CAESAREA, Israel – IceCure Medical Ltd. (NASDAQ:ICCM), a developer of minimally invasive cryoablation expertise, introduced a 30% enhance in gross sales of its ProSense® system and disposable probes for the primary quarter ended March 31, 2024, primarily pushed by greater gross sales within the U.S. and Japan. This development displays the continued adoption of the ProSense® system, which is used to destroy tumors by freezing, providing a substitute for surgical tumor removing.
The corporate accomplished its landmark ICE3 trial, submitting the total information set to the U.S. Meals and Drug Administration (FDA) for advertising and marketing authorization of ProSense® for treating early-stage T1 invasive breast most cancers with cryoablation and adjuvant hormone remedy. The ICE3 trial confirmed promising outcomes, with a 96.3% estimated 5-year native recurrence-free fee in a subgroup of sufferers handled with ProSense® adopted by hormone remedy.
Impartial research globally have additionally supported the efficacy and security of the ProSense® system throughout numerous indications. Notably, a examine in Japan reported no breast most cancers native recurrence 5 years after therapy and excessive affected person satisfaction. One other examine in Italy confirmed a 100% tumor discount in early-stage breast most cancers sufferers deemed inoperable at 6 and 12 months post-cryoablation.
Additional, an unbiased examine highlighted ProSense® as a promising various therapy for extra-pelvis endometriosis, with sufferers experiencing important ache discount. Moreover, analysis from Case Western Reserve College steered that ProSense® would possibly activate the physique’s pure immune response by enhancing CD8+ T cells.
Monetary outcomes for Q1 2024 confirmed revenues of $743,000 in comparison with $710,000 for a similar interval in 2023, with a web lack of $3,609,000, or $0.08 per share. The corporate’s money and money equivalents, together with short-term deposits, had been roughly $11 million as of March 31, 2024.
IceCure additionally acquired a patent allowance in Japan for a novel cryogen stream management expertise and submitted a 510(okay) submitting to the FDA for its XSense™ system and cryoprobes, demonstrating its management in cryoablation applied sciences.
The corporate’s monetary measures embody non-GAAP gross revenue and non-GAAP gross margin, which exclude income from unique distribution agreements, offering a clearer image of gross revenue from gross sales of methods and disposables. These non-GAAP monetary measures are reconciled to the closest comparable GAAP measures in Appendix A of the press launch.
The knowledge on this article relies on a press launch assertion from IceCure Medical.
InvestingPro Insights
IceCure Medical Ltd. (NASDAQ:ICCM) has demonstrated a strong 30% enhance in gross sales, signaling a rising market acceptance of its ProSense® system. This efficiency aligns with the latest monetary information, which exhibits a notable quarterly income development of 33.65% in Q1 2024. The corporate’s market capitalization stands at a modest $47.1M, reflecting its rising standing within the medical expertise sector.
Analyzing the corporate’s monetary well being and future prospects, one InvestingPro Tip highlights that IceCure holds extra cash than debt on its stability sheet, offering a stable basis for sustained operations and potential development. Furthermore, analysts count on gross sales to proceed their upward development within the present 12 months, which could possibly be an encouraging signal for buyers contemplating the corporate’s progressive method to most cancers therapy.
Nonetheless, it’s essential to notice that IceCure isn’t at the moment worthwhile, with a detrimental P/E ratio of -3.89, and analysts don’t anticipate profitability this 12 months. Moreover, the corporate’s money burn fee is some extent of concern, as indicated by one other InvestingPro Tip. Buyers ought to weigh these elements alongside the corporate’s gross sales development and product improvement milestones.
For these fascinated about deeper evaluation, there are further InvestingPro Suggestions accessible that delve into facets equivalent to the corporate’s long-term returns and dividend coverage. To discover these insights and extra, go to https://www.investing.com/professional/ICCM and think about using the coupon code PRONEWS24 to get an extra 10% off a yearly or biyearly Professional and Professional+ subscription.
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