IceCure Medical Reports Full Year 2023 Financial Results: Global ProSense and Disposables Sales Increase 26% as Company Continues Transition to Commercial Phase and Expects to Submit ICE3 Breast Cancer Study Data to FDA

Medical Reports Full Year 2023 Financial Results: Global ProSense and Disposables Sales Increase 26% as Company

Continues Transition to Commercial Phase and Expects to Submit ICE3 Breast Cancer Study Data to FDA this Month for Marketing Clearance

call to be held today at 10:00 am Eastern Time; Focus on U.S. market for ProSense in breast cancer indication

Israel, April 3, 2024 - 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 reported sales as of and for the twelve months ended December 31, 2023 increased 26% compared to the

twelve months ended December 31, 2022, as the Company continues to transition from a research and development and clinical phase company

to a commercial phase company.

Key Financial Highlights:

have achieved what we believe is the most significant milestone in our company's history with the completion of the ICE3 breast

cancer study and reporting of topline results," stated IceCure's CEO, Eyal Shamir. "In the next few weeks, we will

be reporting full results and submitting them to the FDA for review. We believe the data from ICE3 and numerous independent studies of

ProSense in breast cancer support our thesis that ProSense can have a very meaningful positive impact

on the health and wellbeing of women with early-stage breast cancer. Our U.S. commercial team is ready to launch marketing and distribution

of ProSense for breast cancer as we await the U.S. Food and Drug Administration's ("FDA") decision.

Should the FDA grant clearance, we believe this decision would further boost commercial demand in global markets where ProSense

already has approval for breast cancer."

are pleased that the ICE3 full data results will be presented at the highly influential American Society of Breast Surgeons ("ASBrS")

25th Annual Meeting by ICE3 Investigator Dr. Richard Fine and by Dr. Michael Berry. Breast surgeons considering ProSense

for their practice are eager to see the results, and we are hopeful that they will be impressed by the data."

initiated studies in many other indications continue to increase in Europe, the U.S., and Asia. The growing number of independent studies,

we believe, is a very strong indicator of future adoption."

we increased our commercial activities through medical conferences and added more distributors, we had a corresponding growth in 2023

revenues, system, and probe sales. While total revenues in 2023 were up slightly to $3.2 million, compared to $3.1 million in 2022, a

more meaningful increase of 26% or $0.6 million in ProSense system and disposable probe sales demonstrates continued

and Recent Significant Operating, Clinical, Regulatory & Commercial Highlights:

ICE3 Breast Cancer Study and Reported Topline Results: IceCure successfully completed a 10-year long landmark study, the largest

controlled multicenter clinical trial ever performed for liquid nitrogen (LN2) based cryoablation of low-risk, early-stage malignant

breast tumors. In the ICE3 study, 96.39% of patients (187 out of 194 patients) were local recurrence-free with no significant device-related

adverse events or complications reported. These results are in line with data from numerous third-party studies conducted by physicians

currently using ProSense .

ICE3 Data to be Submitted to FDA: The Company plans to complete the analysis and evaluation of the full data set and expects to submit

the results to the FDA in April 2024. The FDA requested this data as part of IceCure's De Novo Classification Request for Marketing

Authorization of ProSense for the treatment of early-stage low-risk breast cancer.

Full Results to be Presented at ASBrS's 25th Annual Meeting: Dr. Richard Fine, ICE3 Investigator, will present the

full ICE3 study results at the ASBrS's annual meeting, the most prominent event in the U.S. for breast surgeons, in a presentation

titled "Cryoablation Without Excision for Early-Stage Breast Cancer; ICE3 Trial 5 year follow up on Ipsilateral Breast Tumor Recurrence".

Additionally, ICE3 Investigator Dr. Michael Berry will present a session titled "Cryoablation: Is It Ready for Primetime?".

Approval Received in Brazil, Canada, and China: ProSense now has regulatory approvals in 15 countries for a broad

range of indications.

Rollout Momentum with New Distribution and Installations in Portugal, India, and Brazil: IceCure entered a non-exclusive distribution

agreement with Medicin lia Corm dica - MC Medical, Lda., the largest distributor of third-party medical devices in

Portugal. The first breast cryoablation procedure in India was performed in 2023 with ProSense and there has been strong

interest in the country at medical conferences where IceCure's cryoablation system was featured. In Brazil, where ProSense

received regulatory approval in 2023, IceCure's in-country distributor has launched commercial activities and procedures

Investigator Initiated Studies Build Data to Support Potential New Indications, Adoption, and Reimbursement: Numerous third-party

studies have been initiated to evaluate ProSense in various indications. Results from completed studies have been presented

at medical conferences and published in peer-reviewed journals including studies from Spain and Italy that demonstrated ProSense 's

efficacy in early-stage breast cancer, with data similar to ICE3's topline results. Two endometriosis studies in France revealed

ProSense 's potential in treating a condition that afflicts 190 million women globally. With current treatments

only aiming to control symptoms and no curative option available, endometriosis is an indication for which ProSense may

deliver significant benefits to patients and payors alike. Another study in France reported a 92% disease-free survival rate in kidney

cancer patients treated with ProSense . These data support further adoption and reimbursement, particularly in countries

where ProSense has already been approved for these indications. Elucidating ProSense 's efficacy

in cancer, a study at Case Western Reserve University in the U.S., demonstrated that ProSense boosts immune response

against caner by enhancing CD8+ T cell response.

Portfolio and Technology Pipeline Continue to Grow: IceCure added three more patents to its expanding cryoablation-focused IP portfolio.

In March 2024, IceCure was issued a patent in Japan for a novel cryogen flow control system to optimize patient outcomes. The U.S. and

Japan both issued patents to IceCure for a novel cryogenic pump for its next-generation cryoablation systems. In April 2024, the Company

filed a 510(k) submission with the FDA for its next-generation single probe XSense System and cryoprobes for all the indications

for which ProSense has already received the requisite FDA clearance.

Results for the Twelve Months Ended December 31, 2023

for the twelve months ended December 31, 2023 were $3.2 million compared to $3.1 million for the twelve months ended December

31, 2022. The minor increase is due to the increase in ProSense systems and disposables sales which was offset by the

decrease in revenue recognition from the exclusive distribution rights agreement with Terumo Corporation in Japan. For the twelve months

ended December 31, 2023, the Company reported a 26% increase in ProSense systems and disposable probes sales to

$3 million, compared to $2.3 million for the twelve months ended December 31, 2022, driven by higher sales in the U.S. and other territories.

profit was $1.3 million for the twelve months ended December 31, 2023 compared to $1.4 million for the twelve months ended

December 31, 2022. Gross margin was 40% for the twelve months ended December 31, 2023, compared to 47% for the twelve months ended December

31, 2022. Non-GAAP gross profit and non-GAAP gross margin for the year ended December 31, 2023, increased by $0.3 million, or 47%, to

$1 million, compared to $0.7 million for the year ended December 31, 2022. The increase in non-GAAP gross profit and non-GAAP gross margin,

without taking into consideration revenue from the exclusive distribution agreements, is attributable to the increase of 26% in revenue

from sales of ProSense systems and probes while the increase in cost of revenues was 18%.

and development expenses for the twelve months ended December 31, 2023, were $8.3 million compared to $9.1 million for

the twelve months ended December 31, 2022. The decrease was primarily due to the depreciation of NIS against the USD on NIS-denominated

expenses such as payroll and related benefits, a reduction in our development expenses for the XSense System, and a decrease in

clinical and regulatory costs.

support of ongoing global commercial adoption and in anticipation of increasing U.S. commercial efforts, sales and marketing expenses

for the twelve months ended December 31, 2023 were $4.4 million, compared to $3.2 million for the twelve months ended

December 31, 2022. General and administrative expenses for the twelve months ended December 31, 2023 decreased by 30% to $4.2 million,

compared to $5.9 million the twelve months ended December 31, 2022. A portion of the decrease was due to a decrease in director

and officer insurance costs and the depreciation of NIS against USD on NIS denominated expenses such as payroll and related benefits.

operating expenses for the twelve months ended December 31, 2023 decreased to $16.9 million, compared to $18.2 million for

the twelve months ended December 31, 2022. The decrease in operating expenses was attributable to reductions in research and development

expenses and general and administrative expenses, which were partially offset by the increase in sales and marketing expenses.

loss for the twelve months ended December 31, 2023 decreased by 14% to $14.7 million, or $0.32 per share, compared with

a net loss of $17.0 million, or $0.46 per share, for the same period last year.

of December 31, 2023, the Company had cash and cash equivalents, including short-term deposits, of approximately $11.1 million,

compared to $23.7 million as of December 31, 2022. As of March 31, 2024, the Company had cash and cash equivalents,

including short-term deposits, of approximately $11 million. To ensure the Company is in a position to achieve its near-term objectives,

IceCure has implemented an expense reduction plan that will reduce its non-revenue generating and clinical efforts costs, lowering the

monthly cash utilization and ensuring it can meet its primary goals in 2024.

Non-U.S. GAAP Measures

addition to disclosing financial results prepared in accordance with accounting principles generally accepted in the United States of

America (U.S. GAAP), this press release contains non-U.S. GAAP financial measures that the Company uses as measures of its performance.

These measures may be different from non-GAAP financial measures used by other companies. The Company calculates (i)

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; and (ii) non-GAAP gross margin is a percentage of non-GAAP gross profit from revenues from sales

of systems and disposables which reflects the gross margins on our systems and disposables sales. These non-GAAP financial measures are

included as a supplemental disclosure because they are performance measures used by our management and board of directors to determine