Last month, IceCure Medical’s tumor-freezing technology won FDA approval for treating early-stage breast cancer. Now, the Israel-based medtech is touting a new study showing its procedure combined with radiation may extend survival for patients with an inoperable form of lung cancer.
IceCure’s ProSense system aims to destroy tumors by freezing them using liquid nitrogen. The minimally invasive procedure, known as cryoablation, is performed on an outpatient basis.
The study, published in the peer-reviewed journal PLOS One, found patients with stage 1 non-small cell lung cancer had a five-year overall survival rate of 74% when receiving stereotactic body radiation therapy (SBRT) followed by treatment with IceCure’s system.
That’s a better outcome than patients who receive SBRT alone and similar to patients whose tumors are removed through surgery, the company said in announcing the results Nov. 3. Previously published studies showed a five-year survival rate between 41% and 52% for patients undergoing SBRT alone and between 67% and 82% for patients who had surgery, according to the company.
The study, led by Hiroaki Nomori, M.D., of Kashiwa Kousei General Hospital in Japan, included 64 patients with an average tumor size of 2.7 cm. The results showed a five-year local control rate of 93%, suggesting a low rate of tumor recurrence, and no treatment-related deaths. The most common complication was a collapsed lung, occurring in 40% of patients.
“While radiation therapy is the standard of care for inoperable stage 1 NSCLC patients, using SBRT alone unfortunately results in far lower overall survival and lower local control than surgery in certain patients,” IceCure CEO Eyal Shamir said in a statement.
He said the study “provides very encouraging results confirming that combining SBRT with our cryoablation system offers inoperable patients longer life expectancy and may also provide a minimally invasive option to surgery for the broader population of stage 1 NSCLC patients.”
In October, IceCure received FDA marketing authorization to market ProSense in the U.S. for local treatment of early-stage, low-risk breast cancer, when combined with adjuvant endocrine therapy, in women 70 and older.