Full Press Release Details
Regulatory Filing in Vietnam for Approval of ProSense
Company is rapidly expanding its global regulatory
and commercial reach
CAESAREA, Israel, August 29, 2022 -- IceCure
Medical Ltd. (NASDAQ: ICCM) (TASE: 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
it has submitted a regulatory filing with the Department of Medical Equipment and Construction ("DMEC") of Vietnam's
Ministry of Health for the ProSense System and accessories.
The application covers indications including benign
and malignant breast tumors, benign and malignant lung tumors, benign and malignant liver tumors, kidney cancer, ablation of cancerous
or malignant tissue, musculoskeletal tumors, and other indications.
Vietnam's medical device market was valued
at $1.4 billion in 2019 and was projected to grow 10% annually through 2024, according to the U.S. Department of Commerce, with overall
healthcare expenditures in the country totaling $17 billion. Liver, lung, and breast cancer were the three most prevalent cancers in Vietnam
in 2020 according to the World Health Organization.
"Asia is a significant market for ProSense
and Vietnam is one of the fastest growing healthcare markets in the region. Having started the regulatory process in Vietnam, we anticipate
high interest from potential distributors in the country," stated IceCure CEO, Eyal Shamir. "This comes on the heels of our
recent successes in the region with Shanghai Medtronic Zhikang Medical Devices Co. Ltd. in China and Terumo in Japan, Singapore, and Thailand."
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 the CE Mark.
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 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 its regulatory approval process in Vietnam for various indications through the Ministry of Health's DMEC, potential
high interest from potential distributors in the country. 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 Securities Exchange Commission (the "SEC") on April 1, 2022, as amended, 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
email: ronent@icecure-medical.com