and the expectation that these findings will further support the growing clinical adoption of ProSense as an alternative to surgical excision for benign breast tumors. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission ("SEC") on March 27, 2025, 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:Email: investors @Reidman-6914Logo - https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/icecure-medical-reports-independent-study-published-in-plos-one-demonstrating-prosense-cryoablation-safe-and-effective-in-treatment-of-breast-fibroadenomas-302701021.htmlSOURCE IceCure Medical
Original: IceCure Medical Reports Independent Study Published in PLOS One Demonstrating ProSense® Cryoablation Safe and Effective in Treatment of Breast Fibroadenomas
US Market News
3月前
IceCure Medical Successfully Completes 5-Year Patient Follow Up in ICESECRET Kidney Cancer Cryoablation Study: Final Analysis Expected in Second Quarter of 2026February 23, 2026 8:30 AM
PR Newswire (US)
Previously released interim data from 111 patients demonstrated ProSense® is safe and effective in destruction of kidney tumors with 88.7% recurrence-free rateIncidence of kidney cancer is growing worldwide, with an estimated 400,000 new cases globally; over 80,000 of which are in the U.S. alone highlighting a growing unmet needProSense® is approved for benign and malignant kidney tumors in the U.S., Europe, and numerous other countriesCAESAREA, Israel, Feb. 23, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure," "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced the completion of its last patients' five-year follow up evaluation in its ICESECRET clinical trial of ProSense® for the treatment of small renal masses ("SRMs") in kidney cancer patients. ICESECRET, a prospective, multicenter, single-arm clinical trial, was performed at Bnai Zion Medical Center in Haifa, Israel and Shamir Medical Center in Be'er Ya'akov, Israel and is led by Principal Investigator Prof. Halahmi Sarel. The trial included 114 patients (138 lesions) with localized SRMs of ≤5 cm ablated with ProSense® cryoablation under CT guidance. Follow-up visits were performed at six weeks, six months, one year and then annually up to five years after the procedure using ProSense®. During follow-up visits, data related to local recurrence, based on CT imaging, was collected. Safety was determined by monitoring procedure-related adverse events throughout the study."Interim three-year data from ICESECRET, which was collected from 111 eligible patients at the time, was presented a year ago and demonstrated the strong potential of ProSense® cryoablation as a safe and effective option for patients who are otherwise ineligible for kidney preserving surgery, a growing unmet need," stated Eyal Shamir, IceCure's Chief Executive Officer. "Importantly, ProSense® already has regulatory approval to treat kidney cancer in key markets including the U.S. and Europe. We are now working closely with Prof. Sarel on data analysis and publication, with the intention of bringing this minimally invasive procedure to patients in Israel with kidney cancer."SRMs are increasingly detected due to widespread imaging and represent a growing clinical challenge, particularly among elderly patients and those with comorbidities who are not suitable candidates for surgery. Minimally invasive, nephron-sparing treatment options that preserve kidney function, while effectively controlling tumors, are critically needed.About ProSense®The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company's website.ProSense® is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens the door to fast and convenient office-based procedures for breast tumors.About IceCure MedicalIceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction 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 option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe and Asia.Forward Looking StatementThis 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 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 statements in this press release when it discusses: the expected timing of the final analysis of data from the ICESECRET study, including the expectation that results will be available by the end of the first half of 2026; the clinical performance, safety, efficacy and recurrence-free rates associated with ProSense® cryoablation treatment of kidney tumors; the potential of ProSense® as a safe and effective treatment option for patients with SRMs and those ineligible for kidney-preserving surgery; and the anticipated clinical adoption, utilization and expansion of ProSense® in the treatment of kidney cancer. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024 filed with the SEC on March 27, 2025, 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.Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpgIR Contact:
Michael Polyviou
732-232-6914
investors@icecure-medical.com
View original content:https://www.prnewswire.com/news-releases/icecure-medical-successfully-completes-5-year-patient-follow-up-in-icesecret-kidney-cancer-cryoablation-study-final-analysis-expected-in-second-quarter-of-2026-302694500.htmlSOURCE IceCure Medical
Original: IceCure Medical Successfully Completes 5-Year Patient Follow Up in ICESECRET Kidney Cancer Cryoablation Study: Final Analysis Expected in Second Quarter of 2026
US Market News
4月前
IceCure Announces Planned Departure of CFO Following Nine Years of Service and Key Milestones AchievedFebruary 9, 2026 4:30 PM
PR Newswire (US)
Ronen Tsimerman will continue as CFO until successor is appointedCAESAREA, Israel, Feb. 9, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), a developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that after nearly a decade of service with IceCure, Chief Financial Officer Ronen Tsimerman has informed the Company of his decision to leave the Company to pursue new opportunities. The Company has initiated a search for a new Chief Financial Officer and has identified compelling candidates with significant experience commercializing disruptive technologies. Some candidates have recently advanced in the selection process to interviews with IceCure's Board of Directors. Mr. Tsimerman will continue in his role until a successor is appointed, to ensure a smooth transition.
"Ronen has been a valued contributor over the years, and his skilled financial and operational leadership allowed IceCure Medical to achieve several key milestones, including our listing on the Nasdaq, fundraisings to support the completion of our ICE3 study, the largest of its kind for cryoablation, and the subsequent U.S. Food and Drug Administration marketing clearance of ProSense® for low-risk breast cancer, in late 2025 ," stated IceCure's Chief Executive Officer, Eyal Shamir. "Ronen has been a trusted colleague and friend to our entire team and we wish him well in his future endeavors and are pleased to have his continued support over the next few months as we transition to a new CFO.""I am extremely proud of the great work we've accomplished at IceCure. Our mission and the collaborative work with regulatory agencies, medical societies, caregivers and patients across the globe to bring the first and only on-label treatment in the U.S. for the minimally invasive treatment of low-risk breast cancer is truly an amazing accomplishment," Mr. Tsimerman stated. "I thank Eyal and the entire team for their professional excellence and partnership in advancing the Company's mission."About ProSense®The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company's website.ProSense® is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens the door to fast and convenient office-based procedures for breast tumors.About IceCure MedicalIceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction 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 option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and Asia.Forward Looking StatementThis 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 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 statements in this press release when it discusses: the timing and completion of the planned transition of its Chief Financial Officer, the search for and appointment of a successor Chief Financial Officer, and the Company's expectations regarding continuity of financial leadership and operations during the transition period. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024 filed with the SEC on March 27, 2025, 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:Email: investors @Reidman-6914Logo - https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/icecure-announces-planned-departure-of-cfo-following-nine-years-of-service-and-key-milestones-achieved-302682657.htmlSOURCE IceCure Medical
Original: IceCure Announces Planned Departure of CFO Following Nine Years of Service and Key Milestones Achieved
Boing x 2
6月前
Here is why 50,000 interventional radiologists is likely very important.
"Interventional Radiologists (IRs) are medical doctors who specialize in diagnosing and treating a wide range of conditions using minimally invasive, image-guided procedures.
They use real-time imaging technologies—like X-rays (fluoroscopy), CT scans, ultrasound, and MRI—to guide small instruments, such as needles and catheters, through the skin or blood vessels to a target area in the body.
Here is an overview of the types of procedures an Interventional Radiologist is allowed to perform, categorized by the area of treatment:
💉 Vascular & Circulatory System Procedures
These procedures deal with blood vessels (arteries and veins):
Angiography and Angioplasty/Stenting: Diagnosing and treating narrowed or blocked blood vessels. This involves using a balloon to open the vessel (angioplasty) and often placing a small mesh tube (stent) to keep it open.
Embolization: Blocking blood flow to a specific area. This is used to stop bleeding (e.g., in trauma or postpartum hemorrhage), shrink tumors (by cutting off their blood supply), or treat conditions like uterine fibroids (Uterine Fibroid Embolization) and varicoceles.
Thrombolysis/Thrombectomy: Dissolving or removing blood clots from arteries or veins, often used for deep vein thrombosis (DVT) or pulmonary embolism (PE).
IVC Filter Placement/Retrieval: Placing a small filter in the largest vein (inferior vena cava) to catch blood clots and prevent them from reaching the lungs.
Venous Access: Placement of long-term catheters, ports, or dialysis access devices.
⚕️ Cancer Treatment (Interventional Oncology)
IRs are key members of the cancer treatment team, often performing:
Tumor Ablation: Destroying tumors using extreme heat (Radiofrequency Ablation - RFA, Microwave Ablation) or cold (Cryoablation) delivered through a needle.
Chemoembolization (TACE) & Radioembolization (Y-90): Highly targeted therapies for liver cancer where chemotherapy or radioactive particles are delivered directly into the arteries feeding the tumor.
🔬 Biopsies and Drainage
These are fundamental IR procedures:
Image-Guided Biopsy: Using a needle under imaging guidance (CT, ultrasound, etc.) to collect tissue samples from almost any organ (lung, liver, kidney, bone, etc.) for diagnosis.
Abscess/Fluid Drainage: Placing a catheter to drain abnormal fluid collections, such as abscesses, cysts, or excess fluid around the lungs (thoracentesis) or in the abdomen (paracentesis).
🦴 Spine and Musculoskeletal Procedures
Vertebral Augmentation (Vertebroplasty/Kyphoplasty): Treating painful spinal compression fractures by injecting bone cement into the collapsed vertebra.
Pain Management Injections: Targeted injections for pain, such as nerve blocks or facet joint injections, using imaging guidance for precision.
🦠 Non-Vascular Organ Interventions
Biliary Interventions: Placing drains or stents to relieve blockages in the bile ducts, often caused by stones or tumors.
Genitourinary Interventions: Placing tubes (nephrostomy) or stents to relieve urinary blockages, often caused by kidney stones or tumors.
Gastrointestinal Access: Placement of feeding tubes directly into the stomach (gastrostomy) or small intestine (jejunostomy).
Key Takeaway
Interventional Radiologists are essentially minimally invasive procedure specialists. Their unique authority comes from their expertise in medical imaging (diagnosing conditions) combined with their specialized training in image-guided access and treatment (performing the procedure), which often allows for treatments that replace the need for traditional, open surgery."
It gives them another tool to treat cancer. If they adopt it for use it is big.
Boing X 2
midastouch017
9月前
IceCure Granted Notice of Allowance for U.S. Patent for its Next-Generation XSense™ Cryoprobes
https://finance.yahoo.com/news/icecure-granted-notice-allowance-u-123000158.html
The invention is designed to improve cryoprobe extraction, further reducing risk of tissue trauma, leading to lower costs and improved patient experience
XSense™ System with Cryoprobes recently received regulatory approval in the U.S. and Israel
CAESAREA, Israel, Sept. 18, 2025 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced it has received a Notice of Allowance from the U.S. Patent and Trademark Office for its patent titled "Cryoprobe".
"Our industry-leading liquid-nitrogen-based cryoablation platform has been further advanced with this latest invention, a cryoprobe technology," stated IceCure's Chief Executive Officer, Eyal Shamir. "There is an abundance of data, much of it from independent studies, showing that minimally invasive cryoablation procedures with our flagship ProSense® system have resulted in an improved patient experience with excellent medical outcomes. This new cryoprobe technology, which is integrated in our next-generation XSense™ system, further reduces any potential risk of tissue trauma as the cryoprobe is extracted from the patient at the end of the short, minimally invasive outpatient procedure."
This invention introduces a novel method for safely and efficiently extracting the cryoprobe after tissue freezing during cryoablation procedures. The cryoprobe's tip is integrated with a heater, temperature sensor, and controlled gas pulses, enabling precise estimation and management of the cryoprobe's external surface temperature—even while embedded in frozen tissue. Designed to be compatible with a wide range of XSense™ system cryoprobe types, the new cryoprobe technology is a versatile solution for multiple clinical scenarios.
midastouch017
9月前
Cancer Immunotherapy Surge Drives $258B Market as FDA Accelerates Approvals
IceCure Medical Ltd. (NASDAQ: ICCM) has received regulatory approval from Israel's Ministry of Health for its next-generation XSense™ cryoablation system across multiple oncology indications, including breast cancer treatment. The approval encompasses general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology applications. XSense™ had previously received FDA clearance in mid-2024 for all indications approved for the company's flagship ProSense® system.
"We believe that this latest regulatory approval for our next-generation cryoablation system reaffirms IceCure's leadership position in liquid-nitrogen based cryoablation," said Eyal Shamir, CEO of IceCure Medical. "The minimally invasive cryoablation option that we offer across a broad range of indications can de-escalate cancer care, reduce treatment costs for payers, and accelerate recovery time for patients."
The XSense™ platform technology provides minimally invasive tumor destruction by freezing, targeting benign and cancerous lesions in breast, kidney, lung, and liver applications. IceCure's liquid-nitrogen-based systems offer a transportable design enabling office-based procedures for breast tumors with reduced surgical risks and complications.
midastouch017
9月前
IceCure Receives Regulatory Approval in Israel for its Next-Generation XSense™ Cryoablation System for Breast Cancer and Other Indications
https://finance.yahoo.com/news/icecure-receives-regulatory-approval-israel-123000831.html
Approved for a broad range of indications including in gynecology, oncology and general surgery
CAESAREA, Israel, Sept. 15, 2025 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced it has received regulatory approval from the Medical Device Division of Israel's Ministry of Health ("AMAR") for its next-generation single cryoprobe cryoablation system, the XSense™ System and CryoProbes.
As of mid-2024, XSense™ and its cryoprobes have also received regulatory clearance in the United States from the U.S. Food and Drug Administration ("FDA") for all of the indications for which ProSense®, the Company's flagship cryoablation system, has already received from the FDA.
"We believe that this latest regulatory approval for our next-generation cryoablation system reaffirms IceCure's leadership position in liquid-nitrogen based cryoablation," stated IceCure's Chief Executive Officer, Eyal Shamir. "The minimally invasive cryoablation option that we offer across a broad range of indications can de-escalate cancer care, reduce treatment costs for payers, and accelerate recovery time for patients."
"We are particularly pleased with the breast cancer indication approval in Israel, as we believe the growing body of evidence on cryoablation as a minimally invasive option for breast cancer supports accelerated commercial adoption," Shamir added.
XSense™ is now approved in Israel for all indications for which ProSense® has already received approval in Israel, including general surgery, dermatology, neurology, including cryoanalgesia, thoracic surgery, ENT (ear, nose, throat), gynecology, oncology (including benign and malignant breast tumors), proctology and urology.