By Brian Blum
A promising new technology for improving colonoscopies got its start as a way to remotely explore smuggling tunnels.
When a tunnel is discovered, homeland security or military personnel need to quickly and safely determine what’s inside. Beersheva-based startup IBEX Technologies developed a thin inflatable “sleeve” that can be robotically piloted into a dark tunnel. A camera attached to the front end of the sleeve transmits real-time live video and high-resolution images.
IBEX’s RoboSleeve also can be used by first responders in disaster areas, such as earthquakes, hurricanes and collapsed mines, and to inspect sewage, water and gas piping systems.
As IBEX’s founders, Oleg Popov and Raphael Moisa, continued to work on their autonomous sleeve, they thought about other types of “tunnels” that might be relevant for their technology. That’s when they hit on the idea that would become Consis Medical, a spin-off from IBEX focused on the 2-meter long tunnel inside the human body: the colon.
Colonoscopies are the current gold standard for early detection and prevention of colorectal cancer, the second most lethal cancer in the world with 1.4 million new cases diagnosed a year worldwide.
Doctors recommend regularly colonoscopies beginning at age 50. More than 15 million colonoscopy tests a year are performed in the United States, and colonoscopies are becoming more common around the world. If colon cancer is caught early, the five-year relative survival rate is 92 percent.
However, colonoscopies are expensive. A single endoscope – the medical device used to perform the procedure – costs upwards of $60,000, and clinics typically purchase several endoscopes. In addition, cleaning an endoscope after each use costs about $100 due to the special equipment needed.
Moreover, the procedure is notoriously uncomfortable and runs a chance of complications, including perforating the colon.
Tested on animals and simulators
Based on its tunnel-investigation technology, Consis Medical designed a self-propelled disposable endoscope that enters the colon like a “soft elongated party balloon, the type you make animals out of,” explains Ido Agmon, Consis Medical’s business development manager.
As the balloon inflates, using liquid or gas, an “inverted sleeve expands and carries itself all the way through the colon, gently and quickly.”
The device — so far tested in animal models and colon simulators — is meant to be cheaper, safer and more comfortable than a traditional endoscope, which Agmon describes as “an elongated semi-rigid tube that the doctor has to navigate through the colon. It’s very painful, it takes time and it’s not pleasant at all, not for the patient and not for the doctor either.”
There’s minimal friction between the colon and the Consis Medical sleeve because “it only expands from its front end and doesn’t have to be pushed,” he adds.
The balloon is discarded afterward. The only part needing cleaning is the electronic head containing a camera and light source.
“It’s the size of a capsule, less than 10 centimeters long,” Agmon points out. “That’s a big difference than cleaning a 2-meter-long endoscope with many small cavities and channels.”
Cheaper than the competition?
Although the Consis Medical sleeve works very differently than Given Imaging’s PillCam Colon 2 camera capsule or Check-Cap’s C-Scan x-ray capsule – both Israeli companies – all are intended to be less invasive than traditional colonoscopies.
Another Israeli company, GI View, received FDA approval a year ago for its disposable self-propelled endoscope. German company Invendo (acquired by Danish medical equipment maker Ambu in 2017) makes a disposable endoscope that received FDA approval in January 2018.
Agmon says Consis Medical’s projected price is the lowest, at about $100 per unit, and could also help the company break into emerging economies, including China and India, where the number of colonoscopies is growing rapidly.
“Our plan is to get into the first human clinical trials in the next 12 months,” Agmon says. It will be another three to four years until the FDA approves a fully functional device.
He says the company is looking to collaborate, rather than compete, with big companies in the colonoscopy space such as Olympus in order to bring down the costs of the exam and to help avoid lawsuits like the one that resulted in a $6.6 million judgment following a deadly superbug outbreak linked to a contaminated Olympus endoscope.
“This market needs to go single use,” Agmon stresses. “That’s why Ambu bought Invendu.”
Regarding virtual colonoscopies, Agmon says there are two problems: First, virtual usually means using a CT machine with x-rays to examine the colon, not necessarily a cheaper or safer alternative.
Second, while virtual exams and capsule technologies can spot suspicious polyps, they cannot remove them. A classic colonoscopy is needed in order to do a biopsy “So most doctors prefer the real colonoscopy from the start,” Agmon says.
Consis Medical has its own management team and investors – primarily the Israeli Innovation Authority — and is still small, with just three people on staff. The goal for 2018, Agmon says, is to raise $2 million to build out the team and take the company through clinical trials.