- Data presentation at the highly influential American Society of Breast Surgeons (“ASBrS”) Annual Meeting by Drs. Richard Fine Winner of Scientific Impact Award as voted by Breast Surgeons
- ASBrS President-Elect, Dr. michael berrypresented data and stated that “cryoablation is ready for prime time.”
- The company is exploring the use of adjuvant hormone therapy to treat women with early-stage T1 invasive breast cancer.
- Available reimbursement codes for facility costs that are expected to increase in usage upon receipt of marketing authorization
- Minimally invasive ProSense® cryoablation offers highly favorable medical economics
Caesarea, Israel, April 15, 2024 /PRNewswire/ — IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure” or the “Company”) announced the launch of the ProSense® System, a minimally invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal. I'm a developer. announced today that it has submitted final data to the U.S. Food and Drug Administration (“FDA”) seeking marketing approval for Prosense® for the treatment of patients with early T1 invasive breast cancer with cryoablation and adjuvant hormonal therapy. His ProSense®, which received FDA Breakthrough Designation, is already approved in the United States for use in several other indications, including the treatment of benign breast tumors, kidney and liver tumors.
The Company has provided the following requested data to the FDA.
- Complete dataset of ICE3 5-year follow-up.
- Sub-analysis of ICE3 results compared to data from the “LUMINA” study (sponsored study) Canada's The Ontario Clinical Oncology Group evaluated the risk of recurrence in patients with low-risk Luminal A breast cancer who underwent tumor removal surgery and received adjuvant hormone therapy.
- Analysis of ICE3 data compared to updated PRISMA meta-analysis.and
- Real-world data from worldwide use of ProSense®, including data from post-market commercial applications and independent third-party research.
The ICE3 trial was the largest multicenter clinical trial of liquid nitrogen (LN2)-based cryoablation for low-risk, early-stage breast tumors ever conducted. His 5-year recurrence-free rate in this landmark study evaluating IceCure's minimally invasive 20-40 minute outpatient cryoablation procedure was consistent with expectations and is now the standard of care for early-stage tumors. The results were similar to those obtained with enucleation. Breast cancer patient.
The analysis estimated that 96.3% of the subgroup of patients treated with ProSense® cryoablation followed by hormonal therapy had no local recurrence at the 5-year follow-up evaluation. Comparing this result from the ICE3 study shows similar results in 5-year recurrence rates compared to patients who received hormone therapy after tumor removal in the LUMINA study, which reported a 97.7% recurrence-free rate at 5-year follow-up. is shown to have been obtained. In the PRISMA meta-study including Lumina, he reported a recurrence-free rate of 97.19% at 5-year follow-up. The ICE3 results are also consistent with real-world usage data for his ProSense® by third parties in regions where his IceCure cryoablation system is used to treat early-stage breast cancer. In the final ICE3 analysis, no serious adverse events or complications related to the device were reported, and all patients and physicians reported satisfaction with her ProSense® procedure.
“We believe ICE3 is a groundbreaking study, and the efficacy data for our minimally invasive Prosense® cryoablation procedure compares favorably with the more invasive breast surgery that is the current standard of care for early-stage breast cancer. We are pleased to report that our comparison showed similar results in relapse,” said IceCure CEO. Eyal Shamil.
“I attended the ASBrS Annual Meeting with our marketing and clinical teams and witnessed the overwhelmingly positive response from breast surgeons who voted for Dr. Fine's presentation to receive the Scientific Impact Award. shows just how big an impact our cryoablation technology is expected to have, and Dr. Berry, ASBrS President-elect, further demonstrates its potential and is ready for cryoablation. I decided that.
“The first reimbursement codes are already in place, and our U.S. marketing and commercial teams are ready and waiting for the FDA's response. Rapid adoption is expected until the DeNovo classification request for marketing is approved.
Key data presented at ASBrS 2024 Annual Meeting
Final data from ICE3 were presented to leading breast surgeons from across the country by ICE3 Investigator Dr. David Johnson at the ASBrS 25th Annual Meeting. Richard Fine And Dr. michael berry. Dr. Fine gave an oral presentation entitled, “Five-year follow-up of the ICE3 trial of non-resecting cryoablation for early breast cancer and ipsilateral breast tumor recurrence.” Dr. Berry, President-elect of ASBrS, gave an oral presentation titled “Cryoablation: Are you ready for prime time?”
Dr. Berry said, “In my opinion, cryoablation is safe and consistent with what we see with standard of care, and based on data showing that cryoablation is safe and consistent with what we see with standard of care, cryoablation is an alternative to surgical resection for select patient populations.'' We believe that ablation is 'prime time.'
Dr. Fine said, “Cryoablation is a safe, minimally invasive ablation procedure that, like lumpectomy in similar patient populations, has an acceptably low 5-year same-breast recurrence rate and is an office-based, non-invasive procedure. It has the advantage of being a surgical treatment.” Clinical trials or registries are needed to confirm that cryoablation is a viable alternative to surgical resection in appropriately selected patients. ”
health economics
Cryoablation, a minimally invasive outpatient procedure that does not require general anesthesia, is less expensive than the standard of care lumpectomy. It also reduces the risk of re-excision (follow-up surgery) compared to the 14-21% re-excision rate for lumpectomy.
IceCure's application to the U.S. Centers for Medicare and Medicaid Services (CMS) is the first and only Medicare coverage approval for a cryoablation procedure for breast cancer. CMS assigned CPT Category III code 0581T to Outpatient Payment Classification 5091, Level 1 Breast/Lymphatic Surgery and Related Payment Assignments by CMS at approximately 12:00 p.m. $3,400 Facility usage fee only. Additional compensation, including physician payments, is expected upon establishment of a permanent CPT Category I code. This code is conditional on factors including the Company's receipt of FDA marketing approval for ProSense® for breast cancer.
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive treatment option that destroys tumors by freezing them. This system uniquely harnesses the power of liquid nitrogen to create a large lethal zone for maximum efficacy in tumor destruction in benign and cancerous lesions such as the breast, kidney, lung, and liver.
ProSense® increases value for patients and providers by accelerating recovery and reducing pain, surgical risks, and complications. With its portable design and use of liquid nitrogen, ProSense® opens the door to quick and convenient office-based treatment of breast tumors.
About Ice Cure 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, including breast cancer, kidney cancer, and bone cancer. Cancer and lung cancer are the main areas of focus. Its minimally invasive technique is a safe and effective alternative to surgical tumor removal in the hospital, and is a relatively short procedure that is easy to perform. The system has been marketed and marketed for approved and approved indications worldwide to date, including in the United States. Europeand 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 “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,” and similar expressions or variations of such words refer to future For the purpose of identifying forward-looking statements. For example, IceCure uses forward-looking statements in this press release when discussing: Once we receive regulatory clearance from the FDA, we expect rapid adoption. How much of an impact cryoablation technology is expected to have for women with early-stage breast cancer. Cryoablation is in its “prime of prime” as an alternative to surgical resection, claims Dr. Berry. And Dr. Fine's assertion that further research is needed to confirm cryoablation is a viable alternative to surgical resection. Historical results of scientific research and clinical and preclinical studies do not guarantee that the conclusions of future studies or trials will suggest the same or similar conclusions. Important factors that could cause actual results, developments and management decisions to differ materially from those anticipated in these forward-looking statements include, among others: our planned levels of revenue and capital expenditures; our available cash and ability to obtain additional funds; the Company's ability to market and sell its products;Development of laws and regulations in US and other countries. our ability to maintain 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 health care professionals about its products;political, economic and military instability middle east,especially Israel; and the factors described in the “Risk Factors” section of our Annual Report on Form 20-F for the year ended. December 31, 2023 Filed with the U.S. Securities and Exchange Commission (“SEC”) April 3, 2024, and other documents filed or provided to the SEC, are available on the SEC's website at www.sec.gov. We undertake no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
IR Contact:
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michael poliview
Phone: 732-232-6914
tod kelly
Phone: 310-625-4462
Source IceCure Medical
