Tech Summit

BOSTON – At the 2016 AGA Tech Summit, which was sponsored by the AGA Center for GI Innovation and Technology, there was a special session on “How to Innovate in Digestive Health.” Here are some of the highlights of the discussion.

1. The changing reimbursement climate is affecting innovation, too.
According to Harry Glorikian, currently an entrepreneur-in-residence to GE Ventures, Menlo Park, Calif., the clock is ticking for the “one-size-fits-all” therapeutics approach, where accuracy and precision are low to moderate, and cost and comparative effectiveness evidence may be lacking. Tomorrow’s approach, he said, will push for increased accuracy and precision, targeting diagnostics, monitoring, and therapies to appropriate subpopulations. Increased attention to cost and comparative effectiveness will be more and more important as well.

2. Medicare is agnostic to most medical technologies.
What does this mean? According to Dr. Louis Jacques, chief clinical officer and senior vice president at the health care consulting firm ADVI, Washington, CMS will generally reimburse for a medical device if there is “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population.” This means that the presumption lies in favor of reimbursement.

3. Not only is the bar higher, but the rules of engagement are changing in medical device innovation.
According to Dr. Tom Shehab, a gastroenterologist who now is a principal at Arboretum Ventures, Ann Arbor, Mich., medical device commercialization needs to take into account the needs of all stakeholders, ranging from the FDA to CMS, to private insurers, to the physicians and patients who will be the end-users of the innovations.

However, that’s not all, said Dr. Shehab. A place at the table must be held for the health care executives who manage facilities, oversee payer groups, and administer managed care plans. To bring the device to market, innovators must also take funders’ needs and preferences into account. These may range from venture capital and private equity firms to strategic acquirers, to federal sources such as the NIH.

4. A device doesn’t need to be disruptive to be great.
As a matter of fact, said Mr. Glorikian, sometimes incremental change is a good thing – finding a new clamp or a new screw may make a tricky procedure easier, and larger medical device manufacturers are sometimes happy to acquire the rights to a clever solution to a vexing problem.

5. A truly disruptive device may be harder to get off the ground.
Dr. Christopher Macomber, a chief surgical resident at the University of Massachusetts Medical School, Boston, and a serial entrepreneur, told the story of an innovative medical device to treat systemic lupus erythematosus. Though early trials showed extremely promising results, Dr. Macomber is still searching for the backers and the buyout to bring this product to market. “It’s such a paradigm shift that it’s been a tough sell,” he said.

6. You don’t need to leave your practice to become an innovator.
Even those in academic medicine can find room to innovate, though the environment comes with challenges, said Dr. Christopher Thompson, professor of medicine at Harvard Medical School, Boston. These can include competing time demands and a less-flexible and sometimes bureaucratic administration.

On the other hand, having the support of a legal department experienced in intellectual property protection can bolster an inexperienced innovator, and there’s often the opportunity for significant intellectual cross-pollination, said Dr. Thompson.

7. Some physicians do find success and gratification outside the practice of medicine.
Dr. Steven Drury, global medical director of surgical innovations, Medtronic, Boston, said that his greatest challenge was making the decision to leave his pathology practice to join industry. However, he said that he finds great satisfaction in the challenges of his work now, and he feels that he now serves a much wider population of patients – all those who benefit from the devices he helps bring to market.

8. If you have a good idea, protect it early.
Seema Basu, Ph.D., director of licensing and strategic collaborations at Partners Healthcare, Boston, said early protection of intellectual property is key. Her institution, she said, affords early collaboration with innovators to help them protect good ideas and explore commercial potential. “Have confidentiality agreements in place before detailed discussions with third parties,” said Dr. Basu.

BOSTON – At the 2016 AGA Tech Summit, which was sponsored by the AGA Center for GI Innovation and Technology, there was a special session on “How to Innovate in Digestive Health.” Here are some of the highlights of the discussion.

1. The changing reimbursement climate is affecting innovation, too.
According to Harry Glorikian, currently an entrepreneur-in-residence to GE Ventures, Menlo Park, Calif., the clock is ticking for the “one-size-fits-all” therapeutics approach, where accuracy and precision are low to moderate, and cost and comparative effectiveness evidence may be lacking. Tomorrow’s approach, he said, will push for increased accuracy and precision, targeting diagnostics, monitoring, and therapies to appropriate subpopulations. Increased attention to cost and comparative effectiveness will be more and more important as well.

2. Medicare is agnostic to most medical technologies.
What does this mean? According to Dr. Louis Jacques, chief clinical officer and senior vice president at the health care consulting firm ADVI, Washington, CMS will generally reimburse for a medical device if there is “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population.” This means that the presumption lies in favor of reimbursement.

3. Not only is the bar higher, but the rules of engagement are changing in medical device innovation.
According to Dr. Tom Shehab, a gastroenterologist who now is a principal at Arboretum Ventures, Ann Arbor, Mich., medical device commercialization needs to take into account the needs of all stakeholders, ranging from the FDA to CMS, to private insurers, to the physicians and patients who will be the end-users of the innovations.

However, that’s not all, said Dr. Shehab. A place at the table must be held for the health care executives who manage facilities, oversee payer groups, and administer managed care plans. To bring the device to market, innovators must also take funders’ needs and preferences into account. These may range from venture capital and private equity firms to strategic acquirers, to federal sources such as the NIH.

4. A device doesn’t need to be disruptive to be great.
As a matter of fact, said Mr. Glorikian, sometimes incremental change is a good thing – finding a new clamp or a new screw may make a tricky procedure easier, and larger medical device manufacturers are sometimes happy to acquire the rights to a clever solution to a vexing problem.

5. A truly disruptive device may be harder to get off the ground.
Dr. Christopher Macomber, a chief surgical resident at the University of Massachusetts Medical School, Boston, and a serial entrepreneur, told the story of an innovative medical device to treat systemic lupus erythematosus. Though early trials showed extremely promising results, Dr. Macomber is still searching for the backers and the buyout to bring this product to market. “It’s such a paradigm shift that it’s been a tough sell,” he said.

6. You don’t need to leave your practice to become an innovator.
Even those in academic medicine can find room to innovate, though the environment comes with challenges, said Dr. Christopher Thompson, professor of medicine at Harvard Medical School, Boston. These can include competing time demands and a less-flexible and sometimes bureaucratic administration.

On the other hand, having the support of a legal department experienced in intellectual property protection can bolster an inexperienced innovator, and there’s often the opportunity for significant intellectual cross-pollination, said Dr. Thompson.

7. Some physicians do find success and gratification outside the practice of medicine.
Dr. Steven Drury, global medical director of surgical innovations, Medtronic, Boston, said that his greatest challenge was making the decision to leave his pathology practice to join industry. However, he said that he finds great satisfaction in the challenges of his work now, and he feels that he now serves a much wider population of patients – all those who benefit from the devices he helps bring to market.

8. If you have a good idea, protect it early.
Seema Basu, Ph.D., director of licensing and strategic collaborations at Partners Healthcare, Boston, said early protection of intellectual property is key. Her institution, she said, affords early collaboration with innovators to help them protect good ideas and explore commercial potential. “Have confidentiality agreements in place before detailed discussions with third parties,” said Dr. Basu.

BOSTON – At the 2016 AGA Tech Summit, which was sponsored by the AGA Center for GI Innovation and Technology, there was a special session on “How to Innovate in Digestive Health.” Here are some of the highlights of the discussion.

1. The changing reimbursement climate is affecting innovation, too.
According to Harry Glorikian, currently an entrepreneur-in-residence to GE Ventures, Menlo Park, Calif., the clock is ticking for the “one-size-fits-all” therapeutics approach, where accuracy and precision are low to moderate, and cost and comparative effectiveness evidence may be lacking. Tomorrow’s approach, he said, will push for increased accuracy and precision, targeting diagnostics, monitoring, and therapies to appropriate subpopulations. Increased attention to cost and comparative effectiveness will be more and more important as well.

2. Medicare is agnostic to most medical technologies.
What does this mean? According to Dr. Louis Jacques, chief clinical officer and senior vice president at the health care consulting firm ADVI, Washington, CMS will generally reimburse for a medical device if there is “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population.” This means that the presumption lies in favor of reimbursement.

3. Not only is the bar higher, but the rules of engagement are changing in medical device innovation.
According to Dr. Tom Shehab, a gastroenterologist who now is a principal at Arboretum Ventures, Ann Arbor, Mich., medical device commercialization needs to take into account the needs of all stakeholders, ranging from the FDA to CMS, to private insurers, to the physicians and patients who will be the end-users of the innovations.

However, that’s not all, said Dr. Shehab. A place at the table must be held for the health care executives who manage facilities, oversee payer groups, and administer managed care plans. To bring the device to market, innovators must also take funders’ needs and preferences into account. These may range from venture capital and private equity firms to strategic acquirers, to federal sources such as the NIH.

4. A device doesn’t need to be disruptive to be great.
As a matter of fact, said Mr. Glorikian, sometimes incremental change is a good thing – finding a new clamp or a new screw may make a tricky procedure easier, and larger medical device manufacturers are sometimes happy to acquire the rights to a clever solution to a vexing problem.

5. A truly disruptive device may be harder to get off the ground.
Dr. Christopher Macomber, a chief surgical resident at the University of Massachusetts Medical School, Boston, and a serial entrepreneur, told the story of an innovative medical device to treat systemic lupus erythematosus. Though early trials showed extremely promising results, Dr. Macomber is still searching for the backers and the buyout to bring this product to market. “It’s such a paradigm shift that it’s been a tough sell,” he said.

6. You don’t need to leave your practice to become an innovator.
Even those in academic medicine can find room to innovate, though the environment comes with challenges, said Dr. Christopher Thompson, professor of medicine at Harvard Medical School, Boston. These can include competing time demands and a less-flexible and sometimes bureaucratic administration.

On the other hand, having the support of a legal department experienced in intellectual property protection can bolster an inexperienced innovator, and there’s often the opportunity for significant intellectual cross-pollination, said Dr. Thompson.

7. Some physicians do find success and gratification outside the practice of medicine.
Dr. Steven Drury, global medical director of surgical innovations, Medtronic, Boston, said that his greatest challenge was making the decision to leave his pathology practice to join industry. However, he said that he finds great satisfaction in the challenges of his work now, and he feels that he now serves a much wider population of patients – all those who benefit from the devices he helps bring to market.

8. If you have a good idea, protect it early.
Seema Basu, Ph.D., director of licensing and strategic collaborations at Partners Healthcare, Boston, said early protection of intellectual property is key. Her institution, she said, affords early collaboration with innovators to help them protect good ideas and explore commercial potential. “Have confidentiality agreements in place before detailed discussions with third parties,” said Dr. Basu.

BOSTON – Many of the disorders that gastroenterologists treat do not have very effective treatments, so there is lots of room for innovation, according to Dr. Sidhartha R. Sinha of Stanford (Calif.) University.

Gastroenterologists should get involved in innovation early because there is much to learn, he advised in a video interview at the 2016 AGA Tech Summit. It can be a tough business, but if one focuses on the clinical need and considers the number of patients who could benefit from such advances, then innovation can be a rewarding path to pursue, Dr. Sinha noted.

The AGA Tech Summit is sponsored by the AGA Center for GI Innovation and Technology.

BOSTON – Many of the disorders that gastroenterologists treat do not have very effective treatments, so there is lots of room for innovation, according to Dr. Sidhartha R. Sinha of Stanford (Calif.) University.

Gastroenterologists should get involved in innovation early because there is much to learn, he advised in a video interview at the 2016 AGA Tech Summit. It can be a tough business, but if one focuses on the clinical need and considers the number of patients who could benefit from such advances, then innovation can be a rewarding path to pursue, Dr. Sinha noted.

The AGA Tech Summit is sponsored by the AGA Center for GI Innovation and Technology.

BOSTON – Many of the disorders that gastroenterologists treat do not have very effective treatments, so there is lots of room for innovation, according to Dr. Sidhartha R. Sinha of Stanford (Calif.) University.

Gastroenterologists should get involved in innovation early because there is much to learn, he advised in a video interview at the 2016 AGA Tech Summit. It can be a tough business, but if one focuses on the clinical need and considers the number of patients who could benefit from such advances, then innovation can be a rewarding path to pursue, Dr. Sinha noted.

The AGA Tech Summit is sponsored by the AGA Center for GI Innovation and Technology.

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.

BOSTON – More than half a century after the first successful kidney transplant, various new strategies are being pursued to intervene when major organs, such as the heart or kidney, are failing, according to experts at the 2016 AGA Tech Summit, which was sponsored by the AGA Center for GI Innovation and Technology.

Strategies include regenerating tissue and employing artificial devices to perform the function of the failing organ. For tissue regeneration, some of the most promising work is being done in the treatment of the decompensated liver. The unmet need is enormous.

Most patients are not candidates for liver transplant, and those with severe disease have a 30%-50% risk of dying within 90 days of diagnosis, explained Dr. Bill Frank, vice president of medical sciences at Vital Therapies in San Diego. Given the limitations of liver transplantation, he and fellow researchers at Vital Therapies designed an extracorporeal system that continuously delivers a proprietary line of human C3A liver cells. This immortal cell line expresses a number of proteins relevant to liver function, including cytochrome P450 isoenzymes, coagulation factors, growth factors, anti-inflammatory proteins, and anti-apoptotic factors.

The system, called ELAD®, has already been evaluated in a phase III trial conducted in patients with alcohol-induced liver decompensation (AILD). In the study, 203 patients were randomized to ELAD® or usual care. Although those randomized to ELAD® did not have a significantly improved survival at the end of 3 months compared with controls, which was the primary study endpoint, there was a trend toward a survival in benefit in the prespecified subgroups of younger patients (median age 46.9 years) and patients with lower MELD scores (less than 28). In these, the risk of death was reduced by more than 40% (P = .77) and more than 35% (P = .167), respectively.

The outcomes in these subgroups were sufficient for the Food and Drug Administration to permit further clinical trials, and Dr. Frank suggested that this approach remains promising.

“ELAD® treatment has the potential to modulate or reduce the inflammatory response and apoptosis and promote hepatic regeneration,” reported Dr. Frank, noting that it might be used for the treatment of a variety of types of liver decompensation, not just AILD. This includes small-for-size liver, liver damage due to hepatitis C virus (HCV) infection, and even septic liver disease.

A new phase III trial in patients with AILD is anticipated in the first half of 2016, and top-line data are expected by mid-2018, he added. Bringing those interested in GI technology up to speed on a key problem in solid organ transplantation, John J. Sninsky, Ph.D., chief scientific officer at CareDX, Inc. in Brisbane, Calif., reported progress in minimizing key factors involved in graft rejection. This continues to be one of the biggest hurdles in ensuring long-term survival.

“Suboptimal immunosuppressive dosing and the threat of allograft rejection must be balanced with excessive dosing and increased risks of infections and cancer,” Dr. Sninsky said. He described an array of approaches to reduce protein expression or other signals from donor grafts that prompt an immunologic response, but he focused on current initiatives to identify signals of rejection before they produce adverse clinical consequences so immunosuppressive therapy can be adjusted in time.

Of these strategies, cell-free DNA (cfDNA) is intriguing because it is released from dying cells in both the allograft and recipient, and next-generation sequencing can distinguish their respective genomes, Dr. Sninsky said. In a recent longitudinal study of heart and kidney transplant recipients, levels of donor cfDNA rose significantly before biopsy-confirmed transplant rejection. Moreover, donor cfDNA levels dropped after adjustment of immunosuppressive therapy.

“The cfDNA compartment also harbors information about specific infectious diseases and somatic mutations associated with cancer development,” Dr. Sninsky said. Such technology could one day help fulfill a “significant unmet need” for tools to help monitor how patients are responding to transplant, he added.

In the acutely failing kidney, transplantation may not be feasible, but an alternative strategy involving a bioartificial kidney is showing promise in clinical trials, according to Dr. H. David Humes, professor of nephrology, University of Michigan, Ann Arbor. He predicted that such a device might be commercially available sometime in 2017.

Describing the bioartificial kidney as a “renal tubule assist device,” Dr. Humes, who was instrumental in its development, said that living cells are employed to perform their normal filtration activities but also to regulate immune function. Dr. Humes said this extracorporeal device can “buy time” when patients are recovering from an acute insult. In particular, this device is promising for those with renal failure in the intensive care unit, where the mortality associated with this complication is approximately 50%.

Although the current work is focused on acute renal injury, Dr. Humes acknowledged that the ongoing work might eventually lead to an implantable device employing the same principles for patients in end-stage renal disease. This development, however, may be years away.

BOSTON – More than half a century after the first successful kidney transplant, various new strategies are being pursued to intervene when major organs, such as the heart or kidney, are failing, according to experts at the 2016 AGA Tech Summit, which was sponsored by the AGA Center for GI Innovation and Technology.

Strategies include regenerating tissue and employing artificial devices to perform the function of the failing organ. For tissue regeneration, some of the most promising work is being done in the treatment of the decompensated liver. The unmet need is enormous.

Most patients are not candidates for liver transplant, and those with severe disease have a 30%-50% risk of dying within 90 days of diagnosis, explained Dr. Bill Frank, vice president of medical sciences at Vital Therapies in San Diego. Given the limitations of liver transplantation, he and fellow researchers at Vital Therapies designed an extracorporeal system that continuously delivers a proprietary line of human C3A liver cells. This immortal cell line expresses a number of proteins relevant to liver function, including cytochrome P450 isoenzymes, coagulation factors, growth factors, anti-inflammatory proteins, and anti-apoptotic factors.

The system, called ELAD®, has already been evaluated in a phase III trial conducted in patients with alcohol-induced liver decompensation (AILD). In the study, 203 patients were randomized to ELAD® or usual care. Although those randomized to ELAD® did not have a significantly improved survival at the end of 3 months compared with controls, which was the primary study endpoint, there was a trend toward a survival in benefit in the prespecified subgroups of younger patients (median age 46.9 years) and patients with lower MELD scores (less than 28). In these, the risk of death was reduced by more than 40% (P = .77) and more than 35% (P = .167), respectively.

The outcomes in these subgroups were sufficient for the Food and Drug Administration to permit further clinical trials, and Dr. Frank suggested that this approach remains promising.

“ELAD® treatment has the potential to modulate or reduce the inflammatory response and apoptosis and promote hepatic regeneration,” reported Dr. Frank, noting that it might be used for the treatment of a variety of types of liver decompensation, not just AILD. This includes small-for-size liver, liver damage due to hepatitis C virus (HCV) infection, and even septic liver disease.

A new phase III trial in patients with AILD is anticipated in the first half of 2016, and top-line data are expected by mid-2018, he added. Bringing those interested in GI technology up to speed on a key problem in solid organ transplantation, John J. Sninsky, Ph.D., chief scientific officer at CareDX, Inc. in Brisbane, Calif., reported progress in minimizing key factors involved in graft rejection. This continues to be one of the biggest hurdles in ensuring long-term survival.

“Suboptimal immunosuppressive dosing and the threat of allograft rejection must be balanced with excessive dosing and increased risks of infections and cancer,” Dr. Sninsky said. He described an array of approaches to reduce protein expression or other signals from donor grafts that prompt an immunologic response, but he focused on current initiatives to identify signals of rejection before they produce adverse clinical consequences so immunosuppressive therapy can be adjusted in time.

Of these strategies, cell-free DNA (cfDNA) is intriguing because it is released from dying cells in both the allograft and recipient, and next-generation sequencing can distinguish their respective genomes, Dr. Sninsky said. In a recent longitudinal study of heart and kidney transplant recipients, levels of donor cfDNA rose significantly before biopsy-confirmed transplant rejection. Moreover, donor cfDNA levels dropped after adjustment of immunosuppressive therapy.

“The cfDNA compartment also harbors information about specific infectious diseases and somatic mutations associated with cancer development,” Dr. Sninsky said. Such technology could one day help fulfill a “significant unmet need” for tools to help monitor how patients are responding to transplant, he added.

In the acutely failing kidney, transplantation may not be feasible, but an alternative strategy involving a bioartificial kidney is showing promise in clinical trials, according to Dr. H. David Humes, professor of nephrology, University of Michigan, Ann Arbor. He predicted that such a device might be commercially available sometime in 2017.

Describing the bioartificial kidney as a “renal tubule assist device,” Dr. Humes, who was instrumental in its development, said that living cells are employed to perform their normal filtration activities but also to regulate immune function. Dr. Humes said this extracorporeal device can “buy time” when patients are recovering from an acute insult. In particular, this device is promising for those with renal failure in the intensive care unit, where the mortality associated with this complication is approximately 50%.

Although the current work is focused on acute renal injury, Dr. Humes acknowledged that the ongoing work might eventually lead to an implantable device employing the same principles for patients in end-stage renal disease. This development, however, may be years away.

BOSTON – More than half a century after the first successful kidney transplant, various new strategies are being pursued to intervene when major organs, such as the heart or kidney, are failing, according to experts at the 2016 AGA Tech Summit, which was sponsored by the AGA Center for GI Innovation and Technology.

Strategies include regenerating tissue and employing artificial devices to perform the function of the failing organ. For tissue regeneration, some of the most promising work is being done in the treatment of the decompensated liver. The unmet need is enormous.

Most patients are not candidates for liver transplant, and those with severe disease have a 30%-50% risk of dying within 90 days of diagnosis, explained Dr. Bill Frank, vice president of medical sciences at Vital Therapies in San Diego. Given the limitations of liver transplantation, he and fellow researchers at Vital Therapies designed an extracorporeal system that continuously delivers a proprietary line of human C3A liver cells. This immortal cell line expresses a number of proteins relevant to liver function, including cytochrome P450 isoenzymes, coagulation factors, growth factors, anti-inflammatory proteins, and anti-apoptotic factors.

The system, called ELAD®, has already been evaluated in a phase III trial conducted in patients with alcohol-induced liver decompensation (AILD). In the study, 203 patients were randomized to ELAD® or usual care. Although those randomized to ELAD® did not have a significantly improved survival at the end of 3 months compared with controls, which was the primary study endpoint, there was a trend toward a survival in benefit in the prespecified subgroups of younger patients (median age 46.9 years) and patients with lower MELD scores (less than 28). In these, the risk of death was reduced by more than 40% (P = .77) and more than 35% (P = .167), respectively.

The outcomes in these subgroups were sufficient for the Food and Drug Administration to permit further clinical trials, and Dr. Frank suggested that this approach remains promising.

“ELAD® treatment has the potential to modulate or reduce the inflammatory response and apoptosis and promote hepatic regeneration,” reported Dr. Frank, noting that it might be used for the treatment of a variety of types of liver decompensation, not just AILD. This includes small-for-size liver, liver damage due to hepatitis C virus (HCV) infection, and even septic liver disease.

A new phase III trial in patients with AILD is anticipated in the first half of 2016, and top-line data are expected by mid-2018, he added. Bringing those interested in GI technology up to speed on a key problem in solid organ transplantation, John J. Sninsky, Ph.D., chief scientific officer at CareDX, Inc. in Brisbane, Calif., reported progress in minimizing key factors involved in graft rejection. This continues to be one of the biggest hurdles in ensuring long-term survival.

“Suboptimal immunosuppressive dosing and the threat of allograft rejection must be balanced with excessive dosing and increased risks of infections and cancer,” Dr. Sninsky said. He described an array of approaches to reduce protein expression or other signals from donor grafts that prompt an immunologic response, but he focused on current initiatives to identify signals of rejection before they produce adverse clinical consequences so immunosuppressive therapy can be adjusted in time.

Of these strategies, cell-free DNA (cfDNA) is intriguing because it is released from dying cells in both the allograft and recipient, and next-generation sequencing can distinguish their respective genomes, Dr. Sninsky said. In a recent longitudinal study of heart and kidney transplant recipients, levels of donor cfDNA rose significantly before biopsy-confirmed transplant rejection. Moreover, donor cfDNA levels dropped after adjustment of immunosuppressive therapy.

“The cfDNA compartment also harbors information about specific infectious diseases and somatic mutations associated with cancer development,” Dr. Sninsky said. Such technology could one day help fulfill a “significant unmet need” for tools to help monitor how patients are responding to transplant, he added.

In the acutely failing kidney, transplantation may not be feasible, but an alternative strategy involving a bioartificial kidney is showing promise in clinical trials, according to Dr. H. David Humes, professor of nephrology, University of Michigan, Ann Arbor. He predicted that such a device might be commercially available sometime in 2017.

Describing the bioartificial kidney as a “renal tubule assist device,” Dr. Humes, who was instrumental in its development, said that living cells are employed to perform their normal filtration activities but also to regulate immune function. Dr. Humes said this extracorporeal device can “buy time” when patients are recovering from an acute insult. In particular, this device is promising for those with renal failure in the intensive care unit, where the mortality associated with this complication is approximately 50%.

Although the current work is focused on acute renal injury, Dr. Humes acknowledged that the ongoing work might eventually lead to an implantable device employing the same principles for patients in end-stage renal disease. This development, however, may be years away.

BOSTON – Dr. Tom Shehab is a gastroenterologist who now works in venture capital. As a principal at the Ann Arbor, Mich., firm Arboretum Ventures, he was able to give his colleagues at the AGA Tech Summit a realistic perspective on what’s needed to show value in GI innovation.

“I look at oncology products, I look at cardiology products, at urology products, at women’s health products. And I would say that we, as a profession in GI, we’re a bit behind” in the ability to present and articulate a convincing value proposition for innovations, said Dr. Shehab, formerly a physician executive.

Courtesy Arboretum Ventures

Though many clinician innovators have new and better ways to solve technology or work-flow problems in the clinic or operating room, Dr. Shehab said that he looks for more. He wants to see thought given to a plan for each stage of the design cycle. “If you have a value proposition that’s just about discovery and ideation, and you can’t talk to me or my partners about the rest of this pathway, you’re dead in the water,” he said.

“Vision without execution is hallucination,” he added, quoting Thomas Edison. “That’s why our funnel gets very narrow very fast.”

When he and his partners evaluate new technology to assess whether they will invest, Dr. Shehab said he makes sure the innovator understands and can fully explain the “Who, What, Why, and How” of the innovation.

Who: Dr. Shehab said that developers need to know not just who the end user is, but who the actual buyer will be. Is it the patient, the payer, the hospital executive, or the physician? Understanding this key point will help frame the kind and amount of information needed to prove value.

Importantly, a business plan has to include the possibility that shifts in the reimbursement language will change the answer to the question. “The buyer in health care is changing all the time,” said Dr. Shehab.

What: Dr. Shehab said that he wants innovators to be able to tell them how their product is different, and how is it clinically superior to available options. What about this product can demonstrate cost savings?

“There was a time that if I showed noninferiority – that I wasn’t worse – and if I showed quality of life was adequate, that was enough to move forward. I think now that the bar has changed,” he said. Innovators now need to show “not just efficacy but effectiveness.”

Why: An entrepreneur with a new medical technology must be able to understand – and explain – why the product is compelling to the end user. Dr. Shehab said he asks, “Why will it displace what is already being used in clinical practice?”

Recommending that entrepreneurs talk to a wide variety of people about their ideas, Dr. Shehab said, “The person you need to listen to the most is the person who told you this is the worst idea ever.” They may see something that the innovator is missing, usually one of three things: “Buyers don’t want it, the payers aren’t going to pay for it, or it doesn’t fit into the clinical flow. “

How: More and more, said Dr. Shehab, he makes sure that he knows how technologies he supports will work in an evolving reimbursement system. “How would this product fit into a dramatically different payment model?” he asks entrepreneurs.

He advised keeping a close eye on the trend toward bundled reimbursement, since even a small incremental expense has to show value to justify purchase by the hospital or health care organization when reimbursement is fixed. “Your reimbursement pathway is not a checkbox any more. It’s the most important item,” he said. “An effective value proposition tells the story of your device, but a great value proposition shows that you have a terrific device that also fits into the ‘real world’ of health care.”

The summit was sponsored by the AGA Center for GI Innovation and Technology. Dr. Shehab disclosed that he is a partner and investor in Arboretum Ventures.

koakes@frontlinemedcom.com

On Twitter @karioakes

BOSTON – Dr. Tom Shehab is a gastroenterologist who now works in venture capital. As a principal at the Ann Arbor, Mich., firm Arboretum Ventures, he was able to give his colleagues at the AGA Tech Summit a realistic perspective on what’s needed to show value in GI innovation.

“I look at oncology products, I look at cardiology products, at urology products, at women’s health products. And I would say that we, as a profession in GI, we’re a bit behind” in the ability to present and articulate a convincing value proposition for innovations, said Dr. Shehab, formerly a physician executive.

Courtesy Arboretum Ventures

Though many clinician innovators have new and better ways to solve technology or work-flow problems in the clinic or operating room, Dr. Shehab said that he looks for more. He wants to see thought given to a plan for each stage of the design cycle. “If you have a value proposition that’s just about discovery and ideation, and you can’t talk to me or my partners about the rest of this pathway, you’re dead in the water,” he said.

“Vision without execution is hallucination,” he added, quoting Thomas Edison. “That’s why our funnel gets very narrow very fast.”

When he and his partners evaluate new technology to assess whether they will invest, Dr. Shehab said he makes sure the innovator understands and can fully explain the “Who, What, Why, and How” of the innovation.

Who: Dr. Shehab said that developers need to know not just who the end user is, but who the actual buyer will be. Is it the patient, the payer, the hospital executive, or the physician? Understanding this key point will help frame the kind and amount of information needed to prove value.

Importantly, a business plan has to include the possibility that shifts in the reimbursement language will change the answer to the question. “The buyer in health care is changing all the time,” said Dr. Shehab.

What: Dr. Shehab said that he wants innovators to be able to tell them how their product is different, and how is it clinically superior to available options. What about this product can demonstrate cost savings?

“There was a time that if I showed noninferiority – that I wasn’t worse – and if I showed quality of life was adequate, that was enough to move forward. I think now that the bar has changed,” he said. Innovators now need to show “not just efficacy but effectiveness.”

Why: An entrepreneur with a new medical technology must be able to understand – and explain – why the product is compelling to the end user. Dr. Shehab said he asks, “Why will it displace what is already being used in clinical practice?”

Recommending that entrepreneurs talk to a wide variety of people about their ideas, Dr. Shehab said, “The person you need to listen to the most is the person who told you this is the worst idea ever.” They may see something that the innovator is missing, usually one of three things: “Buyers don’t want it, the payers aren’t going to pay for it, or it doesn’t fit into the clinical flow. “

How: More and more, said Dr. Shehab, he makes sure that he knows how technologies he supports will work in an evolving reimbursement system. “How would this product fit into a dramatically different payment model?” he asks entrepreneurs.

He advised keeping a close eye on the trend toward bundled reimbursement, since even a small incremental expense has to show value to justify purchase by the hospital or health care organization when reimbursement is fixed. “Your reimbursement pathway is not a checkbox any more. It’s the most important item,” he said. “An effective value proposition tells the story of your device, but a great value proposition shows that you have a terrific device that also fits into the ‘real world’ of health care.”

The summit was sponsored by the AGA Center for GI Innovation and Technology. Dr. Shehab disclosed that he is a partner and investor in Arboretum Ventures.

koakes@frontlinemedcom.com

On Twitter @karioakes

BOSTON – Dr. Tom Shehab is a gastroenterologist who now works in venture capital. As a principal at the Ann Arbor, Mich., firm Arboretum Ventures, he was able to give his colleagues at the AGA Tech Summit a realistic perspective on what’s needed to show value in GI innovation.

“I look at oncology products, I look at cardiology products, at urology products, at women’s health products. And I would say that we, as a profession in GI, we’re a bit behind” in the ability to present and articulate a convincing value proposition for innovations, said Dr. Shehab, formerly a physician executive.

Courtesy Arboretum Ventures

Though many clinician innovators have new and better ways to solve technology or work-flow problems in the clinic or operating room, Dr. Shehab said that he looks for more. He wants to see thought given to a plan for each stage of the design cycle. “If you have a value proposition that’s just about discovery and ideation, and you can’t talk to me or my partners about the rest of this pathway, you’re dead in the water,” he said.

“Vision without execution is hallucination,” he added, quoting Thomas Edison. “That’s why our funnel gets very narrow very fast.”

When he and his partners evaluate new technology to assess whether they will invest, Dr. Shehab said he makes sure the innovator understands and can fully explain the “Who, What, Why, and How” of the innovation.

Who: Dr. Shehab said that developers need to know not just who the end user is, but who the actual buyer will be. Is it the patient, the payer, the hospital executive, or the physician? Understanding this key point will help frame the kind and amount of information needed to prove value.

Importantly, a business plan has to include the possibility that shifts in the reimbursement language will change the answer to the question. “The buyer in health care is changing all the time,” said Dr. Shehab.

What: Dr. Shehab said that he wants innovators to be able to tell them how their product is different, and how is it clinically superior to available options. What about this product can demonstrate cost savings?

“There was a time that if I showed noninferiority – that I wasn’t worse – and if I showed quality of life was adequate, that was enough to move forward. I think now that the bar has changed,” he said. Innovators now need to show “not just efficacy but effectiveness.”

Why: An entrepreneur with a new medical technology must be able to understand – and explain – why the product is compelling to the end user. Dr. Shehab said he asks, “Why will it displace what is already being used in clinical practice?”

Recommending that entrepreneurs talk to a wide variety of people about their ideas, Dr. Shehab said, “The person you need to listen to the most is the person who told you this is the worst idea ever.” They may see something that the innovator is missing, usually one of three things: “Buyers don’t want it, the payers aren’t going to pay for it, or it doesn’t fit into the clinical flow. “

How: More and more, said Dr. Shehab, he makes sure that he knows how technologies he supports will work in an evolving reimbursement system. “How would this product fit into a dramatically different payment model?” he asks entrepreneurs.

He advised keeping a close eye on the trend toward bundled reimbursement, since even a small incremental expense has to show value to justify purchase by the hospital or health care organization when reimbursement is fixed. “Your reimbursement pathway is not a checkbox any more. It’s the most important item,” he said. “An effective value proposition tells the story of your device, but a great value proposition shows that you have a terrific device that also fits into the ‘real world’ of health care.”

The summit was sponsored by the AGA Center for GI Innovation and Technology. Dr. Shehab disclosed that he is a partner and investor in Arboretum Ventures.

koakes@frontlinemedcom.com

On Twitter @karioakes

BOSTON – Personalized medicine is being used the most in oncology for diagnosis and it is showing us, for example, that there is not one type of leukemia but about 40, said Mara Aspinall, keynote speaker and executive chairman of GenePeeks. Gastroenterology is just beginning to use personalized medicine by using metabolites of gut microbiota and patient biomarkers to subtype disease and aid treatment. The nature of this kind of medicine is data driven and requires gastroenterologists to work together to accumulate data to analyze on a large scale, said Ms. Aspinall at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

BOSTON – Personalized medicine is being used the most in oncology for diagnosis and it is showing us, for example, that there is not one type of leukemia but about 40, said Mara Aspinall, keynote speaker and executive chairman of GenePeeks. Gastroenterology is just beginning to use personalized medicine by using metabolites of gut microbiota and patient biomarkers to subtype disease and aid treatment. The nature of this kind of medicine is data driven and requires gastroenterologists to work together to accumulate data to analyze on a large scale, said Ms. Aspinall at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

BOSTON – Personalized medicine is being used the most in oncology for diagnosis and it is showing us, for example, that there is not one type of leukemia but about 40, said Mara Aspinall, keynote speaker and executive chairman of GenePeeks. Gastroenterology is just beginning to use personalized medicine by using metabolites of gut microbiota and patient biomarkers to subtype disease and aid treatment. The nature of this kind of medicine is data driven and requires gastroenterologists to work together to accumulate data to analyze on a large scale, said Ms. Aspinall at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Dr. Thomas Shehab, speaking at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology, said that if he had one tip to offer a company working on a value proposition for their medical device, it would be to put it in the context of this dramatic time of change in health care. It doesn’t matter what the device is. It has to address changing realities in payment. The AGA Center for GI Innovation and Technology is a unique resource for innovators, he said, because it brings together groups that wouldn’t otherwise meet, like CEOs of startups, doctors, government stakeholders, and business interests such as his venture capital firm Arboretum Ventures.

Dr. Thomas Shehab, speaking at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology, said that if he had one tip to offer a company working on a value proposition for their medical device, it would be to put it in the context of this dramatic time of change in health care. It doesn’t matter what the device is. It has to address changing realities in payment. The AGA Center for GI Innovation and Technology is a unique resource for innovators, he said, because it brings together groups that wouldn’t otherwise meet, like CEOs of startups, doctors, government stakeholders, and business interests such as his venture capital firm Arboretum Ventures.

Dr. Thomas Shehab, speaking at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology, said that if he had one tip to offer a company working on a value proposition for their medical device, it would be to put it in the context of this dramatic time of change in health care. It doesn’t matter what the device is. It has to address changing realities in payment. The AGA Center for GI Innovation and Technology is a unique resource for innovators, he said, because it brings together groups that wouldn’t otherwise meet, like CEOs of startups, doctors, government stakeholders, and business interests such as his venture capital firm Arboretum Ventures.

BOSTON – Two award-winning researchers have received funding from the AGA Research Foundation to support their research into less invasive diagnostic techniques for GI patient care. The researchers shared updates on their findings at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Update on AGA-Boston Scientific Career Development Technology & Innovation Award
Guan Xu, Ph.D., of the University of Michigan, Ann Arbor, received the 2015 AGA–Boston Scientific award to support his investigation of an experimental, optically induced ultrasonic imaging technique called photoacoustic imaging, or PAI, in Crohn’s disease.

PAI uses pulsed laser light to penetrate tissues at different depths, allowing researchers to distinguish the absorption spectra indicative of the different chemical compositions seen in inflammatory and fibrous intestinal strictures.

Though a number of experimental modalities are being investigated to characterize intestinal strictures less invasively, tissue biopsy is still considered the only reliable way to determine whether strictures are inflammatory or fibrous. Inflammatory strictures can be treated medically, while collagen-based fibrotic strictures must be removed surgically or treated with endoscopic dilation.

Dr. Xu joined Michigan’s radiology department as a postdoctoral research fellow in 2012 and is now a research investigator there. He previously helped develop a photoacoustic ultrasound imaging system for finger arthritis, designed for use in a clinical setting.

Dr. Xu and colleagues in the radiology, pathology, engineering and internal medicine departments at the University of Michigan are now investigating in animal models whether PAI is as accurate as tissue biopsy in distinguishing the two types of intestinal strictures seen in Crohn’s. They are also designing a capsule PAI device that can be fitted to an endoscope.

The PAI technology builds on and extends the ultrasound technology that is currently the standard of care, explained Dr. Xu, saying “We are standing on the shoulders of giants.”

At the Tech Summit, Dr. Xu presented an update of his research. Preliminary results have revealed significant differences in photoacoustic signal intensity among normal, inflammatory, and fibrotic bowel tissues in rats, and also strong correlations between photoacoustic images and histology in human stricture tissues. A prototype capsule PAI probe has been developed and it will soon be tested on mouse and rabbit models.

In an interview, Dr. Xu expressed “sincere gratitude to the AGA Research Foundation and Boston Scientific for the support of our preliminary study. We will work toward translation of our system to clinics.”

If Dr. Xu and his colleagues’ work is successful, clinicians may one day be able to distinguish between inflammatory and fibrotic intestinal strictures in Crohn’s disease patients without needing to perform endoscopic biopsy. The team’s findings may also prove useful in the preclinical investigation of antifibrotic medical therapies.

Update on AGA-Covidien Research & Development Pilot Award in Technology
Dr. David A. Katzka received the 2015 AGA–Covidien (now Medtronic) award, for his ongoing research into a simple, inexpensive technology as a possible alternative to repeat endoscopy and biopsy to monitor therapeutic response in people with eosinophilic esophagitis (EoE).

EoE is thought to result from exposure to food antigens, leading to inflammation and stricture formation. Current treatment recommendations include topical steroids and elimination diets, both of which are effective. However, response to withdrawal or reintroduction of problem foods often needs to be reassessed with repeat endoscopy and biopsy, which is both costly and time consuming.

Dr. Katzka, head of the Esophageal Interest Group at the Mayo Clinic in Rochester, Minn., has been developing the Cytosponge, an easily swallowed encapsulated mesh that expands in the stomach. Upon retrieval (by means of an attached string), the sponge provides a sample of esophageal mucosa. The technology was originally developed as a screening modality for esophageal cancer and Barrett’s esophagus. Unlike with endoscopy, no sedation is required.

A preliminary feasibility study in 20 patients with EoE who underwent both Cytosponge and endoscopic biopsy found good correlation of eosinophils between the two technologies, and a high sensitivity (84%) in diagnosing EoE. Genetic analysis of patient specimens obtained with Cytosponge showed consistency with previous transcriptome data seen on biopsy specimens. Importantly, patients favored the Cytosponge as faster and easier to tolerate than endoscopy.

Dr. Katzka’s research team is now studying a larger patient group to compare the Cytosponge with endoscopic biopsy as a reliable and independent means of monitoring disease activity and response to therapy. Genomic analysis is also being performed on specimens so that as molecular predictors of response to therapy are further developed and become available, these tests may be also be performed – with the idea of limiting or eliminating the need for endoscopy.

Dr. Katzka reported recruitment of 79 EoE patients in addition to the 20 patients from the pilot study. Thirty-five of these patients had active EoE and 44 were in remission. The accuracy of the Cytosponge in comparison to biopsy remained high, with 81% sensitivity and 79% specificity.

Furthermore, five patients were diagnosed with active disease with the Cytosponge who were not diagnosed by biopsy. The endoscopic abrasion scores were all 0 or 1. The procedure was well tolerated, with near universal preference for undergoing the Cytosponge procedure rather than sedated endoscopy. A trial to use the sponge for monitoring diet therapy is underway, with 35 patients currently being recruited.

The study has also expanded to become multicenter, starting with Dr. Evan Dellon at the University of North Carolina, where 15 patients have undergone the procedure with central processing of pathology at the Mayo Clinic.

Announcement of 2016 AGA-Medtronic Research & Development Pilot Award in Technology
The 2016 AGA-Medtronic award winner is Wa Xian, Ph.D., assistant professor at the University of Texas Health Science Center, Houston. In naming Dr. Xian as the awardee, Dr. Michael L. Kochman said that her work proposes to test the hypothesis that inflammatory bowel disease is caused by genetic defects in the intestines’ epithelial barriers to gut microbes. Dr. Xian will build on her previous work of cloning colonic stem cells to test the genetic defect hypothesis, said Dr. Kochman, professor of medicine at Penn Medicine.

Kari Oakes contributed to this report.

BOSTON – Two award-winning researchers have received funding from the AGA Research Foundation to support their research into less invasive diagnostic techniques for GI patient care. The researchers shared updates on their findings at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Update on AGA-Boston Scientific Career Development Technology & Innovation Award
Guan Xu, Ph.D., of the University of Michigan, Ann Arbor, received the 2015 AGA–Boston Scientific award to support his investigation of an experimental, optically induced ultrasonic imaging technique called photoacoustic imaging, or PAI, in Crohn’s disease.

PAI uses pulsed laser light to penetrate tissues at different depths, allowing researchers to distinguish the absorption spectra indicative of the different chemical compositions seen in inflammatory and fibrous intestinal strictures.

Though a number of experimental modalities are being investigated to characterize intestinal strictures less invasively, tissue biopsy is still considered the only reliable way to determine whether strictures are inflammatory or fibrous. Inflammatory strictures can be treated medically, while collagen-based fibrotic strictures must be removed surgically or treated with endoscopic dilation.

Dr. Xu joined Michigan’s radiology department as a postdoctoral research fellow in 2012 and is now a research investigator there. He previously helped develop a photoacoustic ultrasound imaging system for finger arthritis, designed for use in a clinical setting.

Dr. Xu and colleagues in the radiology, pathology, engineering and internal medicine departments at the University of Michigan are now investigating in animal models whether PAI is as accurate as tissue biopsy in distinguishing the two types of intestinal strictures seen in Crohn’s. They are also designing a capsule PAI device that can be fitted to an endoscope.

The PAI technology builds on and extends the ultrasound technology that is currently the standard of care, explained Dr. Xu, saying “We are standing on the shoulders of giants.”

At the Tech Summit, Dr. Xu presented an update of his research. Preliminary results have revealed significant differences in photoacoustic signal intensity among normal, inflammatory, and fibrotic bowel tissues in rats, and also strong correlations between photoacoustic images and histology in human stricture tissues. A prototype capsule PAI probe has been developed and it will soon be tested on mouse and rabbit models.

In an interview, Dr. Xu expressed “sincere gratitude to the AGA Research Foundation and Boston Scientific for the support of our preliminary study. We will work toward translation of our system to clinics.”

If Dr. Xu and his colleagues’ work is successful, clinicians may one day be able to distinguish between inflammatory and fibrotic intestinal strictures in Crohn’s disease patients without needing to perform endoscopic biopsy. The team’s findings may also prove useful in the preclinical investigation of antifibrotic medical therapies.

Update on AGA-Covidien Research & Development Pilot Award in Technology
Dr. David A. Katzka received the 2015 AGA–Covidien (now Medtronic) award, for his ongoing research into a simple, inexpensive technology as a possible alternative to repeat endoscopy and biopsy to monitor therapeutic response in people with eosinophilic esophagitis (EoE).

EoE is thought to result from exposure to food antigens, leading to inflammation and stricture formation. Current treatment recommendations include topical steroids and elimination diets, both of which are effective. However, response to withdrawal or reintroduction of problem foods often needs to be reassessed with repeat endoscopy and biopsy, which is both costly and time consuming.

Dr. Katzka, head of the Esophageal Interest Group at the Mayo Clinic in Rochester, Minn., has been developing the Cytosponge, an easily swallowed encapsulated mesh that expands in the stomach. Upon retrieval (by means of an attached string), the sponge provides a sample of esophageal mucosa. The technology was originally developed as a screening modality for esophageal cancer and Barrett’s esophagus. Unlike with endoscopy, no sedation is required.

A preliminary feasibility study in 20 patients with EoE who underwent both Cytosponge and endoscopic biopsy found good correlation of eosinophils between the two technologies, and a high sensitivity (84%) in diagnosing EoE. Genetic analysis of patient specimens obtained with Cytosponge showed consistency with previous transcriptome data seen on biopsy specimens. Importantly, patients favored the Cytosponge as faster and easier to tolerate than endoscopy.

Dr. Katzka’s research team is now studying a larger patient group to compare the Cytosponge with endoscopic biopsy as a reliable and independent means of monitoring disease activity and response to therapy. Genomic analysis is also being performed on specimens so that as molecular predictors of response to therapy are further developed and become available, these tests may be also be performed – with the idea of limiting or eliminating the need for endoscopy.

Dr. Katzka reported recruitment of 79 EoE patients in addition to the 20 patients from the pilot study. Thirty-five of these patients had active EoE and 44 were in remission. The accuracy of the Cytosponge in comparison to biopsy remained high, with 81% sensitivity and 79% specificity.

Furthermore, five patients were diagnosed with active disease with the Cytosponge who were not diagnosed by biopsy. The endoscopic abrasion scores were all 0 or 1. The procedure was well tolerated, with near universal preference for undergoing the Cytosponge procedure rather than sedated endoscopy. A trial to use the sponge for monitoring diet therapy is underway, with 35 patients currently being recruited.

The study has also expanded to become multicenter, starting with Dr. Evan Dellon at the University of North Carolina, where 15 patients have undergone the procedure with central processing of pathology at the Mayo Clinic.

Announcement of 2016 AGA-Medtronic Research & Development Pilot Award in Technology
The 2016 AGA-Medtronic award winner is Wa Xian, Ph.D., assistant professor at the University of Texas Health Science Center, Houston. In naming Dr. Xian as the awardee, Dr. Michael L. Kochman said that her work proposes to test the hypothesis that inflammatory bowel disease is caused by genetic defects in the intestines’ epithelial barriers to gut microbes. Dr. Xian will build on her previous work of cloning colonic stem cells to test the genetic defect hypothesis, said Dr. Kochman, professor of medicine at Penn Medicine.

Kari Oakes contributed to this report.

BOSTON – Two award-winning researchers have received funding from the AGA Research Foundation to support their research into less invasive diagnostic techniques for GI patient care. The researchers shared updates on their findings at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Update on AGA-Boston Scientific Career Development Technology & Innovation Award
Guan Xu, Ph.D., of the University of Michigan, Ann Arbor, received the 2015 AGA–Boston Scientific award to support his investigation of an experimental, optically induced ultrasonic imaging technique called photoacoustic imaging, or PAI, in Crohn’s disease.

PAI uses pulsed laser light to penetrate tissues at different depths, allowing researchers to distinguish the absorption spectra indicative of the different chemical compositions seen in inflammatory and fibrous intestinal strictures.

Though a number of experimental modalities are being investigated to characterize intestinal strictures less invasively, tissue biopsy is still considered the only reliable way to determine whether strictures are inflammatory or fibrous. Inflammatory strictures can be treated medically, while collagen-based fibrotic strictures must be removed surgically or treated with endoscopic dilation.

Dr. Xu joined Michigan’s radiology department as a postdoctoral research fellow in 2012 and is now a research investigator there. He previously helped develop a photoacoustic ultrasound imaging system for finger arthritis, designed for use in a clinical setting.

Dr. Xu and colleagues in the radiology, pathology, engineering and internal medicine departments at the University of Michigan are now investigating in animal models whether PAI is as accurate as tissue biopsy in distinguishing the two types of intestinal strictures seen in Crohn’s. They are also designing a capsule PAI device that can be fitted to an endoscope.

The PAI technology builds on and extends the ultrasound technology that is currently the standard of care, explained Dr. Xu, saying “We are standing on the shoulders of giants.”

At the Tech Summit, Dr. Xu presented an update of his research. Preliminary results have revealed significant differences in photoacoustic signal intensity among normal, inflammatory, and fibrotic bowel tissues in rats, and also strong correlations between photoacoustic images and histology in human stricture tissues. A prototype capsule PAI probe has been developed and it will soon be tested on mouse and rabbit models.

In an interview, Dr. Xu expressed “sincere gratitude to the AGA Research Foundation and Boston Scientific for the support of our preliminary study. We will work toward translation of our system to clinics.”

If Dr. Xu and his colleagues’ work is successful, clinicians may one day be able to distinguish between inflammatory and fibrotic intestinal strictures in Crohn’s disease patients without needing to perform endoscopic biopsy. The team’s findings may also prove useful in the preclinical investigation of antifibrotic medical therapies.

Update on AGA-Covidien Research & Development Pilot Award in Technology
Dr. David A. Katzka received the 2015 AGA–Covidien (now Medtronic) award, for his ongoing research into a simple, inexpensive technology as a possible alternative to repeat endoscopy and biopsy to monitor therapeutic response in people with eosinophilic esophagitis (EoE).

EoE is thought to result from exposure to food antigens, leading to inflammation and stricture formation. Current treatment recommendations include topical steroids and elimination diets, both of which are effective. However, response to withdrawal or reintroduction of problem foods often needs to be reassessed with repeat endoscopy and biopsy, which is both costly and time consuming.

Dr. Katzka, head of the Esophageal Interest Group at the Mayo Clinic in Rochester, Minn., has been developing the Cytosponge, an easily swallowed encapsulated mesh that expands in the stomach. Upon retrieval (by means of an attached string), the sponge provides a sample of esophageal mucosa. The technology was originally developed as a screening modality for esophageal cancer and Barrett’s esophagus. Unlike with endoscopy, no sedation is required.

A preliminary feasibility study in 20 patients with EoE who underwent both Cytosponge and endoscopic biopsy found good correlation of eosinophils between the two technologies, and a high sensitivity (84%) in diagnosing EoE. Genetic analysis of patient specimens obtained with Cytosponge showed consistency with previous transcriptome data seen on biopsy specimens. Importantly, patients favored the Cytosponge as faster and easier to tolerate than endoscopy.

Dr. Katzka’s research team is now studying a larger patient group to compare the Cytosponge with endoscopic biopsy as a reliable and independent means of monitoring disease activity and response to therapy. Genomic analysis is also being performed on specimens so that as molecular predictors of response to therapy are further developed and become available, these tests may be also be performed – with the idea of limiting or eliminating the need for endoscopy.

Dr. Katzka reported recruitment of 79 EoE patients in addition to the 20 patients from the pilot study. Thirty-five of these patients had active EoE and 44 were in remission. The accuracy of the Cytosponge in comparison to biopsy remained high, with 81% sensitivity and 79% specificity.

Furthermore, five patients were diagnosed with active disease with the Cytosponge who were not diagnosed by biopsy. The endoscopic abrasion scores were all 0 or 1. The procedure was well tolerated, with near universal preference for undergoing the Cytosponge procedure rather than sedated endoscopy. A trial to use the sponge for monitoring diet therapy is underway, with 35 patients currently being recruited.

The study has also expanded to become multicenter, starting with Dr. Evan Dellon at the University of North Carolina, where 15 patients have undergone the procedure with central processing of pathology at the Mayo Clinic.

Announcement of 2016 AGA-Medtronic Research & Development Pilot Award in Technology
The 2016 AGA-Medtronic award winner is Wa Xian, Ph.D., assistant professor at the University of Texas Health Science Center, Houston. In naming Dr. Xian as the awardee, Dr. Michael L. Kochman said that her work proposes to test the hypothesis that inflammatory bowel disease is caused by genetic defects in the intestines’ epithelial barriers to gut microbes. Dr. Xian will build on her previous work of cloning colonic stem cells to test the genetic defect hypothesis, said Dr. Kochman, professor of medicine at Penn Medicine.

Kari Oakes contributed to this report.

BOSTON – Many developers of innovative medical technologies don’t realize that insurers are going to want to see evidence that a new technology improves health outcomes before they will consider paying for it, according to Dr. Louis Jacques, senior vice president and chief clinical officer for ADVI, a health care advisory services firm in Washington.

The Centers for Medicare & Medicaid Services generally seeks “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population” when determining Medicare coverage, Dr. Jacques said in a presentation at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Medicare is less likely to pay if there is something controversial about the available evidence, he said in an interview. “The controversy is usually about inadequate evidence or lack of applicability to the affected Medicare beneficiary population,” Dr. Jacques said, noting that the typical Medicare patient, a 74-year-old woman with comorbid conditions taking multiple medications, often is not the type of person included in clinical trials that would generate such evidence.

Medicare is looking for “adequate evidence that a treatment strategy using the new therapeutic technology, compared to alternatives, leads to improved clinically meaningful health outcomes in Medicare beneficiaries,” he said.

Similarly, new diagnostic technologies should provide the physician with additional information that can alter treatment recommendations, resulting in therapeutic changes that improve outcomes.

Dr. Jacques noted that over the next several years, the health care system will move away from fee for service and begin more and more to pay for value, with physicians becoming more accountable for outcomes and cost.

He advised those developing a new device or treatment to think about how they would justify a particular treatment approach to their colleagues. They need to ask themselves: “What is the value proposition that supports what they are recommending? Are they choosing it because it has better outcomes, is less likely to have an adverse event, is more efficiently provided, or is it something that is less expensive?” he said.

Two major health reform laws will change how insurers pay for new medical devices, though the impact of these changes remains to be seen. According to Harry Glorikian, a health care consultant based in Lexington, Mass., the Affordable Care Act and the Medicaid and CHIP Reauthorization Act (MACRA) put many items into play, most notably fundamental changes in Medicare/Medicaid and the shift from fee-for-service to value-based payment.

“It’s a crazy time because of the need for virtually all hospital-based organizations to operate under both fee-for-service and non–fee-for-service payment arrangements right now,” he said in an interview.

Along with those two reform laws, the Health & Human Services department has set a schedule for transitioning to paying for the value – rather than the volume – of care. The initial goal – 30% of Medicare payments based on value by the end of 2016 – was reached in early March.

“HHS also set a goal of tying 85% of all traditional Medicare payments to quality or value by 2016 and 90% by 2018 through programs such as the Hospital Value-Based Purchasing and the Hospital Readmissions Reduction programs. This will be huge, and its impact will be tremendous,” he added.

One tool physicians can leverage to show value in this new payment landscape is the AGA Digestive Health Recognition Program, a quality improvement program and clinical data registry that allows clinicians to demonstrate quality of care for several disease states (colorectal cancer, hepatitis C virus, and irritable bowel disease) (www.gastro.org/DHRP).

Over the next 5-10 years, watch for changes in value-based payment models and a long-term move to a single-payer system, said Mr. Glorikian. In addition, expect changes in the workforce in terms of who delivers care and how.

Finally, physicians will need to use big data to manage patients, prescribe therapy, and integrate all aspects of medical practice, he said.

Dr. Jacques disclosed that he has financial relationships with Exact Sciences and Medtronic.

BOSTON – Many developers of innovative medical technologies don’t realize that insurers are going to want to see evidence that a new technology improves health outcomes before they will consider paying for it, according to Dr. Louis Jacques, senior vice president and chief clinical officer for ADVI, a health care advisory services firm in Washington.

The Centers for Medicare & Medicaid Services generally seeks “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population” when determining Medicare coverage, Dr. Jacques said in a presentation at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Medicare is less likely to pay if there is something controversial about the available evidence, he said in an interview. “The controversy is usually about inadequate evidence or lack of applicability to the affected Medicare beneficiary population,” Dr. Jacques said, noting that the typical Medicare patient, a 74-year-old woman with comorbid conditions taking multiple medications, often is not the type of person included in clinical trials that would generate such evidence.

Medicare is looking for “adequate evidence that a treatment strategy using the new therapeutic technology, compared to alternatives, leads to improved clinically meaningful health outcomes in Medicare beneficiaries,” he said.

Similarly, new diagnostic technologies should provide the physician with additional information that can alter treatment recommendations, resulting in therapeutic changes that improve outcomes.

Dr. Jacques noted that over the next several years, the health care system will move away from fee for service and begin more and more to pay for value, with physicians becoming more accountable for outcomes and cost.

He advised those developing a new device or treatment to think about how they would justify a particular treatment approach to their colleagues. They need to ask themselves: “What is the value proposition that supports what they are recommending? Are they choosing it because it has better outcomes, is less likely to have an adverse event, is more efficiently provided, or is it something that is less expensive?” he said.

Two major health reform laws will change how insurers pay for new medical devices, though the impact of these changes remains to be seen. According to Harry Glorikian, a health care consultant based in Lexington, Mass., the Affordable Care Act and the Medicaid and CHIP Reauthorization Act (MACRA) put many items into play, most notably fundamental changes in Medicare/Medicaid and the shift from fee-for-service to value-based payment.

“It’s a crazy time because of the need for virtually all hospital-based organizations to operate under both fee-for-service and non–fee-for-service payment arrangements right now,” he said in an interview.

Along with those two reform laws, the Health & Human Services department has set a schedule for transitioning to paying for the value – rather than the volume – of care. The initial goal – 30% of Medicare payments based on value by the end of 2016 – was reached in early March.

“HHS also set a goal of tying 85% of all traditional Medicare payments to quality or value by 2016 and 90% by 2018 through programs such as the Hospital Value-Based Purchasing and the Hospital Readmissions Reduction programs. This will be huge, and its impact will be tremendous,” he added.

One tool physicians can leverage to show value in this new payment landscape is the AGA Digestive Health Recognition Program, a quality improvement program and clinical data registry that allows clinicians to demonstrate quality of care for several disease states (colorectal cancer, hepatitis C virus, and irritable bowel disease) (www.gastro.org/DHRP).

Over the next 5-10 years, watch for changes in value-based payment models and a long-term move to a single-payer system, said Mr. Glorikian. In addition, expect changes in the workforce in terms of who delivers care and how.

Finally, physicians will need to use big data to manage patients, prescribe therapy, and integrate all aspects of medical practice, he said.

Dr. Jacques disclosed that he has financial relationships with Exact Sciences and Medtronic.

BOSTON – Many developers of innovative medical technologies don’t realize that insurers are going to want to see evidence that a new technology improves health outcomes before they will consider paying for it, according to Dr. Louis Jacques, senior vice president and chief clinical officer for ADVI, a health care advisory services firm in Washington.

The Centers for Medicare & Medicaid Services generally seeks “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population” when determining Medicare coverage, Dr. Jacques said in a presentation at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Medicare is less likely to pay if there is something controversial about the available evidence, he said in an interview. “The controversy is usually about inadequate evidence or lack of applicability to the affected Medicare beneficiary population,” Dr. Jacques said, noting that the typical Medicare patient, a 74-year-old woman with comorbid conditions taking multiple medications, often is not the type of person included in clinical trials that would generate such evidence.

Medicare is looking for “adequate evidence that a treatment strategy using the new therapeutic technology, compared to alternatives, leads to improved clinically meaningful health outcomes in Medicare beneficiaries,” he said.

Similarly, new diagnostic technologies should provide the physician with additional information that can alter treatment recommendations, resulting in therapeutic changes that improve outcomes.

Dr. Jacques noted that over the next several years, the health care system will move away from fee for service and begin more and more to pay for value, with physicians becoming more accountable for outcomes and cost.

He advised those developing a new device or treatment to think about how they would justify a particular treatment approach to their colleagues. They need to ask themselves: “What is the value proposition that supports what they are recommending? Are they choosing it because it has better outcomes, is less likely to have an adverse event, is more efficiently provided, or is it something that is less expensive?” he said.

Two major health reform laws will change how insurers pay for new medical devices, though the impact of these changes remains to be seen. According to Harry Glorikian, a health care consultant based in Lexington, Mass., the Affordable Care Act and the Medicaid and CHIP Reauthorization Act (MACRA) put many items into play, most notably fundamental changes in Medicare/Medicaid and the shift from fee-for-service to value-based payment.

“It’s a crazy time because of the need for virtually all hospital-based organizations to operate under both fee-for-service and non–fee-for-service payment arrangements right now,” he said in an interview.

Along with those two reform laws, the Health & Human Services department has set a schedule for transitioning to paying for the value – rather than the volume – of care. The initial goal – 30% of Medicare payments based on value by the end of 2016 – was reached in early March.

“HHS also set a goal of tying 85% of all traditional Medicare payments to quality or value by 2016 and 90% by 2018 through programs such as the Hospital Value-Based Purchasing and the Hospital Readmissions Reduction programs. This will be huge, and its impact will be tremendous,” he added.

One tool physicians can leverage to show value in this new payment landscape is the AGA Digestive Health Recognition Program, a quality improvement program and clinical data registry that allows clinicians to demonstrate quality of care for several disease states (colorectal cancer, hepatitis C virus, and irritable bowel disease) (www.gastro.org/DHRP).

Over the next 5-10 years, watch for changes in value-based payment models and a long-term move to a single-payer system, said Mr. Glorikian. In addition, expect changes in the workforce in terms of who delivers care and how.

Finally, physicians will need to use big data to manage patients, prescribe therapy, and integrate all aspects of medical practice, he said.

Dr. Jacques disclosed that he has financial relationships with Exact Sciences and Medtronic.

BOSTON – Gastroenterologists need to recognize that obesity is not one but multiple diseases and band together with other specialists in an interdisciplinary fashion to develop workable plans for long-term weight control, according to a panel of experts at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

More than one-third of U.S. adults have obesity, at a medical cost of between $147 and $300 billion annually, according to the Centers for Disease Control and Prevention. There are many reasons people suffer from obesity, said Dr. Robert Fanelli, chief of minimally invasive surgery and surgical endoscopy at the Guthrie Clinic in Sayre, Pa. These range from poor diet to genetics, and, accordingly, physicians are going to have to turn to personalized care.

“The time has come for gastroenterologists to play a role in addressing this crisis,” said Dr. Sarah Streett, clinical associate professor of medicine at Stanford (Calif.) University. “Gastroenterologists are uniquely positioned to help in this area because we are, by training, internists, digestive disease specialists, and endoscopists, and endoscopic bariatric therapies are entering the armamentarium of tools to treat obesity,” she added.

Over the last few decades, GI experts’ attention has focused on colon cancer screening and significant innovations in the areas of endoscopic therapeutics and the treatment of hepatitis and inflammatory bowel disease, Dr. Streett said, “but many in GI appreciate that obesity is a root cause for so many of the conditions that we’re already treating: esophageal reflux and its complications, fatty liver disease, gallbladder disease, and gastrointestinal cancers.”

Because the disease is complex, said Dr. Streett, who is also the chair of the AGA Practice Management and Economics Committee, it’s imperative to work collaboratively with others, including obesity medicine specialists, dietitians, counselors, psychologists, and bariatric surgeons, to create a continuum of care tailored to patients’ individual needs, with good nutrition, physical activity, and stress reduction as central tenets.

AGA – in conjunction with the Society of American Gastrointestinal and Endoscopic Surgeons, the Obesity Society, and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition – is developing a program to guide gastroenterologists who want to develop comprehensive care management programs to treat obesity with a multimodal approach, she said. The initiative, called “POWER: Practice Guide on Obesity and Weight Management, Education and Resources,” will be made available on the AGA website later this year.

For patients in need, there are safe, robust surgical options to manage obesity, including gastric bypass and sleeve gastrectomy, said Dr. Kevin Reavis, a bariatric surgeon at the Oregon Clinic in Portland. The safety record for bariatric surgery is now on par with elective gallbladder surgery and matches or betters heart surgery, he said. A less invasive option is the endoscopic placement of devices like gastric balloons that generate an early sense of satiety by applying pressure to the upper stomach.

Moving toward the future, there is a lot of “out of the box thinking” that has led to research into ways to alter consumption and digestion of food with such approaches as blocking the vagus nerve or employing deep brain stimulation. Although some devices or interventions are designed to block calories from being absorbed from the GI tract, others may be able to reset patients’ metabolic balance, enabling easier weight loss and maintenance.

Physicians’ understanding of obesity is changing, said Dr. Lee Kaplan, director of the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital, Boston. “We now understand that the body has an elaborate and powerful regulatory system that seeks to maintain a stable amount of fat,” a phenomenon he characterized as “the fat mass set point.”

Changes in modern society, including the type of foods we eat, lack of exercise, disturbed sleep, increased stress, and medications that stimulate appetite, all send aberrant signals to the brain, causing it to seek too high a fat mass, he said. Any therapy that is to be successful must lower that set point.

Different from other heterogeneous disorders like cancer, it’s not yet clear which treatments will work best for which types of obesity, Dr. Kaplan noted. Meanwhile, “we’re recommending more and more that we approach obesity in the same way that we approach any other disease, which is to start with lifestyle changes,” he said, “and if that doesn’t work, to move on to more classically medical approaches, including medications and surgery.”

Once an effective treatment is implemented, continuing care is essential. Obesity is not cured with current treatments, which means that patients require ongoing support.

After weight is reduced, “we abandon patients as a matter of routine,” said Dr. Kaplan, noting that this is not the case in other serious chronic diseases. This is one aspect of obesity care that “we must change.”

Dr. Kaplan receives consulting fees from Eisai, Ethicon, GI Dynamics, Novo Nordisk, and Vivus, and has an ownership interest in GI Dynamics. Dr. Fanelli is a part owner of Allurion Technologies, a company that manufacturers an intragastric balloon for weight loss, and an advisor to EndoGastric Solutions. Dr. Streett and Dr. Reavis reported no relevant financial disclosures.

BOSTON – Gastroenterologists need to recognize that obesity is not one but multiple diseases and band together with other specialists in an interdisciplinary fashion to develop workable plans for long-term weight control, according to a panel of experts at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

More than one-third of U.S. adults have obesity, at a medical cost of between $147 and $300 billion annually, according to the Centers for Disease Control and Prevention. There are many reasons people suffer from obesity, said Dr. Robert Fanelli, chief of minimally invasive surgery and surgical endoscopy at the Guthrie Clinic in Sayre, Pa. These range from poor diet to genetics, and, accordingly, physicians are going to have to turn to personalized care.

“The time has come for gastroenterologists to play a role in addressing this crisis,” said Dr. Sarah Streett, clinical associate professor of medicine at Stanford (Calif.) University. “Gastroenterologists are uniquely positioned to help in this area because we are, by training, internists, digestive disease specialists, and endoscopists, and endoscopic bariatric therapies are entering the armamentarium of tools to treat obesity,” she added.

Over the last few decades, GI experts’ attention has focused on colon cancer screening and significant innovations in the areas of endoscopic therapeutics and the treatment of hepatitis and inflammatory bowel disease, Dr. Streett said, “but many in GI appreciate that obesity is a root cause for so many of the conditions that we’re already treating: esophageal reflux and its complications, fatty liver disease, gallbladder disease, and gastrointestinal cancers.”

Because the disease is complex, said Dr. Streett, who is also the chair of the AGA Practice Management and Economics Committee, it’s imperative to work collaboratively with others, including obesity medicine specialists, dietitians, counselors, psychologists, and bariatric surgeons, to create a continuum of care tailored to patients’ individual needs, with good nutrition, physical activity, and stress reduction as central tenets.

AGA – in conjunction with the Society of American Gastrointestinal and Endoscopic Surgeons, the Obesity Society, and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition – is developing a program to guide gastroenterologists who want to develop comprehensive care management programs to treat obesity with a multimodal approach, she said. The initiative, called “POWER: Practice Guide on Obesity and Weight Management, Education and Resources,” will be made available on the AGA website later this year.

For patients in need, there are safe, robust surgical options to manage obesity, including gastric bypass and sleeve gastrectomy, said Dr. Kevin Reavis, a bariatric surgeon at the Oregon Clinic in Portland. The safety record for bariatric surgery is now on par with elective gallbladder surgery and matches or betters heart surgery, he said. A less invasive option is the endoscopic placement of devices like gastric balloons that generate an early sense of satiety by applying pressure to the upper stomach.

Moving toward the future, there is a lot of “out of the box thinking” that has led to research into ways to alter consumption and digestion of food with such approaches as blocking the vagus nerve or employing deep brain stimulation. Although some devices or interventions are designed to block calories from being absorbed from the GI tract, others may be able to reset patients’ metabolic balance, enabling easier weight loss and maintenance.

Physicians’ understanding of obesity is changing, said Dr. Lee Kaplan, director of the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital, Boston. “We now understand that the body has an elaborate and powerful regulatory system that seeks to maintain a stable amount of fat,” a phenomenon he characterized as “the fat mass set point.”

Changes in modern society, including the type of foods we eat, lack of exercise, disturbed sleep, increased stress, and medications that stimulate appetite, all send aberrant signals to the brain, causing it to seek too high a fat mass, he said. Any therapy that is to be successful must lower that set point.

Different from other heterogeneous disorders like cancer, it’s not yet clear which treatments will work best for which types of obesity, Dr. Kaplan noted. Meanwhile, “we’re recommending more and more that we approach obesity in the same way that we approach any other disease, which is to start with lifestyle changes,” he said, “and if that doesn’t work, to move on to more classically medical approaches, including medications and surgery.”

Once an effective treatment is implemented, continuing care is essential. Obesity is not cured with current treatments, which means that patients require ongoing support.

After weight is reduced, “we abandon patients as a matter of routine,” said Dr. Kaplan, noting that this is not the case in other serious chronic diseases. This is one aspect of obesity care that “we must change.”

Dr. Kaplan receives consulting fees from Eisai, Ethicon, GI Dynamics, Novo Nordisk, and Vivus, and has an ownership interest in GI Dynamics. Dr. Fanelli is a part owner of Allurion Technologies, a company that manufacturers an intragastric balloon for weight loss, and an advisor to EndoGastric Solutions. Dr. Streett and Dr. Reavis reported no relevant financial disclosures.

BOSTON – Gastroenterologists need to recognize that obesity is not one but multiple diseases and band together with other specialists in an interdisciplinary fashion to develop workable plans for long-term weight control, according to a panel of experts at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

More than one-third of U.S. adults have obesity, at a medical cost of between $147 and $300 billion annually, according to the Centers for Disease Control and Prevention. There are many reasons people suffer from obesity, said Dr. Robert Fanelli, chief of minimally invasive surgery and surgical endoscopy at the Guthrie Clinic in Sayre, Pa. These range from poor diet to genetics, and, accordingly, physicians are going to have to turn to personalized care.

“The time has come for gastroenterologists to play a role in addressing this crisis,” said Dr. Sarah Streett, clinical associate professor of medicine at Stanford (Calif.) University. “Gastroenterologists are uniquely positioned to help in this area because we are, by training, internists, digestive disease specialists, and endoscopists, and endoscopic bariatric therapies are entering the armamentarium of tools to treat obesity,” she added.

Over the last few decades, GI experts’ attention has focused on colon cancer screening and significant innovations in the areas of endoscopic therapeutics and the treatment of hepatitis and inflammatory bowel disease, Dr. Streett said, “but many in GI appreciate that obesity is a root cause for so many of the conditions that we’re already treating: esophageal reflux and its complications, fatty liver disease, gallbladder disease, and gastrointestinal cancers.”

Because the disease is complex, said Dr. Streett, who is also the chair of the AGA Practice Management and Economics Committee, it’s imperative to work collaboratively with others, including obesity medicine specialists, dietitians, counselors, psychologists, and bariatric surgeons, to create a continuum of care tailored to patients’ individual needs, with good nutrition, physical activity, and stress reduction as central tenets.

AGA – in conjunction with the Society of American Gastrointestinal and Endoscopic Surgeons, the Obesity Society, and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition – is developing a program to guide gastroenterologists who want to develop comprehensive care management programs to treat obesity with a multimodal approach, she said. The initiative, called “POWER: Practice Guide on Obesity and Weight Management, Education and Resources,” will be made available on the AGA website later this year.

For patients in need, there are safe, robust surgical options to manage obesity, including gastric bypass and sleeve gastrectomy, said Dr. Kevin Reavis, a bariatric surgeon at the Oregon Clinic in Portland. The safety record for bariatric surgery is now on par with elective gallbladder surgery and matches or betters heart surgery, he said. A less invasive option is the endoscopic placement of devices like gastric balloons that generate an early sense of satiety by applying pressure to the upper stomach.

Moving toward the future, there is a lot of “out of the box thinking” that has led to research into ways to alter consumption and digestion of food with such approaches as blocking the vagus nerve or employing deep brain stimulation. Although some devices or interventions are designed to block calories from being absorbed from the GI tract, others may be able to reset patients’ metabolic balance, enabling easier weight loss and maintenance.

Physicians’ understanding of obesity is changing, said Dr. Lee Kaplan, director of the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital, Boston. “We now understand that the body has an elaborate and powerful regulatory system that seeks to maintain a stable amount of fat,” a phenomenon he characterized as “the fat mass set point.”

Changes in modern society, including the type of foods we eat, lack of exercise, disturbed sleep, increased stress, and medications that stimulate appetite, all send aberrant signals to the brain, causing it to seek too high a fat mass, he said. Any therapy that is to be successful must lower that set point.

Different from other heterogeneous disorders like cancer, it’s not yet clear which treatments will work best for which types of obesity, Dr. Kaplan noted. Meanwhile, “we’re recommending more and more that we approach obesity in the same way that we approach any other disease, which is to start with lifestyle changes,” he said, “and if that doesn’t work, to move on to more classically medical approaches, including medications and surgery.”

Once an effective treatment is implemented, continuing care is essential. Obesity is not cured with current treatments, which means that patients require ongoing support.

After weight is reduced, “we abandon patients as a matter of routine,” said Dr. Kaplan, noting that this is not the case in other serious chronic diseases. This is one aspect of obesity care that “we must change.”

Dr. Kaplan receives consulting fees from Eisai, Ethicon, GI Dynamics, Novo Nordisk, and Vivus, and has an ownership interest in GI Dynamics. Dr. Fanelli is a part owner of Allurion Technologies, a company that manufacturers an intragastric balloon for weight loss, and an advisor to EndoGastric Solutions. Dr. Streett and Dr. Reavis reported no relevant financial disclosures.