- Two independent studies of ProSense® cryoablation in
breast cancer were presented, one of which won the Highest Scoring
Abstract Award in its category
- Hands-on ProSense® training featured during the SIO
Mini Masterclass on Breast Cryoablation; the session was extremely
well attended with presentations led by interventional oncology and
breast cancer thought leaders
- FDA's decision on ProSense® market authorization for
early-stage breast cancer expected Q1 2025
CAESAREA, Israel, Feb. 4, 2025
/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 its participation as one of the sponsors of the Breast
Cryoablation Mini Masterclass held during the 2025 Society of
Interventional Oncology (SIO) Annual Meeting in Las Vegas, which took place January 29 to February 3, 2025.
Two independent studies demonstrating ProSense®'s safety and
efficacy in breast cancer were shared in poster presentations. A
study performed in the Netherlands
titled "The Treatment of Breast Cancer with Percutaneous Thermal
Ablation: Results of the THERMAC trial" was awarded "Highest
Scoring Abstract" in the "Other Category". This study found that
cryoablation was the only thermal ablative technique that satisfied
the requirements to warrant a randomized Phase 3 trial comparing
thermal ablation with surgery.
IceCure sponsored a Breast Cryoablation Mini Master Class on
February 1, 2025. Participants in the
half-day course received a comprehensive overview of ablative
therapies including breast cancer therapies and patient selection
for breast cryoablation. The course was led by experts in breast
cryoablation in the fields of interventional oncology, breast
radiology, and breast surgery, including Robert Ward, MD, Franco
Orsi, MD, Richard Fine, MD,
who was the lead author of the ICE3 trial on cryoablation of
early-stage, low-risk breast cancer publication, and co-primary
investigator of the ICE3 trial, Kenneth
Tomkovich, MD.
"As the medical community and we look forward to the U.S. Food
and Drug Administration's decision on market authorization of
ProSense® in early-stage breast cancer, we are pleased to see a
heightened level of interest in our cryoablation system from
exactly those doctors who may be employing it upon approval in the
U.S.," IceCure's Chief Executive Officer, Eyal Shamir commented. "We congratulate the
doctors from the Netherlands and
Romania whose cryoablation
abstracts were presented and well received. Their research
presented at SIO, a global medical conference with a high
attendance by U.S. physicians, shows an increase in awareness of
and eagerness to adopt ProSense®, especially for breast
cryoablation."
Highlights of the independent studies are the
following:
Title: "The Treatment of Breast Cancer with Percutaneous
Thermal Ablation: Results of the THERMAC trial"
Authors: L. Riks, S.M. Wooldrik, E.M.F. van de Voort, G.M.
Struik, A. Moelker, G.G.L. Yo, M.J.P.V. Macco, R.H.J.A. Sinke, S.
Wilhelmus, M. Franckena, E. Birnie, T. van Dalen, C.Verhoef,
T.M.A.L. Klem
Objective: The objective of this study was to determine the
efficacy rate in terms of complete ablation for the most promising
techniques of thermal ablation: radiofrequency ablation (RFA),
microwave ablation (MWA), and cryoablation (CA) for patients with
early-stage breast cancer to warrant a randomized Phase 3 trial
comparing thermal ablation with surgery.
Conclusion: Cryoablation was the only thermal ablative
technique that met the minimum requirements and will therefore be
selected for the Phase 3 trial. Complete ablation was reached in
72% in the MWA arm and in 94% in the CA arm. Treatment in the RFA
arm was terminated prematurely due to reaching a protocol-defined
stopping rule after 5 inclusions. Adverse events occurred in 44%
and 0% of patients in the MWA and CA arms, respectively.
Title: "Initial experience in Romania - tumor reduction and safety outcomes
of percutaneous cryoablation for benign and malignant breast
lesions at a single-center"
Authors: Georgiana-Cristiana
Camen, Michael Schenker
Objective: The study aimed to evaluate the safety and
efficacy of a liquid nitrogen-based cryoablation system for
treating breast lesions, representing the first experience at Saint
Nectarie Oncology Center in Romania.
Conclusion: Cryoablation proved safe and effective for
tumors ≤35 mm. Technical success was 100% with high physician and
patient satisfaction and very good cosmetic results. Data
collection is ongoing, with expectations high for long-term
outcomes. With increased experience, Saint Nectarie Oncology Center
aims to integrate cryoablation into its breast unit's protocol,
enhancing the institution's approach to breast care.
About ProSense®
The ProSense® Cryoablation System is a minimally
invasive cryosurgical tool that provides the option to destroy
tumors by freezing them. The system uniquely harnesses the power of
liquid nitrogen to create large lethal zones for maximum efficacy
in tumor destruction in benign and cancerous lesions, including
breast, kidney, lung, and liver.
ProSense® enhances patient and provider value by accelerating
recovery, reducing pain, surgical risks, and complications. With
its easy, transportable design and liquid nitrogen utilization,
ProSense® opens that door to fast and convenient office-based
procedures for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets advanced
liquid-nitrogen-based cryoablation therapy systems for the
destruction 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 impending U.S. Food and Drug Administration decision on the
market authorization of ProSense® in early-stage breast cancer and
the belief that there is increased awareness of and eagerness to
adopt ProSense®, especially for breast cryoablation. 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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