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IL0011224156
State: 17.08.2024 | 11PM
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ICCM

IceCure Medical Ltd
GICS: - · Sector: Healthcare · Sub-Sector: Medical Devices
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IceCure Medical Ltd
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Mon, 13.01.2025       IceCure Medical

Increase in sales of ProSense®, based on preliminary unaudited results, demonstrate growing adoption of ProSense® cryoablation for breast tumors.FDA decision on market authorization of ProSense® for early-stage breast cancer is expected in the first quarter of 2025.FDA Advisory Panel voted in favor of ProSense®'s benefit-risk profile for early-stage low risk breast cancer.Positive ProSense® results reported through 10 peer-reviewed journals and 23 presentations at medical conferences.

CAESAREA, Israel, Jan. 13, 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 alternative to surgical tumor removal, today issued the following letter to shareholders from its Chief Executive Officer, Eyal Shamir.

Mon, 06.01.2025       IceCure Medical

CAESAREA, Israel, Jan. 6, 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 alternative to surgical tumor removal, today announced it has received a notification letter from Nasdaq Stock Market LLC ("Nasdaq") confirming that it has regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) (the "Rule").

Fri, 03.01.2025       IceCure Medical

XSense™ system's innovative cryogenic connector technology designed to improve safety and maintain the integrity of cryogen used in the cryoablation procedure

CAESAREA, Israel, Jan. 3, 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 alternative to surgical tumor removal, today announced it has received an Intention to Grant Notice from the European Patent Office for its invention titled "Cryogenic System Connector". This invention was recently granted a patent in the United States.

Mon, 16.12.2024       IceCure Medical

ICE3 trial results presented by ICE3 Co-Principal Investigator Dr. Kenneth TomkovichFDA Advisory Panel voted in favor of IceCure's ProSense® cryoablation benefit-risk profile in early-stage low risk breast cancer in Nov. 2025FDA's marketing authorization decision expected in Q1, 2025 

CAESAREA, Israel, Dec. 16, 2024 /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 alternative to surgical tumor removal, today announced that data from its ICE3 trial of ProSense's® in early-stage breast cancer were presented at the Radiological Society of North America's 2024 Annual Meeting on December 5, 2024 in Chicago, IL. The abstract titled "Cryoablation as a primary treatment for low-risk breast cancer less than 1.5 cm without surgical excision final results of the ICE3 Trial" was presented by Dr. Kenneth Tomkovich, co-principal investigator of the ICE3 trial.

Thu, 05.12.2024       IceCure Medical

Data confirm previous results showing that ProSense® cryoablation is highly effective for kidney tumors < 3 cm and a safe procedure for kidney tumors < 5 cm in people ineligible for surgery Interim results presented at the Israeli Urological Association Conference in Eilat, IsraelProSense® is approved for benign and malignant kidney tumors in the U.S., Europe and numerous other countries

CAESAREA, Israel, Dec. 5, 2024 /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 alternative to surgical tumor removal, today announced interim results from the Company's ICESECRET study of cryoablation for patients with small renal masses ('SRM') who cannot be offered kidney preserving surgery. Data were presented on December 5, 2024 at the Israeli Urological Association Conference in Eilat, Israel. The presentation titled 'Renal Mass Cryoablation - Interim Analysis of ICESECRET Study' was delivered by Dr. Keren Boguslavsky of Bnai Zion Medical Center.

Tue, 26.11.2024       IceCure Medical

FDA Marketing Authorization Decision on Early Stage-Low Risk Breast Cancer Expected in Q1 2025

Conference call to be held today at 10:00 am Eastern Time

CAESAREA, Israel, Nov. 26, 2024 /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 alternative to surgical tumor removal, today reported financial results as of and for the nine months ended September 30, 2024. Sales of ProSense® consoles and disposable probes increased by 36%. Gross profits increased by 41%, while non-GAAP gross profits grew by 104%. Gross margins increased to 43%, while non-GAAP gross margin increased to 40%, compared to 27% in the same period in 2023].

Mon, 25.11.2024       IceCure Medical

Invention facilitates treatment of larger tumors and is a significant leap forward in the field of cryoablation

CAESAREA, Israel, Nov. 25, 2024 /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 alternative to surgical tumor removal, today announced it has received a Notice of Allowance from the Japan Patent Office for its invention titled 'Cryogenic System with Multiple Submerged Pumps'.

Wed, 20.11.2024       IceCure Medical

CAESAREA, Israel, Nov. 20, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, announced today that it will issue a press release with its financial and operational results as of and for the nine months ended September 30, 2024 before the Nasdaq Stock Market opens on Tuesday, November 26, 2024. The Company will also discuss such results and other corporate developments on a conference call at 10:00 a.m. EST on the same day.

Tue, 19.11.2024       IceCure Medical

PRECICE study, financed by the Umberto Veronesi Foundation and the Italian Ministry of Health, is led by multidisciplinary collaborators including breast surgeons, interventional radiologists, and breast imaging and pathology specialists

PRECICE is exclusively using ProSense® to treat all 233 Luminal A and B patients >50 years of age with early-stage breast cancer, a wider population of patients than ICE3  

Article published in European Journal of Cancer Prevention describes the PRECICE study and presents the role of cryoablation in the move toward de-escalation of surgical treatment

Fri, 08.11.2024       IceCure Medical

FDA decision on marketing authorization expected in the first quarter of 2025

CAESAREA, Israel, Nov. 8, 2024 /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 alternative to surgical tumor removal, announced the U.S. Food and Drug Administration's ("FDA") Medical Device Advisory Committee Panel's (the "Advisory Panel") favorable recommendation with 9 panelists voting in favor and 5 voting against the benefit-risk profile of IceCure's ProSense®. The majority of panelists voted that the benefits of IceCure's ProSense® System outweigh the risks when used according to the proposed indications for the treatment of patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. Among those that voted "no", there were three who stated that if the FDA applied adequate special controls, this would have swayed their opinion in favor.

Tue, 29.10.2024       IceCure Medical

Comments from key stakeholders, including doctors, nurses, researchers, and breast cancer patients, are available on FDA websiteFDA Advisory Panel providing recommendations and vote on information concerning the benefit-risk profile for a De Novo marketing submission of the IceCure ProSense® Cryoablation System in early-stage low risk breast cancer scheduled for November 7, 2024

CAESAREA, Israel, Oct. 29, 2024 /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 alternative to surgical tumor removal, today announced that a large number of public comments have been posted from key stakeholders ahead of the U.S. Food and Drug Administration (the 'FDA') Medical Device Advisory Committee Panel (the 'Advisory Panel') for marketing authorization of ProSense® cryoablation in early-stage low risk breast cancer, which is scheduled to take place on Thursday, November 7, 2024. The purpose of the Advisory Panel is for the FDA to obtain independent expert advice on scientific, technical and policy matters related to the potential granting of marketing authorization of ProSense® for treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. The Advisory Panel will include breast surgeons, interventional radiologists, industry representatives from the regulatory community, and other experts.

Mon, 21.10.2024       IceCure Medical

Innovative cryogenic system connector technology designed to improve usability and maintain the integrity of cryogen used in the cryoablation procedure

CAESAREA, Israel, Oct. 21, 2024 /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 alternative to surgical tumor removal, today announced it has received a Notice of Allowance for its invention titled "Cryogenic System Connector" from the U.S. Patent and Trademark Office. This is the first global patent issued for the cryogenic system connector, a key component of IceCure's next-generation liquid nitrogen-based XSense™ cryoablation system. Several other patent applications for this technology are pending in key markets.

Mon, 07.10.2024       IceCure Medical

ICE3 trial results presentation by Co-Principal Investigator Dr. Kenneth Tomkovich wins EUSOBI 2024 Abstract Award THERMAC Trial on Treatment of Breast Cancer with Percutaneous Thermal Ablation (cryoablation, radiofrequency, and microwave) wins EUSOBI Young Physician Scientist Competition – cryoablation demonstrates 94% complete rate of ablation IceCure exhibited ProSense® and conducted hands-on demos and Q&A sessions with breast cryoablation experts Dr. Lucía Graña-López and Dr. Federica Di Naro
Tue, 24.09.2024       IceCure Medical

Publication comes ahead of the FDA Advisory Panel Meeting for Marketing Authorization of ProSense® in Early-Stage Low Risk Breast Cancer scheduled for November 7, 202496.3% recurrence free rate for women treated with ProSense® cryoablation and endocrine therapy; 100% of patients and treating physicians were satisfied with the cosmetic outcome.Lead study author, Dr. Richard E. Fine, is an ICE3 investigator and winner of the 2024 American Society of Breast Surgeons' Scientific Impact Award for his presentation of the ICE3 trial data.ProSense® offers women the choice of a quick minimally invasive in-office procedure under local anesthesia with minimal pain, minimal scarring and rapid recovery as compared to lumpectomy which involves full anesthesia and hours of surgery and recovery, followed by 1-2 weeks of limited movement.
Mon, 16.09.2024       IceCure Medical

Liquid nitrogen- (LN2) based ProSense® found to have favorable safety compared to argon-based cryoablation systems, as well as being more cost effective and easier to manageIndependent study conducted at the European Institute of Oncology (IEO) demonstrates interventional radiology use cases for ProSense® for indications that are approved in various markets across the world

CAESAREA, Israel, Sept. 16, 2024 /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 alternative to surgical tumor removal, today announced the publication of an independent study led by Dr. Franco Orsi, Director of Interventional Radiology at the European Institute of Oncology (IEO) in Milan, Italy and an expert ProSense® user. The study titled "Liquid Nitrogen-Based Cryoablation: Complication Rates for Lung, Bone, and Soft Tissue Tumors" was published by Oxford University Press on behalf of the British Institute of Radiology.

Thu, 12.09.2024       IceCure Medical

Public forum to evaluate ProSense® cryoablation as a minimally invasive alternative to lumpectomy for an estimated 70,000 women diagnosed in U.S. annually with early-stage low risk breast cancerFDA decision regarding marketing authorization of ProSense® expected by early 2025

CAESAREA, Israel, Sept. 12, 2024 /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 alternative to surgical tumor removal, today announced the U.S. Food and Drug Administration's ("FDA") Medical Device Advisory Committee Panel (the "Advisory Panel") is scheduled to take place on Thursday, November 7, 2024. The purpose of the Advisory Panel is for the FDA to obtain independent expert advice on scientific, technical and policy matters related to the De Novo Classification Request for marketing authorization of ProSense® for the indication of treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy.

Wed, 04.09.2024       IceCure Medical

Company presentation to focus on how IceCure's industry-leading ProSense® enables non-surgical treatment of benign and cancerous tumors and upcoming near-term regulatory and operating catalysts 

CAESAREA, Israel, Sept. 4, 2024 /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 alternative to surgical tumor removal, today announced that the Company's Chief Executive Officer, Eyal Shamir, will conduct one-on-one meetings with institutional investors at both the H.C. Wainwright and Lake Street Capital Markets conferences, while the Company's Chief Financial Officer and Chief Operating Officer, Ronen Tsimerman, will join the H.C. Wainwright meetings virtually.

Wed, 28.08.2024       IceCure Medical

Further broadens the uses and applications of IceCure's cryoablation platform into a wide range of technology fieldsOver 50 patents issued and allowed worldwide for IceCure's platform cryoablation technology

CAESAREA, Israel, Aug. 28, 2024 /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 alternative to surgical tumor removal, today announced it has received a Notice of Allowance from the U.S. Patent and Trademark Office ("USPTO") for a continuation application based on the Company's issued patent titled "Cryogen Pump". The original patent, which was also issued by the European Patent Office and the Japan Patent Office, as well as the continuation, will be in effect until 2041.

Tue, 20.08.2024       IceCure Medical

Near-term regulatory and operating catalysts have potential to accelerate adoption of ProSense® for treatment of early-stage, low risk breast cancer

Conference call to be held today at 10:00 am Eastern Time

CAESAREA, Israel, Aug. 20, 2024 /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 alternative to surgical tumor removal, today reported financial results as of and for the six months ended June 30, 2024.

Wed, 14.08.2024       IceCure Medical

After a median follow-up of 16 months, the complete ablation rate in Luminal A and B breast cancer tumors ≤ 25mm was 100%Study concluded that most non-surgical patients with early-stage breast cancer accepted cryoablation when the treatment was offered and that cryoablation is a safe, effective alternative to surgery and well-tolerated as an out-patient procedure 

CAESAREA, Israel, Aug. 14, 2024 /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 alternative to surgical tumor removal, today announced the publication of an independent study titled "Acceptance and results of cryoablation for the treatment of early breast cancer in non-surgical patients" in the British Journal of Radiology, a publication of the British Institute of Radiology. The single-site study, led by Lucia L. Garna Lopez, PhD, was conducted by researchers in the radiology, oncology, and surgery departments at Hospital Lucus Augusti in Lugo, Spain.

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