Exhibit 99.3




IceCure Medical Reports First Half 2023 Financial & Operational Results:
Global Adoption of Cryoablation Technology Gaining Momentum


Company awaits FDA’s response to its regulatory filing for early-stage low risk breast cancer in patients who are at high risk for surgery


Renowned physician, Dr. Robert Ward, to participate on the Company’s conference call scheduled for today at 10am EDT


CAESAREA, Israel, August 14, 2023 -- 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 financial results as of and for the six months ended June 30, 2023, as well as operational and recent corporate developments.


Second Quarter Highlights and Recent Achievements


Successful transition from clinical stage to commercial stage continues as ProSense received regulatory approvals in Canada and China


Accelerated adoption with new distribution agreement in Portugal


Cryoablation achieved a 92.8% efficacy in avoiding secondary surgery during a physician-sponsored cryoablation study of endometriosis, which affects about 10% of women who are at reproductive age globally, or 190 million people according to the World Health Organization (WHO)


“Our goal this year is to successfully transition from a development/clinical stage to a commercial stage company. I believe the regulatory clearances for ProSense in Canada and China demonstrate that we are well on our way to achieving our objective,” stated IceCure Chief Executive Officer, Eyal Shamir. “We remain highly committed to this strategy and believe it will be significantly enhanced upon U.S. Food and Drug Administration (FDA) approval. The FDA review is continuing to progress and is consistent with the standard de novo review process. We remain highly engaged with the FDA and we look forward to its pending response. We are also implementing our go-to market strategy through greater market awareness and are working to increase reimbursement for ProSense procedures in order to make it accessible to those seeking a non-invasive alternative to a lumpectomy, today’s standard of care.”


Second Quarter of 2023 and Recent Operating Highlights


ProSense Used in American Society of Breast Surgeons (ASBrS) Annual Meeting’s 1st Ever Course on Cryoablation:  At the ASBrS 24th Annual Meeting, the Society's first-ever continuing medical education ("CME") course on cryoablation was conducted using the ProSense system. Attending surgeons got first-hand experience using ProSense and were presented interim results from IceCure's ICE3 clinical trial. A high level of interest in cryoablation was expressed from attending surgeons and from ASBrS leadership during the annual meeting.


Regulatory Approvals Received in Canada and China: Health Canada, the Canadian government’s regulatory agency, has approved the ProSense System, introducers, and disposable cryoprobes as cryosurgical tools for numerous indications. China’s National Medical Products Administration ("NMPA") approved the IceSense3 (ProSense's brand name in China) disposable cryoprobes for commercial use in combination with the Company's IceSense3 system console, which was previously approved by the NMPA.


Expanded Distribution of ProSense into Portugal with Upfront Sales of Systems and Probes: IceCure entered into a non-exclusive distribution agreement with Medicinália Cormédica – MC Medical, Lda. ("MC Medical"), the largest distributor of third-party medical devices in Portugal. MC Medical made an initial purchase of two ProSense consoles, along with disposable cryoprobes and introducers.






ProSense at a Leading Hospital in India is 1st in the Country to Offer Breast Cancer Cryoablation: ProSense was installed and inaugurated at Kovai Medical Center and Hospital ("KMCH") in Coimbatore, India. To the Company's knowledge, this constitutes the first instance of cryoablation for breast cancer treatment offered in the country.


92.8% Efficacy in Avoiding Secondary Surgery Reported in a Study That Used ProSense for Cryoablation of Endometriosis: A study published in the Journal of Vascular and Interventional Radiology and conducted at the Sorbonne University Department of Interventional Radiology and Oncology, Tenon Hospital in Paris, France, concluded that percutaneous cryoablation is a safe and effective procedure that significantly reduces pain and obtains local control of extraperitoneal endometriosis. ProSense was one of two types of cryoablation systems used in the single-site study. The efficacy rate of cryoablation to avoid secondary surgery was 92.8% per patient and 93.6% per nodule treated. Median pain-free survival rates were 93.75% at 6 months and 82.72% after 36 months. The independent study and paper were not sponsored by IceCure.


Financial Results as of and for the Six Months Ended June 30, 2023


For the six months ended June 30, 2023, the Company reported a 9% increase in revenues to $1.65 million compared to revenues of $1.5 million for the six months ended June 30, 2022. A 32% increase was reported for revenues from sales of systems and disposable probes for the six months ended June 30, 2023, which were $1.37 million compared to $1.03 million for the six months ended June 30, 2022, driven by higher sales in the United States, China, and other territories, partially offset by a decrease in sales in Europe. Revenue recognition from the exclusive distribution rights agreement in Japan with Terumo Corporation was $274 thousand compared to $484 thousand for the six months ended June 30, 2022.


Gross profit was $0.75 million for the six months ended June 30, 2023, compared to approximately $0.82 million for the six months ended June 30, 2022. Gross margin was 46% for the six months ended June 30, 2023, compared to 54% for the six months ended June 30, 2022. The decrease in gross profit and gross margin is primarily attributable to the decrease in revenue recognition from the Terumo distribution agreement.


Research and development expenses for the six months ended June 30, 2023, were $4.19 million compared to $4.65 million for the six months ended June 30, 2022. The decrease is primarily due to a reduction in development expenses of IceCure's next-generation single-probe system and a decrease in clinical and regulatory costs.


In anticipation of ramping up U.S. commercial efforts, sales and marketing expenses for the six months ended June 30, 2023, were $2.25 million, compared to $1.53 million for the six months ended June 30, 2022.


General and administrative expenses for the six months ended June 30, 2023, were $2.35 million, compared to $3.34 million for the six months ended June 30, 2022. The decrease is mainly due to a decrease in directors' and officers' insurance costs.


Total operating expenses for the six months ended June 30, 2023, were $8.79 million, compared to $9.52 million for the six months ended June 30, 2022. The decrease in operating expenses was primarily attributable to a reduction in research and development expenses and directors' and officers' insurance costs.


Net loss reported for the six months ended June 30, 2023, decreased to $7.66 million, or $0.17 per share, compared with a net loss of $8.97 million, or $0.24 per share, for the same period last year.


As of June 30, 2023, the Company had cash and cash equivalents, including short-term deposits, of approximately $16.7 million, compared to $23.66 million as of December 31, 2022.


Conference call & webcast info:


August 14, 2023, at 10:00 am ET 

US: 1-888-642-5032 

Israel/International: +972-3-9180610


A live webcast will be available at: https://veidan.activetrail.biz/IcecureQ2-2023


A recording of the webcast will be available for a limited time at: https://ir.icecure-medical.com/news-events/events-presentations 






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 and Israeli 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 goal to transition from a clinical stage to commercial stage company; and its looking forward to a response from the FDA as to the Company’s ProSense de novo review process; and that Class III device clearance in Brazil for the Company’s probes is expected by the end of Q1 2024.


Because such statements deal with future events and are based on IceCure’s current expectations, they are subject to various risks and uncertainties and actual results, performance, or achievements of IceCure could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, many of which are beyond the control of the Company, including those 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:


Michael Polyviou 

Phone: 732-232-6914 

Email: mpolyviou@evcgroup.com


Todd Kehrli 

Phone: 310-625-4462 

Email: tkehrli@evcgroup.com









   As of
June 30,
   As of December 31,
   (Unaudited)   (Audited) 
   U.S. dollars in thousands 
Cash and cash equivalents   3,031    23,659 
Deposits   13,648    - 
Restricted deposit   296    296 
Trade accounts receivables   118    78 
Inventory   2,751    2,857 
Prepaid expenses and other receivables   589    1,240 
Total current assets   20,433    28,130 
Prepaid expenses and other long-term assets   34    34 
Right-of-use assets   706    668 
Property and equipment, net   1,520    1,356 
Total non-current assets   2,260    2,058 
TOTAL ASSETS   22,693    30,188 
Trade accounts payable   652    714 
Lease liabilities   208    167 
Other current liabilities   2,995    3,455 
Total current liabilities   3,855    4,336 
Long-term lease liabilities   399    430 
Total non-current liabilities   399    430 
Ordinary shares, No par value; Authorized 2,500,000,000 shares; Issued and outstanding: 45,623,434 shares as of June 30, 2023 and December 31, 2022, respectively          
Additional paid-in capital   101,505    100,831 
Accumulated deficit   (83,066)   (75,409)
Total shareholders’ equity   18,439    25,422 









   Six months ended
June 30,
   2023   2022 
   U.S. dollars in thousands
(except per share data)
Revenues   1,647    1,512 
Cost of revenues   893    694 
Gross profit   754    818 
Research and development expenses   4,190    4,649 
Sales and marketing expenses   2,253    1,533 
General and administrative expenses   2,349    3,342 
Operating loss   8,038    8,706 
Financial expenses (income), net   (381)   262 
Net loss and comprehensive loss   7,657    8,968 
Basic and diluted net loss per share   0.168    0.244 
Weighted average number of shares outstanding used in computing basic and diluted loss per share   45,623,434    36,814,382 









   Six months ended
June 30,
   2023   2022 
   U.S. dollars in thousands 
Cash flows from operating activities        
Net loss   (7,657)   (8,968)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation   158    104 
Share-based compensation   674    885 
Exchange rate changes in cash and cash equivalents and short-term deposits   98    562 
Changes in assets and liabilities:          
Decrease (increase) in trade accounts receivables   (40)   272 
Decrease in prepaid expenses and other receivables   651    1,287 
Decrease (increase) in inventory   106    (696)
Decrease in right of use assets   62    95 
Increase (decrease) in trade accounts payable   (62)   56 
Decrease in lease liabilities   (90)   (172)
Increase (decrease) in other current liabilities   (460)   279 
Decrease in other long-term liabilities   -    (549)
Net cash used in operating activities   (6,560)   (6,845)
Cash flows from investing activities          
Investment in short-term deposits   (13,648)   (4,277)
Purchase of property and equipment   (322)   (493)
Net cash used in investing activities   (13,970)   (4,770)
Cash flows from financing activities          
Exercise of pre-funded warrants   -    1 
Net cash provided by financing activities   -    1 
Increase (decrease) in cash and cash equivalents   (20,530)   (11,614)
Cash and cash equivalents at beginning of the year   23,659    25,621 
Effect of exchange rate fluctuations on balances of cash and cash equivalents   (98)   (539)
Cash and cash equivalents at end of period   3,031    13,468 
Non-cash activities        
Obtaining a right-of-use asset in exchange for a lease liability   100    -