Aqueduct Medical, a medical devices startup in the NGT3 incubator in Nazareth, Israel, has received US Food and Drug Administration (FDA) approval for its innovative cervical dilator, said to be the only one of its kind that enables cervical dilation in only three to five minutes without need for general anesthesia.

“Now that we have both CE [Europe] and FDA approval and a strong IP portfolio, we feel 2017 can be a breakthrough year,” CEO Amnon Weichselbaum tells ISRAEL21c, adding that the company is seeking a key strategic partner and $3 million in its second funding round.

Marketing of Aqueduct 100 will begin in the first quarter of 2017 in Europe (Spain, France Germany and Italy initially) and in the third quarter of 2017 in the United States.

Dilating a woman’s cervix is necessary for intrauterine diagnostic or operative procedures such as abortions or removal of uterine polyps. In the United States, three million gynecological procedures requiring cervical dilation are performed annually, a similar number in Europe, and 10 million such procedures in all potential markets for Aqueduct 100.

The two current methods for cervical dilation take hours or require general anesthesia, and expose the patient to risks during and after the procedure.

Aqueduct 100, currently manufactured in Israel, uses balloons together with a catheter that injects a saline wash and gently dilates the cervix in minutes. The innovative device reduces the risk of infection and perforation, and because it does not require local or general anesthesia, can be used in outpatient and private clinics.

Since its establishment in 2013 by Omer Harpaz, Aqueduct Medical has raised $1.3 million from Israel’s Innovation Authority (Office of the Chief Scientist in the Ministry of the Economy), private investors and NGT3. Comprehensive clinical studies were performed in Spain.