deut8-18
2 월 전
If anyone is interested in listening to meeting
Advisory Committee Meeting | In Person
November 7, 2024: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
November 7, 2024
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Meeting Information
Event Materials
Date:
November 7, 2024
Time:
9:00 AM - 6:00 PM ET
What is an advisory committee?
Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.
Webcast Information
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Paullee
2 월 전
8:39 AM EDT, October 29, 2024 (Benzinga Newswire)
Comments from key stakeholders, including doctors, nurses, researchers, and breast cancer patients, are available on FDA website
FDA 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.
TechandBio
3 월 전
IceCure initial addressable market for early stage is 70,000 breast cancer patients per year in the US.
Tumor Ablation Market Expected to Reach $2.4B by 2028 from 1.1 Billion in 2021
US Cryoablation Market 2024
Breast Tumors =Approximately 310,000 new invasive breast cancer patients.
U.S. clinical market analysis of invasive breast cancer
Low risk, early stage, T1 invasive breast cancer
Initial addressable market of 70,000 breast cancer
patients per year in the U.S.
• 310,720 new cases of invasive breast cancer will be
diagnosed in 2024 in the U.S.¹
• Luminal-A is the most common breast cancer
subtype and represents 50-60% of all breast
cancers.
• Tumor size distribution suggests that T1(2cm or
smaller) is 67% of all breast cancers tumors.
IceCure additional markets:
• 81,610 new kidney cases
• 41,630 new liver cancer cases
• 234,580 new lung cancer cases
Cryogenics is used by tens of millions of people for recovery whether its ice bath freezing chambers or cold plunges freezing and killing cancer tumors will trend up as cancer patients realize more natural organic way that has much better results than any medications on the market and minus the major side effects IceCure has 97% Complete Response rate for cancer patients that's compared to Mercks Keytruda for 38% response rate.
IceCure Biz Presentation
https://d1io3yog0oux5.cloudfront.net/_645bffe72972ea00b5b9677cd4a4444b/icecuremedical/db/2291/21959/pdf/IceCure+Medical+%28ICCM%29+Company+Presentation+-+29-Aug-2024+FINAL.pdf
$ICCM
TechandBio
3 월 전
Peer Reviewed Paper Published today in the Peer Reviewed Annals of Surgical Oncology Journal: ProSense® Cryoablation Without Excision for Early-Stage, Low-Risk Breast Cancer Demonstrates 96.3% Recurrence Free Rate
Cryogenics treatment will be a game changer in Breast Cancer and other oncology indications Freezing and Killing cancerous Tumors! ( No surgeries or medications with ill side effects and low efficacy)
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, 2024
96.3% 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.
Key highlights and findings from the Peer Reviewed article include:
194 patients meeting eligibility received successful cryoablation treatment per protocol and were included in the final results for analysis.
The mean age was 74.9 years (55–94) with a mean tumor size of 7.4 mm transverse (2.8–14.0 mm) and 8.1 mm sagittal (2.5–14.9 mm).
With a mean follow-up period of 54.16 months for the total population of the ICE3 trial, the IBTR rate at 5 years was 4.3% and breast cancer survival was 96.7%.
Of the 124 patients who received cryoablation and endocrine therapy, the IBTR was 3.7%, resulting in a recurrence-free rate of 96.3%.
No serious device-related adverse events were reported.
Quality-of-life score demonstrated statistically significant improvement (p < 0.001) in distress at 6 months as compared with baseline.
100% of patients and treating physicians were satisfied with the cosmetic outcome.
ICE3 is a non-randomized trial that was conducted at 19 sites in the U.S.
IceCure 30 Million market cap
PLSE 1.1 Billion market cap was a 30 million dollar company a few years ago.
Billionaires are majority shareholders in both companies
IceCure Medical's ProSense Cryoablation System the next paradigm in Oncology works better than surgery or any Pill or antibody treatment
Kidney Cancer Cure Survival Case
$ICCM
TechandBio
3 월 전
97% Complete response by freezing & Tumor kiling rate for Breast Cancer safer after 5 years no Pill or IV based medication in efficacy comes close to IceCure Cryoblation Platform.
Study Published in the British Journal of Radiology Demonstrates IceCure's ProSense® is a Safe Procedure with 97.7% Technical Success Rate in Treating Tumors of the Lung, Bone, and Soft Tissues.
Published by Oxford University Press on behalf of the British Institute of Radiology.
https://finance.yahoo.com/news/study-published-british-journal-radiology-120000504.html
IceCure Medical's ProSense Cryoablation System
The traditional pillars of cancer treatment have been surgery, radiotherapy, and chemotherapy. Now cancer patients have the benefit of a fourth pillar, interventional oncology
$ICCM
midastouch017
3 월 전
Study Published in the British Journal of Radiology Demonstrates IceCure's ProSense® is a Safe Procedure with 97.7% Technical Success Rate in Treating Tumors of the Lung, Bone, and Soft Tissues
https://finance.yahoo.com/news/study-published-british-journal-radiology-120000504.html
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 manage
Independent 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.
"Cryoablation with liquid nitrogen has a growing role in early oncology treatments across a wide variety of cancer types and particularly for patients who may have multiple comorbidities and/or who want to avoid surgery. As interventional radiologists are increasingly and effectively using cryoablation, it's important to note Dr. Orsi and his colleagues underscore in the paper that interventional radiology is now the fourth pillar of the oncology field, alongside clinical oncology, surgical oncology and radiation therapy," stated IceCure's Chief Executive Officer, Eyal Shamir. "We are very pleased that ProSense® is providing a minimally invasive option to treat cancer patients early, safely and effectively."
The study assessed the complication rate both during and 24 hours after treatment with IceCure's cryoablation system in 85 patients who were treated for 96 lesions (tumors), 36.4% of which were lesions in bones, 18.8% in lungs, and 44.8% in soft tissue. The primary technical success rate, defined as complete tumor coverage, was 97.7% (83 of 85 patients). Patients with benign and malignant tumors were treated for either curative or palliative intent. Minor complications resolved themselves without intervention or merely required simple interventions such as drainage. The study concluded that cryoablation using an LN2-based system, such as ProSense®, is safe across various tumor sizes and locations, with only minor complications observed.
LN2-based cryoablation was compared to argon-based systems in the study who point to the benefits of LN2 procedures including its suitability for office-based procedures performed under local anesthesia, compared to argon systems which typically require general anesthesia and are therefore less suitable for office procedures. The study also addresses the challenges of argon systems requiring large argon gas cylinders, which necessitate dedicated storage space and trained personnel for transport, as well as the higher cost of the procedure due to the use of multiple cryoprobes as well as the use of noble gases, argon and helium. The study demonstrates that LN2-based systems, such as ProSense®, are more cost effective and easier to manage.
Two previously published independent lung cancer studies of ProSense® in the treatment of lung cancer, which evaluated the procedure's local control and recurrence free rate, reported 96% and 100% three-year recurrence free rates. Independent and IceCure-sponsored studies of other interventional radiology indications are ongoing.
midastouch017
4 월 전
IceCure Announces FDA Advisory Panel Meeting Date for Marketing Authorization of ProSense® in Early-Stage Low Risk Breast Cancer Scheduled for November 7, 2024
https://finance.yahoo.com/news/icecure-announces-fda-advisory-panel-120000234.html
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 cancer
FDA 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.
"This public forum transparency ensures key stakeholders, including women with early-stage low risk breast cancer, their doctors and payors, can exchange views and data regarding the potential benefits of minimally invasive cryoablation with ProSense® as an alternative to surgery," stated IceCure's CEO, Eyal Shamir. "Following the Advisory Panel, we anticipate that the FDA will make a decision regarding marketing clearance of ProSense® by early 2025."
The Advisory Panel will include breast surgeons, interventional radiologists and industry representatives from the regulatory community. The vast body of data available on ProSense® as a treatment for early-stage low risk breast cancer will be reviewed by the Advisory Panel, including results from the Company's ICE3 study, the largest controlled multicenter clinical trial ever performed for liquid nitrogen-based cryoablation of early-stage malignant breast tumors. Per the analysis, at the 5-year follow-up evaluation, 96.3% of the subgroup of patients treated with ProSense® cryoablation, followed by adjuvant endocrine therapy, were estimated to be free from local recurrence. 100% patient and physician satisfaction was reported. The Advisory Panel is expected to make its recommendations at the conclusion of the meeting, at which time the FDA will commence its review process.
The FDA generally makes Advisory Panel meeting materials and the live webcast link available to the public no later than two business days before the meeting, at which time IceCure intends to share the link with shareholders via a press release.
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.
ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens that door to fast and convenient office-based procedure for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.
midastouch017
4 월 전
USPTO Grants Notice of Allowance for Additional Patent on IceCure's Novel Cryogenic Pump Technology: Reinforces IceCure's Global IP Leadership in Cryoablation Technologies
https://finance.yahoo.com/news/uspto-grants-notice-allowance-additional-123000903.html
Further broadens the uses and applications of IceCure's cryoablation platform into a wide range of technology fields
Over 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.
"This new patent will support IceCure's potential for increasing the number of indications, procedures and applications that can be performed with our next-generation industry-leading platform cryoablation systems," stated IceCure Chief Executive Officer Eyal Shamir. "We believe that further fortifying our cryoablation intellectual property ("IP") estate in the U.S. is well timed both with respect to the indications for which we already have U.S. Food and Drug Administration ("FDA") approval as well as the FDA's decision on clearance for early-stage breast cancer, the decision which we expect in the first quarter of next year."
IceCure's novel cryogenic pump is submersible in liquid nitrogen, works in a closed circuit, improves the cooling rate during a procedure, and is designed to be used for multiple procedures or longer duration procedures without the need to refill liquid nitrogen. Moreover, this pump enables the use of a wider range of cryoprobes and catheters. The pump has been integrated into IceCure's next-generation XSense™ cryoablation system.
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