Full Press Release Details
Study Using IceCure's ProSense Finds:
"Cryoablation Allows the Ultimate
De-escalation of Surgical Therapy for Select Breast Cancer Patients"
CAESAREA, Israel, December 13, 2023
- IceCure Medical Ltd. (Nasdaq: ICCM), developer of the ProSense System, a minimally-invasive cryoablation technology
that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the publication of a study titled
"Cryoablation Allows the Ultimate De-escalation of Surgical Therapy for Select Breast Cancer Patients" in the
peer-reviewed journal Annals of Surgical Oncology.
The independent study, in which ProSense
was one of two cryoablation systems analyzed, was overseen and conducted at the Breast Center of Excellence and the Department of Surgery,
School of Medicine at Texas Tech University Health Sciences Center by Sonia Y. Khan MD, Jaclyn Cole MD, Zaina Habrawi MD, Michael W. Melkus
PhD, and Rakhshanda Layeequr Rahman MD.
A total of 32 early-stage breast cancer patients
with a median age of 70 (range of 50-91) were treated with cryoablation. Six of the 32 patients (18.5%) received adjuvant radiation, and
31 of 32 patients (97%) received adjuvant endocrine therapy. The mean follow-up was 15 months, with 20 patients (62.5%) completing two
years, and 12 patients (37.5%) completing more than three years.
All patients were disease-free at the last follow-up
visit, and no major complications from the procedure were reported. One patient had regional disease at 18 months. She did not have sentinel
node biopsy and did not take endocrine therapy. She had delayed axillary dissection, started endocrine therapy, and remains disease-free
after 5 years of follow-up evaluation. One patient died one year after cryoablation due to unrelated causes. The patient population in
this study is similar to the population in IceCure's ongoing ICE3 study, the largest controlled multi-center clinical trial ever
performed in the U.S. for liquid nitrogen-based cryoablation of small, low-risk, early-stage malignant breast tumors as an alternative
Highlights from the article include:
is an excellent option for select patients to avoid general anesthesia, and enjoy a potential cure without surgery through an outpatient
procedure with minimal disruption of life." Stated study co-author, Dr. Rakhshanda Layeequr Rahman
"This independent study is quite compelling
in that it goes beyond providing data. It presents the case that due to widespread screening with mammography, early-stage tumors can
be treated with new, safe, and effective treatments that minimize the impact on patients and the healthcare system in general,"
stated IceCure's Chief Executive Officer, Eyal Shamir. "We are grateful, as always, to the growing number of medical professionals
who are using ProSense to improve patient outcomes and going above and beyond to publish their results for the advancement of innovative
new treatments that improve care."
ProSense cryoablation is a minimally invasive,
non-surgical, outpatient 40-minute treatment option that destroys tumors by freezing them. The procedure only requires a local 1% lidocaine
injection (similar to its use by dentists when performing certain dental procedures) enabling the patient to remain alert during the procedure
and then walk out of the doctor's office to resume their day. ProSense has been investigated and proven effective in various
clinical applications, including breast tumors, kidney cancer, lung cancer, and in palliative care. Independent and company-sponsored
clinical studies of ProSense have shown strong results, with high rates of tumor destruction, and patient and physician satisfaction.
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.
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 that early-stage tumors can be treated effectively due to screening mammography. 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.