- MRI reveals disappearance of hemorrhagic signal and
development of necrotic changes
- Pain reduced from a median of 7 on a scale of 0 - 10 to a
median of 1, with some patients reporting 0
CAESAREA, Israel, March 4,
2024 /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 results from an independent study
conducted at University Hospital, Nimes, France, titled "BEYOND PAIN: Cryoablation of
endometriotic nodules using liquid nitrogen" were presented at the
European Congress of Radiology ("ECR") 2024 in Vienna, Austria on February 29, 2024.
Five doctors participated in the study, including interventional
radiologist and ProSense® user Prof. Julien Frandon, who has
previously led hands-on training sessions with ProSense® at
multiple medical conferences.
The investigator-initiated single-site study enrolled 7 women,
ages 30-45 years, with endometriosis in the abdominal wall and
para-diaphragmatic areas. Treatment with ProSense® cryoablation
took about 30 minutes.
One month following treatment, assessment by MRI revealed
hemorrhagic signal had disappeared and necrotic changes developed.
All patients were satisfied with the treatment and reported their
pain decreased from a median of 7 on a visual analog scale of 0 –10
to a median of 1, with some patients reporting 0.
The study concluded that based on the investigator's experience,
ProSense® and single-probe percutaneous cryoablation with liquid
nitrogen appears to be a promising alternative that offers speed,
minimally invasive qualities, safety and more cost-effective
treatment of extra-pelvis endometriosis. Since the results are
based on a limited number of patients, further data is required
with a larger patient cohort to gain comprehensive understanding of
this treatment approach.
Prof. Frandon commented, "At our hospital in Nimes, we use
ProSense®️ because, as a single probe, liquid nitrogen-based
system, it's easier for our team of interventional radiologists to
use than traditional multi-probe, argon-based systems. Since 2019,
we have performed more than 150 ProSense®️ procedures with great
efficacy, safety and patient satisfaction. I'm happy to see a
growing number of indications treated with cryoablation,
benefitting patients from early, minimally-invasive
intervention."
"While surgical removal would have been the standard of care
treatment for endometriosis nodules, ProSense® gives interventional
radiologists and other practitioners a safe and effective
minimally-invasive option. We are very pleased that all patients
treated in this study were relieved of their endometriosis
condition and pain within as little as a month following
treatment," stated IceCure CEO Eyal
Shamir.
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive
treatment 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
procedure for breast tumors.
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
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 ProSense
as being a promising alternative treatment for extra-pelvis
endometriosis. 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, 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.
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