January 7, 2020
IceCure Receives FDA Clearance for Expanded Indications of Cryoablation Technology and Approval of MultiSense System
January 7, 2020—IceCure Medical Ltd. announced FDA clearance of expanded indications for the company’s cryoablation technology. The Israeli company plans to significantly extend its United States operations in target markets for indications with existing CPT codes and reimbursement.
According to IceCure Medical, 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; and further neurology indications. The company’s nonsurgical liquid nitrogen (LN2) cryoablation technology destroys benign and cancerous tumors.
The company explained that the new clearance broadens the previous general FDA approval and allows the company to market its advanced nonsurgical cryoablation products for the treatment of new specific indications, which 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 IceCure’s new MultiSense system, allowing treatment with three needles in unison, which is intended to help reduce the length of procedures and to improve the treatment of multiple tumors as well as for larger masses.
The general approval previously given to the company’s 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, advised IceCure Medical.