Icecure Medical Ltd. - ICCM STOCK NEWS

IceCure Medical's ProSense® has been selected for the PRECICE study, a major breast cryoablation research initiative led by the European Institute of Oncology. The study, sponsored by the Umberto Veronesi Foundation and Italian Ministry of Health, will exclusively use ProSense® to treat 233 patients aged 50+ with early-stage breast cancer (Luminal A and B).

The study details were published in the European Journal of Cancer Prevention, highlighting cryoablation as a potential alternative to surgical treatment. The research will evaluate technical effectiveness with a five-year median follow-up, examining procedure failure rates through various imaging methods and additional endpoints including quality of life and economic outcomes.

IceCure Medical (Nasdaq: ICCM) received a favorable recommendation from the FDA Advisory Panel for its ProSense® cryoablation system with a 9-5 vote supporting its benefit-risk profile for treating early-stage low risk breast cancer. The panel's decision was based on comprehensive data from the ICE3 study and stakeholder testimonies. Three of the dissenting voters indicated they would have voted in favor with adequate FDA special controls. The FDA's final marketing authorization decision is expected in Q1 2025. ProSense® offers a minimally-invasive alternative to lumpectomy by destroying tumors through freezing.

IceCure Medical (NASDAQ: ICCM) announced significant stakeholder engagement ahead of the FDA Medical Device Advisory Committee Panel scheduled for November 7, 2024. The panel will evaluate the marketing authorization of ProSense® cryoablation system for treating early-stage low risk breast cancer. The Advisory Panel will include breast surgeons, interventional radiologists, and industry experts who will provide recommendations on the benefit-risk profile of ProSense®, a minimally-invasive technology that destroys tumors by freezing as an alternative to surgical removal. Public comments from doctors, nurses, researchers, and breast cancer patients are available on the FDA website, with the FDA's final decision expected by early 2025.

IceCure Medical (Nasdaq: ICCM) has received a Notice of Allowance from the U.S. Patent and Trademark Office for its invention titled "Cryogenic System Connector". This is the first global patent issued for this key component of IceCure's next-generation XSense™ cryoablation system, which uses liquid nitrogen. The XSense™ system and its cryoprobes have FDA clearance for all indications already approved for IceCure's flagship ProSense® system.

The innovative connector technology is designed to improve usability and maintain cryogen integrity during cryoablation procedures. XSense™ has the potential to address additional indications in the global tumor ablation market, estimated at $1.67 billion in 2023. IceCure's CEO, Eyal Shamir, emphasized the company's commitment to strengthening its intellectual property assets as its cryoablation systems gain worldwide commercial traction.

IceCure Medical's ProSense® cryoablation technology was featured in six global studies at the 2024 European Society of Breast Imaging (EUSOBI) Conference. Highlights include:

1. The ICE3 trial abstract won the EUSOBI 2024 Abstract Award, showing a 96.3% recurrence-free rate for small, low-risk breast cancers treated with ProSense® and endocrine therapy.

2. The THERMAC Trial, comparing thermal ablation methods, won the EUSOBI Young Physician Scientists Prize. Cryoablation demonstrated the highest complete ablation rate at 94% with no adverse events.

3. IceCure exhibited ProSense® at EUSOBI, conducting demos and Q&A sessions with breast cryoablation experts.

4. Six studies presented at EUSOBI 2024 showcased ProSense®'s efficacy in treating breast cancer and fibroadenomas, supporting IceCure's global commercial activities.

IceCure Medical announced the publication of its ICE3 trial results in the Annals of Surgical Oncology. The study, titled 'Cryoablation Without Excision for Early–Stage Breast Cancer: ICE3 Trial 5–Year Follow–Up on Ipsilateral Breast Tumor Recurrence', presents findings on using ProSense® cryoablation for early-stage, low-risk breast cancer.

Key results include:

• 96.3% recurrence-free rate for women treated with ProSense® and endocrine therapy
• 4.3% ipsilateral breast tumor recurrence rate at 5 years
• 96.7% breast cancer survival rate
• 100% patient and physician satisfaction with cosmetic outcomes
• No serious device-related adverse events reported

The publication precedes IceCure's FDA Advisory Panel Meeting for ProSense® marketing authorization, scheduled for November 7, 2024.

IceCure Medical (Nasdaq: ICCM) announced the publication of an independent study on its ProSense® cryoablation system in the British Journal of Radiology. The study, led by Dr. Franco Orsi at the European Institute of Oncology, demonstrated a 97.7% technical success rate in treating tumors of the lung, bone, and soft tissues. ProSense®, a liquid nitrogen-based system, was found to have favorable safety compared to argon-based systems and to be more cost-effective and easier to manage.

The study assessed 85 patients with 96 lesions, showing only minor complications that resolved without significant intervention. It highlighted cryoablation's growing role in early oncology treatments, particularly for patients with comorbidities or those avoiding surgery. The research also emphasized interventional radiology as the fourth pillar of oncology, alongside clinical oncology, surgical oncology, and radiation therapy.

IceCure Medical (Nasdaq: ICCM) announced that the FDA's Medical Device Advisory Committee Panel will meet on November 7, 2024, to evaluate ProSense® cryoablation as a minimally invasive alternative to lumpectomy for early-stage low risk breast cancer. This public forum will review data, including results from the ICE3 study, which showed a 96.3% recurrence-free rate at 5 years for patients treated with ProSense® and adjuvant endocrine therapy. The FDA is expected to make a decision on marketing authorization by early 2025. ProSense® could potentially benefit an estimated 70,000 women diagnosed annually in the U.S. with this condition.

IceCure Medical (Nasdaq: ICCM), developer of minimally-invasive cryoablation technology, announced its participation in two upcoming investor conferences. CEO Eyal Shamir will conduct one-on-one meetings with institutional investors at both the H.C. Wainwright 26th Annual Global Investment Conference (September 9-11, 2024) and the Lake Street Capital Markets 8th Annual Best Ideas Growth Conference (September 12, 2024).

The company's presentation will focus on its ProSense® technology for non-surgical treatment of benign and cancerous tumors, as well as upcoming regulatory and operating catalysts. CFO and COO Ronen Tsimerman will join the H.C. Wainwright meetings virtually. A virtual presentation will be available on-demand starting September 9 at 7:00 AM ET for the H.C. Wainwright conference.