Israel's InSightec won Chinese approval for its noninvasive uterine fibroid treatment, clearing the company to market its ultrasound-powered device in the fast-growing market.
InSightec's ExAblate uses a focused stream of ultrasound energy to destroy fibroids from outside the body, pairing the ablation technology with MRI monitoring to keep track of procedure outcomes. The device won its first U.S. approval back in 2004, and, with the Chinese Food and Drug Administration's blessing, ExAblate is the first ultrasound uterine fibroid treatment cleared in both countries, the company said.
In clinical studies targeted to win Chinese approval, ExAblate safely and successfully treated women with symptomatic fibroids, InSightec said, providing a reliable alternative to hysterectomy with no risk of infection.
"We are extremely proud to have received CFDA approval for ExAblate, which is another vote of confidence in ExAblate's high safety profile and excellent outcomes," CEO Kobi Vortman said in a statement.
But that's not all the ExAblate technology can do. As InSightec rolls into China with uterine fibroid approval, the company is in the midst of global studies to prove the device's worth in treating essential tremor, bone tumors and Parkinson's disease. In October, the FDA approved ExAblate to treat pain from bone metastases, and, in February, the agency gave InSightec the go-ahead to launch a Phase III trial for the neuro-focused version of the device.
The Israeli company is largely bankrolled by GE Healthcare ($GE), and the global giant ponied up $27.6 million of InSightec's $30.9 million Series C in December, cash the company is using to chase down new ExAblate indications and expand its U.S. commercial force.
- read the announcement