“To date, it’s been 100% accurate. We didn’t cause any failures.” — Dr. Doron Besser, cofounder and president of Envizion Medical.
By Brian Blum, ISRAEL21c
When Israeli transit startup Moovit launched in 2012, it was described as “the Waze of public transportation.” Since then, many startups have dubbed themselves the Waze of this and that.
But here’s a new appellation we hadn’t heard before: Israeli startup Envizion Medical wants to be “the Waze of feeding tubes.”
Yes, feeding tubes, which are inserted into the stomachs of patients who cannot eat or drink normally for reasons such as surgery, intubation, unconsciousness (which became a greater issue during the Covid-19 pandemic) or premature birth.
Feeding tubes are typically placed through “blind insertion,” guided by feel.
But of the 30 million feeding tubes placed annually — 9 million in the United States — some two to five percent end up in the tracheobronchial tree (which transports air into the lungs), resulting in a 30% chance of a collapsed lung or death. That’s close to 1.5 million patients worldwide.
One review looking at nearly 10,000 insertions found that 187 went into the lungs by mistake. Five patients died as a result.
Envizion cofounder and president Dr. Doron Besser has personal experience with just such a tragedy: When his sister was under treatment for breast cancer, a misplaced feeding tube entered her lungs. This error was “a highly significant contributing factor” in her death.
Besser wanted to ensure this would never happen again.
Sensors and AI
The “gold standard” today is to use X-rays to assist in positioning a feeding tube. “But an X-ray is only performed after the procedure,” Besser tells ISRAEL21c. “So, if there was any damage, it was already done.”
The other issue is time.
Nutrition must be delivered via the feeding tube as quickly as possible, ideally within 24 to 48 hours. But an X-ray might need to be performed two to four times to determine the proper placement.
“It could be more than 48 hours for confirmation from the radiologist,” Besser explains, and that could lead to malnourishment.
Envizion’s Envue system uses a feeding tube with a small sensor at the tip. Another sensor is placed on the patient and maintains accuracy even if the patient moves.
As the tube moves through the nose or mouth (90% of feeding tubes enter through the nose) to the esophagus into the stomach or small intestine, electromagnetic navigation displays on a computer screen exactly where the tube is, with a view from above and from the side.
Artificial intelligence and machine learning help guide the process. If Envizion’s algorithm senses the tube is heading toward the lung, the doctor or nurse receives a visual alert.
How effective is the Envizion system?
“To date, it’s been 100% accurate. We didn’t cause any failures,” Besser tells ISRAEL21c.
Compare that with Cortrak from Avanos, a competing system for placing feeding tubes using electromagnetic navigation. Avanos recalled its product earlier this year after the FDA warned that it could result in “serious injuries or death.” Since Cortrak came on the market in 2015, there have been 60 injuries and 23 deaths.
What went wrong with Cortrak?
“Their system simply draws a line,” Besser explains. “They place a receiver in a specific point on a patient which divides the chest into four quadrants. The problem is that the receiver moves around – even some mechanically ventilated patients have the ability to move. There’s a gag and cough reflex. No one likes a feeding tube down their throat. I had it twice in my life, once when I was wounded in the military, and it was one of the worst experiences. I just wanted to take it out!”
Besser credits the Cortrak debacle with “educating the market. It taught everyone about the necessity of this product” and paved the way for Envizion’s success.
“If Cortrak was the Atari, we’re the Sony PlayStation.”
A PlayStation, that is, that’s been tested at such prestigious facilities as the Cleveland Clinic and the St. Vincent network of hospitals run by Ascension, one of the largest private healthcare systems in the United States.
Used in 40 American hospitals
Besser, an orthopedic physician and serial entrepreneur, was part of the original management team at SuperDimension, which developed a navigation system for bronchoscopies (a procedure where a thin tube is inserted into the lungs) and was acquired by Covidien in 2012 for $350 million. Medtronic bought Covidien for $42 billion in 2014.
To launch Envizion, Besser teamed up with Shay Tsuker, chief investment officer at Excellence Nessuah Mutual Funds Management Company. Tsuker serves as Envizion’s chairman of the board.
Envizion received FDA clearance for Envue in 2019. Within 12 months, the company had signed its first partnership agreement.
Besser says Envizion’s feeding tube placement system has been used tens of thousands of times in dozens of US hospitals. Besser envisions that his company “will be in over 40 US hospitals by the end of 2022 and over 100 in 2023.”
Using a “razor and razor blades” (or “printer and ink”) business model, the overall system is relatively inexpensive (like a razor or printer) while the company makes money by selling tubes and sensors (like razor blades or ink).
Envizion currently has 40 employees in two offices – Tel Aviv and Chicago – and has raised $30 million.
Covid and Envue
The pandemic had a positive effect on Envizion’s business, Besser says, because doctors and nurses dealing with severely ill Covid patients desperately needed a product like Envue.
“The fact that we sold thousands of procedures during this time is a success,” he says.
With staffing shortages at many medical facilities around the world, the Israeli system is simpler and faster to use. Setup, alignment and insertion take just a few minutes compared with up to 30 minutes for the old-fashioned “blind insertion” methods.
Besser sums up the impetus for building Envizion: The potential to “significantly improve risky feeding protocols was too large to ignore, especially with the knowledge that human error in medicine can be fatal.”