April 28, 2020
IceCure Continues Global Expansion of ProSense Cryoablation System With Approval in India
April 28, 2020—IceCure Medical announced regulatory approval in India for the sale and marketing of the company’s next-generation, liquid nitrogen–based ProSense system and associated products for the destruction of benign and cancerous tumors by cryoablation in extensive indications, including breast, lung, bone, kidney cancer, and more. Additionally, IceCure advised it has entered into an exclusive agreement to distribute its products in the New Delhi area, with product delivery expected at the end of 2020.
The ProSense system has received FDA 510(k) and CE Mark clearance. The company plans to continue its marketing efforts to bring its cryoablation technology to additional markets and is working to obtain regulatory approvals and extend tumor treatment indications into additional organs.
On April 22, IceCure Medical announced an exclusive distribution agreement with MTS Medical Technology in Germany. Under the agreement, MTS Medical will purchase a minimum quantity of ProSense products and consumables no later than the end of March 2021. The agreement is valid for an initial period of 18 months; should minimum quantities be met, it could be extended for an additional 3-year period.
The company also recently announced the expansion of its distribution territory into Singapore under a strategic agreement with Terumo Corporation. Additionally, it will introduce the ProSense system in Thailand with installation at Bumrungrad International Hospital in Bangkok.
“IceCure’s innovative minimally invasive ProSense cryoablation system is consistent with our strategy to adopt cutting-edge, world-class technologies to advance patient care,” commented Jeremy Ford, Laboratory Research & Technology Director from Bumrungrad International Hospital. “By reducing operating room procedures, the ProSense system brings significant benefits in enabling a safe and effective alternative treatment for our oncology patients.”
In January, the company announced FDA clearance of expanded indications to market its cryoablation technology for the treatment of cancerous and benign tumors of the kidney; liver; ear, nose, and throat; and further neurology indications.