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IceCure Medical Receives Regulatory Approval in China for Commercial Use of its IceSense3 Disposable Cryoprobes This approval allows the use of the IceSense3 disposable cryoprobes in combination with the Company's IceSen

Key Takeaway: IceCure Medical has received regulatory approval from China's National Medical Products Administration for its IceSense3 disposable cryoprobes, enabling commercial use alongside the previously approved IceSense3 console. This marks a significant advancement for the company's minimally invasive cryoablation technology targeting various types of tumors, including those of the breast, lung, and kidneys. With approximately 430,000 new breast cancer cases reported in China in 2022, IceCure sees a promising market opportunity. The company anticipates monetizing its distribution agreements effectively following this approval.

Market Sentiment Analysis

POSITIVE FACTORS

  • IceCure Medical received regulatory approval for its IceSense3 cryoprobes in China.
  • The approval opens access to a significant healthcare market with an increasing number of cancer cases.
  • The company's technology offers a minimally invasive alternative to traditional tumor removal surgeries.
  • Expected commercialization could lead to effective monetization of distribution agreements in China.

Full Press Release Details

IceCure Medical Receives Regulatory Approval
in China for Commercial Use of its IceSense3 Disposable Cryoprobes
CAESAREA, Israel, March 28, 2023 -- IceCure
Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation
technology, the ProSense System (marketed under the brand name IceSense3 in China), that destroys tumors by freezing as
an alternative to surgical tumor removal, today announced the National Medical Products Administration ("NMPA") of China approved
the Company's IceSense3 disposable cryoprobes for commercial use, to be used in combination with the Company's IceSense3 console,
which was previously approved by the NMPA.
With this latest approval, the Company and its
partners in China can address a significant market with its novel and proven technology to treat malignant and benign tissue of the breast,
lung, bone, liver, and kidneys, as well as palliative interventions.
"With approximately 430,000 new breast cancer
cases in 2022 alone, and a healthcare system readily adopting new technologies that produce improved outcomes, we see China as a prime
market for our cryoablation system," stated Eyal Shamir, IceCure's Chief Executive Officer. "Having received regulatory
approval for commercial sales of both our console and cryoprobes, we expect to effectively monetize our distribution agreement in the
IceCure Medical Ltd. (Nasdaq:
ICCM) (TASE: 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 to date by the U.S. Food and Drug Administration and approved in Europe with
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 addressing a significant market with its novel and proven technology to treat malignant and benign tissue of the breast,
lung, bone, liver, and kidneys, as well as palliative interventions, seeing China as a prime market for its cryoablation system, and its
expectation to effectively monetize its distribution agreement in the Chinese market. 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, 2021 filed with the SEC on April 1, 2022, which is 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 recent approval did IceCure Medical receive in China?

IceCure Medical was approved for commercial use of its IceSense3 disposable cryoprobes.

What does the IceSense3 technology treat?

IceSense3 treats malignant and benign tissue in the breast, lung, bone, liver, and kidneys.

Who is the CEO of IceCure Medical?

Eyal Shamir is the CEO of IceCure Medical.

What type of procedure is IceCure's technology considered?

IceCure's technology is a minimally invasive procedure for tumor treatment.

Where is the IceSense3 console already approved?

The IceSense3 console has already received approval in China.

Last updated: Mar 28, 2023