ICE3

Independent Study Results in Japan Demonstrate Zero (0%) Breast Cancer Local Recurrence 5 Years Following Treatment with IceCure's ProSense®, Adding to Continued Positive Data Published Globally

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星期二, 五月 7, 2024
Cryoablation, Cancer, Safety, Breast cancer, Woman, Freezing, Recurrence, Life, Patient, Neoplasm, Hospital, Patient satisfaction, ICE3, Quality of life, Medical imaging

The Study was led by Dr. Hisanori Kawamoto, M.D., Ph.D. from the Department of Breast Surgery, Breast and Imaging Center at St. Marianna University School of Medicine in Japan.

Key Points: 
  • The Study was led by Dr. Hisanori Kawamoto, M.D., Ph.D. from the Department of Breast Surgery, Breast and Imaging Center at St. Marianna University School of Medicine in Japan.
  • The authors of the Study refer to recent trials, including IceCure's ICE3 trial, for evidence that cryoablation results in local cancer control rates comparable to lumpectomies in early-stage breast cancer patients.
  • We are very pleased with these results and are hopeful that ProSense® may become a favored option in Japan upon regulatory approval for early-stage breast cancer."
  • Terumo Corporation owns the exclusive distribution rights for ProSense® in Japan for a 5-year term following regulatory approval.

As Early-Onset Breast Cancer Cases Soar in North America and EU, Biotech Ramps Up Response

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星期二, 四月 30, 2024
FDA, Pancreatic cancer, News, Breast, Fulvestrant, Fast track (FDA), ONC, MBC, PFE, Classification, ICE3, Breast cancer, Paclitaxel, Learning, Kidney, Woman, Economics, Hand, Traction, TSX, Optimism, Eli Lilly and Company, Patient satisfaction, Proteolysis, Freezing, Survival, NEO, Marketing, Clinical trial, CDK, University, Progression-free survival, Recurrence, Disease, Chimera, Patient, Liver, Neoplasm, Type, Growth, Pharmaceutical industry

VANCOUVER, BC, April 30, 2024 /PRNewswire/ -- USA News Group – An alarming rise in early-onset cancers has medical experts very concerned, as cancer cases in younger people are rising sharply. In particular, a surge in cases of breast cancer is being witnessed in Canada, the USA, and the EU, with extra concern to patients thought to be in remission contracting breast cancer a second time, according to a new study from the University of Cambridge. However, there's still optimism towards new treatments, and significant growth of 9.3% CAGR in the metastatic HR+/HER2- breast cancer market through 2032 has treatment developers working harder to make gains for patients. Among the biotech companies currently making strides are Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), IceCure Medical Ltd (NASDAQ: ICCM), Atossa Therapeutics, Inc. (NASDAQ: ATOS), Arvinas, Inc. (NASDAQ: ARVN), and Pfizer Inc. (NYSE: PFE) (NEO: PFE).

Key Points: 
  • Recently, Oncolytics announced that they had submitted a Type C meeting request to the FDA to discuss a forthcoming trial for pelareorep aimed at treating HR+/HER2- metastatic breast cancer (mBC) patients.
  • "A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.
  • The company looks forward to meeting with the FDA in Q2 2024 to finalize the trial design and goals for using pelareorep in treating metastatic breast cancer.

As Early-Onset Breast Cancer Cases Soar in North America and EU, Biotech Ramps Up Response

Retrieved on: 
星期二, 四月 30, 2024
FDA, Pancreatic cancer, News, Breast, Fulvestrant, Fast track (FDA), ONC, MBC, PFE, Classification, ICE3, Breast cancer, Paclitaxel, Learning, Kidney, Woman, Economics, Hand, Traction, TSX, Optimism, Eli Lilly and Company, Patient satisfaction, Proteolysis, Freezing, Survival, NEO, Marketing, Clinical trial, CDK, University, Progression-free survival, Recurrence, Disease, Chimera, Patient, Liver, Neoplasm, Type, Growth, Pharmaceutical industry

VANCOUVER, BC, April 30, 2024 /PRNewswire/ -- USA News Group – An alarming rise in early-onset cancers has medical experts very concerned, as cancer cases in younger people are rising sharply. In particular, a surge in cases of breast cancer is being witnessed in Canada, the USA, and the EU, with extra concern to patients thought to be in remission contracting breast cancer a second time, according to a new study from the University of Cambridge. However, there's still optimism towards new treatments, and significant growth of 9.3% CAGR in the metastatic HR+/HER2- breast cancer market through 2032 has treatment developers working harder to make gains for patients. Among the biotech companies currently making strides are Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), IceCure Medical Ltd (NASDAQ: ICCM), Atossa Therapeutics, Inc. (NASDAQ: ATOS), Arvinas, Inc. (NASDAQ: ARVN), and Pfizer Inc. (NYSE: PFE) (NEO: PFE).

Key Points: 
  • Recently, Oncolytics announced that they had submitted a Type C meeting request to the FDA to discuss a forthcoming trial for pelareorep aimed at treating HR+/HER2- metastatic breast cancer (mBC) patients.
  • "A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.
  • The company looks forward to meeting with the FDA in Q2 2024 to finalize the trial design and goals for using pelareorep in treating metastatic breast cancer.

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

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星期一, 四月 15, 2024
Luminal, Cryoablation, FDA, CMS, Kidney, Meta-analysis, LUMINA, Risk, Woman, Food, Economics, Freezing, Marketing, Recurrence, Breast, PRISMA, Patient, Liver, LN2, CPT, Society, Classification, Physician, Medicare, Neoplasm, Patient satisfaction, Clinical trial, Annual general meeting, ICE3, Breast cancer, Birth control

The ICE3 study was the largest controlled multicenter clinical trial ever performed for liquid nitrogen (LN2) based cryoablation of low-risk, early-stage malignant breast tumors.

Key Points: 
  • The ICE3 study was the largest controlled multicenter clinical trial ever performed for liquid nitrogen (LN2) based cryoablation of low-risk, early-stage malignant breast tumors.
  • ICE3 results are also in line with data from real-world use of ProSense® by third parties in territories where IceCure's cryoablation system is used to treat early-stage breast cancer.
  • Driven by favorable healthcare economics combined with patient satisfaction and demand, we expect rapid adoption pending FDA granting the DeNovo Classification Request for Marketing Approval."
  • Dr. Fine gave an oral presentation titled "Cryoablation Without Excision for Early-Stage Breast Cancer; ICE3 Trial 5 year follow up on Ipsilateral Breast Tumor Recurrence."

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

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星期三, 四月 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

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星期二, 三月 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

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星期四, 三月 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: 
星期二, 一月 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

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星期一, 一月 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

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星期三, 一月 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.