- Unbiased, third-party information printed in extremely influential peer-reviewed journal, Cancers, concluded cryoablation with ProSense® is a protected, native therapy for breast most cancers with low complication fee, excessive full ablation fee and passable total survival (OS), development free survival (PFS) and native tumor management
- 8.9% recurrence fee in inhabitants of 45 sufferers who had beforehand acquired numerous therapies earlier than cryoablation together with surgical procedure, radiation remedy, or chemotherapy with tumor sizes of as much as 4 centimeters in diameter. Of these sufferers, 11 had recurrent tumors and 21 had metastatic illness
- The upper-risk inhabitants on this European examine contrasts with the early-stage breast most cancers affected person topics within the U.S. ICE3 examine
CAESAREA, Israel, July 9, 2024 /PRNewswire/ — IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure”, “IceCure Medical” or the “Firm”), developer of minimally-invasive cryoablation know-how that destroys tumors by freezing as a substitute for surgical tumor removing, immediately introduced the publication of an unbiased examine evaluating its flagship cryoablation system ProSense® titled: “CT-Guided Percutaneous Cryoablation of Breast Most cancers: A Single-Heart Expertise” in Cancers, a number one peer-reviewed oncology journal. The examine, led by Principal Investigator Professor Thomas J. Vogl, was carried out on the Institute of Radiology and Nuclear Medication, College Hospital Frankfurt, at Goethe College, Germany.
Professor Vogl commented, “Liquid Nitrogen-based cryoablation was discovered to be a protected native therapy for breast most cancers, with a low complication fee—in actual fact, none had been noticed within the examine. We skilled a really excessive full ablation fee of 100%. Total survival, development free survival and native tumor management had been all good, particularly given the very heterogenous affected person inhabitants. The truth that this can be a minimally invasive process that may be carried out on an outpatient foundation with wonderful beauty outcomes are clear benefits. We look ahead to additional evaluations of cryoablation particularly compared to different therapy modalities for early, recurrent, and metastatic breast most cancers.”
“Whereas this examine’s affected person inhabitants may be very totally different from our U.S. based mostly ICE3 examine and the goal indication for which we’ve got filed for regulatory approval within the U.S., the outcomes of the examine are extremely helpful for ProSense® customers in Europe the place our system is permitted for normal breast most cancers therapy. This increased threat affected person inhabitants included sufferers with metastatic illness and tumors of as much as 4 centimeters in diameter, as in comparison with our ICE3 examine inhabitants with early-stage illness and tumors smaller than 2 centimeters in diameter, indicating a really totally different recurrence fee. Importantly, it additional informs and helps the use instances of ProSense® throughout a broader vary of breast most cancers diagnoses, from newly recognized early-stage to metastatic and recurrent illness,” acknowledged IceCure CEO Eyal Shamir. “We thank Dr. Vogl, his staff, and College Hospital Frankfurt for his or her initiative in conducting this examine and increasing the physique of data for the cryoablation of breast most cancers.”
This unbiased examine, which acquired no monetary assist from IceCure, retrospectively evaluated the efficacy and security of liquid-nitrogen based mostly CT-guided cryoablation with ProSense®. Sufferers had been handled in out-patient settings with healing intention for non-metastatic sufferers, whereas sufferers with metastases had been handled to realize native tumor management. The affected person inhabitants (n=45, with 56 tumors) with a imply age of 55.6 ± 12.5 years (vary, 31.3–86.0 years) was very heterogeneous and totally different from IceCure’s ICE3 examine inhabitants and included 11 sufferers with recurrent tumors and 21 sufferers with metastatic illness. Sufferers had been noticed at three, six, 9, and 12 months, respectively, and after the primary 12 months had been adopted up biannually. There have been 4 instances of native tumor development, representing a fee of 8.9%. There have been no issues noticed in any of the 56 ablations and preliminary full ablation was achieved in 100% of instances.
About ProSense®
The ProSense® Cryoablation System offers a minimally invasive therapy choice to destroy tumors by freezing them. The system uniquely harnesses the facility of liquid nitrogen to create massive deadly zones for max efficacy in tumor destruction in benign and cancerous lesions, together with breast, kidney, lung, and liver.
ProSense® enhances affected person and supplier worth by accelerating restoration, decreasing ache, surgical dangers, and issues. With its straightforward, transportable design and liquid nitrogen utilization, ProSense® opens that door to quick and handy office-based process for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets superior liquid-nitrogen-based cryoablation remedy techniques for the therapy of tumors (benign and cancerous) by freezing, with the first focus areas being breast, kidney, bone and lung most cancers. Its minimally invasive know-how is a protected and efficient various to hospital surgical tumor removing that’s simply carried out in a comparatively brief process. The Firm’s flagship ProSense® system is marketed and offered worldwide for the indications cleared and permitted up to now together with within the U.S., Europe and China.
Ahead Trying Statements
This press launch comprises forward-looking statements throughout the which means of the “protected harbor” provisions of the Non-public Securities Litigation Reform Act of 1995 and different Federal securities legal guidelines. Phrases equivalent to “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and related expressions or variations of such phrases are supposed to establish forward-looking statements. For instance, IceCure is utilizing ahead trying statements on this press launch when it discusses: additional evaluations of cryoablation, particularly compared to different therapy modalities for early, recurrent and metastatic breast most cancers. Historic outcomes of scientific analysis and scientific and preclinical trials don’t assure that the conclusions of future analysis or trials will recommend equivalent and even related conclusions. Essential elements that would trigger precise outcomes, developments and enterprise selections to vary materially from these anticipated in these forward-looking statements embrace, amongst others: the Firm’s deliberate degree of revenues and capital expenditures; the Firm’s out there money and its potential to acquire further funding; the Firm’s potential to market and promote its merchandise; authorized and regulatory developments in america and different international locations; the Firm’s potential to keep up its relationships with suppliers, distributors and different companions; the Firm’s potential to keep up or shield the validity of its patents and different mental property; the Firm’s potential to reveal and educate medical professionals about its merchandise; political, financial and navy instability within the Center East, particularly in Israel; in addition to these elements set forth within the Danger Components part of the Firm’s Annual Report on Kind 20-F for the 12 months ended December 31, 2023 filed with the SEC on April 3, 2024, and different paperwork filed with or furnished to the SEC which can be found on the SEC’s web site, www.sec.gov. The Firm undertakes no obligation to replace these statements for revisions or adjustments after the date of this launch, besides as required by regulation.
IR Contact:
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Michael Polyviou
Telephone: 732-232-6914
Todd Kehrli
Telephone: 310-625-4462
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SOURCE IceCure Medical
