INSIGHTEC, the leader in MR guided Focused Ultrasound (MRgFUS) therapy, announced that the United States Food and Drug Administration (FDA) has approved its next generation Exablate system to treat symptomatic uterine fibroids and changed the labeling to allow consideration for women who desire to maintain fertility. The updated labeling specifies that ablation of uterine fibroid tissue can now be considered for women with symptomatic uterine fibroids, who desire to retain fertility and spare their uterus.

INSIGHTEC’s Exablate therapy platform is transforming medicine by presenting a non-invasive treatment alternative that combines two technologies: Focused Ultrasound, which is used to ablate the fibroid tissue, and Magnetic Resonance Imaging (MRI), which is used to guide the ultrasound waves to the specific target tissue and provide real-time feedback on treatment progress and outcome. The result of the above integration is a breakthrough, non-invasive, real-time guided and controlled therapy platform that enables outpatient procedures.

This change in labeling provides younger women suffering from symptomatic fibroids access to a new, non-invasive treatment option that is safe, effective and keeps their uterus intact without compromising their existing ability to get pregnant. The approval is based on accumulated, documented clinical data on 118 patients’ pregnancies post Exablate MRgFUS treatments.

Dr. Kobi Vortman, CEO and founder of INSIGHTEC 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".

“This is a major breakthrough in the treatment of symptomatic uterine fibroids.” said professor Haywood Brown, MD, chairman of Obstetrics and Gynecology, Duke University School of Medicine. “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."

Eric Dolen, MD, Ohio Health adds, “MRgFUS is a valid treatment option for patients with symptomatic uterine fibroids. This change in labeling acknowledges this treatment option to be suitable not only for women who are family complete, but also for women who still plan on conceiving".

In addition to the change of labeling, the FDA also approved INSIGHTEC’s next generation Exablate system which offers treating physicians a more advanced technology. This important milestone also means that more patients in North America can now benefit from MRgFUS treatments.

Ramya Singh, INSIGHTEC’s vice president of Americas 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."

Professor Alan H. Matsumoto, MD, Radiology chairman at the University of Virginia and president of the Society of Interventional Radiology commented, "The new version of the Exablate system enables treating physicians greater control of and more flexibility in treating fibroids with a clearer 3D view of the on-going treatment. With this new technology, treatment time is reduced allowing for treatment of more fibroid tissue in a given time."

These announcements reflect continuous strategic, technical, and regulatory commitments in an effort to continuously expand the patient population that is eligible for the treatment.

INSIGHTEC’s treatment platform was approved by the United States FDA for the treatment of the entire symptomatic fibroid tissue in 2009. This is the second labeling adjustment approved by the FDA since then.