IceCure Medical has announced an exclusive distribution agreement with global medical company, Terumo Corporation. The new agreement will accelerate the commercialization of its ProSense™ cryoablation system and associated consumables to treat malignant breast tumors in Japan and Singapore.
Under the terms of the agreement, in exchange for granting exclusive distribution rights and obtaining regulatory approvals for ProSense™ and its consumables, Terumo will commit up to USD $2 million. This will include a one-time, up-front payment of USD $1 million to IceCure 30-days after signing the agreement and the remainder in milestones.
The agreement also comprises Terumo's undertaking to purchase 10 ProSense™ system consoles and consumables at the time of signing for use in clinical trials to support regulatory filing.
Terumo will also be responsible for, and incur costs for, obtaining all regulatory approvals and insurance indemnifications in Japan, with regulatory rights owned by Terumo. Initial regulatory approval is anticipated in Japan in a few years.
"We are excited to partner with Terumo, a leading global medical company, in this milestone agreement,” Eyal Shamir, IceCure's CEO, said. “With Terumo's proven medical distribution network and the necessary sales and marketing expertise, this new partnership will support rapid commercialization of our cryoablation solution in Japan and Singapore, pending regulatory approval."
"The ProSense™ system has already demonstrated excellent progress as a rapid, in-office solution for the treatment of breast tumors. With its expanding clinical data as a non-surgical alternative to treat cancer, the innovative ProSense™ system makes an exciting addition to our portfolio to address key unmet needs and improve patient outcomes," said Tsuyoshi Tomita, Group Manager, General Hospital Products Group, Terumo.