- Data presentation at highly influential American Society
of Breast Surgeons ("ASBrS") Annual Meeting by Dr. Richard Fine wins Scientific Impact Award as
voted by breast surgeons
- President-Elect of the ASBrS, Dr. Michael Berry, presents data and states
"cryoablation is ready for prime time"
- Company seeks indication for treating women with early
stage T1 invasive breast cancer with adjuvant hormone
therapy
- Available reimbursement code for facility expense
expected to enhance usage upon receiving marketing
authorization
- Minimally-invasive ProSense® cryoablation offers highly
favorable healthcare economics
CAESAREA, Israel, April 15,
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,
announced today that it has submitted final data to the U.S. Food
and Drug Administration ("FDA") requesting marketing authorization
for ProSense® for the indication of treating patients with early
stage T1 invasive breast cancer with cryoablation and adjuvant
hormone therapy. ProSense®, which received the FDA's Breakthrough
Designation, is already cleared for use in the U.S. for several
other indications, including treating benign tumors of the breast,
and tumors in the kidney and liver.
The Company provided the following requested data to the
FDA:
- ICE3 5-year follow up full data-set;
- sub-analysis of the ICE3 results compared with data from the
"LUMINA" study (a study sponsored by Canada's Ontario Clinical Oncology Group,
which evaluated the risk of recurrence in patients with low-risk
Luminal A breast cancer who were treated with lumpectomy surgery
and who had received adjuvant hormone therapy);
- analysis of the ICE3 data compared to an updated PRISMA
meta-analysis; and
- real-world data from the use of ProSense® globally, including
post-market commercial use as well as data from independent
third-party studies.
The ICE3 study was the largest controlled multicenter clinical
trial ever performed for liquid nitrogen (LN2) based cryoablation
of low-risk, early-stage malignant breast tumors. The 5-year
recurrence-free rates from this groundbreaking study, which
evaluated IceCure's minimally invasive 20-to-40-minute outpatient
cryoablation procedure, were in line with expectations and show
similar outcomes to lumpectomy, the current standard of care for
early-stage breast cancer patients.
Per the analysis, at the 5-year follow-up evaluation, 96.3% of
the subgroup of patients treated with ProSense® cryoablation,
followed by hormone therapy, were estimated to be free from local
recurrence. A comparison of this result, from the ICE3 study, shows
similar outcomes in 5-year recurrence rates compared to patients
who were treated with lumpectomy followed by hormone therapy in the
LUMINA study, which reported a 97.7% recurrence free rate at 5-year
follow up and the PRISMA meta-study, which included Lumina,
reporting a 97.19% recurrence free rate at 5-year follow up. ICE3
results are also in line with data from real-world use of ProSense®
by third parties in territories where IceCure's cryoablation system
is used to treat early-stage breast cancer. In the final ICE3
analysis, no significant device related adverse events or
complications were reported, and all patients and physicians
reported satisfaction with the ProSense® procedure.
"We believe ICE3 is a ground-breaking study and are excited to
report that the efficacy data of our minimally invasive ProSense®
cryoablation procedure show similar outcomes in recurrence compared
to more invasive breast surgery, the current standard of care for
early-stage breast cancer," stated IceCure CEO, Eyal Shamir.
"I, along with our marketing and clinical team, were at the
ASBrS Annual Meeting where we witnessed an overwhelmingly positive
response from breast surgeons who voted on Dr. Fine's presentation
to win the Scientific Impact Award, demonstrating how impactful our
cryoablation technology is expected to be for women with
early-stage breast cancer. Further demonstrating its potential,
ASBrS's President-Elect Dr. Berry deemed cryoablation is ready for
prime time."
"Initial reimbursement codes are already in place and our U.S.
marketing and commercial team is ready, as we await the FDA's
response. Driven by favorable healthcare economics combined with
patient satisfaction and demand, we expect rapid adoption pending
FDA granting the DeNovo Classification Request for Marketing
Approval."
Topline Data Presented at the ASBrS 2024 Annual
Meeting
Final data from ICE3 were presented to leading breast surgeons
from across the U.S. at the ASBrS 25th Annual Meeting by ICE3
Investigators Dr. Richard Fine and
Dr. Michael Berry. Dr. Fine gave an
oral presentation titled "Cryoablation Without Excision for
Early-Stage Breast Cancer; ICE3 Trial 5 year follow up on
Ipsilateral Breast Tumor Recurrence." Dr. Berry, President-Elect of
the ASBrS, gave an oral presentation titled "Cryoablation: Is It
Ready for Primetime?"
Dr. Berry stated, "In my opinion, cryoablation is 'primetime' as
an alternative to surgical resection in a highly selected patient
population based on data that show it is safe and aligned with what
we are seeing in standard of care."
Dr. Fine commented, "Cryoablation is a safe, minimally invasive
ablative procedure with acceptably low 5-year same breast
recurrence similar to that of lumpectomy for similar patient
populations, with the benefit of being an office-based, nonsurgical
treatment. Further study within a clinical trial or registry is
needed to confirm cryoablation as a viable alternative to surgical
excision in the appropriately selected patients."
Healthcare Economics
As a minimally invasive outpatient procedure with no need for
general anesthesia, cryoablation costs less than standard of care
lumpectomy. It also reduces risk of re-excision (follow up surgery)
as compared to a re-excision rate of 14-21% in lumpectomy.
IceCure's application to the U.S. Centers for Medicare &
Medicaid Services (CMS) is the first and only Medicare coverage
approval of a cryoablation procedure for breast cancer. CMS
assigned CPT Category III code 0581T to ambulatory payment
classification 5091, Level 1 Breast/Lymphatic Surgery and Related
payment assignment by the CMS at approximately $3,400 for the facility fee alone. Additional
coverage, including payment for the physician, is expected upon
establishment of the permanent CPT Category I code, which is
conditioned on factors including the Company's receipt of FDA
marketing authorization of ProSense® for breast cancer.
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 statements in this press release when it discusses: that
the Company expects rapid adoption if regulatory clearance from the
FDA is granted; how impactful cryoablation technology is expected
to be for women with early-stage breast cancer; Dr. Berry's
assertion that cryoablation is 'primetime' as an alternative to
surgical resection; and Dr. Fine's assertion that further study is
needed to confirm cryoablation as a viable alternative to surgical
excision. 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 U.S.
Securities and Exchange Commission (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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