IceCure Medical has successfully completed treatment of the first two patients in a multi-centred clinical trial using the IceSense3 cryoablation system (exposure to extreme cold temperatures) to treat breast cancer without surgery.
Dr Linsey Gold in conjunction with Regional Medical Imaging and Dr Richard Fine from the West Clinic have completed their first cases.
The company said that the ICE3 trial is significantly expanding the data on cryoablation and may create a paradigm shift in the treatment of breast cancer.
Dr Gold said: "Breast cancer awareness month during October is the perfect time to kick off this important initiative.
"The treatment of breast cancer has evolved to include not only mastectomy but also breast-conserving lumpectomy.
"Cryoablation enables treatment of breast cancer without a surgical scalpel or tissue removal, effectively killing the tumour in place. This promises many clinical and quality of life benefits for patients. We hope to prove them in this study."
The trial is recruiting and following women aged over 65, diagnosed with luminal A breast tumours measuring less than 1.5cm in diameter.
In the trial, these patients will receive adjunctive therapy based on local standards of care.
The trial, developed by an esteemed and diverse scientific advisory board is underway at 20 carefully selected US sites, which have experience using IceSense3 consoles to treat benign breast tumours, including fibroadenomas.
The company will use its resources to provide clinical and technological support to sites during the cancer trial.
Dr Fine said: "Improved screening allows physicians to identify breast cancer earlier, when it’s smaller.
"Advances in molecular profiling (tumour biology) help us better determine which breast cancers have higher or lower risks of recurrence. We can then individualise approaches to treatment.
"Now with the ICE3 study, we may have the first effective non-surgical treatment option for some low risk patients."
The company claims that the start of the ICE3 trial, combined with the recent evolution of its business model, establishes them as the technological leader in the field of breast cancer treatment by using minimally invasive, non-surgical cryoablation.
Image: Illustration of IceSense3 Cryoablation System freezing a breast tumour. Photo: courtesy of PRNewswire/ IceCure Medical.