Health Canada Approves IceCure Medical's Minimally Invasive ProSense Cryoablation System

Rhea-AI Summary

IceCure Medical's ProSense System receives approval from Health Canada, expanding its market potential in North America. The ProSense System is a minimally-invasive cryoablation technology that destroys tumors by freezing, offering an alternative to surgical tumor removal. IceCure has already received interest from healthcare providers in Canada and plans to expand its activities in the country. With Canada's highly ranked healthcare system and estimated total health spending of $331 billion in 2022, this approval opens up new opportunities for IceCure.

Positive

• Approval from Health Canada strengthens IceCure's market potential in North America
• ProSense System offers a minimally-invasive alternative to surgical tumor removal
• IceCure plans to expand activities in Canada based on strong interest from healthcare providers
• Canada's healthcare system is ranked as one of the top in the world
• Estimated total health spending in Canada was $331 billion in 2022

Negative

• None.

• Strong interest in ProSense from healthcare providers in Canada strengthens market potential
• ProSense now approved throughout North America

CAESAREA, Israel, July 24, 2023 /PRNewswire/ -- 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:

• Tumors – ablation of benign and malignant tumors of the lung, liver, kidneys, and musculoskeletal system, and benign tumors of the breast;
• General surgery;
• Palliative intervention; and
• Other surgeries.

 

 

"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.

IR Contact:
Michael Polyviou
Email: mpolyviou@evcgroup.com
732-232-6914

Todd Kehrli
Email: tkehrli@evcgroup.com
310-625-4462

 

View original content:https://www.prnewswire.com/news-releases/health-canada-approves-icecure-medicals-minimally-invasive-prosense-cryoablation-system-301883778.html

SOURCE IceCure Medical

FAQ

What is the ProSense System?

The ProSense System is a minimally-invasive cryoablation technology developed by IceCure Medical. It destroys tumors by freezing, providing an alternative to surgical tumor removal.

What is the significance of the approval from Health Canada?

The approval from Health Canada expands IceCure's market potential in North America. It allows the company to sell and implement the ProSense System, disposable cryoprobes, and introducers as cryosurgical tools for various indications in Canada.

What opportunities does this approval create for IceCure?

The approval opens up new opportunities for IceCure to engage with healthcare providers in Canada. The company has already received strong interest from Canadian healthcare providers and plans to expand its activities in the country.

What is the significance of Canada's healthcare system?

Canada's healthcare system is highly ranked globally and is considered one of the top healthcare systems in the world. This provides a favorable environment for IceCure to introduce its ProSense System and cater to the healthcare needs in the country.

How much was Canada's total health spending in 2022?

Canada's total health spending was estimated at $331 billion in 2022. This indicates a significant investment in healthcare and potential market size for IceCure's ProSense System.