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 2023

Earnings data Q2 2023

Earnings data Q3 2023

Earnings data Q4 2023

Earnings data Q1 2024

Earnings data Q2 2024

Earnings data Q3 2024

Earnings data Q4 2024

Icecure Medical reports revenue growth and regulatory milestones in Q1

Icecure Medical Ltd (ICCM) demonstrated strong revenue growth and regulatory progress in Q1 2024, despite a net loss, reflecting a resilient business outlook.
The company's focus on product development, market acceptance, and strategic planning underscores a commitment to long-term success and sustainability.
Addressing cost management, optimizing pricing strategies, and seizing market opportunities will be crucial for Icecure to enhance profitability and drive growth.

Icecure Medical reports robust Q2 sales growth and FDA progress

Icecure Medical's Q2 2024 performance showcased strong sales growth and improved financial metrics.
While facing challenges such as regulatory processes and leadership continuity, the company's strengths lie in its product acceptance and fundraising success.
Opportunities in FDA approvals and market expansion present avenues for future growth and profitability for Icecure Medical.

Icecure Medical reports robust Q3 results, eyes FDA decisions

Icecure Medical's Q3 2024 performance reflects strong financial growth, strategic market expansion, and a focus on regulatory milestones. With a robust cash position, the company is well-positioned to drive future innovation and commercialization efforts. Balancing priorities and seizing growth opportunities will be crucial for Icecure's continued success in the competitive healthcare landscape.

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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 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

ProSense® system and disposables sales continue upward trend compared to the equivalent prior year period Expanded regulatory footprint, growing body of evidenced-based data, and distribution agreements demonstrate an increasing acceptance of minimally invasive alternatives to standard of care cancer treatment ICE3 trial remains on track and expected to be completed in the first quarter of 2024 Conference call scheduled for today at 10 am EST CAESAREA, Israel , Nov. 15, 2023 /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 financial results as of and for the nine months ended September 30, 2023, as well as operational and recent corporate developments.

IceCure Medical Reports Financial Results as of and for the Nine Months Ended September 30, 2023, and Provides Update on Recent Operational Highlights

Objective is to reopen file to address comments and find appropriate comparator group that is more representative of the patient population the Company is seeking to treat with its ProSense® system Company seeks to complete the review process, establish special controls, and finalize classification of ProSense® CAESAREA, Israel , Nov. 15, 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 it has filed a request for supervisory review ("appeal") under 21 CFR 10.75 with the U.S. Food and Drug Administration ("FDA") regarding the agency's denial of the Company's De Novo Classification Request for treating patients with early-stage, low risk breast cancer.

IceCure Medical Files Appeal with U.S. FDA Requesting a Review of its De Novo Classification for ProSense® in Early-Stage Breast Cancer

CAESAREA, Israel , Nov. 8, 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 it will issue a press release with its financial and operational results as of and for the nine months ended September 30, 2023 before the Nasdaq Stock Market opens on Wednesday, November 15, 2023 and also discuss such results and other corporate developments on a conference call at 10:00 a.m.

IceCure Medical to Report Third Quarter 2023 Financial & Operational Results on November 15, 2023

Independent, non-sponsored studies by doctors using ProSense® to treat cancers of the breast, lung, kidney, and musculoskeletal system, as well as endometriosis and fibroadenomas Growing body of scientific data, including 13 breast cancer studies, is expected to drive adoption ProSense® is approved for various indications in 15 countries including the U.S., Canada, Europe, Brazil, and China CAESAREA, Israel , Nov. 6, 2023 /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 in parallel with the growing adoption of ProSense®, the number of independent, non-sponsored studies of its cryoablation system has significantly increased.

Substantial Evidence-Based Data Currently Being Generated by 19 Ongoing Studies Using IceCure Medical's ProSense® Cryoablation System

ICE3 trial will be finalized in Q1 2024 IceCure's distributor in India, Novomed, exhibited ProSense® and received a high level of interest from doctors, clinics, and hospitals ProSense was used to perform India's first breast cryoablation procedure in June 2023 CAESAREA, Israel , Oct. 30, 2023 /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 its participation in the 10th Annual Conference of the Breast Imaging Society of India (BISICON 2023) in conjunction with its in-country distributor, Novomed, from October 27-29, 2023.

IceCure's ICE3 Trial Results Demonstrating 96.91% Recurrence Free Rate Featured in a Presentation at BISICON 2023 in India

Paper cites IceCure's ICE3 interim clinical study results as evidence of safety and efficacy of cryoablation in early-stage breast cancer CAESAREA, Israel , Oct. 25, 2023 /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 a scientific paper titled "Cryoablation Therapy for Early-Stage Breast Cancer: Evidence and Rationale" was recently published in the Journal of Breast Imaging.

Independent Scientific Paper by Doctors Using IceCure's ProSense® Published in Journal of Breast Imaging Presents Advantages of Cryoablation Breast Conserving Over Surgery in Early Breast Cancer Patients

Disappearance of lesions and absence of residual malignant cells in Luminal-A group considered to be predictive for the complete effectiveness of the treatment This is the latest in a growing body of evidence presented by independent, non-sponsored doctors who use ProSense  CAESAREA, Israel , Oct. 5, 2023 /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 findings from an independent breast cancer study, performed by a leading radiologist in Italy, support the safety and efficacy of the Company's ProSense, a minimally-invasive cryoablation system.

Women Deemed Inoperable for Breast Cancer Benefitted from IceCure Medical's ProSense as an Independent Study Performed in Italy Showed a Tumor Reduction Rate of 93.43% to 96.81%

Study was conducted in Spain with women who declined standard of care surgery ProSense is approved for the treatment of breast cancer throughout the European Union CAESAREA, Israel , Oct. 2, 2023 /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 new data was presented at the European Society of Breast Imaging ("EUSOBI ") Scientific Meeting in Valencia, Spain by Lucía Graña-López, MD, PhD, principal investigator of the independent, non-sponsored study.

Independent Study Validates IceCure's ProSense Cryoablation is Safe & Effective Outpatient Procedure for Breast Cancer with 96.8% Success Rate

Growing body of evidence-based data is giving women a minimally invasive alternative to the standard of care lumpectomy Patients throughout the European Union have access to ProSense for the treatment of malignant and benign breast tumors CAESAREA, Israel , Sept. 22, 2023 /PRNewswire/ -- IceCure Medical Ltd.

Renowned Spanish Radiologist Lucía Graña-López to Present Data Using IceCure Medical's ProSense at European Society of Breast Imaging Scientific Meeting 2023

CAESAREA, Israel , Sept. 20, 2023 /PRNewswire/ -- IceCure Medical Ltd.

IceCure Medical Receives FDA Response to De Novo Classification Request for Breast Cancer

ProSense is gaining commercial traction in Europe where it has CE approval for numerous malignant and benign tissue indications. Symposium presenters include Professor Francois Cornelis who used ProSense in an endometriosis study which demonstrated cryoablation's efficacy rate of 92.8% in avoiding secondary surgery and Professor Julien Frandon who conducted a feasibility study of ProSense with positive results in kidney, bone, liver, lung, and soft tissue tumors.

IceCure Medical to Join Hands-On Cryoablation Session with ProSense and Host Symposium Led by Renowned Doctors at the CIRCE 2023 Annual Congress

$6.6 million in sales expected in Brazilian market over the next five years per distribution agreement guarantees High level of early interest in ProSense in South America's largest market CAESAREA, Israel , Sept. 5, 2023 /PRNewswire/ -- IceCure Medical Ltd.

IceCure Medical's ProSense Cryoablation System Receives Regulatory Approval in Brazil

Mr. Shad Good brings nearly 20 years of medical device sales and leadership experience, including as U.S. Senior Director of Sales at a global leader in minimally invasive breast diagnostic and therapeutic systems Immediate responsibility is to build out the sales infrastructure as the Company awaits the FDA response to its regulatory filing for early-stage low risk breast cancer in patients who are at high risk for surgery as well as the FDA's response to the final ICE3 results which are due in 2024 CAESAREA, Israel , Aug. 28, 2023 /PRNewswire/ -- IceCure Medical Ltd. ("IceCure" or the "Company") (NASDAQ: ICCM) developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, announced today the appointment of Mr.

IceCure Medical Takes Next Major Initiative as it Prepares to Accelerate the Commercialization of ProSense in U.S. and Canada: Appoints VP of Sales, North America

Terumo Corp

Professor Eisuke Fukuma, who has performed over 600 ProSense breast cancer cryoablation procedures, led a cryoablation symposium with ProSense IceCure joined its exclusive regional distributor, Terumo, to exhibit the ProSense System to physicians seeking minimally invasive alternatives to lumpectomy   CAESAREA, Israel , Aug. 21, 2023 /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, recently participated in the 16th Thai Breast Symposium in Bangkok, Thailand, which was hosted by the Thai Breast Surgeons Society.

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