IceCure Medical Reports Positive Topline Results From ICE3 Cryoablation Breast Cancer Study: Achievement of 96.39% Recurrence Free Rate Brings Company One Step Closer to Providing Women a Non-Surgical Alternative to Lumpectomy
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Insights
The reported success rate of 96.39% for patients remaining local recurrence-free in the ICE3 study is a significant statistic, indicating a high efficacy of the ProSense® cryoablation technology. This efficacy rate is particularly notable given that the study spans a five-year follow-up period, which is a robust duration for assessing the long-term effectiveness of cancer treatments. The absence of significant device-related adverse events or complications further underscores the potential of ProSense® as a safe treatment modality.
From a medical research perspective, the comparison with lumpectomy, the current standard surgical procedure for early-stage breast cancer, is critical. Cryoablation offers a less invasive option, which could imply a shorter recovery time, fewer surgical risks and potentially lower healthcare costs. However, the long-term outcomes compared to traditional surgery will be a focal point for clinicians and patients when considering this alternative treatment.
IceCure Medical's announcement is poised to make a significant impact on the healthcare market, especially within the oncology segment. The successful results from the ICE3 study could lead to a shift in the standard of care for early-stage breast cancer, influencing both patient treatment paths and healthcare provider practices. The market for breast cancer treatments is substantial and the introduction of a new, minimally invasive treatment could disrupt the current market dynamics.
Should the FDA grant marketing authorization, IceCure Medical could capitalize on an early-mover advantage in the cryoablation space for breast cancer. However, adoption rates will depend on factors such as insurance coverage, clinician endorsement and patient awareness. Furthermore, the potential cost savings from a less invasive procedure could be attractive to healthcare systems pressured by rising healthcare costs.
The clinical implications of the ICE3 study's results are substantial for the field of oncology. The high local recurrence-free rate suggests that cryoablation could become a viable option for certain patients with early-stage low-risk malignant breast tumors. For oncologists, the introduction of a new treatment method means revisiting treatment protocols and potentially offering patients an alternative to traditional surgery.
It's important to note that while the study's results are promising, the real-world effectiveness of ProSense® will need to be monitored closely post-approval. Factors such as the learning curve associated with the new technology, patient selection criteria and long-term surveillance strategies will be critical considerations for oncologists integrating cryoablation into their practice.
- Expects to submit full dataset to the FDA in April for marketing authorization of ProSense® for minimally invasive treatment of early-stage breast cancer
- Study represents largest cryoablation study of its kind in the
U.S. for early-stage low-risk malignant breast tumors
Based on the strength of the topline results, ProSense has the potential to be a safe and effective alternative to lumpectomy for early-stage breast cancer. The Company plans to complete the analysis and evaluation of the full data set and expects to submit the results to the
"We are very pleased with this topline outcome and believe these results demonstrate a highly favorable safety and efficacy profile that positions ProSense® as a desirable alternative to lumpectomy for early-stage breast cancer. Having completed the study on schedule, we are now compiling the full data set which we plan to submit to the FDA next month for marketing clearance," stated Eyal Shamir, Chief Executive Officer of IceCure. "While the FDA evaluates the data, we are optimistic their upcoming decision will give women in the
"On behalf of the entire IceCure team, I thank the patients, their families, the sites and the clinicians for taking part in this landmark study. This has been a rigorous and thoroughly performed, ten-year long trial with positive data at each interval that is validated by recent independent studies performed globally by leading physicians ."
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: that the Company anticipates that it will submit the results of the ICE3 study in April 2024; that the Company believes ProSense®'s potential to offer a safe and effective alternative to lumpectomy for early-stage breast cancer; that the ICE3 topline outcome positions ProSense® as a desirable alternative to lumpectomy for early-stage breast cancer; and that the Company is optimistic regarding the upcoming decision by the FDA regarding the Company's De Novo Classification Request for Marketing Authorization of ProSense® for the treatment of early-stage breast 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
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Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
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