Aqueduct Medical, a Nazareth-based medical device startup, said Monday it received FDA approval for a product that enables cervical dilation in a short, three- to five-minute process without a need for general anesthesia.
This means the procedure, used for diagnosis, abortions or removal of uterine polyps, may not have to be performed in an operating room, as currently required.
Marketing of the Aqueduct 100 product, registered as intellectual property of the company, is expected to start in the first quarter of 2017 in Europe and in the third quarter of 2017 in the United States, the company said in a statement.
The startup, which is part of the NGT3 technology incubator in Nazareth, is currently holding clinical trials for marketing in Europe after getting CE marking (European Conformity certification) in February this year. The device is expected to be available in Israel, after approval from the Health Ministry, during 2017.
The target audiences for this device are gynecologists in medical centers, outpatient clinics, and private clinics, who will be able to purchase the device through distributors.
Aqueduct 100 performs radial dilation through insertion of balloons together with a catheter that injects a saline wash and gently dilates the cervix. The device reduces the risk of infection and perforation of the cervix and does not require local or general anesthesia, and therefore it can be performed in medical center outpatient clinics and in private clinics. Current methods for cervical dilation take time and require anesthesia to alleviate the pain of the procedure. In addition, patients are exposed to potential complications following the procedure, Aqueduct said.
In the United States alone, three million gynecological procedures that require cervical dilation are performed annually, along with a similar number in Europe, among a total 10 million such procedures in all potential markets for the Aqueduct Medical device, the company said.
Since its establishment in 2013 by the entrepreneur Omer Harpaz, Aqueduct Medical has raised $1.3 million, from the Office of the Chief Scientist in the Ministry of the Economy, private investors, and NGT3.
The company is preparing for a second round of financing for $3 million. The funds raised will allow the company to set up a distribution network in Europe and in the United States, and continue to hold clinical trials for marketing purposes, while building a database of clinical data, based on the work at medical centers in various countries.
Aqueduct 100 is the first device developed by the company, which aims to create advanced tools for obstetrics and gynecology.
“Aqueduct brings a unique product to the market that enables reducing the overload in operating rooms and reduces the pain and risks for the patients. This is a tremendous advantage and a significant achievement,” Zohar Gendler, the CEO of NGT3, said in the statement.
NGT3 is a venture capital fund with a franchise from the Office of the Chief Scientist in the Economy Ministry to operate as a technology incubator in the field of life sciences. It invests in early-stage technology startups and aims at fostering technology partnerships between Israel’s Jewish and Arab populations.
“The advantages of the device stem from the simplicity of operation and the ability to achieve the required cervical dilation safely and quickly,” Dr. Amnon Weichselbaum, CEO of Aqueduct Medical, said in the statement. “The results of clinical trials attest to that, as well as the positive feedback from physicians who have tried the device.”