Monday, January 20, 2020 7:46:47 PM
Following the additional U.S. Food and Drug Administration (FDA) clearance for its Cryoablation Technology, IceCure Medical Ltd. (TASE: ICCM), an Israeli medical device company, developers of a non-surgical Liquid Nitrogen (LN2) cryoablation technology to destroy benign and cancerous tumors by freezing, plans to significantly extend its U.S. operations in target markets for indications with existing CPT codes and reimbursement. The new FDA clearance will enable the Company to market its solution for the treatment of cancerous and benign tumors of the Kidney; Liver; Ear, Nose and Throat (ENT); and further neurology indications.
Company Profile
7 Ha'Eshel St.
Caesarea 3088900
Israel
972 4 623 0333
http://www.icecure-medical.comSector:
Industry:
Full Time Employees:
IceCure Medical Ltd develops and markets minimally invasive cryoablation therapies for women's health and oncology markets. The company offers ProSense system, a cryoablation solution for breast tumors. IceCure Medical Ltd was founded in 2006 and is headquartered in Caesarea, Israel.
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IceCure Receives FDA Clearance for Expanded Indications of Cryoablation Technology and Regulatory Approval of New MultiSense System; Plans to Increase U.S. Presence and Operations
PR Newswire PR Newswire•January 7, 2020
Expands Use of Cryoablation Technology to Treat Liver and Kidney Tumors
CAESAREA, Israel, Jan. 7, 2020 /PRNewswire/ -- Following the additional U.S. Food and Drug Administration (FDA) clearance for its Cryoablation Technology, IceCure Medical Ltd. (TASE: ICCM), an Israeli medical device company, developers of a non-surgical Liquid Nitrogen (LN2) cryoablation technology to destroy benign and cancerous tumors by freezing, plans to significantly extend its U.S. operations in target markets for indications with existing CPT codes and reimbursement. The new FDA clearance will enable the Company to market its solution for the treatment of cancerous and benign tumors of the Kidney; Liver; Ear, Nose and Throat (ENT); and further neurology indications.
"The additional FDA clearance is a pivotal milestone for IceCure and we now plan to expand our operational capabilities in the addressable markets for labels with existing CPT codes and reimbursement, while driving further revenues," commented Eyal Shamir, CEO of IceCure Medical. "Receipt of this bundled approval is a significant step in our ability to commercialize our products in the U.S., and we believe this along with the other achievements, allow us to enter 2020 with plenty of momentum and revenue generation opportunities."
The new 510K clearance broadens IceCure's previous general FDA approval, and allows the Company to market, advertise and sell its advanced non-surgical cryoablation products for the treatment of new specific indications. This is particularly beneficial for the treatment of kidney and liver tumors where there is already existing CPT codes and reimbursement. Additionally, the approval includes clearance for its new MultiSense system, which will allow treatment with three needles in unison. Not only does this will help to reduce the length of procedures, it will also be highly advantageous in improving the treatment of multiple tumors as well as for larger masses. The general approval previously given to its IceSense3 system enabled one needle treatment that was ideal for small tumor masses. The new approval given relates to all of the company's cryoablation systems (IceSense3™, ProSense™ and MultiSense), including its accompanying products (needles and accessories) and software updates.
The additional FDA approval follows several recent key achievements:
Received an order to supply systems and needles to freeze breast cancer tumors for an independent trial by a leading Chinese hospital
Initial registration to market the Company's probes in China
Regulatory approval in Thailand
Entered into a a strategic agreement with the leading global Japanese medical device company, Terumo Corporation (Tokyo: 4543) (TRUMY: OTC US), for a minimum of US $13.2 million.
Sharon Levita, a medical device veteran and former CFO of Mazor Robotics, joined the Company's Board of Directors. M. Levita brings extensive financial and business management experience in developing successful companies
CPT III code approved by the American Medical Association (AMA) to support further adoption of IceCure's minimally invasive cryoablation treatments for breast cancer
The Company's Chief Executive Officer, Eyal Shamir and Chief Financial Officer, Ronen Tsimerman, will be meeting investors in San Francisco on Monday and Tuesday, January 13th and 14th. Investors and analysts should contact Michael Polyviou at mpolyviou@evcgroup if they would like to schedule a one-on-one meeting.
About IceCure Medical
Founded in 2006, IceCure Medical (TASE: ICCM) is an Israeli medical device company that develops and markets an advanced liquid-nitrogen-based cryoablation therapy for women's health and the interventional oncology market, with the primary focus areas being breast, kidney and lung cancer. Its technology is a safe, effective, non-invasive alternative to surgical tumor removal that is easily performed in a short procedure. The system has US FDA 510k and CE Mark clearance and is sold worldwide. The company has a wholly-owned subsidiary in the United States, IceCure Medical Inc., with offices in New Jersey. To learn more, please visit: www.icecure-medical.com.
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
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