ICE3

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

Retrieved on: 
Wednesday, April 3, 2024
Momentum, Patient, History, Sale, IP, Endometriosis, Depreciation, USD, Marketing, Regulation, Research, Classification, Webcast, Freezing, Woman, Breast cancer, ICE3, Food, Case Western Reserve University, Neoplasm, Cancer, LN2, GAAP, FDA, Annual general meeting, Health, Conference call, Growth, The Twelve Months, Recurrence, Society, Patent, Physician, Kidney cancer

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.

Key Points: 
  • Our U.S. commercial team is ready to launch marketing and distribution of ProSense® for breast cancer as we await the U.S. Food and Drug Administration's ("FDA") decision.
  • Should the FDA grant clearance, we believe this decision would further boost commercial demand in global markets where ProSense® already has approval for breast cancer."
  • "As we increased our commercial activities through medical conferences and added more distributors, we had a corresponding growth in 2023 revenues, system, and probe sales.
  • The FDA requested this data as part of IceCure's De Novo Classification Request for Marketing Authorization of ProSense® for the treatment of early-stage low-risk breast cancer.

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

Retrieved on: 
Tuesday, March 19, 2024
Classification, Patient, Neoplasm, LN2, Freezing, Marketing, Woman, Safety, ICE3, FDA, Food

In the ICE3 study, 96.39% of patients (187 out of 194 patients) were local recurrence-free with no significant device-related adverse events or complications reported.

Key Points: 
  • In the ICE3 study, 96.39% of patients (187 out of 194 patients) were local recurrence-free with no significant device-related adverse events or complications reported.
  • Based on the strength of the topline results, ProSense has the potential to be a safe and effective alternative to lumpectomy for early-stage breast cancer.
  • "We are very pleased with this topline outcome and believe these results demonstrate a highly favorable safety and efficacy profile that positions ProSense® as a desirable alternative to lumpectomy for early-stage breast cancer.
  • "On behalf of the entire IceCure team, I thank the patients, their families, the sites and the clinicians for taking part in this landmark study.

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

Retrieved on: 
Thursday, March 7, 2024
Classification, Breast cancer, ICE3, LINK, Neoplasm, FDA, Cryoablation, Food, Freezing, Conference, Medtech, Patient, Research

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.

Key Points: 
  • 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.
  • Investors may view the presentation at the virtual conference through the following LINK live and for 180 days following conference.
  • Mr. Shamir will provide an update on IceCure's latest developments including the Company's ICE3 breast cancer trial with its pending De Novo Classification Request with the U.S. Food and Drug Administration ("FDA") for marketing clearance of ProSense® for the treatment of patients with early-stage, low-risk breast cancer as well as ProSense®'s increasing global commercial reach and the growing body of independent research on the efficacy of cryoablation.

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

Retrieved on: 
Tuesday, January 30, 2024
Classification, Woman, Neoplasm, Patient, LUMINA, Breast cancer, Freezing, Luminal, Risk, Recurrence, De novo, Food, CFR, FDA, ICE3, Data, LN2, Pharmaceutical industry

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.

Key Points: 
  • The FDA determined there is sufficient basis to reopen the De Novo file and requested IceCure to submit the full 5-year dataset from the Company's ICE3 trial.
  • The final ICE3 study patient is expected to complete her 5-year follow up examination by the end of February 2024.
  • Additionally, the FDA requested that IceCure submit an analysis of the ICE3 results compared with data from the LUMINA study.
  • A full peer-reviewed article on LUMINA results was published in August 2023, while FDA review of IceCure's De Novo request was underway.

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

Retrieved on: 
Monday, January 29, 2024
Surgical oncology, Neoplasm, CentraState Medical Center, Breast imaging, SIO, DRS, Interventional radiology, Society, Breast cancer, Freezing, Oncology, Principal investigator, Education, ICE3, Radiation, Interventional oncology, Master Class, Physician, Medical imaging

This year's SIO meeting featured an educational event, Breast Cryoablation Master Class , the first of its kind by a radiology society.

Key Points: 
  • This year's SIO meeting featured an educational event, Breast Cryoablation Master Class , the first of its kind by a radiology society.
  • Interventional oncologists attending the half-day course learned from multidisciplinary experts in breast imaging, breast surgery, interventional radiology, surgical oncology, medical oncology, and radiation oncology.
  • A literature review of notable studies for breast cryoablation was presented, primarily including interim data from IceCure's ICE3 breast cancer cryoablation study, which demonstrated a 96.91% recurrence free rate.
  • Dr. Tomkovich commented, "The Master Class, which was filled to capacity, included interventional oncologists and breast radiologists seeking education to build a successful breast cryoablation program.

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

Retrieved on: 
Wednesday, January 10, 2024
Distributor, Hope, Woman, Neoplasm, Patient, Endometriosis, Kidney, Neurology, Breast cancer, Malignancy, Freezing, Society, Classification, De novo, Food, Fibroadenoma, Medication, Liver, FDA, CME, Cryoablation, ICE3, Letter, Physician, Human, Lung, Annual general meeting, Kidney cancer, Cryotherapy, Growth, Pharmaceutical industry

Increased Revenues, System, and Probe Sales: Based on our expected preliminary unaudited 2023 results, ProSense® system and disposable probe sales increased by 26% globally over 2022.

Key Points: 
  • Increased Revenues, System, and Probe Sales: Based on our expected preliminary unaudited 2023 results, ProSense® system and disposable probe sales increased by 26% globally over 2022.
  • On a preliminary unaudited basis, as of December 31, 2023, we had cash and cash equivalents, including short-term deposits, of $11 million.
  • The above information reflects preliminary unaudited estimates with respect to certain results of IceCure for the full year ended December 31, 2023, based on currently available information.
  • Because the audit for 2023 is not yet complete, the Company's final results may vary from the preliminary estimates provided herein.

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

Retrieved on: 
Wednesday, December 13, 2023
School, Woman, Ultimate, Cryoablation, Freezing, Study, Surgery, Breast cancer, Surgical oncology, Patient, Mammography, Breast, Neoplasm, Annals of Surgical Oncology, Quality of life, Life, ICE3, Medical imaging, Pharmaceutical industry

A total of 32 early-stage breast cancer patients with a median age of 70 (range of 50-91) were treated with cryoablation.

Key Points: 
  • A total of 32 early-stage breast cancer patients with a median age of 70 (range of 50-91) were treated with cryoablation.
  • Six of the 32 patients (18.5%) received adjuvant radiation, and 31 of 32 patients (97%) received adjuvant endocrine therapy.
  • The mean follow-up was 15 months, with 20 patients (62.5%) completing two years, and 12 patients (37.5%) completing more than three years.
  • Stated study co-author, Dr. Rakhshanda Layeequr Rahman
    "This independent study is quite compelling in that it goes beyond providing data.

IceCure's ProSense® Deepens Regulatory Approval in India

Retrieved on: 
Wednesday, November 29, 2023
Lung, Breast, Freezing, Liver, Tissue, Novomer, Traction, Hospital, Breast cancer, Kidney, CDSCO, Neoplasm, Conference, Trial of the century, Partnership, Growth, General surgery, ICE3

ProSense® was previously marketed and sold in India in accordance with prior regulatory requirements.

Key Points: 
  • ProSense® was previously marketed and sold in India in accordance with prior regulatory requirements.
  • This latest approval, granted in November 2023, confirms that ProSense® meets all updated regulatory requirements in India.
  • The first breast cancer cryoablation procedure in India was conducted using ProSense® in June of 2023, at the Kovai Medical Center and Hospital in Coimbatore.
  • "India is a very important market for us because we see the potential for significant growth with safe, effective, and cost-efficient technologies rapidly adopted.

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

Retrieved on: 
Wednesday, November 15, 2023
Lung, Woman, CIRSE, Freezing, Patient, Participation, Research, Kidney, Marketing, Neoplasm, Conference, Congress, System, ICE3, Hamas, Webcast, Safety, Food, Luminate (company), European Society of Radiology, Conference call, ANVISA, Health, Breast, Cryoablation, Breast cancer, Kidney cancer, Nine Months, Classification, Brazilian Health Regulatory Agency, Prostate, Health Canada, De novo, Circulatory system, Liver, Novomer, Episcopal conference, FDA, Cancer Diagnostic Probe, Medical device, Pharmaceutical industry, Nursing, Medical imaging, Birth control, Cryptocurrency, Broadcasting, Luminal

Gross profit was $0.73 million for the nine months ended September 30, 2023, compared to $0.98 million for the nine months ended September 30, 2022.

Key Points: 
  • Gross profit was $0.73 million for the nine months ended September 30, 2023, compared to $0.98 million for the nine months ended September 30, 2022.
  • Gross margin was 37% for the nine months ended September 30, 2023, compared to 46% for the nine months ended September 30, 2022.
  • Research and development expenses for the nine months ended September 30, 2023, were $6.39 million compared to $6.89 million for the nine months ended September 30, 2022.
  • Total operating expenses for the nine months ended September 30, 2023, were $12.89 million, compared to $13.79 million for the nine months ended September 30, 2022.

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

Retrieved on: 
Wednesday, November 15, 2023
Classification, Woman, Genta (company), De novo, Food, Luminal, Freezing, CFR, Breast cancer, Patient, European, FDA, Marketing, Neoplasm, ICE3, Medical device, Pharmaceutical industry

IceCure filed the De Novo request with the FDA in October 2022 based on interim data from its ICE3 breast cancer study for the Breakthrough Indication of early-stage (Luminal A T1 invasive) low-risk breast cancer patients.

Key Points: 
  • IceCure filed the De Novo request with the FDA in October 2022 based on interim data from its ICE3 breast cancer study for the Breakthrough Indication of early-stage (Luminal A T1 invasive) low-risk breast cancer patients.
  • On September 20, 2023, IceCure announced that the FDA denied its De Novo request.
  • Per the FDA's guidelines, IceCure expects a response to its appeal by the end of January 2024.
  • Outside of the U.S., ProSense® is approved for early-stage breast cancer in numerous countries, including in the European Union, Brazil, and China.