Devices & Diagnostics, Startups

Device offering colonoscopy workaround to boost compliance wins FDA clearance

The Pure-VU system from MOTUS GI allows physicians to clean an inadequately prepped colon during a colonoscopy such that they can see existences of what could be cancerous polyps.

The MOTUS-GI workstation controller to help manage colonoscopies.

The MOTUS GI workstation controller to help manage colonoscopies.

Colorectal cancer is the second-leading cause of cancer-related deaths in the U.S. and while screening tests such as colonoscopy could help in early detection and survival, many Americans choose simply to skip it.

In fact, a 2013 report from the Centers for Diseases Control estimates that one in three adults who are 50 to 75 years old have not been tested for the disease. One major reason is the bowel prep necessary to perform a colonoscopy, a common screening test. People have to drink foul-tasting purgatives and in many cases miss a day’s worth of work to properly prepare for the procedure.

Now one startup is hoping that its new FDA-cleared device will boost screening compliance given that doctors will be able to continue with a colonoscopy and get good visualization of the colon even if they encounter a patient that hasn’t adequately prepped for the screening.

Tirat Carmel, Israel-based MOTUS GI announced last week that the company has received the go ahead from the Food and Drug Administration to market its Pure-Vu system to cleanse poorly prepped colons during the actual colonoscopy procedure.

“One of the greatest challenges with colonoscopies is that the procedure often has to be repeated earlier than recommended guidelines due to an inadequate preparation that can obstruct the visualization of polyps or other anomalies in the colon,” said Mark Pomeranz, CEO of MOTUS GI, in a news release. “With FDA clearance of Pure-Vu, we can now provide physicians with more flexibility in treating their patients, while addressing issues such as early repeat procedures, missed adenomas, reduced patient satisfaction and higher costs that are associated with poorly prepared colons.”

The Pure-Vu System consists of a disposable component and a workstation controller and uses a mixture of water and air to “loosen debris from the colon mucosa while simultaneously evacuating the bowel contents,” according to the company. The disposable component fits over regular colonoscopes thereby integrating with standard workflows and allowing the physician to intra-procedurally clean and then visualize the colon.

The poorly-prepped colon problem and the lack of compliance in screening has brought up innovative alternatives, some of which are already available in the marketplace – for instance Marlborouhg, Massachusetts-based Exact Sciences’ Cologuard that uses a prep-free, non-invasive DNA-based stool test to detect cancerous polyps. And then there is Check-Cap, MOTUS-GI’s compatriot in Israel that is developing an endoscopic capsule that can be swallowed and image the colon as it makes it way through the body though the device is not cleared in the U.S. And earlier this year Medtronic announced that FDA cleared PillCam 2 ingestible capsule, the technology it obtained following its acquisition of Covidien.

Here’s how Pomeranz responded to questions about these competitors, and the market opportunity in an email.

MedCity: The others seem to be saying let’s take bowel prep out of the equation period and then you don’t have to worry about adequately prepped or poorly prepped [colon]. The latter route may have steep hill to climb in terms of adoption, but seems logical.

Pomeranz: It is important to realize that colonoscopy is the gold standard for colorectal cancer screening, but it is also used for diagnosing and treating many other diseases such as irritable bowel syndrome, Crohn’s disease and lower GI bleeding, to name a few. CRC screening only makes up 35 percent of colonoscopy procedures. Colonoscopy is not only a diagnostic procedure but also a therapeutic procedure as polyps can be removed, bleeding complications can be addressed and other procedures are performed. Even though the Pure-Vu system will be attractive to people who are not getting screened due to concerns over having a successful prep, its initial focus will be to improve patient satisfaction and reduce the issues of repeat procedures and lower diagnostic quality associated with poorly prepped colons that happen in approximately 20 percent of the 15 million colonoscopies preformed in the U.S. every year.

MedCity: How are you approaching the market? Who are your main customers?

Pomeranz: We are taking a methodical approach to the market with an initial limited launch into the market in our two main market opportunities and then expanding once we have generated more clinical publications and established our initial beachheads. The first market opportunity is the hospital in-patient where Pure-Vu has the potential to reduce the time to a successful colonoscopy thereby decreasing the length of the patient’s hospital stay, increasing diagnostic quality and thereby reducing costs to the hospital. These patients are extremely difficult to prep as they tend to have low motility in their colon and have various co-morbidities that make it difficult for them to tolerate the current purgatives used for prep.

The other, and ultimately the larger, opportunity is the outpatient setting where the majority are performed in the ambulatory endoscopy centers (AEC). In this setting Pure-Vu reduces the sole dependency on pre-procedural-prep giving the gastroenterologist flexibility to improve patient satisfaction by cleansing dirty colons intra-procedurally. Most patients find the current (requirements) to be a challenge. A typical prep regime entails 24 to 36 hours of a clear liquid diet, drinking up to four liters of very unpleasant tasting purgative, being up most of the night in the bathroom and missing a day (from work).

MedCity: What is your market opportunity?

Pomeranz: With 15 million colonoscopies in the U.S. and over 30 million worldwide, there is an enormous potential for the Pure-Vu system to revolutionize the colonoscopy experience. Not only are current prep regimes extremely unpleasant, approximately 20 percent of the time the colon is inadequately prepared, which can lead to early repeat procedures, missed detection of adenomas or cancerous lesions and increased costs.  Therefore, a device like the Pure-Vu system gives the gastroenterologist a tool with the potential to improve patient care and satisfaction in a cost-effective manner.