|A new study of Novian Health's Novilase Breast Therapy system showed that the device could offer an alternative to lumpectomy in patients with breast cancer.--Courtesy of Novian Health|
Novian Health is trumpeting promising results from a study of its innovative laser ablation treatment for breast cancer, putting wind in the company's sails as it eyes FDA approval for its device.
Results from a multicenter trial of Novian's Novilase Breast Therapy in 61 patients showed that the system completely ablated tumors in 91% of cases without causing serious side effects. The company's system also worked well when paired with MRI technology, Novian said in a statement, correctly predicting whether or treatment was successful in 92% of cases.
The company carried out the study at 11 sites including 8 in the U.S. and three in the U.K., signing on radiologists and breast surgeons as investigators to probe 64 tumors. Novian recently presented its findings at the San Antonio Breast Cancer Symposium.
Chicago-based Novian's Novilase system could offer a big advantage over lumpectomy surgery, which relies on more physically invasive techniques to treat breast cancer. The device is inserted through the skin into the tumor through small incisions, causing little to no scarring or change in the breast's shape and feel, the company said in a statement.
"We saw multiple advantages of using laser therapy to not only destroy the cancer tumor, but to do so with only local anesthetic and less cosmetic damage than traditional lumpectomy. Patients benefit from quicker recovery and are less likely to need additional treatments than with surgery," Dr. Barbara Schwartzberg, the study's principal investigator, said in a statement.
With positive results in tow, Novian is planning to launch a follow-up pivotal clinical trial of its device in 2016. The study will expand on the recent findings, giving the company some added momentum as it chases FDA approval for its product. Novilase is already cleared by the FDA as a surgical alternative to treat benign breast tumors.
- here's the statement