Coming off a $14.5 million public offering, IceCure has secured patent protection in the European Union, and now Japan. The company said it also has patents pending in other major markets, including the United States.
Based in Caesarea, Israel, IceCure’s ProSense System, designed to destroy tumors by freezing. The cryogenic pump is submersible in liquid nitrogen, works in a closed circuit, improves the cooling rate during a procedure, and is designed to be used for multiple procedures or longer-duration procedures without the need to refill liquid nitrogen. The pump also enables temperature control of the cryoprobe, as well as the use of a wider range of cryoprobes and catheters, IceCure said.
“We believe the cryogen pump will be instrumental in enabling practitioners to perform longer-term and multiple procedures more efficiently, as well as allowing for the expansion of cryoablation treatment to more clinical applications in the future,” said CEO Eyal Shamir. “This additional IP in Japan supports our distribution agreement with Terumo for our cryoablation systems in Japan.”
In late December, IceCure reported the closing of its “best efforts” offering of 8,787,880 shares of the company’s ordinary shares priced at the market under Nasdaq rules at a price to the public of $1.65 a share. The gross proceeds of the offering to the company were about $14.5 million, before deducting placement agent fees, commissions, and other estimated offering expenses.
The company intends to use the net proceeds from the offering to fund the development of its next-generation single probe and MultiSense systems, collecting clinical data, adding regulatory approvals in new territories and indications, business development, marketing and selling activities, and for working capital and general corporate purposes.
IceCure Medical’s other key achievements in 2022
- Submitted for regulatory approvals in Canada and Vietnam, and filed a de novo classification request with FDA for its cryogenic pump seeking breakthrough indication for early-stage, low-risk breast cancer patients at high risk of surgery.
- Received regulatory approval in Brazil.
- Received the assignment of a $3,400 CPT category III code from the Centers for Medicare & Medicaid Services for breast cancer cryoablation procedures for facility fees.
- In China, the company entered into an exclusive distribution agreement with Shanghai Medtronic Zhikang Medical Devices (an affiliate of Medtronic), and Beijing Turing Medical Technology.
- Reported interim data from its ICE3 study. In that study there were six cases of ipsilateral breast tumor recurrence out of 194 patients, or 3.09%. The company also noted that interim analysis from its ICESECRET study found the ProSense was safe and effective in treating kidney tumors with an 89.5% recurrence-free rate. Additionally, ProSense for breast cancer was featured in a poster presentation at the Radiological Society of North America’s (RSNA) annual meeting. Two articles featuring ProSense were published in medical journals; one article published in Cancers studied the feasibility and safety of ProSense for kidney, bone, liver, lung, and soft tissue and the other article from Clinics in Oncology studied the use of liquid nitrogen based cryoablation with ProSense in the treatment of metastatic lung cancer.
Original Article: (https://www.mddionline.com/regulatory-quality/icecure-strengthens-ip-cryogenic-pump)