ELBIT IMAGING LTD. ANNOUNCES THAT INSIGHTEC ANNOUNCES THAT THE FDA HAS
APPROVED EXABLATE SYSTEM FOR TREATMENT IN THE USA
Tel Aviv, Israel, October 7, 2015, Elbit Imaging Ltd. (TASE, NASDAQ: EMITF) ("Elbit" or the "Company") announced today that it was informed by InSightec’s Ltd. ("InSightec"), that the United States Food and Drug Administration (FDA) has approved InSightec 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 estimates that such 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.
FDA approval of INSIGHTEC’s next generation Exablate system offers treating physicians a more advanced technology.
The Company holds approximately 82.7% of the share capital of Elbit Medical Technologies Ltd. ("Elbit Medical") (TASE: EMTC-M) (on a fully diluted basis) which, in turn, holds approximately 29.6% of the share capital in InSightec (on a fully diluted basis).
