Cryoablation technology firm Icecure Medical Ltd. raised $6 million (₪20.7 million) in an oversubscribed equity offering. The Caesarea, Israel-based company (TASE:ICCM) plans to use the funds for continued expansion of operations in the U.S., Europe and Asia.

“We see the completion of an oversubscribed fundraise in the current market as a vote of confidence by the main shareholder and the investing public in the company and the management's capability to create long-term value,” said Icecure CEO Eyal Shamir.

Investors included Rosario Capital, Yair Capital Issuing and Finance Ltd.; Apax Underwriters and Offerings; offering consultants Yaron Iluz and Naor al-Hai; as well as attorneys Reut Alfia, Oded Har Even, and Gal Cohen from the international law firm Sullivan; and members of the company’s executive team.

The Prosense system has clearance from the U.S. FDA for use in benign breast tumors, and for both benign and malignant tumors in kidney, liver, neurologic, and ear, nose and throat cancers, according to Tlalit Bussi Tel-Tzure, vice president of business development and global development. The system has CE mark for the same applications plus breast cancer and is also commercially available in Hong Kong, Thailand, Singapore, Central America, and South America.

"Icecure's Prosense cryoablation systems are already helping patients suffering from cancerous and benign tumors on a global scale, with clinical results demonstrating significant success in tumor destruction," Shamir said.

The company posted strong preliminary (unaudited) financial results for the first half of 2020, with revenue of ₪6.5 million (US$1.91 million) more than three times the comparable period in 2019 and 13% higher than the full year 2019 revenue.

The technology

The Prosense system uses closed circuit non-surgical liquid nitrogen cryoablation technology that destroys tumors in a clinic setting in under an hour without the need for general anesthesia. Tumor tissue is frozen with an ultra-slim probe. A freeze-thaw-freeze cycle destroys the tumor, while leaving the healthy surrounding tissue untouched. The body absorbs the dead tissue over time.

“The procedure is an image-guide one, i.e., for breast application, the procedure is done under ultrasound imaging. For interventional radiology applications, the procedure is performed under CT imaging, so that the physician is monitoring the tumor freezing process on the ultrasound/CT monitor,” Tel-Tzure explained.

The procedure takes 20 to 40 minutes and patients are released to their homes for recovery.

The global pandemic has boosted interest for the system. “Recently we are seeing global demand and increased usage across Europe and Asia for breast cancer usage as an alternative to lumpectomy, especially during COVID as the procedure is done in an office setting and doesn’t require a hospital stay nor general anesthesia. It is our estimation that once we complete the ICE3 trial and gain U.S. FDA clearance for breast cancer, the U.S. market will follow as well,” Tel-Tzure said.

U.S. trial

The company is conducting the ICE3 multilocation controlled clinical trial in the U.S. for patients with small, low-risk, early stage malignant breast tumors. The tumors are treated with cryoablation, but not subsequently removed.

Begun in 2014, the trial has so far enrolled and treated 200 women over age 50 in 19 hospitals and medical centers including Columbia University Medical Center and Mount Sinai Beth Israel. Of those, 78 were followed for at least two years.

In a presentation at the American Society of Breast Surgeons conference in 2018, Icecure provided interim results on 146 patients and noted that only one patient experienced cancer recurrence. More than three-quarters of patients resumed full daily activities within 48 hours. No patients had significant device-related complications and 95% reported patient and physician satisfaction with the cosmetic results, the company said.

“Improved screening allows physicians to identify breast cancer earlier, when it’s smaller. Advances in molecular profiling [tumor biology] help us better determine which breast cancers have higher or lower risks of recurrence. We can then individualize approaches to treatment,” said the study’s principal investigator Richard Fine, director of education and research at West Cancer Center’s Comprehensive Breast Center, in Germantown, Tenn. “Now with the ICE3 study, we may have the first effective non-surgical treatment option for some low risk patients.”

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