BOSTON – A group of aspiring innovators appeared before a panel of experts at the 2017 AGA Tech Summit Shark Tank event to make the case for how their novel device or technology could help advance the field of gastroenterology.

“The conversation that occurs here is really the start of other conversations we hope will continue out of this room and into the future to help everyone move their device or concept forward,” Michael L. Kochman, MD, AGAF, chair of the AGA Center for GI Innovation and Technology (CGIT), which sponsors the summit, told the assembled audience of potential investors, regulatory officials, and other innovators. Dr. Kochman also served as one of the “sharks” who sought to ask fundamental questions and identify potential gaps in each business plan in an ultimate attempt to make the product better and market ready. He was joined by V. Raman Muthusamy, MD, CGIT’s incoming chair, and director of interventional endoscopy and general GI endoscopy at the University of California, Los Angeles, where he is also clinical professor of medicine in the division of digestive diseases. The panel also included Jeffrey M. Marks, MD, director of surgical endoscopy at University Hospitals Cleveland Medical Center, and Dennis McWilliams, president and chief commercial officer of Apollo Endosurgery, Inc.

Analyzing RNA biomarkers in stool samples

First to face the sharks was Erica Barnell, an MD/PhD candidate at the Washington University School of Medicine in St. Louis and the chief science officer of Geneoscopy, LLC. She and her collaborators have created a series of patent-pending methods to isolate and preserve neoplasia-associated RNA biomarkers in stool samples. The technology is expected to improve screening for colorectal cancer, which is the second leading cause of cancer-related deaths in the United States, with more than 50,000 deaths annually. The high mortality rate of colorectal cancer is due, in part, to flaws in existing methodologies to screen for the disease and because of a high rate of patient noncompliance with screening guidelines, according to Ms. Barnell.

“They have a lot of fear of the procedure, including the general anesthesia. We need to develop noninvasive procedures to comply with these patient behaviors,” she said.

Clinical data presented by Ms. Barnell showed that their predictive algorithms in a test population of 65 persons had 81% sensitivity and 59% specificity for detecting adenomas of all sizes. Ms. Barnell acknowledged that the specificity rate was not impressive, so she and her colleagues plan to add a fecal immunochemical test in their next round of clinical trial testing.

Among the feedback Ms. Barnell received was Dr. Kochman’s suggestion that geneoscopy would benefit from having strong head-to-head data for their novel screening procedure vs. current procedures to present to the U.S. Food and Drug Administration, which Ms. Barnell said she and her colleagues were already taking into account.

Reducing risk of repetitive motion injuries

Prosper Abitbol, MD, a gastroenterologist in private practice in Boca Raton, Fla., seeks to limit the potential for harm to the clinician who performs hundreds – or more – of colorectal screening procedures annually. The EndoFeed™ device Dr. Abitbol and his team brought to the Shark Tank panel practically eliminates the need for repetitive, coordinated wrist and thumb movements when performing a colonoscopy.

Dr. Abitbol told the panel that a clinician typically uses upwards of 120 motions while performing an endoscopic procedure, often far more. The result, he said, is that more than half of endoscopists report a variety of musculoskeletal injuries, and that the injuries worsen after cumulative years of practice.

The EndoFeed™ drive mechanism moves the instruments through the channel of the endoscope’s insertion tube, making it easy to complete the necessary insertion and extraction motions in biopsies without injury from repetitive motion.

Dr. Abitbol and his team also presented the EndoReVu™, which he said increases polyp detection during screening through the use of a mirror that is inserted through the instrument channel of the scope, and then provides reflective images with existing endoscope optics. The mirror is flexible to ensure there is no damage to surrounding tissue. Both devices presented by Dr. Abitbol are single use and disposable.

He concluded his presentation to the panel by saying, “I spend most of my day in the endoscopy suite every day, and I know what I need to do a better job ... I see [what] the reactions of other doctors and nurses are to this product, and I have no doubt these two products will play a major role in the endoscopy suite.”

However, while Dr. Abitbol was commended for considering the problem of operator fatigue in colonoscopies – something at least one audience member said was too often overlooked – the panel unanimously agreed that for Dr. Abitbol to move his products forward he would need to conduct some rigorous studies to show conclusive data that they improve levels of fatigue.

Identifying, classifying small polyps during a procedure

A vexing problem for clinicians is what to do after detecting a colonic polyp, since the majority of those found are not precancerous. Now, Rizkullah “Ray” Dogum, an MS/MBA candidate, and his colleagues are seeking to market a technology that reads the information gathered by elastic scattering spectroscopy to determine whether a sample is dysplastic, essentially creating the first in vivo definitive polyp classification method.

“Using elastic scattering spectroscopy technology, polyps with negligible malignant potential are detected and classified during the procedure, circumventing the routine track to pathology labs,” Mr. Dogum explained in an interview, noting that this adds up to hundreds of millions of dollars savings per year. An important fact, he said, since as our population ages it requires more screening. “As much as $1 billion could be saved annually if diminutive polyps could simply be diagnosed, resected, and discarded in lieu of histopathological processing,” Mr. Dogum said.

Currently being tested in several clinical trials that so far are yielding what Mr. Dogum says are “promising” results, especially when compared with chromoendoscopy and narrow-band imaging, the patented technology uses a white light that is transmitted through fiber optic cables that are integrated into both the snare and forceps tools; the back-reflection is detected by a computer, making polyp classification possible.

An advantage in practice for using the technology is that it does not require any significant alteration in the current standard practice for colonoscopy and does not disrupt the standard flow of work, meaning there is less training required, according to Mr. Dogum.

An audience member who identified himself as a regulator with the FDA told Mr. Dogum that over the years the agency has “struggled” with how to classify imaging technologies, because they are tools, but do not actually change practice, noting that whether to resect and discard is a clinical decision made at the physician’s discretion, not one determined by a device. He expressed his skepticism that the product would qualify as a Class II device but did suggest that it might qualify as a low-risk, de novo product, something that Mr. Dogum said in an interview following the presentation that he and his collaborators would be interested in pursuing.

Preventing endoscopic retrograde infections

Mining Big Data for algorithms that can detect endoscopic infection clusters is what Susan Hutfless, PhD, an epidemiologist and assistant professor in the division of gastroenterology and hepatology at Johns Hopkins University in Baltimore, told the shark panel she and her collaborators want to do using Medicare and Medicaid claims.

“Using Medicare and Medicaid billing data, our technology identifies endoscopic errors in a succinct and quantitative way,” Dr. Hutfless said in an interview. She explained that this benefits device manufacturers, health care facilities, and insurers. Included on the as-yet unnamed software program’s dashboard are a range of metrics that allows continuous monitoring of care, risk factors, and sources of infection, all to prevent serious outbreaks and the proliferation of illness.

Dr. Hutfless and her team came upon the idea after a string of deadly endoscope-related infectious outbreaks were linked to closed-channel duodenoscopes.

“We think that our technology helps move the field forward, because it provides a solution to contain endoscopically transmitted infections without re-engineering the endoscope,” Dr. Hutfless said. “For instance, there was an outbreak despite the use of a redesigned scope. Our technology is able to identify gaps in the care pathway that include the endoscope itself as well as the possible human factors that may be playing a role.”

Another plus, she told the panel, is that the product would not require FDA approval.

Despite data Dr. Hutfless said she and her collaborators will be presenting later this year at the annual Digestive Disease Week(R) that show a tight correlation between relevant claims data and data collected by the FDA during the infection outbreaks, the panel concluded that the stronger marketing potential for this product would be as a monitoring system, not a predictive one, used in combination with an engineering solution.

Simplifying LED incorporation in scopes

LED is only the fourth lighting technology ever invented, according to Thomas V. Root, president and CEO of Acera Inc. In an interview, Mr. Root said that while LEDs are “overtaking all major lighting markets,” medical device manufacturers have been slow to catch on.

“Acera moves the industry ahead with its elliptical optic that significantly improves the collection efficiency and distribution of the LED light. This optic, provided in a modular assembly, simplifies incorporation of LEDs in the practice of scope design and manufacture,” he said.

By eliminating the light guide tether, the use of LED increases mobility and the potential for low-cost or even single-use devices, Mr. Root said. “The result is that engineers are liberated to reimagine how endoscopes are designed.”

Because half of fires that occur in the endoscopy setting come from malfunctioning light sources, one of the sharks suggested that since the Acera product does not use the infrared wavelengths in its light, and its electrical cord remains cool to the touch while in use, Mr. Root and his colleagues should highlight that as a unique safety feature in their marketing materials.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

Shark Tank returns: Which GI innovations will make it to market?