Full Press Release Details
IceCure Medical's ProSense Cryoablation
System Receives Regulatory Approval in Brazil
CAESAREA, Israel, September 5, 2023 --
IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation
technology, the ProSense System, that destroys tumors by freezing as an alternative to surgical tumor removal, today announced that
its ProSense System has received regulatory approval as a Class III device from the Brazilian Health Regulatory Agency ("ANVISA").
ProSense's disposable cryoprobes and introducers, were previously registered as Class II devices by ANVISA. Applications for both
the ProSense System and its disposable cryoprobes and introducers were submitted to ANVISA by IceCure's distributor in Brazil,
Ktrfios Importa o e Exporta o
ProSense's indications approved by ANVISA
are oncology, which includes the ablation of benign and malignant tissues in the breast, prostate, kidney, lung, liver, musculoskeletal,
and skin tissue, as well as for palliative intervention and other indications.
Healthcare providers are cleared to conduct procedures
with ProSense, its introducers and disposable probes, and Ktrfios is cleared to both market and sell ProSense's introducers and
disposable probes. ANVISA has assessed that the probes, which were initially registered as a Class II device under ANVISA rules, are to
be transitioned to a Class III device and aligned with the Brazilian regulatory system classification for the same class as ProSense.
Therefore, ANVISA has requested that the probes also be submitted by Ktfrios for regulatory approval as a Class III device. The introducers
remain a Class II device and do not require an additional regulatory submission. Class III device clearance for the probes is expected
to be finalized by the end of the first quarter of 2024.
"We are very pleased that ProSense has received
regulatory approval in Brazil. We expect this to translate into near-term revenues. Early indications of market interest point to strong
demand in the largest market in South America where cost-effective, minimally invasive, safe, and effective cryoablation procedures can
offer great benefits compared to traditional surgical interventions," stated IceCure Chief Executive Officer, Eyal Shamir.
With a total population of over 200 million people,
more than 500,000 new cancer cases and more than 250,000 deaths attributed to cancer each year according to the World Health Organization's
Cancer Tomorrow | IARC project, Brazil has an urgent need for minimally invasive cancer treatments.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM)
develops and markets ProSense , an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous)
by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and
effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The ProSense System
is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.
Forward Looking Statements
This press release contains
forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform
Act of 1995 and other Federal and Israeli securities laws. Words such as "expects," "anticipates," "intends,"
"plans," "believes," "seeks," "estimates" and similar expressions or variations of such
words are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in this press release
when it discusses: the expected Class III device clearance for the probes by the end of the first quarter of 2024; the expected near-term
revenues as a result of regulatory approval of ProSense in Brazil; and the potential of ProSense to offer great benefits compared to traditional
surgical interventions. Because such statements deal with future events and are based on IceCure's current expectations, they are
subject to various risks and uncertainties and actual results, performance, or achievements of IceCure could differ materially from those
described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release
are subject to other risks and uncertainties, many of which are beyond the control of the Company, including those set forth in the Risk
Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2022 filed with the SEC on March 29,
2023, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company
undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.