Sightline’s FDA-approved ColonoSight uses air pressure assisted pull technology to pull the scope into the colon. Colon cancer kills 56,000 people every year in the US alone, and one million more are diagnosed with the disease every year. The trouble …
With early detection, the death rate can be dramatically reduced. This may be logical, but not all patients, many of whom assume they are healthy, want to carry out the necessary exploratory procedure – a colonoscopy – because it is unpleasant, sometimes painful, and can even end in a perforated colon.
But now Sightline, a small 25-man Haifa-based start-up has developed a new device called the ColonoSight, which could make a colonoscopy a much easier experience for both the patient, and the doctor.
For patients, one of the biggest problems with existing colonoscopy methods is that they require a doctor to use force to push the scope from behind. This is uncomfortable, and can sometimes damage or perforate the colon.
The ColonoSight, however, uses air pressure assisted pull technology to pull the scope into the colon. The forward force of the device is generated by a pneumatic mechanism just below the tip of the scope. This force draws the scope in, and the operator then navigates with the handles, drastically reducing the need to push from the back. Aside from making the procedure safer, it also reduces the amount of local anesthetic required.
Another benefit of the ColonoSight is that it uses disposable sheaths, eliminating the need for disinfection between procedures. This is a significant improvement for both doctors and patients since it cuts instrument downtime, and reduces the risk of infection.
The ColonoSight also uses an integrated LED (Light emitting diode) light source in the tip, eliminating the need for the traditional fiber-optics now being used in colonoscopy. Fiber-optics are costly to repair.
“The reduction in instrument downtime and in maintenance costs increases physician revenues,” explains Avi Levy, the 43-year-old CEO of Sightline.
Aside from its role as an exploratory instrument, Levy, explains that ColonoSight can also be used for therapeutic treatment. More than 90 percent of colon cancer is caused by small polyps that grow inside the colon. Once the ColonoSight has identified the location of the polyp, it can remove it from the colon, thereby removing the source of the cancer.
The ColonoSight has already been completed, and received FDA approval, but Levy says the company does not plan to put it on the market until the second half of 2005. “We don’t want to skip any of the standard steps and tasks before launching the product,” he explains. “The product is working well, but it’s not ready for the market. We need to finalize our marketing plans, quality assurance and mass production. We want to do everything the right way.”
In trials, the ColonoSight has certainly proved it works. The company carried out trials on 110 people, all of who were apparently healthy and showed no history of any problems. Of this number, 30 were diagnosed with polyps, and a few of them discovered they had cancer. According to Levy, one volunteer had tried and failed to carry out a standard colonoscopy four times, but her colon was so convoluted that the instrument could not reach its destination. The first attempt with the ColonoSight worked.
Sightline actually started life at an Israeli incubator as a security company involved in camera miniaturization. In 1997, the company decided to move into the field of medical devices and began to look around for an area where camera miniaturization would be relevant. After exploring five or six options, the company decided to focus on developing a solution for colonoscopy. “No-one had solutions for that area,” explains Levy. “It was an open market.”
Sightline has two other products, ProctoSight and RectoSight, which have both received FDA and CE approval. The products are for used in rectal procedures. Sightline saw sales of a few hundred thousand dollars for these items in 2003, but decided it should focus firstly upon the ColonoSight, which Levy believes is a much larger potential market.
“The potential market for ProctoSight and RectoSight is about $30m., but to enter it we need to build a market chain and distribution, and invest a few million dollars in it,” says Levy. “We are not at that stage today. What we need to do now is to focus. If a company has too many products it loses focus. ColonoSight is a real breakthrough with a market potential of millions of dollars so we have decided this is our main product.”
Levy is now considering whether to spin ProctoSight and RectoSight off into a separate company.
Sightline’s biggest competitors in the colonoscopy field are big names like Olympus, Pentax, and Fuji. Levy refuses to be deterred, however. “These companies haven’t changed the way they do a colonoscopy for decades,” he says. “What we are offering here is a totally new way to advance the scope.”
There’s undoubtedly room for Sightline. The US market today for colonoscopy is worth about $1.5 billion, and rising rapidly as awareness of the importance of regular preventative testing grows.
One of the main benefits that Sightline has today is that it is accepted for full reimbursement from the insurance companies. “We have no barriers to our entrance into the market,” he says. “This puts us in a very good position in the market today.”
The company is now planning a further round of fund-raising over the coming months, and expects existing investors plus new investors from the US and Israel to finance the round.
Aside from the ColonoSight, Sightline believes its core technology has other wide-ranging applications in the huge, and lucrative gastro-intestinal market. Already the company has developed ThimbleCam, a patented finger camera for surgical and laparoscopic procedures. The camera, which already has CE certification, allows a doctor to see any place that can be reached with a finger.
Small scale sales of this product have already begun.
“I think we have the right product at the right time,” says Levy. “We need to avoid mistakes and play it right. We want to be on the safe side, and not to risk everything. Sometimes when you take a risk at this stage, you lose everything. If you play it right then you may be delayed by six months, but eventually you get there.”