Full Press Release Details
Medical Maintains Positive Momentum and Reports Sales Growth for Cryoablation System in First Quarter of 2024
Israel, May 28, 2024 - IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" 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 reported financial results as of and for the three months ended March 31, 2024. During the quarter,
the Company completed its landmark ICE3 trial and recently achieved several objectives, including: publishing and submitting the full
data set of its ICE3 trial results to the U.S. Food and Drug Administration ("FDA"); and requesting marketing authorization
for ProSense for the indication of treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone
completed ICE3, the largest study of its kind in cryoablation in the U.S., we are now awaiting the FDA's marketing clearance decision,"
stated IceCure's CEO, Eyal Shamir. "ProSense is already cleared and is being used to treat early-stage breast cancer
in numerous countries with great results. Since the U.S. is one of the largest markets in the world, we believe that delivering alternative
surgery-free options to women in the U.S., while establishing ProSense as a gold-standard globally, will have a significant impact
on treating patients with breast cancer."
the first quarter, we also continued to experience an upward trend in sales in the U.S. We successfully managed to lower our operating
expenses in non-revenue generating activities by exercising prudent cash management."
Quarter 2024 and Recent Significant Operating, Clinical, Regulatory & Commercial Highlights:
and Submitted Full ICE3 Breast Cancer Study Data to FDA: IceCure completed the largest controlled multicenter clinical trial ever
performed for liquid nitrogen (LN2) based cryoablation of early-stage malignant breast tumors. 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. 100% patient and physician satisfaction was reported. IceCure submitted the final ICE3 data, along with
other analyses and data, to the FDA requesting marketing authorization of ProSense for the indication of treating patients with
early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. Full ICE3 study results were presented at the American
Society of Breast Surgeons' ("ASBrS") annual meeting by ICE3 investigators, including Dr. Richard Fine who delivered
an oral presentation titled "Cryoablation Without Excision for Early-Stage Breast Cancer; ICE3 Trial 5-year follow-up on Ipsilateral
Breast Tumor Recurrence," which won the ABSrS Scientific Impact Award.
(0%) Breast Cancer Local Recurrence 5 Years After Treatment with ProSense : An independent study performed in Japan was published
in an article titled "Percutaneous ultrasound-guided cryoablation for early-stage primary breast cancer: a follow-up
study in Japan," in the journal Breast Cancer. In addition to no cancer recurrence 5 years following treatment with ProSense ,
researchers also reported excellent cosmetic outcomes, a high degree of patient satisfaction, and improved quality of life post-cryoablation.
with ProSense Resulted in 100% Tumor Reduction in Early-Stage Breast Cancer: An independent study in women deemed inoperable
for breast cancer reported median tumor reduction of 100% at 6 and 12 months following cryoablation. The study was conducted by ProSense
user, Dr. Federica di Naro, of Azienda Ospedaliero-Universitaria Careggi in Florence, Italy.
Found to be Promising Alternative Treatment for Extra-Pelvis Endometriosis: An investigator-initiated single-site study of women
with endometriosis in the abdominal wall and para-diaphragmatic areas found that treatment with ProSense for about 30 minutes resulted
in the disappearance of hemorrhagic signals and development of necrotic changes, as well as pain reduction from a median of 7 on a scale
of 0 - 10 to a median of 1, with some patients reporting 0. The independent study was conducted at University Hospital, N mes,
France, and data were shared at the European Congress of Radiology 2024 in Vienna, Austria in a presentation titled "BEYOND PAIN:
Cryoablation of endometriotic nodules using liquid nitrogen".
Boosts Immune Response Against Cancer by Enhancing CD8+ T Cell Response: An independent study, conducted at Case Western Reserve
University in Cleveland, Ohio and published in OncoImmunology, demonstrated that ProSense can activate the body's natural
immune response by enhancing CD8+ T cells, which are an important arm of immune response. The data support previous studies and suggest
ProSense may produce anti-cancer benefits in humans beyond tumor destruction during a cryoablation procedure.
and Medical Community Interest Continues to Grow with ProSense Featured at Conferences in the U.S., India and Japan: In the
U.S., in addition to ICE3 data being presented at ASBrS, cryoablation gained prominence at the Society of Interventional Oncology (SIO)
Annual Scientific Meeting where the technology was featured in the first breast cryoablation master class at SIO. ICE3 trial data were
cited prominently in the master class given by several ProSense users, including Dr. Kenneth Tomkovich, ICE3's co-principal investigator,
and Dr. Fine. In India, ProSense users and key opinion leaders highlighted the benefits of cryoablation at the Indian Society of
Vascular and Interventional Radiology Conference and the Fourth Breast Imaging & Interventional Techniques conference. ProSense
was featured in a number of sessions, including one titled "Minimal access imaging guided therapies: cryoablative therapies in breast
pathologies". Underscoring global adoption and use of ProSense , Dr. Eisuke Fukuma, PhD, who has performed over 600 breast cryoablation
procedures with ProSense , hosted two events in Japan at the 30th Japan Breast Disease Society and the 8th International Oncoplastic
Breast Surgery Symposium.
Patent Allowance in Japan for a Novel Cryogen Flow Control to Optimize Patient Outcomes: IceCure received a Notice of Allowance from
the Japan Patent Office for its patent application titled "Cryogen Flow Control" for a technology that enhances the efficacy
and precision of cryoablation procedures.
Application for FDA Clearance of Next-Generation XSense System and Cryoprobes: Demonstrating its global leadership in minimally
invasive cryoablation technologies, IceCure submitted a 510(k) filing for its single probe XSense system and cryoprobes to the
FDA for regulatory clearance in all the indications for which ProSense has already received the requisite FDA clearance.
Results for the Three Months Ended March 31, 2024
for the three months ended March 31, 2024 were $743,000 compared to $710,000 for the three months ended March 31, 2023, an
increase of 5%, due to an increase in the sales, which was offset by the end of revenue recognition from the exclusive distribution rights
agreement with Terumo Corporation in Japan for which no revenue was recognized in the three months ended March 31, 2024. For the three
months ended March 31, 2024, the Company reported ProSense systems and disposable probes sales of $743,000 compared to $573,000
for the three months ended March 31, 2023, an increase of 30%, driven primarily by higher sales in the U.S. and Japan.
profit for the three months ended March 31, 2024 was $269,000 compared to $320,000 for the three months ended March
31, 2023. Gross margin for the three months ended March 31, 2024 was 36%, compared to 45% for the three months ended March 31, 2023.
Non-GAAP gross profit for the three months ended March 31, 2024 was $269,000, compared to $183,000 for the three months ended March 31,
2023, an increase of $86,000 or 47%. Non-GAAP gross margin for the three months ended March 31, 2024 was 36% compared to 32% for the
three months ended March 31, 2023. The increase in non-GAAP gross profit and non-GAAP gross margin, which exclude revenue from the exclusive
distribution agreements, was attributable to the increase of 30% in revenue from sales of ProSense systems and probes while the
increase in cost of revenues was 22%. 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.
and development expenses for the three months ended March 31, 2024, were $1,951,000 compared to $2,111,000 for the three
months ended March 31, 2023. The decrease was primarily due to a reduction in development expenses for the XSense System, and
a decrease in clinical and regulatory costs.
and marketing expenses for the three months ended March 31, 2024 were $1,038,000, compared to $1,075,000 for the three months
ended March 31, 2023. General and administrative expenses for the three months ended March 31, 2024 were $930,000, compared to $1,091,000
for the three months ended March 31, 2023. The decrease was due, in part, to a decrease in directors and officers insurance costs and
the depreciation of NIS against USD on NIS-denominated expenses such as payroll and related benefits.
operating expenses for the three months ended March 31, 2024 were $3,919,000, compared to $4,277,000 for the three months ended
March 31, 2023. The decrease in operating expenses was attributable to reductions in research and development, general and administrative
expenses, and sales and marketing expenses.
loss for the three months ended March 31, 2024 was $3,609,000, or $0.08 per share, compared to a net loss of $3,768,000,
or $0.08 per share, for the same period last year.
of March 31, 2024, the Company had cash and cash equivalents, including short-term deposits, of approximately $11 million,
compared to $11 million as of December 31, 2023. As of May 28, 2024, the Company had cash and cash equivalents of approximately
the first quarter of 2024, the Company raised $2.98 million in net proceeds from the sale of 2,210,057 ordinary shares under its at-the-market
("ATM") offering facility, and the compensation paid by the Company with respect to sales of the ordinary shares pursuant
to this ATM facility was $76,000.
Non-U.S. GAAP Measures
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.
Company defines non-GAAP gross profit as gross profit less revenue from exclusive distribution agreements as an indication of our gross
profit from sales of our systems and disposables. 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. The Company defines non-GAAP gross margin
as a percentage of non-GAAP gross profit from sales of our systems and disposables. The Company has provided non-GAAP gross margin in
this press release because it is a key measure used by management and the board of directors as an indication of the Company's
profitability without the impact of revenue from the Company's exclusive distribution agreements. We have provided a reconciliation