CAESAREA, Israel - IceCure Medical Ltd. (NASDAQ:ICCM), a developer of minimally invasive cryoablation technology, announced a 30% increase in sales of its ProSense® system and disposable probes for the first quarter ended March 31, 2024, primarily driven by higher sales in the U.S. and Japan. This growth reflects the continued adoption of the ProSense® system, which is used to destroy tumors by freezing, offering an alternative to surgical tumor removal.
The company completed its landmark ICE3 trial, submitting the full data set to the U.S. Food and Drug Administration (FDA) for marketing authorization of ProSense® for treating early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. The ICE3 trial showed promising results, with a 96.3% estimated 5-year local recurrence-free rate in a subgroup of patients treated with ProSense® followed by hormone therapy.
Independent studies globally have also supported the efficacy and safety of the ProSense® system across various indications. Notably, a study in Japan reported no breast cancer local recurrence five years after treatment and high patient satisfaction. Another study in Italy showed a 100% tumor reduction in early-stage breast cancer patients deemed inoperable at 6 and 12 months post-cryoablation.
Further, an independent study highlighted ProSense® as a promising alternative treatment for extra-pelvis endometriosis, with patients experiencing significant pain reduction. Additionally, research from Case Western Reserve University suggested that ProSense® might activate the body's natural immune response by enhancing CD8+ T cells.
Financial results for Q1 2024 showed revenues of $743,000 compared to $710,000 for the same period in 2023, with a net loss of $3,609,000, or $0.08 per share. The company's cash and cash equivalents, including short-term deposits, were approximately $11 million as of March 31, 2024.
IceCure also received a patent allowance in Japan for a novel cryogen flow control technology and submitted a 510(k) filing to the FDA for its XSense™ system and cryoprobes, demonstrating its leadership in cryoablation technologies.
The company's financial measures include non-GAAP gross profit and non-GAAP gross margin, which exclude revenue from exclusive distribution agreements, providing a clearer picture of gross profit from sales of systems and disposables. These non-GAAP financial measures are reconciled to the nearest comparable GAAP measures in Appendix A of the press release.
The information in this article is based on a press release statement from IceCure Medical.
InvestingPro Insights
IceCure Medical Ltd. (NASDAQ:ICCM) has demonstrated a robust 30% increase in sales, signaling a growing market acceptance of its ProSense® system. This performance aligns with the recent financial data, which shows a notable quarterly revenue growth of 33.65% in Q1 2024. The company's market capitalization stands at a modest $47.1M, reflecting its emerging status in the medical technology sector.
Analyzing the company's financial health and future prospects, one InvestingPro Tip highlights that IceCure holds more cash than debt on its balance sheet, providing a solid foundation for sustained operations and potential growth. Moreover, analysts expect sales to continue their upward trend in the current year, which could be an encouraging sign for investors considering the company's innovative approach to cancer treatment.
Still, it is crucial to note that IceCure is not currently profitable, with a negative P/E ratio of -3.89, and analysts do not anticipate profitability this year. Additionally, the company's cash burn rate is a point of concern, as indicated by another InvestingPro Tip. Investors should weigh these factors alongside the company's sales growth and product development milestones.
For those interested in deeper analysis, there are additional InvestingPro Tips available that delve into aspects such as the company's long-term returns and dividend policy. To explore these insights and more, visit https://www.investing.com/pro/ICCM and consider using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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