Positive Data from IceCure's Kidney Cancer Clinical Study Presented at Interventional Radiology Conference: Minimally Invasive Approach Results in Shorter Hospitalization and Minor Impact on Renal Function

Rhea-AI Summary

IceCure Medical (Nasdaq: ICCM) shared positive interim results from its ICESECRET kidney cancer trial at the 3rd Annual Israeli Conference on Interventional Radiology. The trial features the ProSense® System, a cryoablation technology that freezes tumors. Findings show ProSense® is effective, with an 89.5% recurrence-free rate. Further data is expected in Q4 2024, averaging a 3-year follow-up. The global kidney cancer treatment market, valued at $6.92 billion in 2024, is projected to reach $8.78 billion by 2029. ProSense® is approved in the U.S., Europe, and other regions for benign and malignant kidney tumors. The system offers a minimally invasive alternative to surgery, reducing hospitalization and minimally impacting renal function and hemoglobin levels. CEO Eyal Shamir highlighted the favorable reception of data by interventional radiologists and the potential benefits for kidney cancer patients.

Positive

• 89.5% recurrence-free rate demonstrated in ICESECRET interim results.
• ProSense® system approved for kidney tumors in U.S., Europe, and various other countries.
• Minimally invasive approach results in shorter hospitalization times.
• Minor impact on renal function and hemoglobin levels.
• Global kidney cancer treatment market expected to grow from $6.92 billion in 2024 to $8.78 billion by 2029.
• ProSense® system presented internationally, indicating broad interest and potential market acceptance.

Negative

• Long-term data needed to confirm cryoablation as a viable treatment option.
• Further studies required to substantiate current findings.
• No immediate financial gains or revenue increases were reported.
• Potential risks or side effects of cryoablation not fully disclosed in interim results.

Insights

Medical Research Analyst

The interim results from IceCure's ICESECRET clinical trial showcasing the effectiveness of ProSense® in treating renal tumors present a noteworthy advancement in kidney cancer therapy. The 89.5% recurrence-free rate is a strong validation of the technology's potential. This rate indicates a promising efficacy level, especially when considering the minimally invasive nature of the procedure.

For retail investors, understanding the significance of this data involves acknowledging that a high recurrence-free rate often correlates with better patient outcomes, potentially reducing long-term treatment costs. Moreover, the $6.92 billion global kidney cancer treatment market, with projections to grow significantly, underscores the commercial potential of ProSense®.

The mention of minor impact on renal function and shorter hospitalization times also highlights a key benefit: lower healthcare costs and improved patient convenience. However, investors should note that these are interim results and further data expected in the fourth quarter of 2024 will be important in solidifying these preliminary findings. The pending data on patients with an average follow-up of approximately three years will provide deeper insights into the long-term efficacy and safety of ProSense®.

From a competitive standpoint, if further studies continue to show positive results, IceCure could capture a significant market share by offering a safer and less invasive alternative to traditional surgical methods.

Financial Analyst

Financially, the presentation of positive interim results is a potential catalyst for IceCure Medical Ltd. The high recurrence-free rate and minimal side effects are likely to attract the attention of investors looking for innovative healthcare solutions. Considering the size of the global kidney cancer treatment market—projected to grow from $6.92 billion in 2024 to $8.78 billion by 2029—ProSense® has substantial revenue potential if it continues to demonstrate advantages over existing treatments.

For retail investors, it's essential to recognize that while the current data is promising, the true financial impact will depend on future results and the company's ability to commercialize the technology effectively. Investors should also consider the competitive landscape and regulatory environment. The fact that ProSense® is already approved in multiple regions, including the U.S. and Europe, is a positive indicator of the company's ability to navigate regulatory hurdles.

Another financial consideration is the reduction in hospitalization time and lower impact on renal function, which could translate into cost savings for healthcare systems, making ProSense® an attractive option for payers and providers.

• ICESECRET interim results, as previously announced, demonstrated ProSense® to be safe and effective in treating kidney tumors with 89.5% recurrence-free rate
• More data is expected in the fourth quarter of 2024, including data on patients with an average follow up of approximately 3 years 
• $6.92 billion global kidney cancer treatment market in 2024 expected to reach $8.78 billion by 2029—ProSense® is approved for the treatment of benign and malignant kidney tumors in the U.S., Europe, and numerous other countries

CAESAREA, Israel, June 12, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" 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 announced that data from an interim analysis of its ICESECRET kidney cancer trial were presented at the 3^rd Annual Israeli Conference on Interventional Radiology in Tel Aviv, Israel on June 10, 2024. Dr. Avivit Shoham, Deputy Director of the Vascular and Interventional Radiology Unit at Beilinson Rabin Medical Center, presented a session on Cryotherapy of Renal Malignancies in Israel, which included data previously shared in December 2022 at the Urological Association Conference in Eilat, Israel.

 

 

Professor Sarel Halachmi, the Principal Investigator of the ICESECRET clinical trial, said, "Cryoablation is a safe and effective, minimally invasive ablative approach for treating renal cell carcinoma presenting with tumors ≤3 centimeters, resulting in shorter hospitalization than nephrectomy and minor side effects on the renal function and on hemoglobin levels. Further studies are needed to confirm cryoablation as a viable option to treat kidney lesions."

IceCure's CEO Eyal Shamir added, "The data were very well received by interventional radiologists attending the conference from around the world and locally here in Israel. We are pleased to advance ProSense®'s applications across numerous indications. Kidney cancer is an indication in which our minimally invasive cryoablation system may offer significant benefits."

About ICESECRET
ProSense® is being evaluated for the indication of kidney cancer in ICESECRET, a prospective, multicenter, single-arm clinical trial performed at Bnai-Zion Medical Center, Haifa, Israel, and Shamir Medical Center, Zerifin, Israel. The trial includes 115 patients (138 lesions) with localized small renal masses of ≤5 centimeters who were treated with ProSense® cryoablation under CT guidance. Full engulfment of the renal lesion, including a safety margin of 0.5 centimeters was achieved in approximately 96% of the procedures where there was no anatomical limitation. Follow-up visits are performed 6 weeks, 6 months, 1 year, and then annually up to 5 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 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 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 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 prospective future studies and that ProSense® may be able to offer benefits to patients with kidney cancer. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2023 filed with the SEC on April 3, 2024, 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:

Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462

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SOURCE IceCure Medical

FAQ

What are the interim results of IceCure's ICESECRET kidney cancer trial?

The interim results show ProSense® to be safe and effective in treating kidney tumors with an 89.5% recurrence-free rate.

When is more data from the ICESECRET trial expected?

Further data from the ICESECRET trial is expected in the fourth quarter of 2024.

How large is the global kidney cancer treatment market?

The global kidney cancer treatment market is valued at $6.92 billion in 2024 and is expected to reach $8.78 billion by 2029.

Is ProSense® approved for use outside the U.S.?

Yes, ProSense® is approved for the treatment of benign and malignant kidney tumors in the U.S., Europe, and numerous other countries.

What are the benefits of the ProSense® system for kidney cancer patients?

The ProSense® system offers a minimally invasive alternative to surgery, leading to shorter hospitalizations and minimal impact on renal function and hemoglobin levels.