- U.S. sales continue to increase with 25% jump in
ProSense® system and disposable probe sales in 2023 over prior
year
- ICE3 study is set for completion and final data read
out
CAESAREA, Israel, Jan. 10,
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 issued the following letter to its shareholders from its
Chief Executive Officer, Eyal
Shamir.
Dear shareholders,
2023 was a year of strong growth for IceCure. Cryoablation
became increasingly recognized as a highly favorable minimally
invasive alternative to open surgery and ProSense® achieved an
expanded global rollout with regulatory clearances received in
significantly large markets such as Brazil, Canada, and China. Furthermore, the trend toward
performing cryoablation procedures is increasing amongst breast
surgeons and breast radiologists. We believe that the growing
abundance of peer-reviewed journals publishing ProSense® and
cryoablation studies will have a direct and favorable impact on
IceCure as we continue to expand our global distribution footprint.
We are very optimistic about 2024 and believe it will be a pivotal
year marked by the completion of our ICE3 breast cancer study and
continued penetration in the U.S. and global markets.
2023 Key Achievements
Increased Revenues, System, and Probe Sales: Based
on our expected preliminary unaudited 2023 results, ProSense®
system and disposable probe sales increased by 26% globally over
2022. Product sales in the U.S. were up 25% in 2023 over 2022
levels. On a preliminary unaudited basis, total revenues increased
for the financial year ended December 31,
2023 to $3.2 million, as
compared to $3.1 million in 2022. An
increase in system and probe sales was partially offset by a
decrease in revenue recognition from our distribution agreement
with Terumo Corporation. On a preliminary unaudited basis, as of
December 31, 2023, we had cash and
cash equivalents, including short-term deposits, of $11 million. During the fourth quarter of 2023 we
implemented an expense reduction plan to reduce our non-revenue
generating and clinical development costs, lowering monthly cash
utilization, to help ensure that we meet our primary goals in
2024.
The above information reflects preliminary unaudited estimates
with respect to certain results of IceCure for the full year ended
December 31, 2023, based on currently
available information. Because the audit for 2023 is not yet
complete, the Company's final results may vary from the preliminary
estimates provided herein.
Growing Adoption Among World's Leading Physicians as
Evidenced by 17 Ongoing Independent Studies Across Several
Indications: Our expected 2023 revenue momentum and the growing
number of independent, non-sponsored studies of ProSense® point to
an increased adoption of ProSense® around the world across several
indications. Twelve non-sponsored studies that demonstrate
ProSense®'s safety and efficacy, in line with results reported in
our own studies, have been published in peer reviewed journals and
presented at scientific conferences to date. Our two studies, ICE3
for breast cancer and ICESECRET for kidney cancer, and 17
independent, non-sponsored studies are ongoing. Thirteen of the
published and ongoing studies are for breast cancer with the
remaining studies focused on fibroadenomas, endometriosis, and
malignant or benign tumors of the lung, kidney, and musculoskeletal
system. The increased adoption by physicians of ProSense® is
attributable to a clear need in the market for a safe, effective,
and more cost-efficient alternative to open surgery, combined with
IceCure's well-executed awareness and marketing efforts at world
leading medical conferences for breast care and interventional
radiology. 2023 marked a key year for cryoablation in the U.S. as
the American Society of Breast Surgeons (ASBrS) 2023 Annual Meeting
featured a first-of-its-kind continuing medical education (CME)
course for cryotherapy that used the ProSense® system in its
demonstration. The ASBrS also presented its plan for a proposed
ASBrS breast cancer cryoablation trial during the cryotherapy CME
course.
Completing ICE3 Breast Cancer Study in the U.S.: Only 10
patients remain who need to undergo their five-year follow-up
examinations in our ICE3 study, the largest of its kind in the U.S.
We expect that the last patient will return for her final follow-up
examination in the first quarter of 2024.
ICESECRET Kidney Cancer Study Continues: Interim
results from our study of ProSense® in the treatment of kidney
cancer had reported an impressive 89.5% recurrence-free rate based
on interim results at the end of 2022. We expect ICESECRET's
five-year patient follow-up to be completed in 2026.
Regulatory Approvals Received in Key Global Markets:
Further expanding and supporting the global commercial rollout of
ProSense®, our cryoablation system, and disposable probes now have
regulatory approval in 15 countries, including countries where
approval was granted in 2023 such as China, Canada, and Brazil.
Seeking to Expand Approvals in the U.S. to Include Breast
Cancer: ProSense® is currently approved by the U.S. Food
and Drug Administration (FDA) in general minimally invasive
cryoablation procedures including kidney, liver, neurology, and
fibroadenoma. We are focused on attaining FDA clearance to market
ProSense® to address a significant unmet need for a minimally
invasive option to treat early-stage breast cancer. In 2022, we had
filed a De Novo Classification request with the FDA for regulatory
approval of ProSense® for the indication of early-stage low-risk
breast cancer in patients who are at high risk for surgery, based
on interim data from ICE3. We received a denial from the FDA on our
De Novo request in September 2023 and
subsequently filed an appeal. The FDA's decision has no bearing on
patients in the U.S. for indications already cleared by the FDA.
Our appeal with the FDA focused on the FDA's choice of comparator
group for our ICE3 interim study data. We believe that an
appropriate comparator group agreement with the FDA and subsequent
analysis of the data may lead to marketing clearance for ProSense®
in this indication. We anticipate a response to the appeal from the
FDA by the end of January 2024. Our
continued commitment to the U.S. market, which represents more than
300,000 breast cancer patients diagnosed annually, was further
demonstrated this past year when we appointed Shad Good as our Vice President of Sales for
North America. Mr. Good brings
nearly 20 years of medical device sales and leadership experience,
including as a global leader in minimally invasive breast
diagnostic and therapeutic systems. He is focused on potential
targeted users of ProSense® throughout the U.S. and Canada and continuing to accelerate sales
momentum.
Increased Distributors and Global Installations: In
2023, we entered a non-exclusive distribution agreement with
Medicinália Cormédica – MC Medical, Lda., the largest distributor
of third-party medical devices in Portugal, further expanding the distribution
of ProSense® in Europe where the
system has the European Union's CE mark of regulatory approval. In
India, ProSense® was used to
perform the country's first breast cryoablation procedure at a
hospital where our system was installed earlier in the year. Having
received regulatory approval in Brazil, sales are expected through our
$6.6 million, 5-year distribution
agreement with Ktrfios Importação e Exportação
LTDA.
2024 Objectives
- Driven by growing awareness of ProSense®'s safety and
efficacy in breast cancer and numerous other indications, as
demonstrated through the 17 independent and two IceCure studies, we
are focused on increasing sales of our systems and disposable
probes with corresponding revenues across the globe through current
and new distribution partners.
- Broadening ProSense®'s adoption as a breast cancer
treatment, IceCure's Japanese partner, Terumo Corporation is
expected to submit the request for clearance under a breast cancer
indication with the Pharmaceuticals and Medical Devices Agency in
Japan in the second half of
2024.
- The ICE3 study is expected to be completed by the end of the
first quarter of 2024.
- Top-line results from ICE3 are expected in the second quarter
of 2024. We believe these data, if favorable and in line with the
interim results that demonstrated an estimated 95.7% five-year
recurrence free rate, may lead to additional regulatory approvals
and increased sales in territories where ProSense® is already
approved for breast cancer.
- We anticipate a response from the FDA to our appeal by the end
of January 2024 and are hopeful for a
positive response as we continue to work closely with the FDA
towards an outcome that would make ProSense® available to
women in the U.S. who seek a non-surgical, minimally invasive
option for early-stage breast cancer.
- Our next-generation single-probe cryoablation system is
expected to be introduced in 2024.
We start 2024 with hope and wishes for a peaceful, healthy, and
prosperous year for all.
Sincerely,
Eyal Shamir, CEO
IceCure Medical
About ProSense®
The ProSense® Cyroablation 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 its
expected preliminary results for the financial year ended
December 31, 2023, the Company's
strategy, the belief that the growing number of published studies
will have a direct and favorable impact on the Company, that 2024
will be a pivotal year with the completion of the ICE3 study and
continued penetration in the U.S. and global markets, that the
implementation of its expense reduction plan will help ensure the
Company meets its primary goals in 2024, its belief that the
increased adoption of ProSense® by physicians is attributable to
the cost-effective nature and its successful marketing efforts, its
upcoming follow-up examinations in the ICE3 study in the first
quarter of 2024 that would mark the study's completion and about
which its top-line results are expected in the second quarter of
2024, that the ICESECRET five-year patient follow-up is to be
completed in 2026, its impending expansion of the global commercial
rollout of ProSense® and disposable probes, the impending result,
expected by the end of January 2024,
of the Company's appeal with regards to its ICE3 study, the
Company's focus on increasing sales of its systems across the globe
through current and new distribution partner, Terumo Corporation's
upcoming submission for clearance for ProSense® with the
Pharmaceuticals and Medical Devices Agency in Japan in the second half of 2024, and that the
Company's next-generation single-probe cryoablation system is
expected to be introduced in 2024. 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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