Caesarea, Israel-based Icecure Medical Ltd. has won the FDA’s nod for additional indications for its cryoablation technology, paving the way for use in kidney, liver, ear, nose and throat and new neurology indications. The agency also cleared Icecure’s new Multisense system, which allows physicians to simultaneously treat tumors with three needles. The company said it will use the greenlight to expand its operations in targeted U.S. markets.
“The additional FDA clearance is a pivotal milestone for Icecure, and we now plan to expand our operational capabilities in the addressable markets for labels with existing CPT codes and reimbursement, while driving further revenues,” said Eyal Shamir, Icecure’s CEO. “Receipt of this bundled approval is a significant step in our ability to commercialize our products in the U.S., and we believe this, along with other achievements, allow[s] us to enter 2020 with plenty of momentum and revenue generation opportunities.”
Increases capability to treat large masses
First approved by the FDA in 2010, the new clearance not only paves the way for more indications but also increases Icecure’s capacity to treat larger tumors. With the Multisense system, doctors can treat multiple tumors at once or aim all three needles at larger masses – a distinction from the single-needle Icesense3, which is more appropriate for small tumors.
According to the FDA, the Icecure Family (Icesense3, Prosense and Multisense) cryoablation system “is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures … including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.” The list of specific indications range from urology, oncology, dermatology, gynecology and ENT to thoracic surgery, proctology and general surgery. The Multisense system is indicated for three-probe configuration only.
Icecure plans to target two main markets in the U.S., breast and interventional radiology, Tlalit Bussi Tel-Tzure, Icecure’s vice president of business development and global marketing, told BioWorld MedTech. The focus in breast will be treatment of benign – fibroadenoma – breast tumors. In interventional radiology, the focus is on kidney and liver malignancies where coverage already exists. The CPT codes for kidney (50593) and liver (47383) pay $9,300 and $5,500 per procedure, respectively.
In July 2019, Icecure announced that it had secured a category III CPT code from the American Medical Association’s CTP coding committee for the use of liquid nitrogen-based cryotherapy for breast cancer. The decision had the backing of several medical societies, including the American Society of Breast Surgeons, and followed results of a study showing that cryoablation may be an effective treatment for women with small breast cancer tumors that are genetically identified as relatively nonaggressive.
Icecure currently sells its products both directly in the U.S. and through a distributor, and Tel-Tzure said the plan is to grow both of those channels.
Looking to Asian markets
In addition to the U.S., Icecure’s minimally invasive cryoablation technology is authorized in Israel and CE mark countries. The company is currently applying for registration in Japan via its exclusive distributor, Terumo Corp. The agreement, valued at $13.2 million, provides Terumo with exclusive rights to market Prosense and its consumables in Japan. Terumo also agreed to buy 10 Prosense systems and consumables for use in clinical trials to support regulatory approvals and to manage the approval process in Japan.
Icecure also recently received regulatory approval in Thailand, as well as initial registration to market its probes in China. The company’s systems and needles are being used to freeze breast cancer tumors in an independent trial in China.
Founded in 2006, Icecure has raised about $14 million in venture capital, according to public filings, and currently lists on the Israeli stock exchange, having secured $10 million in a 2011 IPO.
There is plenty of competition in the cryotherapy space, which is expected to hit $319 million worldwide by 2024. Boston Scientific Corp. snapped up U.K.-based BTG plc (British Technology Group) in 2018, shortly after it clinched a Health Canada license for its Icefx cryoablation device. Last year also saw the acquisition of Austin-based Endocare Inc. by Varian Medical Systems. Endocare develops hardware and software solutions to support cryoablation and microwave ablation. Also in the field is Cryotherapeutics GmbH, a Potsdam, Germany-based startup that is developing a cryotherapy system to prevent heart attacks. In June, the company raised €7 million (US$7.8 million) to support clinical studies and further product development.