‘Shark tank’ panel probes GI innovations at AGA Tech Summit

BOSTON – Several innovators had the opportunity to present their novel technologies to a five-person “shark tank” panel – two entrepreneurs, a practicing physician, a venture capitalist, and a businessman – at the 2016 AGA Tech Summit.

After the innovators explained why they expected their products to fill an unmet need, the “sharks” probed for weaknesses and offered advice on what data were needed to confirm a viable advantage over existing options.

“These presentations offer a glimpse into what innovators are working on to improve the practice of gastroenterology,” said Michael L. Kochman, M.D., AGAF, one of the “sharks,” who is chair of the AGA Center for GI Innovation and Technology, which sponsored the summit.

“This ‘shark tank’ is a perfect illustration of what the AGA Center for GI Innovation and Technology is all about – we’re here to help move the field forward and discuss what’s next for the care of patients with digestive disorders.”

In addition to Dr. Kochman, the panel comprised Jay Pasricha, M.D., professor of medicine at Johns Hopkins University, who has been involved in several start-ups; Thomas Shehab, MD, a trained gastroenterologist who is now a principal at Arboretum Ventures; Mr. Brian Tinkham, a founder of Beacon Endoscopic and now vice president, New Technologies, GI Solutions, at Medtronic; and Mr. David Pierce, senior vice president at Boston Scientific.

Amenity Health – MedCline™

Amenity Health developed MedCline™ based on the work of Dr. Carl Melcher, as a positional therapy for nocturnal acid reflux in patients with GERD refractory to pharmacologic treatment. As a component of the GERD treatment plan, MedCline™ is a sleeping device designed to raise the torso and facilitate left-side positioning, both of which have been shown to reduce the risk of nocturnal gastroesophageal reflux disease (GERD). Currently, there are five published studies assessing MedCline™ for nocturnal reflux.

“With so many patients still having nighttime reflux even on daily PPIs and growing concerns of long-term side effects of these medications, it’s a perfect time to bring an effective, nonpharmacological treatment to market like MedCline,™” noted Aaron Clark, COO and co-inventor, at Amenity Health.

MedCline

“We are happy to be offering both patients and physicians a much-needed treatment alternative for nocturnal GERD and are grateful to our research partners for their studies showing that MedCline™ is far more effective at treating nocturnal GERD than bed wedges or propping up the head of the bed,” Mr. Clark said. “We now hope to garner the support of the professional societies and payers to help make MedCline™ more accessible to patients who are in desperate need of nighttime relief.”

All of the sharks agreed that the team at Amenity Health should focus on marketing this device to patients, rather than physicians. Expressing some skepticism about the prospects for third-party reimbursement, all agreed that a direct-to-consumer marketing strategy is needed even if the company can generate more data showing value, such as decreased use of pharmacologic therapy. When told by Mr. Clark that the plan was to market to both physicians and patients, Dr. Pasricha cautioned, “I would require a higher level of evidence [than what was so far presented] before I would recommend it to patients.”

BioInnovate Ireland – Microwave ablation of varices

According to Jonathan Bouchier-Hayes, BSc, MBA, at BioInnovate, current strategies for the treatment of gastroesophageal varices have several limitations. Endoscopic banding, in particular, which is commonly used, requires two to four treatments over several weeks and is associated with a high risk of recurrence. BioInnovate proposes a microwave energy solution integrated into a standard endoscope. By inducing coagulation, the aim of microwave energy is to treat gastroesophageal varices in a single procedure. The advantage of microwave therapy is that it appears to preserve the mucosal layer, reducing the risk of complications associated with endoscopic banding and providing a reduced risk of recurrence. In the experimental studies conducted so far, the fibrosis produced by microwave energy also proved to be a barrier for recurrence. Mr. Bouchier-Hayes believes that the reduction in rebleeding and recurrence will make this approach cost effective. Clinical trials have not yet been initiated.

Several sharks implied that the disadvantages of endoscopic banding, which is widely performed and associated with a relatively low rate of complications, might be less of a concern than was in Mr. Bouchier-Hayes’ analysis of the unmet need, but they were intrigued with this concept if clinical development includes studies that show a cost advantage over current options. To invest, Dr. Shehab reported that he would require a detailed understanding of the specific clinical trials that were planned from which a “go or no-go” decision would be made for further development. Others agreed that it is not just efficacy but economic viability that will be important as development proceeds.

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™

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.

“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.

Dark Canyon Labs – DCL-101 colonoscopy preparation

In an effort to make the colonoscopy preparation process more tolerable, Dark Canyon Labs has developed a novel preparation designed to avoid the bad taste of current options while preserving efficacy. Currently, bowel preps combine polyethylene glycol (PEG) solutions with salts to achieve the cathartic effect. The PEG is tasteless but the salts are not. The concept of the novel prep is to administer the PEG in the usual liquid form but deliver the salts by capsule, avoiding the bad taste. Once the PEG and capsules reach the stomach, they mix and reform the same concentration of a standard prep.

The product as currently formulated reproduces the electrolyte composition of GoLYTELY®. Rather than 4 liters of the typical preps, the patient takes 2 liters of solution along with 48 capsules, according to Dr. Dale Bachwich, cofounder and chief medical officer of Dark Canyon Laboratories and a practicing gastroenterologist.

“A better colonoscopy prep benefits everyone – patients, physicians, endoscopy centers, payers, and society,” said Dr. Bachwich, who presented several sets of data demonstrating that patients far preferred the tasteless prep despite the 48-capsule requirement. Like standard bowel preps, the new formulation can be taken in single or split doses.

The sharks, who were given a taste test in which they compared the liquid portion of the new bowel prep to a conventional prep, agreed that the new prep was relatively tasteless and could provide a large advantage over current formulations despite the large pill burden. However, there was unanimous agreement that the purported advantages, including greater compliance and fewer canceled colonoscopies due to inadequate prep, need to be demonstrated in a well-controlled trial, particularly if the novel bowel preparation has a higher price. Mr. Pierce said that there is a potential value proposition for the advantages Dr. Bachwich outlined, but objective supportive evidence is needed.

BOSTON – Several innovators had the opportunity to present their novel technologies to a five-person “shark tank” panel – two entrepreneurs, a practicing physician, a venture capitalist, and a businessman – at the 2016 AGA Tech Summit.

After the innovators explained why they expected their products to fill an unmet need, the “sharks” probed for weaknesses and offered advice on what data were needed to confirm a viable advantage over existing options.

“These presentations offer a glimpse into what innovators are working on to improve the practice of gastroenterology,” said Michael L. Kochman, M.D., AGAF, one of the “sharks,” who is chair of the AGA Center for GI Innovation and Technology, which sponsored the summit.

“This ‘shark tank’ is a perfect illustration of what the AGA Center for GI Innovation and Technology is all about – we’re here to help move the field forward and discuss what’s next for the care of patients with digestive disorders.”

In addition to Dr. Kochman, the panel comprised Jay Pasricha, M.D., professor of medicine at Johns Hopkins University, who has been involved in several start-ups; Thomas Shehab, MD, a trained gastroenterologist who is now a principal at Arboretum Ventures; Mr. Brian Tinkham, a founder of Beacon Endoscopic and now vice president, New Technologies, GI Solutions, at Medtronic; and Mr. David Pierce, senior vice president at Boston Scientific.

Amenity Health – MedCline™

Amenity Health developed MedCline™ based on the work of Dr. Carl Melcher, as a positional therapy for nocturnal acid reflux in patients with GERD refractory to pharmacologic treatment. As a component of the GERD treatment plan, MedCline™ is a sleeping device designed to raise the torso and facilitate left-side positioning, both of which have been shown to reduce the risk of nocturnal gastroesophageal reflux disease (GERD). Currently, there are five published studies assessing MedCline™ for nocturnal reflux.

“With so many patients still having nighttime reflux even on daily PPIs and growing concerns of long-term side effects of these medications, it’s a perfect time to bring an effective, nonpharmacological treatment to market like MedCline,™” noted Aaron Clark, COO and co-inventor, at Amenity Health.

MedCline

“We are happy to be offering both patients and physicians a much-needed treatment alternative for nocturnal GERD and are grateful to our research partners for their studies showing that MedCline™ is far more effective at treating nocturnal GERD than bed wedges or propping up the head of the bed,” Mr. Clark said. “We now hope to garner the support of the professional societies and payers to help make MedCline™ more accessible to patients who are in desperate need of nighttime relief.”

All of the sharks agreed that the team at Amenity Health should focus on marketing this device to patients, rather than physicians. Expressing some skepticism about the prospects for third-party reimbursement, all agreed that a direct-to-consumer marketing strategy is needed even if the company can generate more data showing value, such as decreased use of pharmacologic therapy. When told by Mr. Clark that the plan was to market to both physicians and patients, Dr. Pasricha cautioned, “I would require a higher level of evidence [than what was so far presented] before I would recommend it to patients.”

BioInnovate Ireland – Microwave ablation of varices

According to Jonathan Bouchier-Hayes, BSc, MBA, at BioInnovate, current strategies for the treatment of gastroesophageal varices have several limitations. Endoscopic banding, in particular, which is commonly used, requires two to four treatments over several weeks and is associated with a high risk of recurrence. BioInnovate proposes a microwave energy solution integrated into a standard endoscope. By inducing coagulation, the aim of microwave energy is to treat gastroesophageal varices in a single procedure. The advantage of microwave therapy is that it appears to preserve the mucosal layer, reducing the risk of complications associated with endoscopic banding and providing a reduced risk of recurrence. In the experimental studies conducted so far, the fibrosis produced by microwave energy also proved to be a barrier for recurrence. Mr. Bouchier-Hayes believes that the reduction in rebleeding and recurrence will make this approach cost effective. Clinical trials have not yet been initiated.

Several sharks implied that the disadvantages of endoscopic banding, which is widely performed and associated with a relatively low rate of complications, might be less of a concern than was in Mr. Bouchier-Hayes’ analysis of the unmet need, but they were intrigued with this concept if clinical development includes studies that show a cost advantage over current options. To invest, Dr. Shehab reported that he would require a detailed understanding of the specific clinical trials that were planned from which a “go or no-go” decision would be made for further development. Others agreed that it is not just efficacy but economic viability that will be important as development proceeds.

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™

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.

“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.

Dark Canyon Labs – DCL-101 colonoscopy preparation

In an effort to make the colonoscopy preparation process more tolerable, Dark Canyon Labs has developed a novel preparation designed to avoid the bad taste of current options while preserving efficacy. Currently, bowel preps combine polyethylene glycol (PEG) solutions with salts to achieve the cathartic effect. The PEG is tasteless but the salts are not. The concept of the novel prep is to administer the PEG in the usual liquid form but deliver the salts by capsule, avoiding the bad taste. Once the PEG and capsules reach the stomach, they mix and reform the same concentration of a standard prep.

The product as currently formulated reproduces the electrolyte composition of GoLYTELY®. Rather than 4 liters of the typical preps, the patient takes 2 liters of solution along with 48 capsules, according to Dr. Dale Bachwich, cofounder and chief medical officer of Dark Canyon Laboratories and a practicing gastroenterologist.

“A better colonoscopy prep benefits everyone – patients, physicians, endoscopy centers, payers, and society,” said Dr. Bachwich, who presented several sets of data demonstrating that patients far preferred the tasteless prep despite the 48-capsule requirement. Like standard bowel preps, the new formulation can be taken in single or split doses.

The sharks, who were given a taste test in which they compared the liquid portion of the new bowel prep to a conventional prep, agreed that the new prep was relatively tasteless and could provide a large advantage over current formulations despite the large pill burden. However, there was unanimous agreement that the purported advantages, including greater compliance and fewer canceled colonoscopies due to inadequate prep, need to be demonstrated in a well-controlled trial, particularly if the novel bowel preparation has a higher price. Mr. Pierce said that there is a potential value proposition for the advantages Dr. Bachwich outlined, but objective supportive evidence is needed.

BOSTON – Several innovators had the opportunity to present their novel technologies to a five-person “shark tank” panel – two entrepreneurs, a practicing physician, a venture capitalist, and a businessman – at the 2016 AGA Tech Summit.

After the innovators explained why they expected their products to fill an unmet need, the “sharks” probed for weaknesses and offered advice on what data were needed to confirm a viable advantage over existing options.

“These presentations offer a glimpse into what innovators are working on to improve the practice of gastroenterology,” said Michael L. Kochman, M.D., AGAF, one of the “sharks,” who is chair of the AGA Center for GI Innovation and Technology, which sponsored the summit.

“This ‘shark tank’ is a perfect illustration of what the AGA Center for GI Innovation and Technology is all about – we’re here to help move the field forward and discuss what’s next for the care of patients with digestive disorders.”

In addition to Dr. Kochman, the panel comprised Jay Pasricha, M.D., professor of medicine at Johns Hopkins University, who has been involved in several start-ups; Thomas Shehab, MD, a trained gastroenterologist who is now a principal at Arboretum Ventures; Mr. Brian Tinkham, a founder of Beacon Endoscopic and now vice president, New Technologies, GI Solutions, at Medtronic; and Mr. David Pierce, senior vice president at Boston Scientific.

Amenity Health – MedCline™

Amenity Health developed MedCline™ based on the work of Dr. Carl Melcher, as a positional therapy for nocturnal acid reflux in patients with GERD refractory to pharmacologic treatment. As a component of the GERD treatment plan, MedCline™ is a sleeping device designed to raise the torso and facilitate left-side positioning, both of which have been shown to reduce the risk of nocturnal gastroesophageal reflux disease (GERD). Currently, there are five published studies assessing MedCline™ for nocturnal reflux.

“With so many patients still having nighttime reflux even on daily PPIs and growing concerns of long-term side effects of these medications, it’s a perfect time to bring an effective, nonpharmacological treatment to market like MedCline,™” noted Aaron Clark, COO and co-inventor, at Amenity Health.

MedCline

“We are happy to be offering both patients and physicians a much-needed treatment alternative for nocturnal GERD and are grateful to our research partners for their studies showing that MedCline™ is far more effective at treating nocturnal GERD than bed wedges or propping up the head of the bed,” Mr. Clark said. “We now hope to garner the support of the professional societies and payers to help make MedCline™ more accessible to patients who are in desperate need of nighttime relief.”

All of the sharks agreed that the team at Amenity Health should focus on marketing this device to patients, rather than physicians. Expressing some skepticism about the prospects for third-party reimbursement, all agreed that a direct-to-consumer marketing strategy is needed even if the company can generate more data showing value, such as decreased use of pharmacologic therapy. When told by Mr. Clark that the plan was to market to both physicians and patients, Dr. Pasricha cautioned, “I would require a higher level of evidence [than what was so far presented] before I would recommend it to patients.”

BioInnovate Ireland – Microwave ablation of varices

According to Jonathan Bouchier-Hayes, BSc, MBA, at BioInnovate, current strategies for the treatment of gastroesophageal varices have several limitations. Endoscopic banding, in particular, which is commonly used, requires two to four treatments over several weeks and is associated with a high risk of recurrence. BioInnovate proposes a microwave energy solution integrated into a standard endoscope. By inducing coagulation, the aim of microwave energy is to treat gastroesophageal varices in a single procedure. The advantage of microwave therapy is that it appears to preserve the mucosal layer, reducing the risk of complications associated with endoscopic banding and providing a reduced risk of recurrence. In the experimental studies conducted so far, the fibrosis produced by microwave energy also proved to be a barrier for recurrence. Mr. Bouchier-Hayes believes that the reduction in rebleeding and recurrence will make this approach cost effective. Clinical trials have not yet been initiated.

Several sharks implied that the disadvantages of endoscopic banding, which is widely performed and associated with a relatively low rate of complications, might be less of a concern than was in Mr. Bouchier-Hayes’ analysis of the unmet need, but they were intrigued with this concept if clinical development includes studies that show a cost advantage over current options. To invest, Dr. Shehab reported that he would require a detailed understanding of the specific clinical trials that were planned from which a “go or no-go” decision would be made for further development. Others agreed that it is not just efficacy but economic viability that will be important as development proceeds.

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™

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.

“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.

Dark Canyon Labs – DCL-101 colonoscopy preparation

In an effort to make the colonoscopy preparation process more tolerable, Dark Canyon Labs has developed a novel preparation designed to avoid the bad taste of current options while preserving efficacy. Currently, bowel preps combine polyethylene glycol (PEG) solutions with salts to achieve the cathartic effect. The PEG is tasteless but the salts are not. The concept of the novel prep is to administer the PEG in the usual liquid form but deliver the salts by capsule, avoiding the bad taste. Once the PEG and capsules reach the stomach, they mix and reform the same concentration of a standard prep.

The product as currently formulated reproduces the electrolyte composition of GoLYTELY®. Rather than 4 liters of the typical preps, the patient takes 2 liters of solution along with 48 capsules, according to Dr. Dale Bachwich, cofounder and chief medical officer of Dark Canyon Laboratories and a practicing gastroenterologist.

“A better colonoscopy prep benefits everyone – patients, physicians, endoscopy centers, payers, and society,” said Dr. Bachwich, who presented several sets of data demonstrating that patients far preferred the tasteless prep despite the 48-capsule requirement. Like standard bowel preps, the new formulation can be taken in single or split doses.

The sharks, who were given a taste test in which they compared the liquid portion of the new bowel prep to a conventional prep, agreed that the new prep was relatively tasteless and could provide a large advantage over current formulations despite the large pill burden. However, there was unanimous agreement that the purported advantages, including greater compliance and fewer canceled colonoscopies due to inadequate prep, need to be demonstrated in a well-controlled trial, particularly if the novel bowel preparation has a higher price. Mr. Pierce said that there is a potential value proposition for the advantages Dr. Bachwich outlined, but objective supportive evidence is needed.