Wednesday, October 12, 2022
IceCure Medical Ltd., developer of minimally-invasive cryoablation technology, the ProSense® System, that destroys tumors by freezing as an alternative to surgical tumor removal, today announced that its ProSense Cryoprobes and Introducers have received regulatory approval from the Brazilian Health Regulatory Agency ("ANVISA"). The application was submitted in June 2022 by KTRFIOS IMPORTACAO E EXPORTACAO LTDA, IceCure's distributor in Brazil ("KTRFIOS").
The ProSense Cryoprobes and Introducers are disposable Class II devices, per ANVISA. Essential components of the ProSense System, Cryoprobes are inserted into the patient during the cryoablation procedure to freeze tumors, and Introducers provide access to the targeted tumor tissue. As the ProSense Cryoablation System is considered a Class III medical device, the application for it was filed separately with ANVISA and is currently pending approval.
"We are very pleased to achieve this first step in the path to receiving full regulatory approval in Brazil," stated IceCure CEO, Eyal Shamir. "Working with KTRFIOS has been highly productive, and we anticipate strong demand in Brazil upon the additional pending approval of the ProSense Cryoablation System."
IceCure's distribution agreement with KTRFIOS includes the guarantee of at least $6.6 million in expected total sales during the five years following the full system's regulatory approval.