U.S. Food and Drug Administration Grants Regulatory Clearance to IceCure for Next-Gen XSense™ Cryoablation System with CryoProbes
IceCure Medical announced that the FDA has granted regulatory clearance for its next-generation XSense™ Cryoablation System with CryoProbes. The system, which uses extreme cold to destroy tissues, is cleared for the same indications as its predecessor, ProSense®. These include applications in general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The technology addresses conditions such as fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions, and warts. CEO Eyal Shamir stated that this clearance validates the safety and efficacy of the platform, potentially enabling the system to address unmet medical needs in the U.S.
- FDA regulatory clearance for the next-generation XSense™ Cryoablation System with CryoProbes.
- Same indications cleared as the flagship ProSense® system, broadening clinical applications.
- Potential to address unmet medical needs in the U.S.
- None.
The FDA's regulatory clearance for IceCure's XSense™ Cryoablation System marks a significant milestone for the company and the industry. This approval signifies that the system has met stringent safety and efficacy standards set by the FDA, which is a positive indicator for the technology's reliability. It’s noteworthy that the new system is designed to treat a range of conditions similar to its predecessor, ProSense®, including various types of tumors and skin lesions. This broad application potential could position IceCure’s technology as a versatile tool in multiple medical fields.
In the short term, this clearance may lead to increased adoption by healthcare providers looking for minimally invasive options, thereby expanding IceCure's market reach in the United States. In the long term, the technology's ability to address
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"This latest FDA regulatory clearance further validates the safety and efficacy of our platform cryoablation technology," commented Eyal Shamir, IceCure's Chief Executive Officer. "The next-generation XSense™ system is cleared for the same indications as our flagship ProSense® system and we believe it has future potential to address other indications in the
XSense™ and its cryoprobes are cleared for all of the indications for which ProSense® has already received the requisite FDA clearance, including general minimally invasive cryoablation in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology and urology. The system is designed to destroy tissue by the application of extreme cold temperatures, including fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions and warts.
About IceCure's Cryoablation Systems
IceCure's platform technology, including the ProSense® Cryoablation System and XSense™ Cryoablation System and CryoProbes, provides a minimally invasive treatment option to destroy tumors by freezing them. The systems uniquely harness 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.
IceCure's cryoablation systems enhance patient and provider value by accelerating recovery, reducing pain, surgical risks and complications. With easy, transportable design and liquid nitrogen utilization, ProSense® and XSense™ open the door to fast and convenient office-based procedure for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems 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 Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the
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 statements in this press release when it discusses the belief that XSense™ has future potential to address other indications in the
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SOURCE IceCure Medical
FAQ
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