- ICE3 trial results presentation by Co-Principal
Investigator Dr. Kenneth Tomkovich
wins EUSOBI 2024 Abstract Award
- THERMAC Trial on Treatment of Breast Cancer with
Percutaneous Thermal Ablation (cryoablation, radiofrequency, and
microwave) wins EUSOBI Young Physician Scientist Competition –
cryoablation demonstrates 94% complete rate of
ablation
- IceCure exhibited ProSense® and conducted hands-on demos
and Q&A sessions with breast cryoablation experts Dr. Lucía
Graña-López and Dr. Federica Di
Naro
CAESAREA, Israel, Oct. 7, 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 that IceCure's ICE3 trial and five additional studies
featuring new data on ProSense's® use in breast cancer and
fibroadenoma were presented at the 2024 European Society of Breast
Imaging (EUSOBI) Scientific Meeting and Annual Conference which
took place in Lisbon, Portugal on
October 3-5, 2024.
The 2024 EUSOBI Abstract Award was received by Dr. Kenneth Tomkovich, Co-Primary Investigator of
the ICE3 trial, for his abstract "Image Guided Cryoablation as a
Primary Treatment for Low-Risk Breast Cancers: Results and Imaging
Findings of the ICE3 Trial." Dr. Tomkovich remarked, "The
significance of a U.S. study gaining such high recognition by a
European medical society is a testament to the excellent results—a
96.3% recurrence free rate for those treated with ProSense® and
endocrine therapy—that demonstrates cryoablation for small,
low-risk breast cancer to be a safe and effective primary treatment
option to surgical lumpectomy."
The THERMAC Trial on Treatment of Breast Cancer with
Percutaneous Thermal Ablation from the
Netherlands was awarded the EUSOBI Young Physician
Scientists Prize. The THERMAC trial compared the efficacy of
treatment in terms of complete ablation with radiofrequency,
microwave, and cryoablation. Cryoablation demonstrated the highest
complete rate of ablation at 94% with no adverse events, making it
the safest and most effective among the methods used in the trial.
In comparison, for patients in the same study who underwent
radiofrequency there was a complete ablation rate of 33% and 50%
experienced mild to moderate adverse events. For patients in the
same study treated with microwave, there was a complete ablation
rate of 73% and 40% experienced mild to moderate adverse
events.
An estimated 1700+ professionals in attendance at EUSOBI had the
opportunity to learn more about the ProSense® Cryoablation System
for the treatment of fibroadenoma and breast cancer, both of which
are approved indications for ProSense® in Europe. IceCure's booth featured live
demonstrations from expert users and the IceCure team, who were on
hand to discuss the growing evidence for breast cancer cryoablation
and ProSense®'s advantages. On October
4, world-leading cryoablation experts, Dr. Lucía Graña-López
of Servizo Galego de Saúde, Spain,
and Dr. Federica Di Naro of Azienda
Ospedaliero-Universitaria Careggi, Italy were at the booth for demonstrations and
Q&A. Both Dr. Grana-Lopez and Dr. Di
Naro have previously published studies demonstrating
ProSense® destroyed or reduced 100% of breast cancer tumors.
"The fact that six major studies on ProSense® in the treatment
of breast cancer were presented, and two
won awards, in Europe's
most prestigious breast imaging conference speaks volumes to the
potential of ProSense® to treat more patients in Europe and around the world," stated IceCure
CEO Eyal Shamir. "The growing body
of evidence from independent, investigator initiated studies
supports our commercial activities globally. We had highly
productive talks at the EUSOBI conference with hospitals, clinics,
and doctors interested in acquiring ProSense® systems so they can
offer a safe and effective minimally invasive option to their
patients."
The following is a summary of six abstracts featuring ProSense®
Cryoablation, including IceCure's ICE3 trial, presented at EUSOBI
2024:
- Study Title: Image Guided Cryoablation as a Primary
Treatment for Low-Risk Breast Cancers: Results and Imaging Findings
of the ICE3 Trial – Dr. Kenneth
Tomkovich, USA
Winner of the EUSOBI 2024
Abstract Award; Received the highest score in the
topic
Conclusion: "The overall 5-year recurrence
rate of 4.3% in the ICE3 trial is similar to reported recurrence
rates for the current gold standard surgical lumpectomy.
Substantial benefits as compared to surgery include performance in
an outpatient setting using local anesthesia, only minor reported
adverse events, and 100% satisfaction with cosmetic outcomes.
Results of the ICE3 trial suggest that cryoablation for small
low-risk breast cancers is a safe and effective primary treatment
option alternative to surgical lumpectomy. Additional trials are
encouraged."
- Study Title: The Treatment of Breast Cancer with
Percutaneous Thermal Ablation: Results of the THERMAC trial
– Dr. Sophie Wooldrik,
the Netherlands
Winner
of the EUSOBI Young Physician Scientist Competition; Rated among
the top 5 abstracts
Conclusion: In this study,
cryoablation demonstrated the highest completed ablation rate (94%)
with no adverse events, making it the most effective and safest
method compared to radiofrequency and microwave.
- Study Title: The Treatment of Breast Cancer with
Percutaneous Thermal Ablation – Cosmetic Outcome and Patient
Satisfaction – Dr. Sophie Wooldrik,
the
Netherlands
Conclusion: Patients
reported cosmetic outcomes to be more favorable following thermal
ablation as compared to surgery. Patients appeared to experience
the least among of pain with cryoablation.
- Study Title: Assessment of pain level and
quality of life (QoL) in breast cancer (BC) patients treated with
Ultrasound-guided Cryoablation – Dr. S.E Balidi Giorgi, D.
Di Naro, et
al.
Conclusion: Ultrasound-guided
cryoablation is a non-invasive and effective treatment in breast
cancer patients ineligible for surgical excision. It is associated
with improvement of pain and QoL. No significant differences in QoL
were found between patients treated with cryoablation and hormone
therapy compared to patients treated only with cryoablation,
confirming that cryoablation maintains good QoL levels in all
breast cancer patients.
- Study Title: Single-center Experience with
Percutaneous Cryoablation for benign and malignant breast lesions
in Romania: Tumor Reduction and
Safety – Dr. Georgina Camen,
Romania
Conclusion:
Cryoablation with a LN2 based system was safe and effective for
tumors 26 mm and smaller. Data collection continues with high
expectations for long-term outcomes.
- Study Title: Single Center Experience with
Percutaneous Cryoablation of Fibroadenomas in Hungary: Volume Reduction and Safety – Dr.
Teodora
Filipov
Conclusion: Liquid nitrogen-based
cryoablation demonstrated both safety and efficacy for the
treatment of fibroadenomas resulting in a 92.9% reduction in volume
one year post procedure.
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,"
"potential," "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 potential of ProSense to treat more
patients in Europe and around the
world. 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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