IceCure Medical, Inc., a medical device company that develops and markets minimally invasive, office-based cryoablation treatment solutions for women's health, has initiated a landmark, multi-centered clinical trial which will study the effect of percutaneous cryoablation on malignant breast tumors.  This announcement comes on the heels of the publication of results from Z1072 cryoablation trial.  

This trial, sponsored by American College of Surgeons Oncology Group (ACOSOG) involved cryoablation of small breast cancer tumors followed by traditional surgical removal.   

The data collected through the ACOSOG trial resulted in some exciting finds, such as the proven success of cryoablation in destroying tumors less than 1.0 cm in diameter. IceCure will build on that data by conducting a trial where breast cancer tumors up to 1.5 cm will be frozen, then followed over time (no surgical excision). This trial will also utilize the more advanced IceSense3 cryoablation system that due to low, stable, cryo temperatures has the potential to completely ablate tumors up to 1.5 cm.

"Our study will employ the IceSense3 system, a third generation cryo technology that provides the coldest, fastest, most stable cryoablation treatment cycles available," said Hezi Himelfarb, IceCure CEO. "The most exciting aspect of this trial is patients with small breast cancers will undergo cryoablation and then subsequently be monitored for the next five years. Their treatment will not require surgical excision or mastectomy."

"Cryoablation has the potential to change the paradigm of treatments available to women with breast cancer and present new horizons of treatment options that are tailored for the specific patient," commented Susan Boolbol, Chief of Division of Breast Surgery Beth Israel New York and Co-PI of the study.

IceCure's clinical trial will recruit and follow-up on women aged 65 years or older diagnosed with luminal A breast carcinoma whose tumors measure less than 1.5 centimeters in diameter. These patients will also receive adjunctive therapy based on local standards of care.  The trial that was crafted by a diverse and esteemed scientific advisory board will be conducted at 20 carefully selected sites throughout the United States and utilize IceSense3 consoles already installed for the treatment of fibroadenomas.  As a market leader in cryoablation treatment of fibroadenomas, IceCure will utilize its resources to provide clinical and technological support to sites.

The benefits of utilizing cryoablation to treat breast disease versus the historical treatment of excision or mastectomy are numerous.  Cryoablation can be performed in a physician's office with use of local anesthetic and ultrasound.  Additionally, because no tissue is removed, there is minimal cosmetic impact with little to no scarring or permanent disfigurement. Further, cryoablation is an economically sound alternative to costly surgery.