Anyone unable to eat food normally receives a feeding tube, a device inserted into the stomach through the abdomen.
Globally, every year more than 1.3 million people need feeding tubes. That translates to 4 million tubes inserted each year because they need to be replaced when they get dislodged or clogged.
Inserting, replacing and removing feeding tubes are unpleasant procedures for patients and time-consuming for nurses.
Israeli pediatric gastroenterologist Dr. Ishay Benuri, a graduate of the Hebrew University of Jerusalem’s first BioDesign program, wanted to redesign feeding tubes to be more easily handled, replaced and removed as well as less prone to dislodging.
Fidmi Medical, the company he founded in 2014 with IP from Hadassah tech-transfer company Hadasit, expects its revolutionary feeding tube to receive US Food and Drug Administration (FDA) approval by mid-2017 and CE approval in Europe sometime later.
Fidmi’s design delivers significant advantages over existing feeding tubes, says CEO Shahar Millis, a mechanical engineer with expertise in medical device R&D and product management.
For starters, Fidmi’s rigid-core silicone internal “bumper” keeps the tube in place better than the current soft bumpers meant to be removed along with the tube. A special tool detaches the tube from the bumper, which then breaks up and is eliminated naturally from the body.
“That allows us to remove only the tube, so there is no need for anesthesia or endoscopy for removal,” Millis tells ISRAEL21c.
However, the entire device rarely needs removing because Fidmi features disposable inner feeding tubes easily removed and replaced externally by anyone.
“The overall solution costs more or less the same to the end user but you get an easy-to-handle, bacteria-free, clog-free tube every week,” says Millis.
In addition, Fidmi’s low profile looks discreet.
“Today when a patient first gets a feeding tube it’s a long tube with a bulky connector to the source of nutrition. When not in use, the tube must be taped against the skin and this often causes irritation and it frequently falls out,” Millis explains.
“There are low-profile devices in the market but they are only used after six to eight months, necessitating another procedure to have the long tube device replaced. Fidmi can be used from day one.”
Millis presented the Fidmi device at the Innovations in Gastroenterology international conference on January 4 in Tel Aviv.
“Feeding tubes in their current shape have been around since the late 1970s, and they look pretty much the same today as they did in the early ’80s,” says Millis. “A lot of major corporations in this field are constantly trying to make their devices better by optimization, but they still have many limitations in terms of reliability, comfort and risks.
“It’s amazing that over 35 years no one came up with a better solution. We approached it differently and were able to bring solution to all major problems in just one product.”
Dr. Stephen Cohen, director of acute care surgery at Greenbrier Medical Center in West Virginia, was so enthusiastic about the Fidmi prototype that he recorded a testimonial on his iPhone for the company to post.
“Current products get clogged all the time, especially in nursing homes, and we should be able to come up with a better device. Fidmi Medical has really met an unmet need,” Cohen says. “This new tube will completely change the paradigm for placing and removing [feeding tubes] with much less chance of a patient accidentally dislodging it. Anybody can unclog it and change it easily. It will soon be the product I go to for every patient who needs a feeding tube.”
Dr. Seth Gross, a gastroenterologist at NYU Langone Medical Center in Manhattan, is involved in a clinical trial of the Fidmi device and has volunteered to present it at the Digestive Disease Week international conference in Chicago next May.
Fidmi is now in the final development stages, Millis says. “We are starting a clinical trial at Hadassah and we’re looking for strategic partners and distributors. We recently raised about half a million dollars and are looking for another $750,000 to complete the regulatory process and start building inventory for sales.”
The company operates within Trendlines Medical, the Medical Device incubator at Israel’s Trendlines Group, where it has the assistance of additional professionals. The devices are being manufactured in Israel.
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