Full Press Release Details
IceCure Medical Reports 36% Sales Growth in
the First Nine Months of 2024 Driven by Global Adoption of ProSense Cryoablation
FDA Marketing Authorization Decision on Early
Stage-Low Risk Breast Cancer Expected in Q1 2025
Conference call to be held today at 10:00 am
CAESAREA, Israel, November 26, 2024 -
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 reported
financial results as of and for the nine months ended September 30, 2024. Sales of ProSense consoles and disposable probes increased
by 36%. Gross profits increased by 41%, while non-GAAP gross profits grew by 104%. Gross margins increased to 43%, while non-GAAP gross
margin increased to 40%, compared to 27% in the same period in 2023].
On November 7, 2024, the U.S. Food and Drug Administration's
("FDA") Medical Device Advisory Committee Panel (the "Advisory Panel") voted in favor of ProSense 's benefit-risk
profile in early-stage low risk breast cancer.
Value Enhancing Catalysts
our efforts have remained focused on the U.S. marketing authorization for ProSense in early-stage breast cancer, the impressive
36% sales growth for the first nine months ended September 30, 2024, compared to the same period last year, demonstrates our commitment
to working with our global partners to accelerate the adoption and increase the utilization of ProSense ," stated IceCure Medical's
CEO, Eyal Shamir. "As we near the end of 2024, it goes without saying that it is shaping up to be a transformative year for IceCure.
We successfully completed the ICE3 trial and published top line data. Furthermore, the positive outcome of the FDA Advisory Panel earlier
this month brings us to the cusp of potential marketing authorization, which, if received, would allow us to offer women a non-surgical
alternative to lumpectomy. We believe, based on current global sales growth and further awareness, understanding, and education of ProSense ,
our cryoablation system will be an indispensable tool for breast surgeons, interventional radiologists and interventional oncologists,
and patients alike."
"The FDA Advisory Panel meeting further
elevated the awareness of ProSense and our goal upon the FDA reaching its decision is to build out the sales infrastructure and footprint
to meet expected demand," Shamir concluded.
Large Body of Published Data on ProSense 's
Efficacy & Safety Continues to Grow
The following is a list of published studies during
and subsequent to the third quarter:
article published in the European Journal of Cancer Prevention on November 6, 2024 outlines the recently launched PRECICE study which
will exclusively use ProSense for the study of cryoablation of early stage, low risk breast cancer - an independent prospective
observational study of 233 women aged 50 and older with unifocal, small, clinically node-negative, luminal A and B breast cancer at the
prestigious European Institute of Oncology in Milan, Italy.
Financial Results for the Nine Months Ended
September 30, 2024 Demonstrate Accelerating Growth of ProSense Adoption and Utilization
systems and disposable probes for the nine months ended September 30, 2024 increased by 36% to $2,316,000 compared to $1,700,000
for the nine months ended September 30, 2023. The growth was primarily attributable to sales in Europe, the U.S., Japan and other
territories in Asia which were partially offset by a decrease in sales in China. Total revenue for the nine months ended September
30, 2024 increased by 22% to $2,416,000 from $1,974,000 for the nine months ended September 30, 2023 due to an increase in the
sale of ProSense systems and disposables, which was partially offset by a decrease in revenue recognition and other services in Japan
of $100,000 and $274,000 in the first nine months of 2024 and 2023, respectively.
the nine months ended September 30, 2024 increased by 41% to $1,034,000 from $731,000 for the nine months ended September 30,
2023. Non-GAAP gross profit more than doubled for the nine months ended September 30, 2024 to $934,000 from $457,000 for the nine months
ended September 30, 2023, an increase of $477,000 or 104%. Gross margin increased to 43% in the nine months ended September 30, 2024 compared
to 37% in the nine months ended September 30, 2023. Non-GAAP gross margin for the nine months ended September 30, 2024 increased to 40%
from 27% for the nine months ended September 30, 2023. The increase in non-GAAP gross profit and non-GAAP gross margin, which exclude
revenue from the exclusive distribution agreements and other services in Japan, was attributable to the increase of 36% in revenue from
sales of ProSense systems and disposables. Non-GAAP gross profit and non-GAAP gross margin are financial measures that may be defined
as "non-GAAP financial measures" by the U.S. Securities and Exchange Commission ("SEC"). For a reconciliation
of these non-GAAP financial measures to the nearest comparable GAAP measure, see Appendix A to this press release.
Research and development
expenses for the nine months ended September 30, 2024 decreased by 15% to $5,401,000 compared to $6,390,000 for the nine months
ended September 30, 2023. The decrease was primarily due to a reduction in development expenses for the XSense System, which received
FDA authorization in June 2024, and a decrease in clinical and regulatory costs as the Company concluded the ICE3 study in March 2024.
Sales and marketing expenses increased for the nine months ended September 30, 2024 to $4,041,000 compared to $3,234,000 for
the nine months ended September 30, 2023 as the Company focused on increased global marketing to support growing sales and in anticipation
of potential marketing authorization for ProSense in early-stage breast cancer in the U.S. General and administrative expenses for
the nine months ended September 30, 2024 decreased to $2,763,000 from $3,268,000 for the nine months ended September 30, 2023, reflecting
the Company's continued prudent budgeting and operating efficiencies.
Total operating expenses
for the nine months ended September 30, 2024 decreased to $12,205,000 from $12,892,000 for the nine months ended September 30, 2023. The
decrease in operating expenses was attributable to reductions in research and development and general and administrative expenses, due
to the Company's initiative to reduce non-critical operating expenses, which were partially offset by an increase in sales and marketing
Net loss for the nine
months ended September 30, 2024 decreased to $10,839,000, or $0.22 per share compared to a net loss of $11,657,000, or $0.26
per share, for the same period last year.
30, 2024, the Company maintained a solid balance sheet with cash and cash equivalents, including short-term deposits, of approximately $10.7
million. As of October 31, 2024, the Company had cash and cash equivalents of approximately $10.0 million. During the first nine months
of 2024, the Company raised $8.1 million in net proceeds from the sale of 8,974,195 ordinary shares under its at-the-market offering facility.
Use of Non-U.S. GAAP Measures
In addition to disclosing financial results prepared
in accordance with accounting principles generally accepted in the U.S. ("U.S. GAAP"), this press release contains certain
financial measures which may be defined as "non-GAAP financial measures" by the SEC. The Company defines non-GAAP gross profit
as gross profit less revenue from exclusive distribution agreements and other services. The Company has provided non-GAAP gross profit
in this press release because it is a key measure used by management and the board of directors as an indication of our gross profit from
sales of our systems and disposables and management believes that it is useful to investors' understanding and assessment of the
Company's gross profit without the impact of revenue recorded from the Company's exclusive distribution agreements and other
services. The Company has provided a reconciliation below of non-GAAP gross profit and non-GAAP gross margin to the most directly comparable
financial measure calculated and presented in accordance with U.S. GAAP. The non-GAAP financial measures disclosed by the Company should
not be considered in isolation or as a substitute for, or superior to, financial measures calculated in accordance with U.S. GAAP and
the financial results calculated in accordance with U.S. GAAP and reconciliations to those financial results should be carefully evaluated.
Conference call & webcast info:
Tuesday, November 26, 2024, at 10:00 am EST
Israel/International: +972-3-918-0696
A live webcast will be available at: https://Veidan.activetrail.biz/IcecureQ3-2024
A recording of the webcast will be available at:
ir.icecure-medical.com/
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,
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
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