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Health Canada Approves IceCure Medical's Minimally Invasive ProSense Cryoablation System Strong interest in ProSense from healthcare providers in Canada strengthens market potential ProSense now approved throughout North

Key Takeaway: IceCure Medical's ProSense Cryoablation System has received regulatory approval from Health Canada, allowing it to be marketed as a minimally invasive tool for tumor destruction. The company anticipates that this approval will facilitate synergies in the broader North American market, as demand from Canadian healthcare providers has already been noted. The ProSense System, which utilizes liquid nitrogen for cryoablation, has existing approvals in 15 countries, including the U.S., Europe, and China. This expansion into Canada is expected to enhance IceCure's visibility and sales potential in North America.

Market Sentiment Analysis

POSITIVE FACTORS

  • Health Canada has approved IceCure's ProSense System, enhancing its market presence.
  • Strong interest from Canadian healthcare providers indicates high demand for ProSense.
  • The approval opens new sales and marketing opportunities in the North American market.

Full Press Release Details

Health Canada Approves IceCure Medical's
Minimally Invasive ProSense Cryoablation System
CAESAREA, Israel, July 24, 2023 -- IceCure
Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense System, a minimally-invasive
cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced that Health Canada,
the Canadian government's regulatory agency, has approved IceCure's ProSense System, disposable cryoprobes, and introducers as cryosurgical
tools for indications including:
"As we continue to gain traction in the United
States, this approval in Canada will create synergies for us in the broader North American market. We have been directly engaging with
healthcare providers through education, hands-on training seminars, marketing, and sales in the U.S. and we will expand these activities
into Canada. We have already been contacted by multiple Canadian healthcare providers with requests to purchase and implement ProSense,"
stated IceCure Chief Executive Officer, Eyal Shamir.
Canada's healthcare system is ranked as
one of the top in the world, with total health spending estimated at $331 billion in 2022.
IceCure's cryoablation system currently
has regulatory approval for various indications in 15 countries, including in the U.S., Europe, and China.
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 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 statement in this press release
when it discusses how Health Canada's regulatory approval will create synergies for the Company in the North American market and
how the Company will expand education, hands-on training seminars, marketing, and sales into Canada.
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.

Frequently Asked Questions

What technology does IceCure Medical's ProSense System use?

The ProSense System utilizes cryoablation technology to freeze and destroy tumors.

Which regulatory agency approved the ProSense System in Canada?

Health Canada approved IceCure Medical's ProSense System as a cryosurgical tool.

What types of cancer can the ProSense System treat?

The ProSense System treats various tumors, focusing on breast, kidney, bone, and lung cancers.

Is the ProSense System approved in other countries?

Yes, it has regulatory approval in 15 countries, including the U.S., Europe, and China.

How does IceCure plan to expand into Canada?

IceCure will engage Canadian healthcare providers through education and training efforts.

Last updated: Jul 24, 2023