Paullee
4 months ago
“Study Using IceCure’s ProSense® Finds: “Cryoablation Allows the Ultimate De-escalation of Surgical Therapy for Select Breast Cancer Patients.”
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
IceCure Medical Ltd.
Date: December 13, 2023 By: /s/ Eyal Shamir
Name: Eyal Shamir
Title: Chief Executive Officer
2
Exhibit 99.1
Study Using IceCure’s ProSense® Finds: “Cryoablation Allows the Ultimate
De-escalation of Surgical Therapy for Select Breast Cancer Patients”
? 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, December 13, 2023 – 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.
The independent study, in which ProSense® was one of two cryoablation systems analyzed, was overseen and conducted at the Breast Center of Excellence and the Department of Surgery, School of Medicine at Texas Tech University Health Sciences Center by Sonia Y. Khan MD, Jaclyn Cole MD, Zaina Habrawi MD, Michael W. Melkus PhD, and Rakhshanda Layeequr Rahman MD.
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.
All patients were disease-free at the last follow-up visit, and no major complications from the procedure were reported. One patient had regional disease at 18 months. She did not have sentinel node biopsy and did not take endocrine therapy. She had delayed axillary dissection, started endocrine therapy, and remains disease-free after 5 years of follow-up evaluation. One patient died one year after cryoablation due to unrelated causes. The patient population in this study is similar to the population in IceCure’s ongoing ICE3 study, the largest controlled multi-center clinical trial ever performed in the U.S. for liquid nitrogen-based cryoablation of small, low-risk, early-stage malignant breast tumors as an alternative to surgery.
Highlights from the article include:
? Regarding cost of care, the article states: “Clinical trials have determined not only that cryoablation is just as effective as surgical resection for early-stage, low-risk tumors, but that cryoablation also provides a superior alternative when it comes to financial implications.”
? Citing ICE3 as a leading study that makes the case for surgical de-escalation, the article states: “The ablative therapies were first entertained as options for women who might not be good surgical candidates or refuse surgery. However, two large multi-institutional studies on cryoablation (Simmons et al. (ACOSOG Z-1072), and Fine et al. (ICE3) have led the way to the use of ablation as a means for further surgical de-escalation for small early-stage, low-risk breast cancers.”
“Cryoablation is an excellent option for select patients to avoid general anesthesia, and enjoy a potential cure without surgery through an outpatient procedure with minimal disruption of life.” Stated study co-author, Dr. Rakhshanda Layeequr Rahman
“This independent study is quite compelling in that it goes beyond providing data. It presents the case that due to widespread screening with mammography, early-stage tumors can be treated with new, safe, and effective treatments that minimize the impact on patients and the healthcare system in general,” stated IceCure’s Chief Executive Officer, Eyal Shamir. “We are grateful, as always, to the growing number of medical professionals who are using ProSense® to improve patient outcomes and going above and beyond to publish their results for the advancement of innovative new treatments that improve care.”
About ProSense®
ProSense® cryoablation is a minimally invasive, non-surgical, outpatient 40-minute treatment option that destroys tumors by freezing them. The procedure only requires a local 1% lidocaine injection (similar to its use by dentists when performing certain dental procedures) enabling the patient to remain alert during the procedure and then walk out of the doctor’s office to resume their day. ProSense® has been investigated and proven effective in various clinical applications, including breast tumors, kidney cancer, lung cancer, and in palliative care. Independent and company-sponsored clinical studies of ProSense® have shown strong results, with high rates of tumor destruction, and patient and physician satisfaction.
subslover
7 months ago
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%
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. This independent study adds to the growing body of scientific data using ProSense in women deemed inoperable for breast cancer.
During the study, ultrasound-guided cryoablation using ProSense was performed on 28 women, who had biopsy-proven malignant lesions, and were deemed inoperable by a multidisciplinary group, and submitted to hormone therapy. At a median age of 73.4 years, 14 of the women were diagnosed with molecular subtype Luminal-A tumors and another 14 diagnosed with Luminal-B tumors. Patients were monitored at one, three, and six months post-procedure, at which time the tumor size reduction rate was evaluated by ultrasound. The effectiveness of the procedure was further evaluated after one year by core needle biopsy on the post-procedural scar (inside the breast at the site of the tumor) to determine the absence of residual tumoral cells. The size reduction rates were as follows:
1 month: 21.59% for Luminal-A vs. 19.83% for Luminal-B
3 months: 70.16% for Luminal-A vs. 60.71% for Luminal-B
6 months: 96.81% for Luminal-A vs. 93.43% for Luminal-B
In the Luminal-A group, there was an absence of residual malignant cells in all biopsy samples and a disappearance of lesions, leading the study to conclude this is a predictive factor for the complete effectives of treatment. Luminal-A is the most common subtype and represents 50%-60% of all breast cancers1.
"The patients in the study were deemed inoperable and had no treatment options available other than hormone therapy, and as we observe breast cancer awareness month, it is reassuring that a minimally invasive cryoablation procedure using IceCure's ProSense system is an available alternative," stated IceCure's CEO, Eyal Shamir. "This was a relatively short independent study that measured tumor size reduction, however the highly favorable results nonetheless validate similar results we are experiencing in our longer-term five-year post-procedure ICE3 study, which we expect to conclude in the first quarter of 2024. We believe the increasing number of doctors using ProSense and conducting these studies on their own initiative is the best testament to the usability and benefit of ProSense in real-world clinical settings."
The data from the Italy study was presented in a poster titled, "Assessing the outcome of cryoablation treatment on different molecular subtype of low-grade breast cancer," at the European Society of Breast Imaging ("EUSOBI") Scientific Meeting that was recently held in Valencia, Spain. The data was presented by Principal Investigator, Dr. F. Di Naro, of Azienda Ospedaliero-Universitaria Careggi, Diagnostic Senology Unit, Florence, Italy. ProSense is approved in Italy for numerous indications, including breast cancer.
1. Yersal O, Barutca S. Biological subtypes of breast cancer: Prognostic and therapeutic implications. World J Clin Oncol. 2014 Aug 10;5(3):412-24. doi: 10.5306/wjco.v5.i3.412. PMID: 25114856; PMCID: PMC4127612.
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.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal and Israeli securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statement in this press release when it discusses: the expected conclusion of its ICE3 study in the first quarter of 2024; and the belief that the increasing number of doctors using ProSense and conducting studies with ProSense is a testament to the usability and benefit of ProSense in real-world clinical settings. Historic results of scientific research, studies and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties and actual results, performance, or achievements of IceCure could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Annual Report on Form
INV4
7 months ago
Good news!
Independent Study Validates IceCure's ProSense Cryoablation is Safe & Effective Outpatient Procedure for Breast Cancer with 96.8% Success Rate
• 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.
In a poster titled "Cryoablation for the treatment of early-stage breast cancer in patients who decline surgery" Dr. Graña-López presented the findings of her study conducted at University Hospital Lucus Augusti in Lugo, Spain which used ProSense for cryoablation treatment of 31 patients with early-stage breast cancer who declined surgery, the standard of care. Dr. Graña-López, a radiologist who specializes in breast and women's imaging, is Head of the Breast Unit at University Hospital Lucus Augusti.
All patients were diagnosed with biopsy-proven early breast cancer (cT1-2cN0-1cM0) with a median tumor size of 24 mm, ranging between 6 to 45 mm. Patients were followed by mammography and ultrasound every 6 months for 2 years and annually thereafter. The median follow-up was 10 months, with a range of 0 to 40 months. Cancer progression was observed in 1 patient (1/31, 3.2%). No major complications were seen and the procedure was well tolerated by all patients.
The study concluded that cryoablation could be an alternative treatment to surgery for breast cancer in patients who reject surgery. Underscoring the need for such an alternative, the poster presented that breast cancer is the most commonly diagnosed malignant neoplasm worldwide and that while surgery is the standard of care for early-stage breast cancer, some patients, most of them elderly, decline standard of care surgery and prefer a less invasive option.
Dr. Graña-López commented, "I've been effectively using ProSense for cryoablation in women who decline surgery with very good results. I think that soon, cryoablation will be a real alternative to surgery in early-stage breast cancer in post-menopausal women. Beyond breast cancer, I believe ProSense can have an impact on the way cancers of the kidney, lung, and thyroid gland are treated."
"Doctors around the world are using ProSense with women who want an alternative to surgery for early- stage breast cancer, and it's highly encouraging to see these physicians publish and share their results with the medical community," stated IceCure's CEO, Eyal Shamir. "These data are very much in line with the interim results of our ICE3 study, the largest of its kind in the U.S., which is expected to conclude in the first quarter of 2024."
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.
https://www.nasdaq.com/press-release/independent-study-validates-icecures-prosense-cryoablation-is-safe-effective
$ICCM
subslover
7 months ago
Independent Study Validates IceCure's ProSense Cryoablation is Safe & Effective Outpatient Procedure for Breast Cancer with 96.8% Success Rate
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.
https://mma.prnewswire.com/media/1941429/IceCure_Logo.jpg
In a poster titled "Cryoablation for the treatment of early-stage breast cancer in patients who decline surgery" Dr. Graña-López presented the findings of her study conducted at University Hospital Lucus Augusti in Lugo, Spain which used ProSense for cryoablation treatment of 31 patients with early-stage breast cancer who declined surgery, the standard of care. Dr. Graña-López, a radiologist who specializes in breast and women's imaging, is Head of the Breast Unit at University Hospital Lucus Augusti.
All patients were diagnosed with biopsy-proven early breast cancer (cT1-2cN0-1cM0) with a median tumor size of 24 mm, ranging between 6 to 45 mm. Patients were followed by mammography and ultrasound every 6 months for 2 years and annually thereafter. The median follow-up was 10 months, with a range of 0 to 40 months. Cancer progression was observed in 1 patient (1/31, 3.2%). No major complications were seen and the procedure was well tolerated by all patients.
The study concluded that cryoablation could be an alternative treatment to surgery for breast cancer in patients who reject surgery. Underscoring the need for such an alternative, the poster presented that breast cancer is the most commonly diagnosed malignant neoplasm worldwide and that while surgery is the standard of care for early-stage breast cancer, some patients, most of them elderly, decline standard of care surgery and prefer a less invasive option.
Dr. Graña-López commented, "I've been effectively using ProSense for cryoablation in women who decline surgery with very good results. I think that soon, cryoablation will be a real alternative to surgery in early-stage breast cancer in post-menopausal women. Beyond breast cancer, I believe ProSense can have an impact on the way cancers of the kidney, lung, and thyroid gland are treated."
"Doctors around the world are using ProSense with women who want an alternative to surgery for early- stage breast cancer, and it's highly encouraging to see these physicians publish and share their results with the medical community," stated IceCure's CEO, Eyal Shamir. "These data are very much in line with the interim results of our ICE3 study, the largest of its kind in the U.S., which is expected to conclude in the first quarter of 2024."
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.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal and Israeli securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statement in this press release when it discusses: the expected conclusion of its ICE3 study in the first quarter of 2024; and that, according to Dr. Graña-López, soon cryoablation will be a real alternative to surgery in early-stage breast cancer in post-menopausal women. Historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties and actual results, performance, or achievements of IceCure could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2022 filed with the SEC on March 29, 2023, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
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midastouch017
8 months ago
IceCure Medical's ProSense Cryoablation System Receives Regulatory Approval in Brazil
https://finance.yahoo.com/news/icecure-medicals-prosense-cryoablation-system-120000697.html
Tue, September 5, 2023 at 3:00 PM GMT+3
$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. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System, that destroys tumors by freezing as an alternative to surgical tumor removal, today announced that its ProSense System has received regulatory approval as a Class III device from the Brazilian Health Regulatory Agency ("ANVISA"). ProSense's disposable cryoprobes and introducers, were previously registered as Class II devices by ANVISA. Applications for both the ProSense System and its disposable cryoprobes and introducers were submitted to ANVISA by IceCure's distributor in Brazil, Ktrfios Importação e Exportação LTDA ("Ktrfios").
ProSense's indications approved by ANVISA are oncology, which includes the ablation of benign and malignant tissues in the breast, prostate, kidney, lung, liver, musculoskeletal, and skin tissue, as well as for palliative intervention and other indications.
Healthcare providers are cleared to conduct procedures with ProSense, its introducers and disposable probes, and Ktrfios is cleared to both market and sell ProSense's introducers and disposable probes. ANVISA has assessed that the probes, which were initially registered as a Class II device under ANVISA rules, are to be transitioned to a Class III device and aligned with the Brazilian regulatory system classification for the same class as ProSense. Therefore, ANVISA has requested that the probes also be submitted by Ktfrios for regulatory approval as a Class III device. The introducers remain a Class II device and do not require an additional regulatory submission. Class III device clearance for the probes is expected to be finalized by the end of the first quarter of 2024.
"We are very pleased that ProSense has received regulatory approval in Brazil. We expect this to translate into near-term revenues. Early indications of market interest point to strong demand in the largest market in South America where cost-effective, minimally invasive, safe, and effective cryoablation procedures can offer great benefits compared to traditional surgical interventions," stated IceCure Chief Executive Officer, Eyal Shamir.
With a total population of over 200 million people, more than 500,000 new cancer cases and more than 250,000 deaths attributed to cancer each year according to the World Health Organization's Cancer Tomorrow | IARC project, Brazil has an urgent need for minimally invasive cancer treatments.
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 ProSense System is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal and Israeli securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in this press release when it discusses: the expected Class III device clearance for the probes by the end of the first quarter of 2024; the expected near-term revenues as a result of regulatory approval of ProSense in Brazil; and the potential of ProSense to offer great benefits compared to traditional surgical interventions. Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties and actual results, performance, or achievements of IceCure could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2022 filed with the SEC on March 29, 2023, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
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SOURCE IceCure Medical
midastouch017
8 months ago
IceCure Medical Continues to Experience Growing Global Interest in ProSense: Featured at the 16th Thai Breast Symposium
https://finance.yahoo.com/news/icecure-medical-continues-experience-growing-120000596.html
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. IceCure representatives, including VP of Business Development & Global Marketing, Tlalit Bussi Tel-Tzure, participated at Terumo Corporation's (Tokyo: 4543;US OTC: TRUMY) booth. Terumo is the Company's exclusive distributor of the ProSense System in Japan and Thailand.
A cryoablation symposium, "Cryoablation Emerging as Effective Treatment for Breast Cancer", was led by Professor Eisuke Fukuma, Director of the Breast Center at Kameda Medical Center, Japan.
Professor Fukuma commented, "I've performed over 600 breast tumor procedures with ProSense with excellent results. Patients have minimal pain, no change to the volume or the shape of the breast, and they can quickly resume their normal activities the day following the procedure. Because of this, many women come to my facility and seek out cryoablation. I am pleased to be here at the conference to inform and educate other doctors on how to use ProSense to benefit their patients."
Israel's Ambassador to Thailand, Orna Sagiv, added, "IceCure's breakthrough technology marks a new era in women's health treatment. This innovative solution to treat benign and malignant tumors allows for a safe and effective procedure without the trauma, pain, and scarring which has been inevitable until now. This technology represents a new hope for patients and their families facing a cancer diagnosis. The partnership between IceCure, an Israeli company, and Terumo Thailand is another manifestation of the Thai-Israeli potential for collaboration that will improve the lives of both Thais and Israelis. The Embassy of Israel supports this unique partnership and hopes it will help save many lives."
"The growing amount of data on ProSense's efficacy in treating tumors of the breast, lung, and kidney supports our sales momentum in Thailand since ProSense was approved to treat these cancers," stated Terumo Thailand's Managing Director, Panapon Chantakulchai. "Highlighting ProSense at the Thai Breast Society Symposium is very timely as the global medical community recognizes the benefits of this cost-efficient, non-invasive and effective option."
IceCure's Tlalit Bussi Tel-Tzure, commented, "We had very strong interest in ProSense both at the Terumo booth and at Professor Fukuma's talk. The awareness around cryoablation as a minimally invasive method to treat early-stage breast cancer continues to gain momentum and ProSense is extremely well positioned as the system of choice for breast surgeons. Terumo has been a great partner for us in Thailand where we expect to see growing sales momentum."
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.
Forward looking Statements
This press release contains forward looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other federal and Israeli securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward looking statements. For example, IceCure is using forward looking statement in this press release when it discusses that IceCure's breakthrough technology marks a new era in women's health treatment, that this technology represents a new hope for patients who face a cancer diagnosis, that the partnership between IceCure and Terumo Thailand will improve the lives of Thais and Israelis, that the ProSense System is well positioned as the system of choice for breast surgeons and that IceCure expects to see growing sales momentum in Thailand. Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties and actual results, performance, or achievements of IceCure could differ materially from those described in or implied by the statements in this press release. The forward looking statements contained or implied in this press release are subject to other risks and uncertainties, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2022 filed with the SEC on March 29, 2023, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
IR Contact:
Michael Polyviou
Phone: 732-232-6914
Email: mpolyviou@evcgroup.com
Todd Kerhli
Phone: 310-625-4462
Email: tkehrli@evcgroup.com
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SOURCE IceCure Medical
midastouch017
9 months ago
Health Canada Approves IceCure Medical's Minimally Invasive ProSense Cryoablation System
https://finance.yahoo.com/news/health-canada-approves-icecure-medicals-120000040.html
Strong interest in ProSense from healthcare providers in Canada strengthens market potential
ProSense now approved throughout North America
CAESAREA, Israel, July 24, 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 Health Canada, the Canadian government's regulatory agency, has approved IceCure's ProSense System, disposable cryoprobes, and introducers as cryosurgical tools for indications including:
Tumors – ablation of benign and malignant tumors of the lung, liver, kidneys, and musculoskeletal system, and benign tumors of the breast;
General surgery;
Palliative intervention; and
Other surgeries.
"As we continue to gain traction in the United States, this approval in Canada will create synergies for us in the broader North American market. We have been directly engaging with healthcare providers through education, hands-on training seminars, marketing, and sales in the U.S. and we will expand these activities into Canada. We have already been contacted by multiple Canadian healthcare providers with requests to purchase and implement ProSense," stated IceCure Chief Executive Officer, Eyal Shamir.
Canada's healthcare system is ranked as one of the top in the world, with total health spending estimated at $331 billion in 2022.
IceCure's cryoablation system currently has regulatory approval for various indications in 15 countries, including in the U.S., Europe, and China.
midastouch017
9 months ago
IceCure Medical Expands Distribution of ProSense® into Portugal Through Agreement with Medicinália Cormédica: Upfront Systems & Probes Sales
https://finance.yahoo.com/news/icecure-medical-expands-distribution-prosense-120000916.html
ProSense has CE mark of regulatory approval in the European Union
Initial purchase of 2 ProSense Systems plus disposable cryoprobes and introducers
CAESAREA, Israel, July 17, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System, that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has entered a non-exclusive distribution agreement with Medicinália Cormédica – MC Medical, Lda. ("MC Medical"), the largest distributor of third-party medical devices in Portugal and a subsidiary of Barcelona, Spain based Werfen, S.A., a world leader in specialized diagnostics operating in 30 countries. Another Werfen, S.A. company, Izasa Scientific, is a ProSense distributor in Spain. This agreement with MC Medical further expands the distribution of ProSense in Europe where the system has the European Union's CE mark of regulatory approval.
Initial purchases by MC Medical include two ProSense consoles, along with disposable cryoprobes and introducers. Healthcare professionals in Portugal will now be able to perform precise and minimally invasive cryoablation procedures for indications including malignant and benign tissue of the breast, kidney, liver, lung, and bone, as well as for palliative interventions.
"We are very pleased to partner with MC Medical to expand the availability of ProSense cryoablation into Portugal," stated Eyal Shamir, CEO of IceCure Medical. "Their dedication to quality and innovation in healthcare aligns with our aim to improve patient outcomes through minimally invasive cryoablation procedures. As the largest distributor of third-party medical devices in Portugal with a staff of 72 professionals across sales, service and support, MC Medical is extremely well equipped to drive ProSense adoption throughout Portugal."
"There is a growing interest in minimally invasive cryoablation procedures in Portugal driven by favorable patient outcomes and healthcare economics. IceCure's ProSense is the best choice for cryoablation systems on the market today. Backed by clinical data and regulatory approvals, ProSense is a system that we believe will gain rapid and wide market traction in Portugal," said Diogo Lima, General Manager of MC Medical.
About Medicinália Cormédica - MC Medical, Lda
Medicinália Cormédica- MC Medical, Lda. is a leading business partner for Medical Device distribution in Portugal with over 60 years of history and a strong track record for introducing disruptive technologies and clinical innovation. They operate with exclusivity rights to market and sell a comprehensive product portfolio from a wide range of manufacturers, with a steady footprint and expertise in areas such as anesthesia, operating rooms, interventional cardiology, cardiothoracic surgery, general surgery, vascular surgery, intensive care, homecare - ostomy, neurovascular intervention, obstetrics, oncology, ENT, biomedical simulation, wound treatment, emergency medicine, and urology.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) (TASE: 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.
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