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
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.
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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
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