- Demand for minimally invasive breast most cancers remedy was overarching theme of the convention
- In a single impartial research led by Professor Fukuma, 389 sufferers handled for as much as 10 years had 99.74% recurrence free fee
- One other impartial research led by Professor Kawamoto discovered 0% breast most cancers native recurrence in five-year comply with up
- ProSense® anticipated to achieve additional traction in Japan, as distribution accomplice Terumo Company plans to submit utility to the Prescription drugs and Medical Gadgets Company (“PMDA”) for regulatory clearance for breast most cancers within the first quarter of 2025
CAESAREA, Israel, July 22, 2024 /PRNewswire/ — IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure”, “IceCure Medical” or the “Firm”), developer of minimally-invasive cryoablation expertise that destroys tumors by freezing as a substitute for surgical tumor removing, at present introduced that key findings from three scientific research of ProSense® within the remedy of breast most cancers had been offered on the thirty second Annual Assembly of the Japanese Breast Most cancers Society on July 12, 2024 in Miyagi, Japan.
Throughout a symposium titled, “New methods and techniques in breast surgical procedure”, chaired by Professor Takayuki Kinoshita, Division of Breast Surgical procedure, NHO Tokyo Medical Middle, knowledge on breast most cancers cryoablation with ProSense® had been offered by Prof. Eisuke Fukuma, Breast Middle, Kameda Medical Middle, and Prof. Hisanori Kawamoto, Division of Breast Surgical procedure, Breast and Imaging Middle at St. Marianna College Faculty of Medication.
Demand for minimally invasive breast most cancers remedy was an overarching theme of the Japanese Breast Most cancers Society Annual Assembly and of excessive curiosity to the over 3,500 assembly attendees. The information on cryoablation was properly acquired on the symposium. Symposium Chair Professor Kinoshita commented, “cryoablation for treating breast most cancers has the potential to grow to be a substitute for open surgical procedure and different minimally invasive options in Japan. The information offered suggests wonderful beauty outcomes. As this process strikes towards being included into routine scientific follow after PMDA approval, we’re happy to have extra knowledge offered at this necessary annual assembly to main breast most cancers physicians in Japan.”
Professor Fukuma, who has carried out over 600 breast cryoablation procedures with ProSense®, offered a abstract of IceCure’s ICE3 research knowledge as properly the most recent knowledge from his ongoing analysis of ProSense® to deal with breast most cancers at Kameda Medical Middle. From April 2014 by way of August 2020, 389 breast most cancers sufferers with tumor lesions of lower than 15 millimeters in diameter had been handled with ProSense®. The ipsilateral breast tumor recurrence fee (IBTR) was 0.26%, leading to a 99.74% recurrence free fee.
“The outcomes with ProSense® proceed to be wonderful, and for this reason cryoablation is turning into a standard process right here,” Professor Fukuma acknowledged. “Sufferers have gotten extra . They’re coming in and asking to be taught extra about it. Along with nice efficacy on treating tumors and favorable beauty outcomes, there may be proof that cryoablation has probably favorable impacts on the immune system, additional bettering long run outcomes.”
Professor Kawamoto offered knowledge from an impartial research he led which demonstrated zero (0%) breast most cancers native recurrence or distant metastasis 5 years following remedy with ProSense®. These findings, which had been revealed within the peer reviewed journal Breast Most cancers, had been beforehand introduced by IceCure on Could 7, 2024. 18 early-stage breast most cancers sufferers with a imply tumor measurement of 9.8 ±2.3 mm who underwent remedy with ProSense® had been adopted for a imply of 44.3 months. No critical opposed occasions had been reported. Beauty outcomes had been wonderful and the general affected person satisfaction stage and affected person high quality of life improved post-cryoablation.
“Japan is an important marketplace for ProSense® since we’re partnered with Terumo Company, the most important medical machine firm within the nation, and a rising variety of medical doctors who’re utilizing ProSense® as a part of their scientific research are publishing compelling outcomes,” acknowledged IceCure CEO Eyal Shamir. “We anticipate Terumo Company will file for regulatory approval of ProSense® for breast most cancers in Japan within the first quarter of 2025, with the intention of creating our cryoablation system extra commercially out there to medical doctors and sufferers alike in Japan.”
About ProSense®
The ProSense® Cryoablation System offers a minimally invasive remedy choice to destroy tumors by freezing them. The system uniquely harnesses the ability of liquid nitrogen to create giant 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, lowering ache, surgical dangers, and issues. With its simple, 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 methods for the remedy of tumors (benign and cancerous) by freezing, with the first focus areas being breast, kidney, bone and lung most cancers. Its minimally invasive expertise is a protected and efficient different to hospital surgical tumor removing that’s simply carried out in a comparatively quick process. The Firm’s flagship ProSense® system is marketed and offered worldwide for the indications cleared and authorized up to now together with within the U.S., Europe and China.
Ahead Trying Statements
This press launch comprises forward-looking statements inside 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 resembling “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and comparable expressions or variations of such phrases are meant to determine forward-looking statements. For instance, IceCure is utilizing ahead trying statements on this press launch when it discusses that cryoablation for treating breast most cancers has the potential to grow to be a substitute for open surgical procedure and different minimally invasive options in Japan, the potential of the upcoming Prescription drugs and Medical Gadgets Company approval of the process and its potential to grow to be routine follow, that cryoablation has probably favorable impacts on the immune system, additional bettering long run outcomes, and the expectation that Terumo Company will file for regulatory approval of ProSense® for breast most cancers in Japan within the first quarter of 2025, with the intention of creating IceCure’s cryoablation system extra commercially out there to medical doctors and sufferers in Japan. Historic outcomes of scientific analysis and scientific and preclinical trials don’t assure that the conclusions of future analysis or trials will counsel equivalent and even comparable conclusions. Essential components 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 stage of revenues and capital expenditures; the Firm’s out there money and its skill to acquire extra funding; the Firm’s skill to market and promote its merchandise; authorized and regulatory developments in the USA and different international locations; the Firm’s skill to take care of its relationships with suppliers, distributors and different companions; the Firm’s skill to take care of or shield the validity of its patents and different mental property; the Firm’s skill to show and educate medical professionals about its merchandise; political, financial and navy instability within the Center East, particularly in Israel; in addition to these components set forth within the Danger Elements part of the Firm’s Annual Report on Type 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.
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