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

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.

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.

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.