Study Published in the British Journal of Radiology Demonstrates IceCure's ProSense® is a Safe Procedure with 97.7% Technical Success Rate in Treating Tumors of the Lung, Bone, and Soft Tissues

Rhea-AI Summary

IceCure Medical (Nasdaq: ICCM) announced the publication of an independent study on its ProSense® cryoablation system in the British Journal of Radiology. The study, led by Dr. Franco Orsi at the European Institute of Oncology, demonstrated a 97.7% technical success rate in treating tumors of the lung, bone, and soft tissues. ProSense®, a liquid nitrogen-based system, was found to have favorable safety compared to argon-based systems and to be more cost-effective and easier to manage.

The study assessed 85 patients with 96 lesions, showing only minor complications that resolved without significant intervention. It highlighted cryoablation's growing role in early oncology treatments, particularly for patients with comorbidities or those avoiding surgery. The research also emphasized interventional radiology as the fourth pillar of oncology, alongside clinical oncology, surgical oncology, and radiation therapy.

Positive

• 97.7% technical success rate in treating tumors of lung, bone, and soft tissues
• Favorable safety profile compared to argon-based cryoablation systems
• More cost-effective and easier to manage than argon-based systems
• Suitable for office-based procedures under local anesthesia
• Previous studies showed 96% and 100% three-year recurrence-free rates in lung cancer treatment

Negative

• None.

Medical Research Analyst

The study's findings on ProSense®'s 97.7% technical success rate and favorable safety profile are highly encouraging for interventional oncology. The system's efficacy across various tumor types (bone, lung, soft tissue) suggests versatility in clinical applications. The low complication rate and resolution of minor issues without significant intervention underscore its safety profile.

Notably, the comparison with argon-based systems highlights ProSense®'s potential advantages in cost-effectiveness and ease of use, particularly for office-based procedures. This could expand access to cryoablation treatments and potentially reduce overall healthcare costs. The high three-year recurrence-free rates (96% and 100%) from previous lung cancer studies further solidify ProSense®'s potential as a viable alternative to surgical tumor removal.

Financial Analyst

This study provides strong clinical validation for IceCure's ProSense® system, potentially boosting its market position. The 97.7% technical success rate and favorable safety profile could drive adoption among healthcare providers, potentially leading to increased sales and market share for IceCure. The system's versatility across multiple tumor types expands its addressable market.

The cost-effectiveness and ease of use compared to argon-based systems present a compelling value proposition, which could accelerate market penetration. This may lead to improved profit margins and revenue growth for IceCure. However, investors should note that while clinical results are promising, market adoption and financial impact may take time to materialize fully. The company's ability to leverage these results for regulatory approvals and market expansion will be important for long-term financial performance.

• Liquid nitrogen- (LN₂) based ProSense® found to have favorable safety compared to argon-based cryoablation systems, as well as being more cost effective and easier to manage
• Independent study conducted at the European Institute of Oncology (IEO) demonstrates interventional radiology use cases for ProSense® for indications that are approved in various markets across the world

CAESAREA, Israel, Sept. 16, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the publication of an independent study led by Dr. Franco Orsi, Director of Interventional Radiology at the European Institute of Oncology (IEO) in Milan, Italy and an expert ProSense® user. The study titled "Liquid Nitrogen-Based Cryoablation: Complication Rates for Lung, Bone, and Soft Tissue Tumors" was published by Oxford University Press on behalf of the British Institute of Radiology.

"Cryoablation with liquid nitrogen has a growing role in early oncology treatments across a wide variety of cancer types and particularly for patients who may have multiple comorbidities and/or who want to avoid surgery. As interventional radiologists are increasingly and effectively using cryoablation, it's important to note Dr. Orsi and his colleagues underscore in the paper that interventional radiology is now the fourth pillar of the oncology field, alongside clinical oncology, surgical oncology and radiation therapy," stated IceCure's Chief Executive Officer, Eyal Shamir. "We are very pleased that ProSense® is providing a minimally invasive option to treat cancer patients early, safely and effectively."

The study assessed the complication rate both during and 24 hours after treatment with IceCure's cryoablation system in 85 patients who were treated for 96 lesions (tumors), 36.4% of which were lesions in bones, 18.8% in lungs, and 44.8% in soft tissue. The primary technical success rate, defined as complete tumor coverage, was 97.7% (83 of 85 patients). Patients with benign and malignant tumors were treated for either curative or palliative intent. Minor complications resolved themselves without intervention or merely required simple interventions such as drainage. The study concluded that cryoablation using an LN₂-based system, such as ProSense®, is safe across various tumor sizes and locations, with only minor complications observed.

LN₂-based cryoablation was compared to argon-based systems in the study who point to the benefits of LN₂ procedures including its suitability for office-based procedures performed under local anesthesia, compared to argon systems which typically require general anesthesia and are therefore less suitable for office procedures. The study also addresses the challenges of argon systems requiring large argon gas cylinders, which necessitate dedicated storage space and trained personnel for transport, as well as the higher cost of the procedure due to the use of multiple cryoprobes as well as the use of noble gases, argon and helium. The study demonstrates that LN2-based systems, such as ProSense®, are more cost effective and easier to manage.

Two previously published independent lung cancer studies of ProSense® in the treatment of lung cancer, which evaluated the procedure's local control and recurrence free rate, reported 96% and 100% three-year recurrence free rates. Independent and IceCure-sponsored studies of other interventional radiology indications are ongoing.

About IceCure Medical

IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems 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 Company's flagship 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 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 growing role of liquid nitrogen-based cryoablation in early oncology treatments. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2023 filed with the SEC on April 3, 2024, 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:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462

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SOURCE IceCure Medical

FAQ

What is the technical success rate of IceCure's ProSense® cryoablation system for treating tumors?

According to the study published in the British Journal of Radiology, IceCure's ProSense® cryoablation system demonstrated a 97.7% technical success rate in treating tumors of the lung, bone, and soft tissues.

How does ProSense® compare to argon-based cryoablation systems?

The study found that ProSense®, a liquid nitrogen-based system, has a favorable safety profile compared to argon-based systems. It is also more cost-effective, easier to manage, and suitable for office-based procedures under local anesthesia.

What types of tumors were treated in the ProSense® study?

The study assessed 96 lesions in 85 patients, with 36.4% of lesions in bones, 18.8% in lungs, and 44.8% in soft tissue. Both benign and malignant tumors were treated for curative or palliative intent.

What were the complication rates for ProSense® cryoablation treatments?

The study reported only minor complications that resolved without intervention or required simple interventions such as drainage. The procedure was found to be safe across various tumor sizes and locations.

What is the stock symbol for IceCure Medical?

IceCure Medical's stock symbol is ICCM, and it is listed on the Nasdaq stock exchange.