Followers | 145 |
Posts | 27565 |
Boards Moderated | 3 |
Alias Born | 02/07/2004 |
Tuesday, September 05, 2023 8:06:41 AM
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
Logo - https://mma.prnewswire.com/media/1941429/IceCure_Logo.jpg
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/icecure-medicals-prosense-cryoablation-system-receives-regulatory-approval-in-brazil-301917626.html
SOURCE IceCure Medical
Recent ICCM News
- 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 • PR Newswire (US) • 04/15/2024 12:35:00 PM
- 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 • PR Newswire (US) • 04/03/2024 12:30:00 PM
- U.S. Futures Dip in Pre-Market, May WTI and June Brent Crude Prices Edge Higher • IH Market News • 04/03/2024 11:11:59 AM
- IceCure Submits FDA Regulatory Filing for New XSense™ Cryoablation System with Cryoprobes • PR Newswire (US) • 04/02/2024 12:30:00 PM
- IceCure Medical to Report 2023 Full Year Financial & Operational Results on April 3, 2024 • PR Newswire (US) • 03/27/2024 12:30:00 PM
- 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 • PR Newswire (US) • 03/19/2024 12:30:00 PM
- IceCure Receives Notice of Patent Allowance in Japan for a Novel Cryogen Flow Control to Optimize Patient Outcomes • PR Newswire (US) • 03/12/2024 12:30:00 PM
- IceCure Medical to Present at 34th Annual Oppenheimer Healthcare MedTech & Services Conference • PR Newswire (US) • 03/07/2024 01:30:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 03/04/2024 01:35:29 PM
- IceCure's ProSense® a Promising Alternative Treatment for Extra-Pelvis Endometriosis: Independent Study Presented at ECR 2024 • PR Newswire (US) • 03/04/2024 01:30:00 PM
- Fourth BRIIT Conference in India Features IceCure's ProSense® in Breast Cancer Imaging & Interventions Workshop • PR Newswire (US) • 02/27/2024 01:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 02/26/2024 01:15:29 PM
- Study Using IceCure's ProSense® Treatment Results in 100% Tumor Reduction in Early-Stage Breast Cancer • PR Newswire (US) • 02/26/2024 01:00:00 PM
- IceCure's ProSense® to be Featured at Two Upcoming Medical Conferences in Japan • PR Newswire (US) • 02/15/2024 01:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 01/30/2024 01:15:02 PM
- U.S. FDA Grants IceCure Medical's Appeal: Reopens De Novo Classification Request for Marketing Authorization of ProSense® for Early-Stage Breast Cancer • PR Newswire (US) • 01/30/2024 01:00:00 PM
- 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 • PR Newswire (US) • 01/29/2024 01:00:00 PM
- IceCure Medical's ProSense® Featured at Indian Society of Vascular and Interventional Radiology Conference: Key Opinion Leaders Highlight Benefits of Cryoablation • PR Newswire (US) • 01/16/2024 01:00:00 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 01/12/2024 09:39:23 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 01/12/2024 09:18:50 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 01/12/2024 09:10:20 PM
- IceCure Medical Regains Compliance with Nasdaq Minimum Closing Bid Price Rule • GlobeNewswire Inc. • 01/12/2024 09:05:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 01/10/2024 01:15:26 PM
- IceCure Medical CEO Issues Letter to Shareholders & Reports Increase in Sales in Preliminary Unaudited 2023 Results • PR Newswire (US) • 01/10/2024 01:00:00 PM
- New Study Reports IceCure's ProSense® Boosts Immune Response Against Cancer: Enhances CD8+ T Cell Response • PR Newswire (US) • 01/03/2024 01:00:00 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM