- Independent study published in Annals of Surgical
Oncology concludes cryoablation
is an oncologically safe and feasible minimally
invasive procedure option in lieu of surgery for patients with
early-stage, low-risk breast cancer
- Study's authors suggest the widespread use of screening
mammography allows for earlier detection - and therefore increased
customization of treatment, less aggressive management, reduced
treatment burden, improved quality of life - and
examines cryoablation as the "next step in the surgical
de-escalation of breast cancer"
- Study suggests that cryoablation provides a
significantly superior alternative when it comes to financial
implications, as compared to surgical resection
CAESAREA, Israel, Dec. 13,
2023 /PRNewswire/ -- 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 to surgery.
Highlights from the article include:
- Regarding cost of care, the article states: "Clinical
trials have determined not only that cryoablation is just as
effective as surgical resection for early-stage, low-risk tumors,
but that cryoablation also provides a superior alternative when it
comes to financial implications."
- Citing ICE3 as a leading study that makes the case
for surgical de-escalation, the article states: "The ablative
therapies were first entertained as options for women who might not
be good surgical candidates or refuse surgery. However, two large
multi-institutional studies on cryoablation (Simmons et al.(ACOSOG
Z-1072), and Fine et al. (ICE3) have led the way to the use of
ablation as a means for further surgical de-escalation for small
early-stage, low-risk breast cancers."
"Cryoablation 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."
About ProSense®
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.
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 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.
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