GI-Logic – AbStats™ system
In collaboration with the UCLA gastroenterology department and the UCLA Wireless Health Institute, GI-Logic developed the AbStats™ system to provide continuous telemetry monitoring of the gastrointestinal tract function. With sensors placed on the patient’s abdomen, telemetry is employed to record and analyze vibrations of the digestive tract. Although there is a wide number of applications being considered, one focus has been on the ability of the AbStats™ system to evaluate postoperative ileus. Clinical studies suggest that this tool can signal when patients can resume eating, including distinguishing between suitability for solid foods relative to a liquid diet.
“The AbStats™ system is being studied in a number of chronic GI conditions and will allow clinic physicians a tool to monitor patient conditions and therapeutic impact of both drugs and interventional therapies. The AbStats™ system was recently cleared by the Food and Drug Administration and will be launching in selective centers in May of 2016,” noted Ken Beres, vice president of marketing and business development at GI Logic.
“The system will allow for care teams to for the first time use objective data to guide the feeding and pharmacological management of patients to both improve outcomes and reduce health care expenses.”
The sharks agreed that this tool has potential clinical utility, but there was also general consensus that more data are needed to confirm that it has value from an economic perspective. They suggested that studies are needed to show how the tool alters clinical decisions in a way that saves money or improves outcomes. Dr. Pasricha suggested, “You have to prove that you are not just another layer of diagnosis,” but are providing information that leads to improved patient care.
GI Therapies – TAGS™
David Fischer
The transabdominal gastrointestinal stimulation (TAGS™) device was developed by GI Therapies as a noninvasive tool for the treatment of chronic constipation. The TAGS™ device, which sends small electric pulses to promote peristaltic contractions, was tested in a small pilot study of six women with gastroparesis and chronic constipation. All five patients who required nutritional support (total parenteral nutrition or enteral feedings) at the start of the study were no longer requiring nutritional support after 3-4 months.
GI Therapies is looking to conduct a larger, sham-controlled trial to investigate the use of TAGS™ for the treatment of symptoms of gastroparesis, according to Dr. David Fischer, a principal at GI Therapies, who noted that current therapeutic options for the treatment of gastroparesis, which is a relatively common problem, are “very limited.” He indicated that interest in alternatives to the current array of pharmacologic therapies “is substantial.”
The sharks agreed that gastroparesis is a common and challenging clinical complaint, and they also encouraged the plans to conduct a well-controlled trial using a sham device. However, there was also consensus that patient selection will be critical to efforts to demonstrate a positive outcome, as placebo responses are substantial and not all forms of gastroparesis may respond to this form of electrical stimulation. Several sharks, including Mr. Tinkham, suggested that the developers should already be considering what type of company might be most interested in acquiring this device if clinical studies confirm benefit.
Wake Forest Institute for Regenerative Medicine – BioSphincter™
Using autologous enteric neural progenitor and smooth muscle cells, Khalil N Bitar, Ph.D., AGAF, was able to bioengineer innervated internal anal sphincters, which have been successfully implanted into rabbits after a sphincterectomy. In these experimental studies, sustained continence was restored over a follow-up of 12 months.
“Fecal incontinence, the inability to control bowel movements allowing stool to leak unexpectedly from the rectum, afflicts 6.6 million people in the United States. The true prevalence is thought to be much higher, but is underreported due to social factors. Fecal incontinence represents the second leading cause of institutionalization in the elderly,” Dr. Bitar noted.
Dr. Khalil N. Bitar, AGAF
“Using autologous cell sources, bioengineered internal anal sphincter, BioSphincter™ is a unique regenerative medicine solution to reinstate function in the anorectum, restoring both smooth muscle and intrinsic neural components, resulting in continence. This regenerative medicine approach to reinstate physiological function to treat fecal incontinence using BioSphincter is promising for translation into clinical practice,” Dr. Bitar added.
The sharks were enthusiastic. Although Dr. Bitar was faced with a barrage of questions about the logistics of harvesting muscle and neuroendocrine cells to create an effective implantable sphincter, they suggested that this could provide a major advance in a condition for which there are now very few options. However, they noted that enthusiasm must be tempered by the relatively early clinical development and the likelihood of many potential hurdles to overcome. Of those intrigued, Mr. Pierce initially questioned whether this approach could be adequately protected as intellectual property from competitors but was reassured by Dr. Bitar’s description of the patentable aspects of the bioengineering.
