After eight years of trials, successes and numerous women happy they no longer have breast cancer, the FDA is holding a meeting next month and inviting comments on the ProSense Cryoablation System, the non-invasive, non-drug cure for some types of breast cancer.
The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee gave notice of its scheduled public advisory meeting in Maryland on Thursday, November 7 and requested comments to be heard that day if submitted no later than this Thursday., October 17.
As a thrilled and cured breast cancer survivor thanks to this cryoablation procedure created by Ice Cure, a company in Caesarea, Israel, eight years ago, I am on the schedule to present testimony during that meeting on the success of the cryoablation performed by Dr. Kenneth Tomkovich, a radiologist at Centra State Hospital in Freehold, at the very onset of the trial period eight years ago.
Purpose of the meeting is for the Committee to discuss, make recommendations, and vote on clinical information related to the request for the ProSense Cryoablation System sponsored by Ice Cure Medical Ltd. The discussion will focus on the sponsor’s proposed indication: “for use in the treatment of patients with early stage, low-risk breast cancer for the treatment of breast cancer with adjuvant endocrine therapy.”
Persons who have had this treatment, want it to be approved so insurance and hospitals will include it, have relatives or friends who have been part of the success rate of this hour long procedure performed without need of either anesthesia or drugs are also invited to send comments to the FDA for consideration during the hearing.
FDA established a docket for public comment at this meeting. For access to sending in comments go to https://www.regulations.gov/document/FDA-2024-N-4057-0001 and click on comment.
Comments received on or before October 17 will be provided to the Committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate. Comments will also be accepted until 11:59 p.m. eastern time at the end of December 9, and all comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. Obviously, these comments will not be addressed during the November session.
The Food and Drug Administration (FDA) in announcing the advisory committee meeting, indicated its general function is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. The meeting is being held at the Holiday inn, Two Montgomery Village Ave., Gaithersburg, Maryland and will begin at 9 a.m., ending at 6 p.m.
Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Persons wishing to submit comments electronically, including attachments, can access HERE. Comments will be posted to the docket unchanged. Because comments will be made public, writers are solely responsible for ensuring their comment does not include any confidential information the writer does not wish to be posted, such as medical information, anyone’s Social Security number, or confidential business information. Persons wishing to submit comments
If you want to submit a comment with confidential information they do not wish to be made available to the public, should submit the comment as a written/paper submission to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For access to the docket to read background documents or the electronic and written/paper comments received, visit HERE and insert the docket number, FDA-2024-N-4057 into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
Please see below on stories that I have written about my own journey with Breast Cancer, and my amazing success with IceCure Cryoblation
I had breast cancer for 47 days: my journey with breast cryoablation
