- Increase in sales of ProSense®, based on preliminary
unaudited results, demonstrate growing adoption of
ProSense® cryoablation for breast tumors.
- FDA decision on market authorization of ProSense® for
early-stage breast cancer is expected in the first quarter of
2025.
- FDA Advisory Panel voted in favor of ProSense®'s
benefit-risk profile for
early-stage low risk breast cancer.
- Positive ProSense® results reported through 10
peer-reviewed journals and 23 presentations at medical
conferences.
CAESAREA, Israel, Jan. 13,
2025 /PRNewswire/ -- IceCure Medical Ltd.
(NASDAQ: ICCM) ('IceCure', 'IceCure Medical' or the 'Company'),
developer of minimally-invasive cryoablation technology that
destroys tumors by freezing as an alternative to surgical tumor
removal, today issued the following letter to shareholders from its
Chief Executive Officer, Eyal
Shamir.
Dear shareholders,
In 2024, we observed a number of rising trends that we believe
clearly demonstrate ProSense®'s potential for widescale adoption
across numerous indications in multiple markets. De-escalation of
surgery, which has become an increasing focus of discussion in the
medical field, is being evaluated in studies and emerging as a
growing trend in practice. As a minimally invasive option,
cryoablation with ProSense® offers an excellent choice for
de-escalation of surgery with results that parallel invasive
surgery - and doctors and their patients are taking notice. The
continued growth in our ProSense® console and disposable probe
sales is in line with this trend.
2024 was truly a pivotal year for IceCure during which we
completed our 10-year long ICE3 study with excellent results. We
had a highly productive public meeting with the U.S. Food and Drug
Administration ('FDA') Medical Device Advisory Committee Panel
('Advisory Panel') that led to a positive vote. We are currently in
ongoing discussions with the FDA, which is expected to make its
decision on marketing authorization for early-stage breast cancer
in the first quarter of 2025. We look forward to executing on
substantial market opportunities in 2025.
As we enter the new year, we have expanded our Board of
Directors to include Vic Lee (Li
Haixiang), our controlling shareholder who truly understands
IceCure's potential to set a new standard for minimally-invasive
procedures. Mr. Lee is the Chairman of VI Asset Management, where
he invests in new medical technologies and robotics. We are honored
to welcome him to our Board of Directors.
2024 Key Achievements
Growth in ProSense® System and Probe Sales Demonstrates
Global Adoption Across Numerous Indications: Based on our
expected preliminary unaudited 2024 results, ProSense® system
and disposable probe sales increased to $3.19 million for the year ended December 31, 2024, compared to $2.96 million in 2023. Revenues for the year
ended December 31, 2024, grew to
$3.29 million compared to
$3.23 million in 2023. Most notably,
the North American market demonstrated significant growth, with a
42% increase in sales compared to 2023. An increase in system and
probe sales was partially offset by a decrease in revenue
recognition from our distribution agreement with Terumo
Corporation. Our cash and cash equivalents balance as of
December 31, 2024, was approximately
$7.5 million.
FDA Advisory Panel Voted in Favor of ProSense®'s Benefit-Risk
Profile for Early-Stage Low Risk
Breast Cancer: Following a public day-long forum, the FDA's
Advisory Panel delivered a favorable recommendation based on the
ICE3 study's final results, with nine panelists voting in favor and
five voting against ProSense®'s benefit-risk profile. The majority
of panelists voted that ProSense®'s benefits outweigh the risks
when used according to the proposed indications for the treatment
of patients with early-stage low risk invasive breast cancer with
cryoablation and adjuvant endocrine therapy. Among those that voted
'no', there were three panelists who stated that if the FDA applied
adequate special controls, this would have swayed their opinion in
favor of ProSense®'s benefit-risk profile.
Final ICE3 Results Reported with 100% Patient and Physician
Satisfaction and 96.3% Recurrence Free Rate: The ICE3
study was the largest controlled multi-center clinical trial ever
performed for liquid nitrogen-based cryoablation of low-risk,
early-stage malignant breast tumors. The five-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, which is the current standard of care for
early-stage breast cancer patients. The results were published in
the prestigious peer-reviewed journal, Annals of Surgical
Oncology, in an article titled, "Cryoablation Without Excision
for Early–Stage Breast Cancer: ICE3 Trial 5–Year Follow–Up on
Ipsilateral Breast Tumor Recurrence." The lead author of the study
is Dr. Richard Fine, an ICE3
Investigator, who co-authored the publication with co-primary
investigator, Dr. Kenneth Tomkovich,
and 24 other doctors who are ProSense® users.
ICESECRET Kidney Cancer Study Interim Results Demonstrate
88.7% Recurrence-Free Rate: Interim results from our study of
ProSense® in the treatment of kidney cancer reported an impressive
88.7% recurrence-free rate. Results were presented at the Israeli
Urological Association Conference in December 2024. Kidney cancer is a largely unmet
need, particularly in patients who are ineligible for
kidney-preserving surgery. The interim results are highly relevant
as ProSense® is approved as a cryosurgical tool in the destruction
of malignant and benign tumors of the kidney in key markets.
Positive ProSense® Results Reported Through 33 Peer-Reviewed
Journals and Medical Conferences: A number of prestigious
medical conferences around the world and peer-reviewed journals
reported on and published data regarding ProSense®'s efficacy and
safety in breast, kidney, lung, bone, and soft tissue cancers.
Several presentations won awards at prestigious medical
conferences, including the Scientific Impact Award at the American
Society of Breast Surgeons' Annual Meeting. The vast majority of
the published data involved independent studies in breast cancer,
and a large number of independent studies are currently
ongoing.
Fortified Intellectual Property with More Patents Granted and
Allowed: IceCure was granted and allowed four new patents in
the U.S., Japan, and Europe covering our latest innovations,
including its next-generation multi-probe cryoablation system,
cryogenic pump, and cryogenic flow control technology.
FDA Granted Regulatory Clearance for XSense™ Cryoablation
System with CryoProbes: The next-generation XSense™ system is
cleared for the same indications that our flagship ProSense® system
is currently approved for, and we believe it has future potential
to address other indications in the U.S. for significant
indications with unmet needs.
2025 Objectives
- We are hopeful that the FDA will grant market authorization for
ProSense® for early-stage breast
cancer in the first quarter of 2025 following the FDA Advisory
Panel's positive vote in November
2024. Authorization, if granted, is expected to increase
direct sales of ProSense® systems and disposable probes in the
U.S, which is currently led by our VP of Sales North America, Mr.
Shad Good, and our U.S. team.
- Greater market traction is expected in the other markets for
ProSense® in breast cancer based on the positive final ICE3 data
and the FDA Advisory Panel's positive vote in favor of ProSense®'s
benefit-risk profile. Market authorization in the U.S., if granted,
is expected to further propel regulatory approvals and global
adoption.
- Terumo, our distributor in Japan, is expected to submit a request for
breast cancer clearance to Japan's
Pharmaceuticals and Medical Devices Agency.
- More peer-reviewed publications are expected from ongoing
independent studies of ProSense® worldwide. Nine abstracts have
already been accepted for publication in the first quarter of 2025
alone.
- In China, IceCure Shanghai is
expected to submit ProSense® and its cryoprobes for regulatory
approval to the National Medical Products Administration ('NMPA')
in early 2025. IceSense3 and its disposable probes have already
been approved by the NMPA.
- We continue to explore opportunities for strategic cooperation
and partnership, driven by our recent advancements and
innovations.
We wish you all a peaceful, healthy, and prosperous 2025.
Sincerely,
Eyal Shamir, CEO
About ProSense®
The ProSense® Cryoablation System is a minimally invasive
cryosurgical tool that provides the 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
procedures for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets advanced
liquid-nitrogen-based cryoablation therapy systems for the
destruction 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 Company's flagship ProSense® 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 its
expected preliminary results for the financial year ended
December 31, 2024; its objectives for
2025, its strategy; that the FDA's decision whether to grant market
authorization to ProSense® for early-stage breast cancer is
expected in the first quarter of 2025, and the effects of a
positive decision on sales and regulatory approvals, its belief
that the growing number of published studies will have a direct and
favorable impact on the Company; that 2025 will be a pivotal year
for the Company with continued penetration in the U.S. and global
markets; its belief that the increased adoption of ProSense®
by physicians is attributable to the cost-effective nature and its
successful marketing efforts; that the ICESECRET interim results
will lead to an increased adoption of ProSense®; its impending
expansion of the global commercial rollout of ProSense® and
disposable probes; the impending result, expected by the end of
January 2025, of its appeal with
regards to its ICE3 study; its 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 early 2025; its belief
that its increased patent portfolio across different markets will
increase adoption of the Company's technologies; that the FDA's
regulatory clearance for XSense™ cryoablation system with
cryoprobes will result in adoption by physicians for significant
indications with unmet needs; and when it discusses exploring
strategic alternatives and seeking to establish cooperation with
potential strategic partners. 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 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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