- Study was conducted in Spain with women who declined standard of care
surgery
- ProSense is approved for the treatment of breast cancer
throughout the European Union
CAESAREA, Israel, Oct. 2, 2023
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or
the "Company"), developer of the ProSense® System, a
minimally-invasive cryoablation technology that destroys tumors by
freezing as an alternative to surgical tumor removal, today
announced that new data was presented at the European Society of
Breast Imaging ("EUSOBI") Scientific Meeting in Valencia, Spain by Lucía Graña-López, MD, PhD,
principal investigator of the independent, non-sponsored study.
In a poster titled "Cryoablation for the treatment of
early-stage breast cancer in patients who decline surgery" Dr.
Graña-López presented the findings of her study conducted at
University Hospital Lucus Augusti in Lugo, Spain which used ProSense for cryoablation
treatment of 31 patients with early-stage breast cancer who
declined surgery, the standard of care. Dr. Graña-López, a
radiologist who specializes in breast and women's imaging, is Head
of the Breast Unit at University Hospital Lucus Augusti.
All patients were diagnosed with biopsy-proven early breast
cancer (cT1-2cN0-1cM0) with a median tumor size of 24 mm, ranging
between 6 to 45 mm. Patients were followed by mammography and
ultrasound every 6 months for 2 years and annually thereafter. The
median follow-up was 10 months, with a range of 0 to 40 months.
Cancer progression was observed in 1 patient (1/31, 3.2%). No major
complications were seen and the procedure was well tolerated by all
patients.
The study concluded that cryoablation could be an alternative
treatment to surgery for breast cancer in patients who reject
surgery. Underscoring the need for such an alternative, the poster
presented that breast cancer is the most commonly diagnosed
malignant neoplasm worldwide and that while surgery is the standard
of care for early-stage breast cancer, some patients, most of them
elderly, decline standard of care surgery and prefer a less
invasive option.
Dr. Graña-López commented, "I've been effectively using ProSense
for cryoablation in women who decline surgery with very good
results. I think that soon, cryoablation will be a real alternative
to surgery in early-stage breast cancer in post-menopausal women.
Beyond breast cancer, I believe ProSense can have an impact on the
way cancers of the kidney, lung, and thyroid gland are
treated."
"Doctors around the world are using ProSense with women who want
an alternative to surgery for early- stage breast cancer, and it's
highly encouraging to see these physicians publish and share their
results with the medical community," stated IceCure's CEO,
Eyal Shamir. "These data are very
much in line with the interim results of our ICE3 study, the
largest of its kind in the U.S., which is expected to conclude in
the first quarter of 2024."
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets ProSense®,
an advanced liquid-nitrogen-based cryoablation therapy 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 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 and
Israeli 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 statement in this press release when it discusses: the
expected conclusion of its ICE3 study in the first quarter of 2024;
and that, according to Dr. Graña-López, soon cryoablation will be a
real alternative to surgery in early-stage breast cancer in
post-menopausal women. Historic 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. Because such statements deal with future
events and are based on IceCure's current expectations, they are
subject to various risks and uncertainties and actual results,
performance, or achievements of IceCure could differ materially
from those described in or implied by the statements in this press
release. The forward-looking statements contained or implied in
this press release are subject to other risks and uncertainties,
many of which are beyond the control of the Company, including
those set forth in the Risk Factors section of the Company's Annual
Report on Form 20-F for the year ended December 31, 2022 filed with the SEC on
March 29, 2023, 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.
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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