It was official at the beginning of the month, but the world got see it this week when NASDAQ put the news of Ice Cure’s cure for some breast cancer on its eight-story high colorful screen right smack in the heart of 42nd street’s theater district!
And because I was the happy recipient of Ice Cure’s wonderful treatment eight years ago, and got to go to Maryland to testify before the Food and Drug Administration about its huge success several months ago, both Nasdaq and Ice Cure also invited me to New York to have my photo taken with the spectacular news in giant letters.
The news is simply that IceCure Medical’s ProSense® Cryoablation has gained the right to market with FDA authorization its painless, quick, and highly successful treatment of Low-Risk Breast Cancer in women age 70 and above, a truly significant development in giving women with breast cancer some wonderful and minimally invasive care.
The ProSense® cryoablation now gives women the choice of this minimally invasive outpatient procedure that destroys tumors by freezing without surgical removal of breast tissue . This first new innovation in the local treatment of early-stage, low-risk breast cancer in decades means the only medical device to be granted FDA marketing authorization for breast cancer treatment is the ProSense cryoablations.
Not only that, but this little frozen needle offers efficacy and safety similar to the standard of care lumpectomy, with excellent cosmetic results and patient satisfaction.
The U.S. Food and Drug Administration (“FDA”) gave its approval, which means insurance policies will now cover the procedure and performed at far less expense and pain or cosmetic problems, to market ProSense® for women aged 70 and over, an estimated population of 46,000 women annually in the U.S.
The first announcement of this was made October 3, by IceCure Medical Ltd. (Nasdaq: ICCM) the developer of minimally invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal. The firm is located in Caesarea Israel.
“We are excited to add a minimally invasive choice around breast cancer treatments and to offer patients an effective, outpatient procedure,” said Eyal Shamir, Chief Executive Officer, IceCure. “With the ProSense® Cryoablation System, we are giving women with low-risk, early-stage breast cancer the choice to freeze their cancer, not their lives, through an effective treatment that minimizes recovery time, and minimal cosmetic changes to the breast.”
ProSense® is the first and only medical device to be granted FDA marketing authorization for the local treatment of breast cancer.
According to the company’s press release, “ProSense® is authorized by the FDA for the local treatment of breast cancer in patients ≥70 years of age with biologically low-risk tumors ≤1.5 cm in size and treated with adjuvant endocrine therapy. Biologically low-risk breast cancer is defined as unifocal tumor, size ≤1.5cm, ER+, PR+, HER2-, Ki-67.”
In layman’s terms, this writer had the procedure done at Centra State Hospital in Freehold eight years ago and has been cancer free ever since.
In fact, by coincidence, the writer had a meeting 25 miles from the hospital two hours after the procedure to finalize plans for a trip to Israel in two weeks, plans that had been made months before.
And to make it even better, when Ice Cure learned this writer was going to Israel, they invited me to visit the plant and people that created the magic in Caesarea, and even picked me up at the Jerusalem hotel where my church group was staying, and drove me to meet the wonderful people and demonstrate the procedure which creed her cancer close to two hours away.
In actuality, they did not even have to show me the procedure. Since it is so non-invasive, a matter of injecting my breast with a frozen needle, I had watched the whole procedure on the same screen the doctor used to insert the needle. I saw how the needle, with nothing in it, just frozen so its cold killed the cells, was inserted directly into the cancerous tumor. I could then watch as the tumor shriveled up from the cold, then went the way of all wasted and dead cells in the body. A bit of cream, a band-aid patch, and I was ready to go to my meeting after the 28-minute procedure.
Dr. Kenneth Tomkovich, a Freehold radiologist, was so convinced Ice Cure had an invention that he was willing to participate, and invite women to trust him, in being part of the trial that would…eight years later….make the procedure available for women over 70.
To this writer’s mind, it should have been approved for women of all ages, or certainly at least younger than simply those lucky enough to be 70 years old. But slow and precise is how the FDA works and this is the first step towards even more success for physicians and women who believe in Ice Cure and Pro-Sense.
However, in granting marketing authorization, the FDA requested,and IceCure readily agreed, to conduct a post-market surveillance study with the aim of producing additional data in this indication. This study is expected to include approximately 400 patients at 30 sites.
“You don’t need any kind of cosmetic follow-up, you don’t have a scar, and you don’t have the feeling of having lost part of your breast, because it’s all still there,” said breast cancer patient and ICE3 trial participant, Pam Dixon, when describing her experience with the ProSense® cryoablation procedure. “There was no pain. It was one of the easiest things I’ve ever done. I don’t remember any limitations on my activity.”
The procedure is monitored in real-time by ultrasound to ensure the ice ball is growing sufficiently around the tumor, and to avoid damage to the skin or muscle. The doctor may use hydro-dissection to protect the skin or muscle during a procedure depending on the location of the tumor.
`ICE3 study lead author, Richard Fine, MD, FACS, of the West Cancer Center & Research Institute in Germantown, TN and past President of the American Society of Breast Surgeons emphasizes that, “The ICE3 study has proven that cryoablation with ProSense® is a safe, minimally invasive ablative procedure with results similar to that of lumpectomy patients who took endocrine therapy, and has the benefit of being an office-based, non-surgical treatment. Further data coming out of the post-market study should continue to support that cryoablation with ProSense® is a successful option in the de-escalation of breast cancer care in appropriately selected patients.”
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