IceCure Submits FDA Regulatory Filing for New XSense™ Cryoablation System with Cryoprobes

Rhea-AI Summary

IceCure Medical files 510(k) submission with the FDA for its next-generation single probe cryoablation system, XSense™ System, and cryoprobes. The submission aims to expand the indications for minimally invasive cryoablation applications, building on the success of the ProSense® System. IceCure continues to lead in liquid nitrogen-based cryoablation technologies, focusing on innovation and market expansion.

Medical Research Analyst

The filing of a 510(k) submission by IceCure Medical Ltd. for FDA clearance of its XSense™ System represents a strategic move to expand its product offerings within the minimally invasive surgery market. The XSense™, being an evolution of the existing ProSense® system, aims to streamline the cryoablation process and potentially offer enhanced performance. The focus on indications already cleared for ProSense® suggests a calculated approach to leverage existing regulatory approvals, which may streamline the clearance process.

From a medical research perspective, the clinical efficacy and safety data of the ProSense® system will likely be scrutinized to predict the potential market adoption of the XSense™. Additionally, the cost-efficiency and patient outcomes associated with this technology will be key factors in determining its impact on healthcare systems and its competitive edge in the market. As minimally invasive procedures continue to gain preference over traditional surgeries due to lower risks and quicker recovery times, technologies like the XSense™ could see increased demand.

Healthcare Economist

The submission for FDA clearance of IceCure's XSense™ System could have economic implications for the healthcare industry, particularly if it offers a cost-efficient alternative to surgical tumor removal. If the system can deliver on its promise of safety and effectiveness, it may lead to a reduction in overall healthcare costs due to shorter hospital stays, less need for anesthesia and quicker patient recovery times compared to traditional surgery.

Furthermore, the potential to use the system across multiple indications, such as kidney, liver and neurological applications, broadens the market opportunity. This could lead to a shift in the standard of care for tumor treatments, potentially disrupting the market for more invasive procedures. The long-term economic impact will depend on the system's adoption rate, reimbursement policies and the outcomes of clinical studies validating its use.

Market Research Analyst

IceCure's announcement regarding the 510(k) submission for its XSense™ System is likely to be closely monitored by investors and competitors alike. The market for minimally invasive surgical solutions is growing and IceCure's positioning as a leader in liquid nitrogen-based cryoablation technologies could be further solidified with the approval and successful commercialization of XSense™.

Market traction of the ProSense® system provides a foundation for the XSense™, but investor confidence will hinge on the FDA's response to the submission and subsequent market adoption. The company's ability to navigate the regulatory landscape and capitalize on the growing demand for minimally invasive treatments will be critical. The stock market response to such announcements can be speculative; however, sustained interest will depend on tangible progress, such as clearance confirmation, partnerships and sales figures post-launch.

Continuous innovation as a global leader in minimally invasive liquid-nitrogen based cryoablation systems

CAESAREA, Israel, April 2, 2024 /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 it has filed a 510(k) submission with the United States Food and Drug Administration ("FDA") for clearance of its next-generation single probe cryoablation system, the XSense™ System and cryoprobes. The filing contains a request for clearance for all of the indications for which ProSense® has already received the requisite FDA clearance, including general minimally invasive cryoablation applications for the kidney, liver, fibroadenomas and neurology.

This new application for IceCure's next-generation single probe XSense™ with cryoprobes is based on the current clearance of the ProSense® System, and is being processed separately from the Company's De Novo application for the breast cancer indication.

"As our ProSense® single probe cryoablation system builds market traction globally, we continue to develop our technology pipeline with innovative single and multi-probe systems," stated IceCure CEO Eyal Shamir. "We believe IceCure is the technological, clinical and market leader in liquid nitrogen-based cryoablation technologies that can have a significant beneficial impact on global healthcare systems by offering safe, effective, patient-friendly and cost-efficient alternatives to more invasive surgical procedures."

About ProSense®

The ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.

ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens that door to fast and convenient office-based procedure for breast tumors.

About IceCure Medical

IceCure Medical (Nasdaq: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.

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 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 Company's continual development of its technology pipeline and the belief that the Company is a leader in liquid nitrogen-based cryoablation technology. Historical 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. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors 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/2319310/IceCure_Medical_Logo.jpg

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SOURCE IceCure Medical

FAQ

What is IceCure Medical 's ticker symbol?

IceCure Medical 's ticker symbol is ICCM.

What technology does IceCure Medical specialize in?

IceCure Medical specializes in minimally invasive liquid-nitrogen based cryoablation systems.

What is the name of IceCure Medical 's next-generation single probe cryoablation system?

IceCure Medical 's next-generation single probe cryoablation system is called XSense™ System.

What is the purpose of IceCure Medical 's 510(k) submission to the FDA?

IceCure Medical 's 510(k) submission to the FDA aims to obtain clearance for its XSense™ System and cryoprobes for various minimally invasive cryoablation applications.

Which indications are included in IceCure Medical 's 510(k) submission?

The indications included in IceCure Medical 's 510(k) submission are for the kidney, liver, fibroadenomas, and neurology applications.