IceCure's ProSense® Cryoablation Safe and Effective in Destruction of Kidney Tumors with 88.7% Recurrence-Free Rate Based on Interim ICESECRET Study Results

Rhea-AI Summary

IceCure Medical (NASDAQ: ICCM) announced promising interim results from their ICESECRET study evaluating ProSense® cryoablation for small renal masses. The study, involving 111 patients with 117 lesions over a mean follow-up of 36 months, showed:

- 82% of patients remained tumor-free
- 88.7% success rate in patients with single tumors <3 cm without prior kidney cancer
- 95.6% successful freezing achievement including safety margins
- Preserved renal function across patient cohort
- Short procedure time of approximately 25 minutes

The technology is currently approved for benign and malignant kidney tumors in the U.S., Europe, and other countries, addressing a significant market with an estimated 81,610 new kidney cancer cases expected in the U.S. in 2024.

Positive

• High efficacy with 88.7% success rate in primary kidney tumors <3 cm
• 95.6% successful freezing achievement with safety margins
• Preserved renal function with no significant changes in critical markers
• Shorter procedure time compared to standard of care
• Already approved in major markets (US, Europe) for kidney tumor treatment

Negative

• 16.2% overall treatment failure rate requiring additional procedures
• Four procedure-related serious adverse events reported, including one severe complication

Insights

Medical Research Analyst

The interim results from the ICESECRET study demonstrate compelling evidence for ProSense®'s efficacy in treating kidney tumors. The 88.7% success rate in patients with tumors <3cm and 83.8% overall success rate are particularly noteworthy. These outcomes, combined with the minimal serious adverse events and preserved renal function, suggest a strong safety profile.

The short procedure time of 25 minutes represents a significant advantage over traditional surgical approaches. The study's robust design, with a mean follow-up period of 36 months and 111 patients, provides credible evidence for the technology's clinical utility. The high ice ball creation success rate of 95.6% indicates reliable technical performance.

With the growing incidence of small renal masses and an estimated 81,610 new kidney cancer cases in the US for 2024, ProSense® addresses a significant market opportunity, particularly for patients ineligible for surgery.

Market Research Analyst

The positive interim results could significantly strengthen IceCure's market position in the minimally invasive tumor treatment space. With ProSense® already approved in major markets like the U.S. and Europe, these clinical outcomes could accelerate market adoption and penetration. The addressable market is substantial, with over 434,000 global kidney cancer cases annually.

For a company with a market cap of $45.5M, this data represents a potential catalyst for growth. The technology's demonstrated effectiveness in treating both benign and malignant kidney tumors expands the potential patient pool. The favorable safety profile and shorter procedure time could drive healthcare provider adoption by offering cost-effective treatment alternatives to traditional surgery.

• Data confirm previous results showing that ProSense^® cryoablation is highly effective for kidney tumors < 3 cm and a safe procedure for kidney tumors < 5 cm in people ineligible for surgery
• Interim results presented at the Israeli Urological Association Conference in Eilat, Israel
• ProSense^® is approved for benign and malignant kidney tumors in the U.S., Europe and numerous other countries

CAESAREA, Israel, Dec. 5, 2024 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ('IceCure', 'IceCure Medical' or the 'Company'), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced interim results from the Company's ICESECRET study of cryoablation for patients with small renal masses ('SRM') who cannot be offered kidney preserving surgery. Data were presented on December 5, 2024 at the Israeli Urological Association Conference in Eilat, Israel. The presentation titled 'Renal Mass Cryoablation - Interim Analysis of ICESECRET Study' was delivered by Dr. Keren Boguslavsky of Bnai Zion Medical Center.

Results were reported at a mean follow-up period of 36 months for 111 patients with 117 lesions. A summary of the key results were:

• In 91 patients (approximately 82%), no tumor recurrence was observed.
• Following an additional cryoablation procedure for the same tumor in 13 patients, the success rate for the overall population was 83.8%, with a mean follow-up time of 39.6 months. In patients without a history of kidney cancer with one tumor < 3 cm, the success rate was 88.7%.
• Freezing of the renal tumor, including safety margins of 0.5 cm, was achieved in 95.6% of the procedures demonstrating high efficacy in cases without anatomic limitation for ice ball creation.
• Four procedure-related serious adverse events were reported, three of which were mild and treated conservatively. One severe complication was observed seven months after the cryoablation procedure.
• Renal function was preserved, on an average basis across the patient cohort, with no significant change in creatinine and hemoglobin levels compared to baseline.
• The procedure time, relative to the standard of care as supported by and documented in medical literature, was short at approximately 25 minutes.

"The ability to offer cryoablation for kidney cancer is a large unmet need, particularly in patients who are ineligible for kidney preserving surgery. We are very pleased that ICESECRET's latest interim results present ProSense^® as a safe and effective option for these patients. These results are particularly important since ProSense^® is already approved for the as a cryosurgical tool in the destruction of malignant and benign tumors of the kidney in key markets including the U.S. and Europe," stated IceCure's Chief Executive Officer, Eyal Shamir.

According to the American Journal of Roentgenology, small renal masses, which may be malignant or benign tumors in the kidney, have been increasing in incidence over the past two decades. According to the American Cancer Society, in 2024, in the United States, an estimated 81,610 new cases of kidney cancer will have been diagnosed, with approximately 14,390 dying from the disease. Globally, there were more than 434,000 new cases of kidney cancer in 2022 and about 156,000 deaths according to World Cancer Research Fund International.

About ICESECRET

ICESECRET, a prospective, multicenter, single-arm clinical trial is being performed at Bnai Zion Medical Center in Haifa, Israel and Shamir Medical Center in Zerifin, Israel and is being led by Principal Investigator Prof. Halahmi Sarel. The trial includes 114 patients (138 lesions) with localized SRM of ≤5 cm that were ablated with ProSense^® cryoablation under CT guidance. Follow-up visits are performed six weeks, six months, one year, and then annually up to five years after the procedure. During the follow-up visits, data related to local recurrence, based on CT imaging, is collected. Safety was determined by monitoring procedure-related adverse events throughout the study.

About ProSense^®

The ProSense^® Cryoablation System is a minimally invasive cryosurgical tool that provides the 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 procedures for breast tumors.

About IceCure Medical

IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction 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 Company's flagship ProSense^® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe and China.

IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914

Todd Kehrli
Phone: 310-625-4462

Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg

 

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SOURCE IceCure Medical

FAQ

What was the success rate of IceCure's (ICCM) ProSense cryoablation for kidney tumors in the ICESECRET study?

The study showed an 88.7% success rate in patients with single tumors <3 cm without prior kidney cancer, and an overall success rate of 83.8% after additional procedures.

How many patients were included in IceCure's (ICCM) ICESECRET study interim results?

The interim results included 111 patients with 117 lesions, with a mean follow-up period of 36 months.

What was the safety profile of ProSense cryoablation in the ICESECRET study by IceCure (ICCM)?

The study reported four procedure-related serious adverse events, with three being mild and treated conservatively, and one severe complication occurring seven months post-procedure.

What is the current approval status of IceCure's (ICCM) ProSense for kidney tumors?

ProSense is approved for both benign and malignant kidney tumors in the United States, Europe, and numerous other countries.