IceCure Medical Maintains Positive Momentum and Reports Sales Growth for Cryoablation System in First Quarter of 2024
IceCure Medical reported a strong Q1 2024 performance with a 30% sales growth for its ProSense® cryoablation system, driven by increased adoption in the U.S. and other global markets. The company completed the landmark ICE3 trial for breast cancer, reporting positive final data and submitting it to the FDA for marketing authorization. Financial highlights include a gross profit of $269,000 and net loss reduction to $3.6 million. Operating expenses decreased due to prudent cash management. The company also secured a new patent in Japan and submitted an FDA application for its next-generation XSense™ system.
- Achieved 30% sales growth for ProSense® system in Q1 2024.
- Completed ICE3 trial with positive final data submitted to FDA.
- Reported 96.3% recurrence-free rate for breast cancer patients in ICE3 trial.
- Independent studies reported zero recurrence and high patient satisfaction.
- Secured a new patent in Japan for cryogen flow control technology.
- Submitted FDA application for next-generation XSense™ system.
- Decreased operating expenses to $3.9 million from $4.3 million in Q1 2023.
- Raised $2.98 million through at-the-market offering.
- Reported a net loss of $3.6 million for Q1 2024.
- Gross profit decreased to $269,000 from $320,000 in Q1 2023.
- Gross margin dropped to 36% from 45% year-over-year.
- Revenues grew only by 5% from $710,000 to $743,000 over the year.
- Operating expenses remain high despite reductions.
IceCure Medical's reported 30% sales growth for its ProSense® cryoablation system is a significant indicator of market adoption, especially within the U.S. and international markets. While the company has successfully increased revenue from
Additionally, the company managed to reduce its operating expenses from
For the retail investor, the cash position is stable with
The final data from the ICE3 trial is a breakthrough for the ProSense® cryoablation system in treating early-stage T1 invasive breast cancer. With a
However, it's important to keep an eye on the pending FDA decision for marketing authorization. Should the ProSense® receive clearance, it will not only validate the clinical efficacy but also potentially open up a substantial market in the U.S., driving further adoption and sales growth. The ongoing independent studies bolster the argument for the ProSense® system's role in cancer treatment, showing both efficacy and safety across various indications.
For retail investors, the implications of FDA approval can be immense, likely catalyzing a significant uptick in stock value. Still, the timeline and outcome of regulatory approval remain critical factors to monitor.
IceCure's ProSense® system has demonstrated a promising enhancement in immune response against cancer. The study from Case Western Reserve University showing an enhanced CD8+ T cell response adds a new dimension to the technology's potential. This suggests that beyond mere tumor ablation, ProSense® may also facilitate a systemic anti-cancer effect. Such findings align with the growing interest in immuno-oncology and could broaden the application of cryoablation technology in oncological treatments.
Moreover, the expansion of applications for ProSense®, including treatments for conditions like endometriosis, indicates a versatile platform technology with multiple revenue streams. Recent independent studies in Europe underpin the system’s broader medical utility and patient benefits, such as reduced pain and improved quality of life post-treatment.
For retail investors, these research developments signal strong future potential for product diversification and long-term adoption in various medical fields. The impact of these studies on market perception and subsequent sales growth can be substantial, reinforcing confidence in the stock's future performance. However, the reliance on ongoing clinical validation and regulatory clearances should be factored into the investment risk profile.
30% sales growth reflects continued adoption of ProSense® in theU.S. and other global markets- Major milestones achieved:
- Completion of landmark ICE3 trial for breast cancer
- Positive final ICE3 trial data - Awaiting FDA Decision
- Independent studies performed globally continue to demonstrate ProSense®'s efficacy and safety across numerous indications
- Conference call to be held today at 11:00 am Eastern Time
![IceCure Medical Logo IceCure Medical Logo](https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg)
"Having completed ICE3, the largest study of its kind in cryoablation in the
"During the first quarter, we also continued to experience an upward trend in sales in the
First Quarter 2024 and Recent Significant Operating, Clinical, Regulatory & Commercial Highlights:
Reported 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,
Zero (
Treatment with ProSense® Resulted in
ProSense® 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, Nîmes,
ProSense® Boosts Immune Response Against Cancer by Enhancing CD8+ T Cell Response: An independent study, conducted at Case Western Reserve University in
Commercial and Medical Community Interest Continues to Grow with ProSense® Featured at Conferences in the
Received Patent Allowance in
Submitted 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.
Financial Results for the Three Months Ended March 31, 2024
Revenues for the three months ended March 31, 2024 were
Gross profit for the three months ended March 31, 2024 was
Research and development expenses for the three months ended March 31, 2024, were
Sales and marketing expenses for the three months ended March 31, 2024 were
Total operating expenses for the three months ended March 31, 2024 were
Net loss for the three months ended March 31, 2024 was
As of March 31, 2024, the Company had cash and cash equivalents, including short-term deposits, of approximately
During the first quarter of 2024, the Company raised
Use of Non-
In addition to disclosing financial results prepared in accordance with accounting principles generally accepted in the
The 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 below of non-GAAP gross profit and non-GAAP gross margin to the most directly comparable financial measure calculated and presented in accordance with
Conference call & webcast info:
Tuesday, May 28, 2024, at 11:00 am EDT
US: 1-888-407-2553
A live webcast will be available at: https://veidan.activetrail.biz/IcecureQ1-2024
A recording of the webcast will be available at: ir.icecure-medical.com/
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive treatment 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 procedure for breast tumors.
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
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: the pending FDA marketing clearance decision for ProSense®, the belief that delivering alternative surgery-free options to women in the
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IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
ICECURE MEDICAL LTD. | ||||||||
As of | As of | |||||||
(Unaudited) | (Audited) | |||||||
ASSETS | ||||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | 10,966 | 10,533 | ||||||
Deposits | - | 529 | ||||||
Trade accounts receivables | 157 | 103 | ||||||
Inventory | 2,111 | 2,275 | ||||||
Prepaid expenses and other receivables | 692 | 744 | ||||||
Total current assets | 13,926 | 14,184 | ||||||
NON-CURRENT ASSETS | ||||||||
Prepaid expenses and other long-term assets | 44 | 34 | ||||||
Right-of-use assets | 627 | 679 | ||||||
Property and equipment, net | 1,456 | 1,513 | ||||||
Total non-current assets | 2,127 | 2,226 | ||||||
TOTAL ASSETS | 16,053 | 16,410 | ||||||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
CURRENT LIABILITIES | ||||||||
Trade accounts payable | 658 | 502 | ||||||
Lease liabilities | 237 | 223 | ||||||
Other current liabilities | 3,210 | 3,146 | ||||||
Total current liabilities | 4,105 | 3,871 | ||||||
NON-CURRENT LIABILITIES | ||||||||
Long-term lease liabilities | 312 | 376 | ||||||
Total non-current liabilities | 312 | 376 | ||||||
SHAREHOLDERS' EQUITY | ||||||||
Ordinary shares, No par value; Authorized 2,500,000,000 shares; Issued and | ||||||||
Additional paid-in capital | 105,306 | 102,224 | ||||||
Accumulated deficit | (93,670) | (90,061) | ||||||
Total shareholders' equity | 11,636 | 12,163 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 16,053 | 16,410 |
ICECURE MEDICAL LTD. | ||||||||
Three months ended | ||||||||
2024 | 2023 | |||||||
| ||||||||
Revenues | 743 | 710 | ||||||
Cost of revenues | 474 | 390 | ||||||
Gross profit | 269 | 320 | ||||||
Research and development expenses | 1,951 | 2,111 | ||||||
Sales and marketing expenses | 1,038 | 1,075 | ||||||
General and administrative expenses | 930 | 1,091 | ||||||
Operating loss | 3,650 | 3,957 | ||||||
Finance expenses (income), net | (41) | (189) | ||||||
Net loss and comprehensive loss | 3,609 | 3,768 | ||||||
Basic and diluted net loss per share | 0.08 | 0.08 | ||||||
Weighted average number of shares outstanding used in computing basic and | 46,736,034 | 45,623,434 |
ICECURE MEDICAL LTD. | ||||||||
Three months ended March 31, | ||||||||
2024 | 2023 | |||||||
Cash flows from operating activities | ||||||||
Net loss | (3,609) | (3,768) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation | 85 | 79 | ||||||
Share-based compensation | 245 | 356 | ||||||
Exchange rate changes in cash and cash equivalents and short time deposits | 43 | 8 | ||||||
Changes in assets and liabilities: | ||||||||
Decrease (increase) in trade accounts receivables | (54) | (65) | ||||||
Decrease in prepaid expenses and other receivables | 52 | 374 | ||||||
Decrease (increase) in inventory | 164 | (71) | ||||||
Decrease in right of use assets | 75 | 48 | ||||||
Increase (decrease) in trade accounts payable | 156 | (29) | ||||||
Decrease in lease liabilities | (73) | (57) | ||||||
Increase in other current liabilities | 64 | 188 | ||||||
Net cash used in operating activities | (2,852) | (2,937) | ||||||
Cash flows from investing activities | ||||||||
Withdrawal of (investment in) short-term deposits | 529 | (14,870) | ||||||
Investment in restricted long term deposits | (10) | - | ||||||
Purchase of property and equipment | (28) | (250) | ||||||
Net cash provided by (used in) investing activities | 491 | (15,120) | ||||||
Cash flows from financing activities: | ||||||||
Issuance of ordinary shares, net of issuance costs | 2,837 | - | ||||||
Net cash provided by financing activities | 2,837 | - | ||||||
Increase (decrease) in cash and cash equivalents | 476 | (18,057) | ||||||
Cash and cash equivalents at beginning of the year | 10,533 | 23,659 | ||||||
Effect of exchange rate fluctuations on balances of cash and cash equivalents | (43) | (8) | ||||||
Cash and cash equivalents at end of period | 10,966 | 5,594 | ||||||
Non-cash activities | ||||||||
Obtaining a right-of-use asset in exchange for a lease liability | 23 | - |
APPENDIX A | ||||||||
Three Months ended | ||||||||
2024 | 2023 | |||||||
GAAP gross profit | $ | 269 | $ | 320 | ||||
Revenue from Exclusive Distribution Agreement | - | (137) | ||||||
Non-GAAP gross profit | $ 269 | $ 183 | ||||||
GAAP gross margin % | 36 % | 45 % | ||||||
Sales of systems and disposables | 743 | 543 | ||||||
Non-GAAP gross profit | $ 269 | $ 183 | ||||||
Non-GAAP gross margin % | 36 % | 32 % |
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SOURCE IceCure Medical
FAQ
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