Insightec said today it won expanded FDA premarket approval for its next generation Exablate system used to treat symptomatic uterine fibroids for patients who wish to retain their uterus and fertility.
The Exablate system uses both focused ultrasound to ablate fibroid tissue and magnetic resonance imaging to guide the ultrasound ablation to specific tissue targets, the Israel-based company said.
“This is a major milestone for the company. Over the years, the FDA has changed Insightec’s labeling for its uterine fibroids treatment, as more and more clinical data became available. We view this change of labeling as a significant one, because it makes MRgFUS treatment for uterine fibroids accessible to many more women in the US, including women who desire fertility-sparing options for their symptomatic uterine fibroids. Insightec will continue to invest in developing our technology, in order to treat a wider range of clinical indications,” CEO Dr. Kobi Vortman said in a prepared statement.
The approval was based upon documented clinical data from 118 patients who became pregnant after receiving treatment with the Exablate device, Insightec said.
“This is a major breakthrough in the treatment of symptomatic uterine fibroids. Gynecologists can now offer patients a treatment that is not only non-invasive and uterus sparing, but with the new labeling, this treatment is also an option for women who are not family complete,” Dr. Professor Haywood Brown of Duke University School of Medicine said in a press release.
The Exablate system was 1st approved by the FDA in 2009. The expansion and approval of the next generation machine was the second labeling adjustment since initial approval, the company said.
“The combination of Insightec’s next generation system and the expansion of our labeling, brings new benefits to treating physicians and women alike, as we can now serve a larger cohort of patients. We as a company stay committed to extending our technological solutions in order to treat additional gynecology and oncology indications,” veep Ramya Singh said in prepared remarks.
Last December, Insightec said it reeled in a $59 million Series D round from institutional investors in the U.S. and Asia and named Dr. Maurice Ferré as chairman of the board.
Earlier, in September, the company reported raising $12.5 million from Shanghai GEOC Hengtong Investment and Fortune China in return for a 5% stake in the Israeli company.
Ferré was chairman & CEO of Make Surgical until its $1.68 billion acquisition by Stryker(NYSE:SYK). He replaces Tom Gentile at InSightec, who departed to assume the president & COO role at GE Capital, according to a press release.