ProSense® Cryoablation Shows Promise as Non-Surgical Alternative for Early-Stage Breast Cancer
• Multiple studies presented at major European oncology conferences demonstrate ProSense® cryoablation system's effectiveness with 94% complete ablation rate in early-stage breast cancer patients.
• Patient satisfaction data reveals 95% of participants would choose cryoablation over traditional breast-conserving surgery, with 100% treatment tolerance and zero complications in key trials.
• IceCure Medical's minimally invasive liquid nitrogen-based technology is gaining commercial traction in Europe, supported by growing evidence that cryoablation with adjuvant therapy produces recurrence rates comparable to surgical approaches.
IceCure Seeks NMPA Approval for Advanced ProSense Cryoablation System in China
• IceCure Medical has submitted a regulatory application to China's NMPA for its ProSense cryoablation system, building upon their existing IceSense3 platform already approved in the market.
• The ProSense system utilizes liquid nitrogen technology to create lethal zones for tumor destruction, featuring five specialized cryoprobes for various surgical applications including breast and lung procedures.
• The portable system offers minimally invasive tumor treatment with shorter recovery times, positioning IceCure to expand its presence in China's growing medical device market.
IceCure Medical Sees Sales Surge and Awaits FDA Decision on ProSense for Breast Cancer
• IceCure Medical reported a 42% increase in North American sales of its ProSense cryoablation system in 2024, signaling growing adoption for breast tumor treatment.
• The company anticipates an FDA decision on ProSense for early-stage breast cancer in Q1 2025, following positive advisory panel feedback based on the ICE3 study.
• ICE3 study results showed a 96.3% recurrence-free rate and 100% patient/physician satisfaction, aligning with lumpectomy outcomes for early-stage breast cancer.
• Interim results from the ICESECRET kidney cancer study demonstrated an 88.7% recurrence-free rate, highlighting ProSense's potential in treating kidney cancer.
IceCure Medical's ProSense Receives Favorable FDA Panel Recommendation
• IceCure Medical's ProSense system received a favorable recommendation from the FDA Medical Device Advisory Committee for treating early-stage, low-risk breast cancer.
• The FDA's positive assessment enhances the likelihood of final FDA approval, expected by the end of Q1 2025, potentially catalyzing the system's adoption.
• IceCure Medical's financial position is stable, with $10.7 million in cash and no debt as of September 30, 2024, alongside a 98% year-over-year revenue increase in Q3 2024.
FDA Panel Backs IceCure's ProSense for Early-Stage Breast Cancer
• An FDA advisory panel has favorably recommended IceCure Medical's ProSense cryoablation system for treating early-stage, low-risk breast cancer.
• The panel voted 9-5 that the benefits of ProSense outweigh the risks when used with adjuvant endocrine therapy, offering a potential alternative to lumpectomy.
• The FDA's final decision on marketing authorization for ProSense is expected in the first quarter of 2025.
• ProSense uses liquid nitrogen to freeze and destroy tumors, providing a minimally invasive treatment option.
FDA Advisory Panel to Review IceCure's ProSense for Early-Stage Breast Cancer
• The FDA's Medical Device Advisory Committee will review IceCure's ProSense cryoablation system for early-stage, low-risk breast cancer on November 7, 2024.
• The advisory panel will provide recommendations on the benefit-risk profile of ProSense for treating early-stage invasive breast cancer with cryoablation and adjuvant endocrine therapy.
• Public comments from stakeholders, including patients and healthcare professionals, are available on the FDA website for the advisory panel's consideration.
• The FDA's decision on marketing authorization for ProSense is expected by early 2025, following the advisory panel's vote.
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