Icecure Medical Ltd

IceCure Medical Ltd. is a commercial stage medical device company. It is engaged in the research, development, and marketing of cryoablation systems, disposables, and technologies based on liquid nitrogen for treating tumors. The company was founded in 2006 and is headquartered in Caesarea, Israel.

Earnings data Q1 2024

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IceCure Medical Ltd. engages in the development and marketing of therapy for the treatment of tumors. Its product, ProSense Cryoablation System, provides invasive treatment option to destroy tumors by freezing them. The company was founded in 2006 and is headquartered in Caesarea, Israel.

IceCure Medical (ICCM) submits final ICE data along with multiple sub-analysis to the FDA seeking approval for marketing authorization for treating early-stage breast cancer.

IceCure Medical (ICCM) Submits Final Cryoablation Data to FDA

Data presentation at highly influential American Society of Breast Surgeons ("ASBrS") Annual Meeting by Dr. Richard Fine wins Scientific Impact Award as voted by breast surgeons  President-Elect of the ASBrS, Dr. Michael Berry, presents data and states "cryoablation is ready for prime time"  Company seeks indication for treating women with early stage T1 invasive breast cancer with adjuvant hormone therapy  Available reimbursement code for facility expense expected to enhance usage upon receiving marketing authorization Minimally-invasive ProSense® cryoablation offers highly favorable healthcare economics  CAESAREA, Israel , April 15, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, announced today that it has submitted final data to the U.S. Food and Drug Administration ("FDA") requesting marketing authorization for ProSense® for the indication of treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy.

IceCure Medical Reports Final ICE3 Breast Cancer Cryoablation Trial Results of 100% Patient and Physician Satisfaction and 96.3% Recurrence Free Rate: Data Submitted to FDA Requesting Marketing Authorization to Treat Early-Stage Breast Cancer

IceCure Medical Ltd. (NASDAQ:ICCM ) Q4 2023 Earnings Conference Call April 3, 2024 10:00 AM ET Company Participants Michael Polyviou - EVC Group, Investor Relations Eyal Shamir - Chief Executive Officer Shad Wood - VP of Sales, North American Tlalit Bussi Tel-Tzure - VP of Business Development and Global Marketing Ronen Tsimerman - Chief Financial Officer and Chief Operating Officer Conference Call Participants Kemp Dolliver - Brookline Capital Markets Yi Che - H.C.

IceCure Medical Ltd. (ICCM) Q4 2023 Earnings Call Transcript

Conference call to be held today at 10:00 am Eastern Time; Focus on U.S. market for ProSense® in breast cancer indication CAESAREA, Israel , April 3, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today reported sales as of and for the twelve months ended December 31, 2023 increased 26% compared to the twelve months ended December 31, 2022, as the Company continues to transition from a research and development and clinical phase company to a commercial phase company.

IceCure Medical Reports Full Year 2023 Financial Results: Global ProSense® and Disposables Sales Increase 26% as Company Continues Transition to Commercial Phase and Expects to Submit ICE3 Breast Cancer Study Data to FDA this Month for Marketing Clearance

Continuous innovation as a global leader in minimally invasive liquid-nitrogen based cryoablation systems CAESAREA, Israel , April 2, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has filed a 510(k) submission with the United States Food and Drug Administration ("FDA") for clearance of its next-generation single probe cryoablation system, the XSense™ System and cryoprobes.

IceCure Submits FDA Regulatory Filing for New XSense™ Cryoablation System with Cryoprobes

Overview of U.S. Commercial Strategy will be Discussed on Conference Call CAESAREA, Israel , March 27, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), 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 it will issue a press release with its financial and operational results as of and for the twelve months ended December 31, 2023 before the Nasdaq Stock Market opens on Wednesday, April 3, 2024.

IceCure Medical to Report 2023 Full Year Financial & Operational Results on April 3, 2024

Expects to submit full dataset to the FDA in April for marketing authorization of ProSense® for minimally invasive treatment of early-stage breast cancer Study represents largest cryoablation study of its kind in the U.S. for early-stage low-risk malignant breast tumors CAESAREA, Israel , March 19, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced positive topline results from the Company's ICE3 study, the largest controlled multicenter clinical trial ever performed for liquid nitrogen (LN2) based cryoablation of low-risk, early-stage malignant breast tumors, following the 5-year follow-up evaluation of the ICE3 study's last patient.

IceCure Medical Reports Positive Topline Results From ICE3 Cryoablation Breast Cancer Study: Achievement of 96.39% Recurrence Free Rate Brings Company One Step Closer to Providing Women a Non-Surgical Alternative to Lumpectomy

Innovating as a global leader in cryoablation technologies, with 42 patents issued and allowed Cryogenic flow control enhances the efficacy and precision of cryoablation procedures CAESAREA, Israel , March 12, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumo rs by freezing as an alternative to surgical tumor removal, today announced it has received a Notice of Allowance from the Japan Patent Office (the "JPO") for its patent application titled "Cryogen Flow Control".

IceCure Receives Notice of Patent Allowance in Japan for a Novel Cryogen Flow Control to Optimize Patient Outcomes

CAESAREA, Israel , March 7, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), 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 the Company's Chief Executive Officer, Eyal Shamir, will present at the 34th Annual Oppenheimer Healthcare MedTech & Services Conference on Tuesday, March 12, 2024, at 8:00am EST.

IceCure Medical to Present at 34th Annual Oppenheimer Healthcare MedTech & Services Conference

MRI reveals disappearance of hemorrhagic signal and development of necrotic changes Pain reduced from a median of 7 on a scale of 0 - 10 to a median of 1, with some patients reporting 0   CAESAREA, Israel , March 4, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), 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 results from an independent study conducted at University Hospital, Nimes, France, titled "BEYOND PAIN: Cryoablation of endometriotic nodules using liquid nitrogen" were presented at the European Congress of Radiology ("ECR") 2024 in Vienna, Austria on February 29, 2024.

IceCure's ProSense® a Promising Alternative Treatment for Extra-Pelvis Endometriosis: Independent Study Presented at ECR 2024

Session conducted by Dr. Rupa Renganathan, who performed India's first breast cancer cryoablation procedure with ProSense®; Expert interview with Dr. Hania Bednarski, who has performed cryoablation breast procedures since 2014 CAESAREA, Israel , Feb. 27, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced ProSense® was featured in a number of sessions, including one titled "Minimal access imaging guided therapies: cryoablative therapies in breast pathologies," at the fourth Breast Imaging & Interventional Techniques (BRIIT) conference at Tata Memorial Centre in Mumbai, India on February 24, 2024.

Fourth BRIIT Conference in India Features IceCure's ProSense® in Breast Cancer Imaging & Interventions Workshop

Independent study in women deemed inoperable for breast cancer reports median tumor reduction of 100% at 6 and 12 months following cryoablation CAESAREA, Israel , Feb. 26, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced new data from a preliminary, independent breast cancer study conducted by Principal Investigator and ProSense® user, Dr. Federica.

Study Using IceCure's ProSense® Treatment Results in 100% Tumor Reduction in Early-Stage Breast Cancer

CAESAREA, Israel , Feb. 15, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced Eisuke Fukuma, MD, PhD, who has performed over 600 breast cryoablation procedures with ProSense®, will host events that feature ProSense® at two upcoming medical conferences in Japan.

IceCure's ProSense® to be Featured at Two Upcoming Medical Conferences in Japan

IceCure to submit full 5-year dataset from entire ICE3 study population to the FDA this spring, ahead of previous expectation CAESAREA, Israel , Jan. 30, 2024 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a 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 ("FDA") has responded affirmatively to the Company's request for supervisory review ("Appeal") under 21 CFR 10.75 regarding the FDA's prior denial of IceCure's De Novo Classification Request for treating patients with early-stage, low risk breast cancer.

U.S. FDA Grants IceCure Medical's Appeal: Reopens De Novo Classification Request for Marketing Authorization of ProSense® for Early-Stage Breast Cancer

IceCure exhibits and provides hands-on demonstrations at SIO 2024 Annual Meeting in California, receiving enthusiastic response from interventional oncologists ICE3 trial data were central to the Breast Cryoablation Master Class taught by several ProSense® users, including Dr. Tomkovich, ICE3's Co-  Principal Investigator, and Dr. Fine, ICE3 Investigator who has treated numerous participants CAESAREA, Israel , Jan. 29, 2024 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the Company is exhibiting and conducting hands-on ProSense® demonstrations at the Society of Interventional Oncology's ("SIO") Annual Scientific Meeting which takes place from January 25-29, 2024 in Long Beach, California.

IceCure Medical's Breast Cryoablation Gains Prominence in the U.S., as Society of Interventional Oncology Annual Meeting Features its First Breast Cryoablation Master Class

ProSense® users speaking at the conference about cryoablation included ISVIR President Dr. Suyash Kulkarni, as well as Dr. Shuvro Roy-Choudhury CAESAREA, Israel , Jan. 16, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), 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 it participated at the Indian Society of Vascular and Interventional Radiology (ISVIR) 24th Annual Conference in Jaipur, India that took place from January 11 th-14th, 2024.

IceCure Medical's ProSense® Featured at Indian Society of Vascular and Interventional Radiology Conference: Key Opinion Leaders Highlight Benefits of Cryoablation

CAESAREA, Israel, Jan. 12, 2024 (GLOBE NEWSWIRE) -- IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure” or the “Company”), 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 it has received a written notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with the minimum bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2), which requires listed securities, including the Company's ordinary shares, to maintain a minimum bid price of $1.00 per share.

IceCure Medical Regains Compliance with Nasdaq Minimum Closing Bid Price Rule

U.S. sales continue to increase with 25% jump in ProSense® system and disposable probe sales in 2023 over prior year ICE3 study is set for completion and final data read out CAESAREA, Israel , Jan. 10, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today issued the following letter to its shareholders from its Chief Executive Officer, Eyal Shamir.

IceCure Medical CEO Issues Letter to Shareholders & Reports Increase in Sales in Preliminary Unaudited 2023 Results

Independent mouse study conducted at Case Western Reserve University School of Medicine, published in OncoImmunology, builds on body of evidence demonstrating cryoablation can activate the body's natural immune response by enhancing CD8+ T cells, which are an important arm of immune response Data support previous studies and suggest ProSense® may produce anti-cancer benefits in humans beyond tumor destruction during cryoablation procedure CAESAREA, Israel , Jan. 3, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: 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 the publication of a study titled "Piezo1 facilitates optimal T cell activation during tumor challenge" in the highly influential peer-reviewed journal OncoImmunology.

New Study Reports IceCure's ProSense® Boosts Immune Response Against Cancer: Enhances CD8+ T Cell Response

Independent study published in Annals of Surgical Oncology concludes cryoablation is   an oncologically safe and feasible minimally invasive procedure option in lieu of surgery for patients with early-stage, low-risk breast cancer Study's authors suggest the widespread use of screening mammography allows for earlier detection - and therefore increased customization of treatment, less aggressive management, reduced treatment burden, improved quality of life - and examines cryoablation as the "next step in the surgical de-escalation of breast cancer" Study suggests that cryoablation provides a significantly superior alternative when it comes to financial implications, as compared to surgical resection CAESAREA, Israel , Dec. 13, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: 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 the publication of a study titled "Cryoablation Allows the Ultimate De-escalation of Surgical Therapy for Select Breast Cancer Patients" in the peer-reviewed journal Annals of Surgical Oncology.

Study Using IceCure's ProSense® Finds: "Cryoablation Allows the Ultimate De-escalation of Surgical Therapy for Select Breast Cancer Patients"

ProSense® is already marketed and sold in India based on previous regulatory requirements and now has been re-classified due to new regulations Breast cancer cryoablation is already performed in India with ProSense® CAESAREA, Israel , Nov. 29, 2023 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), 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 the Central Drugs Standard Control Organization ("CDSCO") in India has granted approval for the ProSense® system based on the CDSCO's updated regulatory requirements.

IceCure's ProSense® Deepens Regulatory Approval in India

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5 Investors Betting Big on IceCure Medical (ICCM) Stock

Independent study concluded: - IceCure system offers significant advantage in ability to re-treat tumors that are initially resistant, achieving a subsequent local control rate of 100% - 92.4% of patients (N= 24) were discharged the day after cyroablation - The technology's ability to preserve renal function post-treatment is paramount for patients' quality of life - Findings serve as a guide for medical professionals in choosing efficient, cost-effective, and patient-friendly treatment options, thereby benefiting society at large by optimizing kidney tumor management Success across multiple indications supports ProSense®'s commercialization, particularly in facilities that can use one device across multiple specialties CAESAREA, Israel , Nov. 28, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: 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 the latest release of a study (the "Study") in a series of independent studies of ProSense® published in peer-reviewed journals demonstrating safety and efficacy.

IceCure System Successfully Treated Kidney Cancer Tumor with 92% Disease-Free Survival Rate and 100% Secondary Local Control Rate

IceCure Medical Ltd. (NASDAQ:ICCM ) Q3 2023 Earnings Conference Call November 15, 2023 10:00 AM ET Company Participants Michael Polyviou - EVC Group, Investor Relations Eyal Shamir - Chief Executive Officer Ronen Tsimerman - Chief Financial Officer and Chief Operating Officer Shay Levav - VP of Regulatory Affairs, Quality Assurance & Clinical Applications Tlalit Bussi Tel-Tzure - VP of Business Development and Global Marketing Conference Call Participants Anthony Vendetti - Maxim Group Ben Haynor - Alliance Global Partner Kemp Dolliver - Brookline Capital Markets Yi Chen - H.C.

IceCure Medical Ltd (ICCM) Q3 2023 Earnings Call Transcript

IceCure Medical Ltd. (ICCM) came out with a quarterly loss of $0.09 per share in line with the Zacks Consensus Estimate.

News for Icecure Medical Ltd Stock (ICCM)