New Standard of Care? IceCure Submits Final ICE3 Data To FDA, Minimally Invasive Cryoablation Shows Similar 5-year Recurrence Outcomes To Surgery With Hormone Therapy

IceCure Medical Ltd. ICCM, the Israeli medical device developer of ProSense®, an advanced liquid-nitrogen-based cryoablation therapy that destroys tumors (benign and cancerous) by freezing them, is one step closer to getting U.S. Food and Drug Administration approval to market ProSense® to treat patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. IceCure just reported final clinical trial results of 100% patient and physician satisfaction with the minimally invasive procedure. At the 5-year follow-up evaluation, 96.3% of the subgroup of patients treated with ProSense® cryoablation, followed by hormone therapy, were estimated to be free from local recurrence

Earlier in April, the company submitted its final data to the FDA which included five-year follow-up data from its ICE3 study, a sub-analysis of the ICE3 results compared to studies that evaluated the risk of recurrence in patients with low-risk Luminal A breast cancer who were treated with lumpectomy surgery and received hormone therapy and real-world data from the use of ProSense® globally, including post-market commercial use as well as data from independent third-party studies. ProSense®, which received the FDA’s Breakthrough Device Designation, is already cleared for use in the U.S. for several other indications, including treating benign tumors of the breast and tumors in the kidney and liver.

Positive Topline Results 

IceCure's ICE3 study was the largest controlled multicenter clinical trial ever performed for liquid nitrogen (LN2) based cryoablation of low-risk, early-stage malignant breast tumors. The five-year recurrence-free rates from the study, which evaluated IceCure’s minimally invasive 20-to-40-minute outpatient cryoablation procedure, were in line with expectations and showed similar outcomes to lumpectomy, the current standard of care for early-stage breast cancer patients, which is breast surgery that requires an operating room and hospital stay. In the ICE3 study, 96.39% of patients (187 out of 194 patients) were local recurrence-free with no significant device-related adverse events or complications reported.

A comparison of this result from the ICE3 study shows similar outcomes in five-year recurrence rates compared to patients in other studies who were treated with lumpectomy followed by hormone therapy. The LUMINA study reported a 97.7% recurrence-free rate at five-year follow-up and the PRISMA meta-study, which included Lumina, reported a 97.19% recurrence-free rate at five-year follow-up. ICE3 results are also in line with data from real-world use of ProSense® by third parties in territories where IceCure’s cryoablation system is used to treat early-stage breast cancer. In the final ICE3 analysis, no significant device-related adverse events or complications were reported, and all patients and physicians reported satisfaction with the ProSense® procedure, the company said. That means 100% of physicians and patients were happy with the treatments they received. 

Dr. Richard Fine, ICE3's lead investigator, presented final data from the ICE3 study at the American Society of Breast Surgeons 25th Annual Meeting, where he commented, “Cryoablation is a safe, minimally invasive ablative procedure with acceptably low five-year same breast recurrence similar to that of lumpectomy for similar patient populations, with the benefit of being an office-based, nonsurgical treatment. Further study within a clinical trial or registry is needed to confirm cryoablation as a viable alternative to surgical excision in the appropriately selected patients."

Dr. Fine's presentation, which received the conference's Scientific Impact Award, was well received by breast surgeons who are constantly looking for treatments that are minimally invasive and effective. 

A New Way To Treat An Old Problem 

What makes cryoablation so attractive to freeze and destroy tumors is that it is minimally invasive, has little pain associated with it and thanks to an ultrasound or computerized tomography can accurately destroy diseased tissue within the tumor zone. 

Cryoablation also costs less than a lumpectomy and reduces the risk of follow-up surgery. With a lumpectomy, the re-excision rate is between 14-21%. IceCure's ProSense® has the potential to become a new standard of care treatment for women with early-stage T1 invasive breast cancer, marking a major improvement to the care available today. Some researchers have even called cryoablation the "ultimate esthetic solution for breast cancer" because it reduces the need for pre-emptive or corrective surgical procedures to maintain or restore breast volume, contour and symmetry. 

“Initial reimbursement codes are already in place and our U.S. marketing and commercial team is ready, as we await the FDA’s response. Driven by favorable healthcare economics combined with patient satisfaction and demand, we expect rapid adoption pending FDA granting the DeNovo Classification Request for Marketing Approval,” stated IceCure CEO Eyal Shamir.

With Reimbursement In Place, IceCure Is Ready To Go

With the final data submitted, IceCure is ready to go once the FDA gives it the green light. The company received what it said was the first Medicare coverage approval of a cryoablation procedure for breast cancer. The Centers for Medicare & Medicaid Services (CMS) set the reimbursement payment at about $3,400 for the facility alone. Additional coverage, including payment for the physician, is expected upon establishment of the permanent CPT Category I code, which is conditioned on factors including the company’s receipt of FDA marketing authorization of ProSense® for breast cancer. Having that reimbursement should enhance the usage of the ProSense® system.

Nearly 300,000 women are diagnosed with invasive breast cancer yearly, and the majority have to undergo invasive treatments and deal with follow-up surgeries in the quest to live cancer-free. IceCure is changing that by freezing tumors to destroy them. IceCure seems poised to do exactly what it set out to do: provide women with an alternative minimally invasive treatment option. 

Featured photo by Angiola Harry on Unsplash.

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