News | FDA | January 30, 2024

IceCure Medical Ltd. has announced that the Food and Drug Administration (FDA) has granted its appeal and reopened its De Novo Classification Request for Marketing Authorization of its ProSense cryoablation technology for early-stage breast cancer.

IceCure Medical Ltd. has announced that the Food and Drug Administration (FDA) has granted its appeal and reopened its De Novo Classification Request for Marketing Authorization of its ProSense cryoablation technology for early-stage breast cancer.

IceCure Medical Ltd. has announced that the Food and Drug Administration (FDA) has granted its appeal and reopened its De Novo Classification Request for Marketing Authorization of its ProSense cryoablation technology for early-stage breast cancer. Image courtesy: IceCure Medical Ltd.


January 30, 2024 — IceCure Medical Ltd. has announced the U.S. Food and Drug Administration (FDA) has responded affirmatively to the Company's request for supervisory review ("Appeal") under 21 CFR 10.75 regarding the FDA's prior denial of IceCure's De Novo Classification Request for treating patients with early-stage, low risk breast cancer. The company is the developer of the ProSense System, an advanced liquid-nitrogen-based minimally-invasive cryoablation technology, as alternative to surgical tumor removal. The therapy treats tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer.

The FDA determined there is sufficient basis to reopen the De Novo file and requested IceCure to submit the full 5-year dataset from the Company's ICE3 trial, according to Ice Cure’s written statement issued today. The final ICE3 study patient is expected to complete her 5-year follow up examination by the end of February 2024. IceCure plans to expedite data monitoring and analysis to submit the final 5-year dataset to the FDA by April 2024, which is several months ahead of the Company's prior submission timeline.

In its initial De Novo classification request in October 2022, IceCure submitted interim results from its ICE3 study, the largest controlled multi-location clinical trial ever performed for liquid-nitrogen (LN2)-based cryoablation of small, low-risk, early-stage malignant breast tumors, noted the company. The ICE3 study will provide 5-year recurrence outcomes on a patient population which represents approximately 65,000 people in the U.S. alone annually.

Additionally, the FDA requested that IceCure submit an analysis of the ICE3 results compared with data from the LUMINA study. That study, sponsored by the Ontario Clinical Oncology Group (Canada), evaluated the risk of recurrence in patients with low-risk Luminal A breast cancer who were treated with lumpectomy surgery with adjuvant hormone therapy. A full peer-reviewed article on LUMINA results was published in August 2023, while FDA review of IceCure's De Novo request was underway.

IceCure was invited by the FDA to submit real-world data from the use of ProSense globally, including post-market commercial use in territories where ProSense is approved for breast cancer, as well as data from independent third-party studies, reported the company statement.

"The FDA has set a very clear path to clearance for ProSense in early-stage breast cancer, which may lead to women having a new, minimally invasive, safe, and effective treatment option," stated IceCure CEO Eyal Shamir. He added, "We remain hopeful that final ICE3 data will be in line with our interim results and are confident that we can deliver the dataset, comparable analysis, and real-world data to the FDA in the next few months."

IceCure Participates in ISO 2024 Breast Cryoablation Master Class

The company also announced that it conducted hands-on ProSense demonstrations at the Society of Interventional Oncology SIO Annual Scientific Meeting, SIO 2024, which took place Jan. 25-29, 2024 in Long Beach, California. In a written statement, the company reported that this year’s meeting included an educational SIO 2024 Breast Cryoablation Master Class, a first-of-its-kind educational event by a radiology society. During the half-day course, a literature review of notable studies for breast cryoablation was presented, primarily including interim data from IceCure's ICE3 breast cancer cryoablation study, which demonstrated a 96.91% recurrence free rate.

Master Class teachers, reported the company, included Kenneth Tomkovich, MD, ICE3's Co-Principal Investigator, Diagnostic and Interventional Radiologist with Princeton Radiology, CentraState Medical Center, and Penn Princeton Medical Center in Princeton, New Jersey; and ICE3 Investigator, Richard Fine, MD, past President of the American Society of Breast Surgeons, Program Director of the Breast Surgical Oncology Fellowship, and Director of Research and Education at the West Comprehensive Breast Center in Germantown, Tennessee.

"SIO 2024 marks a milestone for breast cryoablation in the U.S. medical community as physicians across disciplines from breast surgery to interventional oncologists are looking to adopt cryoablation as a highly desirable option for early-stage breast cancer," Shamir stated. He added, "We are pleased that our interim ICE3 data provided highly meaningful insight…we are very optimistic about the growing use of our cryoablation system in the U.S. where it has regulatory clearance in many indications."

"The Master Class, which was filled to capacity, included interventional oncologists and breast radiologists seeking education to build a successful breast cryoablation program,” commented Tomkovich. He added, “As a radiologist and co-principal investigator of the ICE3 study, I look forward to the presentation of data from the full study population, which I believe will provide even more evidence for physicians to adopt this minimally invasive alternative.”

More information: www.icecure.com

Related content:

IceCure Medical Features Tumor Cryoablation Technology at RSNA 2022

IceCure Medical's Interim Results of the ICE3 Clinical Trial for Early-Stage Breast Cancer Cryoablation featured at RSNA 2021


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