This is the first in a series of stories regarding IceCure’s ProSense® and the FDA’sMedical Device Advisory Committee Panel’s favorable recommendation
Muriel J. Smith of Atlantic Highlands, who participated in the trial for cryoablation therapy eight years ago was one of four women who testified during the hearing Friday in Gathersburg, Maryland before the Advisory Committee panel of 19 voting members led by voting Chair Hobart Harris, MD, MPH of the Division of General Surgery, UCSF, San Francisco, California. The panel also included industry, consumer and patient representatives, and directors of the Food and Drug Administration from Silver Spring, Maryland.
Dr. Kenneth Tomkovich, MD, Freehold Radiologist who participated in the trial for cryoablation and administered the procedure on Smith, is a board certified radiologist in Freehold. He is licensed to practice medicine in New Jersey and Colorado and is affiliated with CentraState Healthcare System and Penn Medicine Princeton Medical Center. He holds a University of Colorado Fellowship, Vascular and completed Interventional Radiology and Rutgers Health/New Jersey Medical School Residency, Radiology-Diagnostic in the 1990s. He has been practicing medicine for 30 years in New Jersey.
IceCure Medical Ltd. developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, announced the U.S. Food and Drug Administration’s (“FDA”) Medical Device Advisory Committee Panel’s favorable recommendation with nine panelists voting in favor and five voting against the benefit-risk profile of IceCure’s ProSense®.
The majority of panelists voted that benefits of IceCure’s ProSense® System outweigh risks when used according to the proposed indications for patients with early-stage low risk invasive breast cancer with cryoablation. Three who voted against recommendation indicated they also would have approved it had the FDA applied adequate special controls.
“This is a significant milestone on the path towards the marketing authorization of ProSense® cryoablation for early-stage low risk breast cancer . I believe this is a critically important development for women seeking an alternative to lumpectomy,” said IceCure’s Chief Executive Officer, Eyal Shamir. “We expect the FDA’s decision, based on the Advisory Panel’s recommendation, in the first quarter of 2025. Our Unite Stat es sales and distribution team is ready to support doctors and patients in the event of a successful marketing authorization for ProSense® in breast cancer.”
The Advisory Panel’s favorable vote was based on the comprehensive body of data available on ProSense® as a treatment for early-stage low risk breast cancer, including results from the Company’s ICE3 study compared with data from the current standard of care, lumpectomy, as well as testimonies and input from a broad range of key stakeholders, including women with breast cancer and their family members, patient advocacy groups, doctors, nurses and researchers.
The Advisory Panel’s purpose was for the FDA to obtain independent non-binding expert advice on scientific, technical and policy matters related to the potential granting of marketing authorization of ProSense® for treating patients with early-stage low risk invasive breast cancer with cryoablation. The Panel included breast surgeons, interventional radiologists, breast oncologists, and representatives from the patient, consumer, and regulatory communities.
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.
IceCure Medical develops and markets advanced liquid-nitrogen-based cryoablation therapy systems 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 Company’s flagship ProSense® system is marketed and sold worldwide
Previous Stories on my Breast Cancer Journey HERE
