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I have the patients to wait this out 2025 should be a golden year. I do expect an offering after FDA approval to cushion the company for US commercial launch and future success.
https://www.icecure-medical.com/
Summer Biz presentation:
https://d1io3yog0oux5.cloudfront.net/_7548b0974a425145cf30e73983d71f6b/icecuremedical/db/2291/21959/pdf/IceCure+Company+Presentation+-+June+2024+-+Final+Clean.pdf
$ICCM
Added three times today under .80. I'm holding.
Need to be patient hold the line! FDA panel meeting on Approval is set for November so Late q4 2024 early Q1 2025 USA FDA approval should happen for early stage breast cancer patients and then 12 months from Japanese application which is set to in by Q1 2025 so we should get approval in late 2025 early 2026 for Japanese Approval Only hiccup for USA approval would be a CRL on manufacturing of the device but not likely USA approval should be a slam dunk in my opinion.
$ICCM
I have 100 stocks in my monitor. 5 were green yesterday with ICCM being one of them.
Timing is everything. Fortunes will be made. Mic drop!
$ICCM
I'm a buyer at .72 cents recently.
You got to see the angles before they are played.
What a solid day in a sea of red.
Most undervalued stock I have come across in years.
$ICCM
Is revenge part of your motivation on promoting this stock or do you truly believe. You went from 10 bucks to 20 in 5 posts. Not accusing...just wondering as I am a novice.
I hope the anti israel investor shorts this with dark pool trades I want to squeeze them to the poor house.
Sales should start ramping up soon.
$ICCM
This company deserves Billion dollar plus market cap=$20.00+ I did the research for you. Talked to management and have commenced talks with other companies in the medical device space to buy them.
CURES CANCER by Freezing and Killing Tumors organically.
The clowns trying to manipulate the price are going to get hit by the IceCure train!
Next Level technology company from Israel.
Only so many shares floating the ATM is being used only when it needs to be! $4 million in quarter one is modest.
$ICCM
PPS easing upwards this week. Good to see.
I disagree! Volume explosion and price appreciation.
This is just the start. I gave you guys ample time to get in at the basement discount fire sale prices. This stock will hit multiple dollars and eventually $10.00+ don't sleep on it.
$ICCM
$10.00 Stock
I think a company like Pulse Bio sciences Love to see Duggan scoop it up. I talked to Pulse management last week and explained that ICCM would be a great compliment to their umbrella of minimally invasive medical device technology. I believe a medium to large cap medical device company or pharma company buys out IceCure.
260k shares average price .72
I will lead you to Victory!
Core Holding!
$ICCM
99% Cancer Free Breast Cancer Complete Response Cure Rate! after 10 years of follow up data on patients
Just went fishing for some shares this morning! Someone is tying to scare people out of their shares I just doubled up!
https://finance.yahoo.com/news/99-74-recurrence-free-rate-123000447.html
Demand for minimally invasive breast cancer treatment was overarching theme of the conference
In one independent study led by Professor Fukuma, 389 patients treated for up to 10 years had 99.74% recurrence free rate
Another independent study led by Professor Kawamoto found 0% breast cancer local recurrence in five-year follow up
ProSense® expected to gain further traction in Japan, as distribution partner Terumo Corporation plans to submit application to the Pharmaceuticals and Medical Devices Agency ("PMDA") for regulatory clearance for breast cancer in the first quarter of 2025.
Already approved in 15 countries.
Minimal invasive procedure that cures Breast Cancer independent studies around the world. Reviewed in a highly reputable medical journal.
$ICCM
Cures 97% of early breast cancer patients after 5 year follow up independent study.
Published in highly recognized medical journal.
92% Cure rate for Late stage Breast cancer patients with large Tumors
IceCure Medical's ProSense Cryoablation System
shame no one cares
Cures 97% of early breast cancer patients after 5 year follow up independent study.
Published in highly recognized medical journal.
92% Cure rate for Late stage Breast cancer patients with large Tumors
FREEZING CANCER IN ITS TRACKS.
The Lee Family one of Asia Richest familes owns 52% of ICCM
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.
Study published in the peer reviewed journal Breast Cancer.
Excellent cosmetic outcomes, high degree of patient satisfaction, and improved quality of life post-cryoablation
Strategic distribution partner of ProSense® in Japan, Terumo Corporation, expects to submit an application for regulatory clearance for breast cancer in the second half of 2024
https://ir.icecure-medical.com/news-events/press-releases/detail/126/independent-study-results-in-japan-demonstrate-zero-0-breast-cancer-local-recurrence-5-years-following-treatment-with-icecures-prosense-adding-to-continued-positive-data-published-globally
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https://ir.icecure-medical.com/news-events/press-releases/detail/134/european-study-provides-more-evidence-supporting-icecures-prosense-is-safe-effective-cryoablation-treatment-for-metastatic-and-recurrent-breast-cancer
IceCure applications: Breast Cancer early and Late Stage, Kidney Lung, Liver Cancer, Pain, and Palliative Care, Fibroadenoma Kills bad fat cells (Obesity) application on tap!
https://www.icecure-medical.com/clinical-applications/
Recap IceCure no surgery in patient setting local anesthetic insurance companies have signed on. no radiation treatment! natural freezing that kills cancer tumors for early stage breast cancer with 97% success rate after 5 Years! This is expanding with late stage breast cancer wide array of oncology indications and large tumors. Lung, Kidney and Liver Cancer Approved in 15 countries and counting sales ramping up no debt or warrants.
Summer IceCure Biz Presentation.
https://d1io3yog0oux5.cloudfront.net/_bff00726f3fc2e5c631f07f65bc0c3de/icecuremedical/db/2291/21959/pdf/IceCure+Company+Presentation+-+June+2024+-+Final+Clean.pdf
$ICCM[/color]
I read TechandBio's posts but usually don't reply. I view them as FYI. I do think we are on the cusp of a breakout soon here.
Cures Cancer
Early Breast Cancer after 5 year follow up 97% complete response rate for early stage breast cancer independent studies completed in multiple countries.
Highly acclaimed peered reviewed journal.
Late stage Breast cancer Data is 92% complete response rate.
ICE3 Trial - Positive Final Results
96.3% Free from local recurrence for patients treated with ProSense® Cryoablation.
100% Safe Procedure
No significant device-related adverse events or complications have been reported.
100% Doctor & Patient Satisfaction with ProSense® Procedure.
No scarring or change to the shape and size of the breast.
Billionaire owns 52% of the shares from one of the wealthiest families
Cryoablation minimally invasive no drugs needed to put the patient out only local anesthetic and the patient is home in two hours no stitches. No surgery no radiation This is very disruptive to the Cancer Space.
Approved in 15 countries.
I have been accumulating shares daily and will continue. Potential to break $10.00 and new highs. I bought PLSE at $1.30 and rode half my shares into the high teens!
Cryoablation is treating Kidney, Bone, Lung and Liver cancer and Palliative care interesting there could be an obesity angle as well as the Freezing temps kills tumors and bad fat cells.. Non Invasive Medicine is growing and as we go move forward in medicine these area of medicine will grow leaps and bounds.
Harvard Health Blog The skinny on freezing fat
https://www.health.harvard.edu/blog/the-skinny-on-freezing-fat-2020031218990#:~:text=Average%20reduction%20in%20fat%20ranges,depending%20on%20the%20desired%20results.
IceCure Medical's ProSense Cryoablation System
Ever get to feel you are talking (or praying) at a wall?
Cancer Cure= 97% success rate for killing cancerous tumors in early stage breast cancer patients! Complete Response rate after 5 year follow up data by independent studies conducted in multiple countries peer reviewed in highly acclaimed medical journals
Late Stage Breast cancer patients harder to treat with large tumors seeing similar data after 12 months.
100% patient and Dr Satisfaction.
Freezing and Killing Cancer in it;s Tracks IceCure Medical, enabling non-surgical
treatment of cancerous tumors.
IceCure website
https://www.icecure-medical.com/
Summer 2024 Biz Presentation:
https://d1io3yog0oux5.cloudfront.net/_5a446bd24270711d45714fda93e00997/icecuremedical/db/2291/21959/pdf/IceCure+Company+Presentation+-+June+2024+-+Final+Clean.pdf
Billionaire owns 52% of ICCM shares.
PLSE 1 Billion market cap was 50 million 2 years ago
ICCM 36 Million market cap
$ICCM
Independent, third-party data published in highly influential peer-reviewed journal, Cancers, concluded cryoablation with ProSense® is a safe, local treatment for early and late stage breast cancer with tumors big and small with non complication rate, high complete ablation rate and satisfactory overall survival (OS), progression free survival (PFS) and
local tumor control 5 year early breast cancer data success rate 97% late stage breast cancer with larger tumors nearly 93% success rate. This is the closest thing in breast cancer to a Cure and best in class results with local local anesthetic vs anesthesia in a surgery setting with 15-20% of lumpectomy patients need to go back for second surgery. This stock has a Billion dollar plus market cap potential by end of next year.=3000% upside if Pulse Bio Sciences did it from the low 1.00 range from 2 years ago and a 50 million dollar market cap a few years to a Billion dollar market cap today.
Both companies have large insider ownership Sales will ramp up for IceCure in the coming quarters.
$ICCM
IceCure Medical's ProSense Cryoablation System (next Frontier in cancer medicine)
Cancer Cure for early stage breast cancer 97% success rate with 5 year follow up independent data.
Approved in 15 countries
Late stage Breast cancer is showing best in class data with large tumor destruction with nearly 93% success rate for late stage breast cancer patients with 1 year follow up. The company is working on a wide array of cancer applications.
Oncology Indications
https://www.icecure-medical.com/clinical-applications/
Freezing Cancer in its Tracks IceCure Medical, enabling non-surgical treatment of cancerous tumors.
Billionaire Victor Lee owns 52% of the ICCM shares a man who help built Tencent into one the most successful tech companies in Asia. Comes from one of the richest families in Asia.
2024 June Presentation.
https://d1io3yog0oux5.cloudfront.net/_5a446bd24270711d45714fda93e00997/icecuremedical/db/2291/21959/pdf/IceCure+Company+Presentation+-+June+2024+-+Final+Clean.pdf
IceCure Medical is proud to share the first renal #ProSense #cryoablation case performed at the Greek 251 Hellenic Air Force Hospital, with support of Dr. Robert Sachner who shared his vast experience of over 250 kidney lesion cryoablation procedures.
Dr. Belinda Barclay-White on Breast Tumor Cryoablation.
Cryoblation ice crystals Killing breast cancer tumors and dead fat. Ice3 Trial 5 year follow up killing 98% of small breast cancers better than surgery also has Data on later stage breast cancers with tumors twice the size as earlier studies with a 93% success rate for late stage Breast cancers.. .
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
https://www.prnewswire.com/news-releases/icecure-medicals-breast-cryoablation-gains-prominence-in-the-us-as-society-of-interventional-oncology-annual-meeting-features-its-first-breast-cryoablation-master-class-302046623.html
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Cryoablation Takes Center Stage at American Society of Breast Surgeons' 24th Annual Meeting.
IceCure's ProSense was the cryoablation system used in first-of-its-kind cryotherapy continuing medical education (CME) course.
High level of interest expressed in cryoablation from attending surgeons and from American Society of Breast Surgeons (ASBrS) leadership.
Plan presented for a proposed ASBrS Cryoablation trial during CME course.
https://ir.icecure-medical.com/news-events/press-releases/detail/81/cryoablation-takes-center-stage-at-american-society-of-breast-surgeons-24th-annual-meeting
Home Media and publications Media Archive SIR 2024 breast cancer
A minimally invasive technique that uses ice to freeze and destroy small, cancerous tumors has now been proven effective for breast cancer patients with large tumors, providing a new treatment path for those who are not candidates for surgery, according to new research to be presented at the Society of Interventional Radiology Annual Scientific Meeting in Salt Lake City.
https://www.sirweb.org/media-and-pubs/media/news-release-archive/sir-2024-breast-cancer-032024/
Choose the Power of Liquid Nitrogen Cryoablation for a Wide Range of Clinical Applications[/color]
https://www.icecure-medical.com/clinical-applications/
June 2024 ICeCure Biz Presentation.
https://d1io3yog0oux5.cloudfront.net/_5a446bd24270711d45714fda93e00997/icecuremedical/db/2291/21959/pdf/IceCure+Company+Presentation+-+June+2024+-+Final+Clean.pdf
$ICCM
Organizations supporting IceCure in the USA:
1.The American Society of Breast Surgeons | ASBRS
2.Society for Integrative Oncology
3.Society of Interventional Radiology
$ICCM
Victor Li, head of one of Hong Kong’s oldest business empires And from one of the richest families in China, has been busy forging partnerships with a slew of mainland Chinese technology companies including (Tencent 3.60 trillion Hong kong dollars) to modernize CK Group including deals after taking over the conglomerate earlier this year.
$ICCM
Victor Li owns over 52% of ICCM
$PLSE was about 1.30 a few years ago to a high of $17.00 this year and their majority owned by Bob Duggan and the company went from a 50 Million market cap to over a billion dollar market cap in no time.
ICCM has massive upside When it breaks $2.00-$10.00+ will happen its all in the charts!.
Very honored to have Vic Li, our leading shareholder and his associate, Yankor Huang, visit the IceCure offices today and see our #LN2 #cryoablation technology in action. Thank you for your continued belief and support in us!
Victor Lee the Business tycoon has been an active major shareholder for 9 years.
https://www.facebook.com/IceCureMedical/posts/2448349238625488/
The Evolving Role of Cryosurgery in Breast Cancer Management: A Comprehensive Review - PMC
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10486449/
Starting to build core positions in small cap hidden gems this is one of them. Once it breaks $2.00 area $10.00+ is in play.
ProSense™ cryoablation system generates ultra-cold temperatures quickly to create large lethal zones for maximum tumor destruction.
Step 1. The cryoprobe is inserted into the tumor at a small incision site.
Step 2 .The tumor is surrounded by an ice ball. The extreme cold kills the tumor tissue.
Step 3. The cryoprobe is removed and a Steri-Strip is applied, requiring no stitches. (local anesthetic) patient is back home in a couple of hours after procedure.
Breast Cancer – U.S. Healthcare Economics &
Reimbursement
Healthcare Economics: Cryoablation costs less than standard-of-care lumpectomy and
further reduces costs by reducing risk of re-excision as compared to lumpectomy.
$ICCM
This is great news for women worldwide. Hope this procedure is 100% successful. This would be such a great medical advancement. In the US, if a woman discovers breast cancer, the best outcome is most likely a partial mastectomy and successful chemotherapy. Discovering breast cancer early requires timely and state of the art testing. The lump test discovers cancer that might require full mastectomy. Women should test regularly.
Bob Duggan thinking about buying IceCure? Fits his ethos to a tee. He's worth about 6 Billion dollars.
The trend of minimal/non invasive technologies not needing surgery is growing substantially from patients to doctors and insurance companies and rain makers like Duggan and many others. The new paradigm of medicine is starting to change at an accelerated pace. ICCM exceptional data now showing treatment for later stage breast cancers with bigger tumors is game changing for IceCure. And displaying remarkable data results for Lung, Kidney, Bone Cancer. Taking a local anesthetic being able to go home in a few hours with no scaring most important the results of IceCure Patients and Doctors are nearly 100% satisfied. Killing cancer by Freezing it in it's tracks with 5 year follow up studies in early breast cancer patients and highly showcased in a highly acclaimed peer reviewed publication approved in 15 countries and the list is growing.
$ICCM
Independent Studies Confirm ICE3 Results
In women with early-stage breast cancer who
declined surgery.
Study conducted by Principal Investigator Lucía Graña-López,
MD, PhD, a radiologist who specializes in breast and women's
imaging, Head of the Breast Unit at University Hospital Lucus
Augusti, Spain—presented at European Society of Breast Imaging Annual Scientific Meeting 2023 96.8% Success rate.
93.4% - 96.8%
Tumor reduction rate
In women deemed inoperable for breast cancer.
Breast Cancer – U.S. Healthcare Economics &
Reimbursement
Healthcare Economics: Cryoablation costs less than standard-of-care lumpectomy and
further reduces costs by reducing risk of re-excision as compared to lumpectomy1
Reimbursement:
Demonstrating its leadership in cryoablation, IceCure is the first company to apply for and
receive Medicare coverage for breast cancer cryoablation through the Centers for Medicare & Medicaid
Services (CMS)
CMS assigned CPT Category III 2 Breast/Lymphatic Surgery and Related Procedures
Priced for coverage by the CMS at approximately $3,400 for the facility fee alone
Additional coverage, including payment for the physician, is expected upon establishment of the
permanent CPT Category I 2 code
Patient demand drives reimbursement.
Large insider buys a few weeks ago 57% of the stock is Insider Owned.
21 Million shares Floating
No warrants no debt no history of reverse splits.
$ICCM
Killing Cancer Tumors by Freezing them new paradigm in medicine.
Growing number of global distribution agreements. More to come!
Insurance Reimbursement: CPT III for breast cancer cryoablation facility fee established.
51 IP Patents
Excellent patient & physician feedback.
Peer Reviewed Journal completed.
Data displaying next level treatment for early and now late stage cancer patients with larger tumors.
Independent clinical trials are investigating the use of cryoablation in the treatment of endometriosis; a condition that impacts over 6.5 million women in the U.S.
Best in Class data displayed in Breast Cancer, Lung Cancer, Bone Cancer, Kidney Cancer.
Growing cancer burden Increasing demand for non/minimal-invasive solutions Push for reduced cost of care by insurers & payers.
June 2024 IceCure Biz Presentation.
https://d1io3yog0oux5.cloudfront.net/_5a446bd24270711d45714fda93e00997/icecuremedical/db/2291/21959/pdf/IceCure+Company+Presentation+-+June+2024+-+Final+Clean.pdf
$ICCM
Presently waiting on FDA approval for marketing the prosense device for breast cancer in the US. I think early to mid 2025 will be where a ton of good news will flow in. In the meantime we should await quarterly results and accumulate.
This higher risk patient population included patients with metastatic disease and tumors of up to 4 centimeters in diameter, as compared to our ICE3 study population with early-stage disease and tumors smaller than 2 centimeters in diameter, indicating a very different recurrence rate. Importantly, it further informs and supports the use cases of ProSense® across a broader range of breast cancer diagnoses, from newly diagnosed early-stage to metastatic and recurrent disease,"
92% non recurrence rate for higher risk later stage breast cancer with tumors twice the size 4 centimeters is remarkable. Someone is trying to steal shares from the low brow. 97% tumor free for early stage breast cancer with tumors 2 centimeters in diameter with 5 years of FOLLOW UP DATA.
$ICCM
European Study Provides More Evidence Supporting IceCure's ProSense® is Safe & Effective Cryoablation Treatment for Metastatic and Recurrent Breast Cancer
Prior Studies where for early stage breast cancer now there is incredible data for dealing with later stage and higher risk breast cancer patients. This is big news it moves when it moves I will keep adding at these levels!
Now have superior data on higher risk breast cancer patients!
Professor Vogl commented, "Liquid Nitrogen-based cryoablation was found to be a safe local treatment for breast cancer, with a low complication rate—in fact, none were observed in the study. We experienced a very high complete ablation rate of 100%.
Treating higher risk breast cancer patients makes ICCM platform more dynamic plus treating Lung, Kidney and Bone cancer patients with cryoblast. Giving options for patients who don't want surgery or radiation treatment with these incredible data points and 100% patient and Dr satisfaction using ICCM technology IceCure will be valued closer to PLSE market cap which is a Billion dollars.[
Independent, third-party data published in highly influential peer-reviewed journal, Cancers, concluded cryoablation with ProSense® is a safe, local treatment for breast cancer with low complication rate, high complete ablation rate and satisfactory overall survival (OS), progression free survival (PFS) and local tumor control.
$ICCM
Not sure why this isn't trading higher. This is much-needed technology and treatment.
even more good news
European Study Provides More Evidence Supporting IceCure’s ProSense® is Safe & Effective Cryoablation Treatment for Metastatic and Recurrent Breast Cancer
? Independent, third-party data published in highly influential peer-reviewed journal, Cancers, concluded cryoablation with ProSense® is a safe, local treatment for breast cancer with low complication rate, high complete ablation rate and satisfactory overall survival (OS), progression free survival (PFS) and local tumor control
? 8.9% recurrence rate in population of 45 patients who had previously received various therapies before cryoablation including surgery, radiation therapy, or chemotherapy with tumor sizes of up to 4 centimeters in diameter. Of those patients, 11 had recurrent tumors and 21 had metastatic disease
? The higher-risk population in this European study contrasts with the early-stage breast cancer patient subjects in the U.S. ICE3 study
CAESAREA, Israel, July 9, 2024 – 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 evaluating its flagship cryoablation system ProSense® titled: “CT-Guided Percutaneous Cryoablation of Breast Cancer: A Single-Center Experience” in Cancers, a leading peer-reviewed oncology journal. The study, led by Principal Investigator Professor Thomas J. Vogl, was conducted at the Institute of Radiology and Nuclear Medicine, University Hospital Frankfurt, at Goethe University, Germany.
Professor Vogl commented, “Liquid Nitrogen-based cryoablation was found to be a safe local treatment for breast cancer, with a low complication rate—in fact, none were observed in the study. We experienced a very high complete ablation rate of 100%. Overall survival, progression free survival and local tumor control were all good, especially given the very heterogenous patient population. The fact that this is a minimally invasive procedure that can be performed on an outpatient basis with excellent cosmetic results are clear advantages. We look forward to further evaluations of cryoablation especially in comparison to other treatment modalities for early, recurrent, and metastatic breast cancer.”
“While this study’s patient population is very different from our U.S. based ICE3 study and the target indication for which we have filed for regulatory approval in the U.S., the results of the study are highly valuable for ProSense® users in Europe where our system is approved for general breast cancer treatment. This higher risk patient population included patients with metastatic disease and tumors of up to 4 centimeters in diameter, as compared to our ICE3 study population with early-stage disease and tumors smaller than 2 centimeters in diameter, indicating a very different recurrence rate. Importantly, it further informs and supports the use cases of ProSense® across a broader range of breast cancer diagnoses, from newly diagnosed early-stage to metastatic and recurrent disease,” stated IceCure CEO Eyal Shamir. “We thank Dr. Vogl, his team, and University Hospital Frankfurt for their initiative in conducting this study and expanding the body of knowledge for the cryoablation of breast cancer.”
This independent study, which received no financial support from IceCure, retrospectively evaluated the efficacy and safety of liquid-nitrogen based CT-guided cryoablation with ProSense®. Patients were treated in out-patient settings with curative intention for non-metastatic patients, while patients with metastases were treated to achieve local tumor control. The patient population (n=45, with 56 tumors) with a mean age of 55.6 ± 12.5 years (range, 31.3–86.0 years) was very heterogeneous and different from IceCure’s ICE3 study population and included 11 patients with recurrent tumors and 21 patients with metastatic disease. Patients were observed at three, six, nine, and 12 months, respectively, and after the first year were followed up biannually. There were four cases of local tumor progression, representing a rate of 8.9%. There were no complications observed in any of the 56 ablations and initial complete ablation was achieved in 100% of cases.
Gets Past $2.00+ then $10.00+ in the play Charts says it all.
Killing all kinds of cancers with follow up Data on patients for 5 years and counting.
This stock should be trading 10-30x the current market cap more inline with Pulse Bio Sciences a Billion dollar market cap that has no revenue and is doing just cosmetic dermatology skin treatments.That stock was trading around a dollar a few years ago.
IceCure will make some people hyper wealthy.
$ICCM
“Cryoablation is a procedure that we know is safe, efficacious, cost effective and cosmetically superior to surgical removal. IceCure has improved upon the technology and developed a system optimized for breast fibroadenoma. My patients have been very happy with the short, painless procedure, and the ability to return to normal activity immediately.”
Andrew Kenler, MD, FACS
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
https://www.prnewswire.com/il/news-releases/independent-study-results-in-japan-demonstrate-zero-0-breast-cancer-local-recurrence-5-years-following-treatment-with-icecures-prosense-adding-to-continued-positive-data-published-globally-302137926.html
$ICCM
IceCure non invasive treatment freezing cancers compared to surgery including breast cancer, Lung cancer, Kidney cancer Fibroadenoma and Palliative care.
I was in Pulse around the $1.75 range and believe IceCure has tremendous growth approved in 15 countries. FDA approval Q4 or early Q1 5 year follow up Data with 100% patient and doctor approval ratings. Over 55% insider ownership. No warrants or debt. 96% non recurrence rate for early stage malignant breast cancer.
RSI 32 Oversold.
June 2024 IceCure Business Presentation.
https://d1io3yog0oux5.cloudfront.net/_1427e4e7e9d44c0c61187db90d33f6f4/icecuremedical/db/2291/21959/pdf/IceCure+Company+Presentation+-+June+2024+-+Final+Clean.pdf
$ICCM
U.S. Food and Drug Administration Grants Regulatory Clearance to IceCure for Next-Gen XSense™ Cryoablation System with CryoProbes
CAESAREA, Israel, July 1, 2024 – 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 marketing authorization from the United States Food and Drug Administration (the “FDA”) for its next-generation single probe cryoablation system, the XSense™ Cryoablation System with CryoProbes.
“This latest FDA regulatory clearance further validates the safety and efficacy of our platform cryoablation technology,” commented Eyal Shamir, IceCure’s Chief Executive Officer. “The next-generation XSense™ system is cleared for the same indications as our flagship ProSense® system and we believe it has future potential to address other indications in the U.S. for significant indications with unmet needs. Through our innovation, IceCure is a global leader in liquid nitrogen-based cryoablation systems that offer a new minimally invasive treatment with benefits for patients, doctors and payors alike.”
XSense™ and its cryoprobes are cleared for all of the indications for which ProSense® has already received the requisite FDA clearance, including general minimally invasive cryoablation in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology and urology. The system is designed to destroy tissue by the application of extreme cold temperatures, including fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions and warts.
About IceCure’s Cryoablation Systems
IceCure’s platform technology, including the ProSense® Cryoablation System and XSense™ Cryoablation System and CryoProbes, provides a minimally invasive treatment option to destroy tumors by freezing them. The systems uniquely harness 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.
IceCure’s cryoablation systems enhance patient and provider value by accelerating recovery, reducing pain, surgical risks and complications. With easy, transportable design and liquid nitrogen utilization, ProSense® and XSense™ open the door to fast and convenient office-based procedure for breast tumors.
Guess Mr Market wasn't happy with the timing
FDA to Convene Advisory Panel for Review of IceCure’s De Novo Marketing Clearance Request for ProSense®, Decision Expected Early 2025; Aligns with Commercial Readiness Plan
? Demonstrates public health importance of assessing ProSense®’s potential to offer optimal treatment that benefits women with early-stage breast cancer
? Patients, patient advocacy groups, doctors, and the general public will be welcome to participate and comment in the open public hearing
? IceCure welcomes a transparent public forum to share ICE3 study results and show how ProSense® cryoablation could potentially offer a minimally invasive alternative treatment to women diagnosed with early-stage breast cancer estimated at 65,000 in the U.S. annually
? ProSense® is already approved for the treatment of early-stage breast cancer in numerous European countries, as well as Brazil, India, and China
CAESAREA, Israel, June 4, 2024 – 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 the U.S. Food and Drug Administration (“FDA”) will convene a Medical Device Advisory Committee for a panel meeting (the “Advisory Panel”) to obtain independent expert advice on scientific, technical, and policy matters related to ProSense® to help the FDA make a sound decision.
“We believe the opportunity to have a public, transparent, and open forum about this important women’s health issue, led by outside, independent experts including physicians and researchers, will be highly beneficial to all stakeholders,” stated IceCure’s CEO, Eyal Shamir. “We applaud the FDA’s decision to convene the Advisory Panel and for acknowledging the public health importance of being able to offer a minimally invasive alternative to lumpectomy. The ICE3 data for ProSense®, which has been consistently positive throughout IceCure’s ICE3 study, will be shared with the Advisory Panel, highlighting its clinical and economic benefits and why women who have undergone a ProSense® cryoablation procedure have reported a 100% satisfaction rate. As we continue to engage with the FDA leading up to the Advisory Panel, we believe increased awareness of ProSense® as a result of the Advisory Panel may enable our U.S. commercial team to further support our commercial efforts upon potential regulatory approval in the U.S.”
The Advisory Panel is expected to convene in the fourth quarter of 2024, with an FDA decision on whether to approve ProSense® expected by early 2025. The FDA is expected to provide the exact date for the Advisory Panel in the coming weeks, which the Company will also make known to its shareholders. The FDA generally makes Advisory Panel meeting materials and the live webcast link available to the public no later than two business days before any meeting. The Advisory Panel will review the vast body of data available on ProSense® as a treatment for early-stage breast cancer, including results from the 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 hormone therapy, were estimated to be free from local recurrence. 100% patient and physician satisfaction was reported.
As part of its De Novo Classification Request for Marketing Authorization, IceCure submitted data, including its final ICE3 study results, to the FDA, as part of its request for clearance for ProSense® for the indication of treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy.
Talk about timing,
"https://ih.advfn.com/stock-market/NASDAQ/icecure-medical-ICCM/stock-news/93980503/fda-to-convene-advisory-panel-for-review-of-icecur"
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