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Robot pill wins AGA Shark Tank competition

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– No one yet has figured out how to shrink doctors so they can make house calls inside the human blood stream as they did in the science fiction movie “Fantastic Voyage.” But the founders of a gastroenterology startup think they have the next best thing – a remote-controlled robot so small it can be swallowed like a pill.

The concept captured the imagination of a panel of judges earlier this month at the 2023 American Gastroenterological Association Tech Summit where it was named the winner of the annual Shark Tank innovation competition. The AGA Tech Summit and Shark Tank are the flagship events of the AGA Center for GI Innovation and Technology.

“This could be a game-changing investment down the line,” one of the judges, Amrita Sethi, MD, from Columbia University Medical Center in New York, said in an interview.

Vidyard Video

COURTESY AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Hawyard, Calif.–based Endiatx is early in its voyage. The disposable motorized pill, called PillBot, swims through the stomach beaming video back to its operators, but CEO Torrey Smith, an aerospace engineer, sees future generations of the device operating on any diseased tissues that can be treated with surgery. “We believe teeny robots can go anywhere in the body,” he said.

The company executives envision that one day, robots small enough to enter the human brain will be able to eat away at tumors. “Imagine having your brain surgery while you’re on a ride at Disneyland,” said Endiatx cofounder and chair Alex Luebke. If that sounds fanciful, Mr. Smith cites a case report of a botfly larva that wormed its way into a human skull and ate a golf-ball sized chunk of brain.

Endiatx has raised $3 million and sent 24 of its robots swimming into the stomachs of its founding team. Mr. Smith himself has swallowed 15. Operators can use an external device with a joystick. Engineers have experimented with an Xbox video game controller to navigate around the stomach. The procedure requires no anesthesia.

The company expects to apply for Food and Drug Administration approval in 2025 or 2026. Mr. Smith is hoping the agency will approve it quickly because the robot pills are similar enough to passive camera pills that have been on the market for years.

But he also sees it as a crucial step forward because controlling the robot with three electric motors squirting water in six directions will allow physicians to point it at what they really need to see, not just hope to get a lucky shot of a problem area as the device floats by.

The most immediate technical challenge is improving the quality of the pill’s video. “We’re evaluating different cameras but we know we can’t be inferior on the imaging side,” Mr. Smith said.

Attention from the AGA is crucial because the team of engineers wants physicians to help it improve the robot pill, Mr. Luebeke said. “We can build anything, but we need guidance about what the market needs. Doctors have to say, ‘We need you to tweak it this way or that way.’ ”

The business opportunity is large, Mr. Smith said, with 7.5 million upper endoscopies out of 223 million endoscopic procedures done per year in the United States.

Endiatx figures the gross margin on procedures with the robot pills is 90%-95% because the manufacturing cost is about $50 per pill, but physicians can bill $500 for them using existing CPT codes for passive pill cameras.

Dr. Sethi said the robot pill stood out among other contenders because of the dire need for improved endoscopy technology.

Endiatx will represent AGA at the 2023 Digestive Disease Week® (DDW) Shark Tank pitch competition.

 

 

Four other finalists

The choice that received the most votes from the audience was Ezalife’s Button Huggie, a device for securing gastrostomy and cecostomy buttons. It includes a reusable, child-proof lid with a disposable, biodegradable, gauze sponge and a base layer held in place with a long-wearing adhesive. This prevents button movement in the tract, which can delay wound healing and lead to complications. In addition, the Button Huggie is much easier to put in place. “Our device is novel, with no direct competitors,” said CTO/COO Tyler Mironuck.

Currently patients are advised to fasten gastrostomy and cecostomy buttons with tape, but the buttons are dislodged 7% of the time, he said. The company estimates that patients spend an average of $100 a month on tape and gauze. The Button Huggie can be manufactured for $56, and the company envisions selling them for $300.

The device is exempt from needing a 510K FDA approval, so it can get to the market quickly. Nevertheless, the company is conducting a clinical trial with 200 patients at five children’s hospitals, Mr. Mironuck said.

NovaScan was a finalist for nsCanary, a device that uses electrical impedance to detect cancer. The device hinges on the company’s discovery that the Cole relaxation frequency is orders of magnitude different for cancerous and benign tissue, yet not affected by mass. By measuring this frequency, the nsCanary can find cancer in tissue acquired through biopsy forceps, snare polypectomy, mucosal resection, and endoscopic ultrasound-guided fine needle biopsy. It works in seconds without the need to interpret images.

Atlas Endoscopy was recognized for REN, a robotic colonoscopy system. The operator uses an external actuating magnet above the patient to guide a disposable ultracompliant endoscope through the colon. The company says this form of navigation prevents looping, reduces pain, and minimizes tissue stress.

Limaca Medical was recognized for Precision, a motorized, automated, rotational cutting and coring needle for endoscopic ultrasound biopsy. Manual biopsy needles now on the market require repeat passes in and out of the endoscope to obtain fragments of tissue, but Precision obtains larger intact samples of tumor tissue in a single pass.

Dr. Sethi has served as a consultant for Boston Scientific, Medtronic and Olympus; as a board member for EndoSound and has received grant support from FUJIFILM.
 

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– No one yet has figured out how to shrink doctors so they can make house calls inside the human blood stream as they did in the science fiction movie “Fantastic Voyage.” But the founders of a gastroenterology startup think they have the next best thing – a remote-controlled robot so small it can be swallowed like a pill.

The concept captured the imagination of a panel of judges earlier this month at the 2023 American Gastroenterological Association Tech Summit where it was named the winner of the annual Shark Tank innovation competition. The AGA Tech Summit and Shark Tank are the flagship events of the AGA Center for GI Innovation and Technology.

“This could be a game-changing investment down the line,” one of the judges, Amrita Sethi, MD, from Columbia University Medical Center in New York, said in an interview.

Vidyard Video

COURTESY AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Hawyard, Calif.–based Endiatx is early in its voyage. The disposable motorized pill, called PillBot, swims through the stomach beaming video back to its operators, but CEO Torrey Smith, an aerospace engineer, sees future generations of the device operating on any diseased tissues that can be treated with surgery. “We believe teeny robots can go anywhere in the body,” he said.

The company executives envision that one day, robots small enough to enter the human brain will be able to eat away at tumors. “Imagine having your brain surgery while you’re on a ride at Disneyland,” said Endiatx cofounder and chair Alex Luebke. If that sounds fanciful, Mr. Smith cites a case report of a botfly larva that wormed its way into a human skull and ate a golf-ball sized chunk of brain.

Endiatx has raised $3 million and sent 24 of its robots swimming into the stomachs of its founding team. Mr. Smith himself has swallowed 15. Operators can use an external device with a joystick. Engineers have experimented with an Xbox video game controller to navigate around the stomach. The procedure requires no anesthesia.

The company expects to apply for Food and Drug Administration approval in 2025 or 2026. Mr. Smith is hoping the agency will approve it quickly because the robot pills are similar enough to passive camera pills that have been on the market for years.

But he also sees it as a crucial step forward because controlling the robot with three electric motors squirting water in six directions will allow physicians to point it at what they really need to see, not just hope to get a lucky shot of a problem area as the device floats by.

The most immediate technical challenge is improving the quality of the pill’s video. “We’re evaluating different cameras but we know we can’t be inferior on the imaging side,” Mr. Smith said.

Attention from the AGA is crucial because the team of engineers wants physicians to help it improve the robot pill, Mr. Luebeke said. “We can build anything, but we need guidance about what the market needs. Doctors have to say, ‘We need you to tweak it this way or that way.’ ”

The business opportunity is large, Mr. Smith said, with 7.5 million upper endoscopies out of 223 million endoscopic procedures done per year in the United States.

Endiatx figures the gross margin on procedures with the robot pills is 90%-95% because the manufacturing cost is about $50 per pill, but physicians can bill $500 for them using existing CPT codes for passive pill cameras.

Dr. Sethi said the robot pill stood out among other contenders because of the dire need for improved endoscopy technology.

Endiatx will represent AGA at the 2023 Digestive Disease Week® (DDW) Shark Tank pitch competition.

 

 

Four other finalists

The choice that received the most votes from the audience was Ezalife’s Button Huggie, a device for securing gastrostomy and cecostomy buttons. It includes a reusable, child-proof lid with a disposable, biodegradable, gauze sponge and a base layer held in place with a long-wearing adhesive. This prevents button movement in the tract, which can delay wound healing and lead to complications. In addition, the Button Huggie is much easier to put in place. “Our device is novel, with no direct competitors,” said CTO/COO Tyler Mironuck.

Currently patients are advised to fasten gastrostomy and cecostomy buttons with tape, but the buttons are dislodged 7% of the time, he said. The company estimates that patients spend an average of $100 a month on tape and gauze. The Button Huggie can be manufactured for $56, and the company envisions selling them for $300.

The device is exempt from needing a 510K FDA approval, so it can get to the market quickly. Nevertheless, the company is conducting a clinical trial with 200 patients at five children’s hospitals, Mr. Mironuck said.

NovaScan was a finalist for nsCanary, a device that uses electrical impedance to detect cancer. The device hinges on the company’s discovery that the Cole relaxation frequency is orders of magnitude different for cancerous and benign tissue, yet not affected by mass. By measuring this frequency, the nsCanary can find cancer in tissue acquired through biopsy forceps, snare polypectomy, mucosal resection, and endoscopic ultrasound-guided fine needle biopsy. It works in seconds without the need to interpret images.

Atlas Endoscopy was recognized for REN, a robotic colonoscopy system. The operator uses an external actuating magnet above the patient to guide a disposable ultracompliant endoscope through the colon. The company says this form of navigation prevents looping, reduces pain, and minimizes tissue stress.

Limaca Medical was recognized for Precision, a motorized, automated, rotational cutting and coring needle for endoscopic ultrasound biopsy. Manual biopsy needles now on the market require repeat passes in and out of the endoscope to obtain fragments of tissue, but Precision obtains larger intact samples of tumor tissue in a single pass.

Dr. Sethi has served as a consultant for Boston Scientific, Medtronic and Olympus; as a board member for EndoSound and has received grant support from FUJIFILM.
 

– No one yet has figured out how to shrink doctors so they can make house calls inside the human blood stream as they did in the science fiction movie “Fantastic Voyage.” But the founders of a gastroenterology startup think they have the next best thing – a remote-controlled robot so small it can be swallowed like a pill.

The concept captured the imagination of a panel of judges earlier this month at the 2023 American Gastroenterological Association Tech Summit where it was named the winner of the annual Shark Tank innovation competition. The AGA Tech Summit and Shark Tank are the flagship events of the AGA Center for GI Innovation and Technology.

“This could be a game-changing investment down the line,” one of the judges, Amrita Sethi, MD, from Columbia University Medical Center in New York, said in an interview.

Vidyard Video

COURTESY AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Hawyard, Calif.–based Endiatx is early in its voyage. The disposable motorized pill, called PillBot, swims through the stomach beaming video back to its operators, but CEO Torrey Smith, an aerospace engineer, sees future generations of the device operating on any diseased tissues that can be treated with surgery. “We believe teeny robots can go anywhere in the body,” he said.

The company executives envision that one day, robots small enough to enter the human brain will be able to eat away at tumors. “Imagine having your brain surgery while you’re on a ride at Disneyland,” said Endiatx cofounder and chair Alex Luebke. If that sounds fanciful, Mr. Smith cites a case report of a botfly larva that wormed its way into a human skull and ate a golf-ball sized chunk of brain.

Endiatx has raised $3 million and sent 24 of its robots swimming into the stomachs of its founding team. Mr. Smith himself has swallowed 15. Operators can use an external device with a joystick. Engineers have experimented with an Xbox video game controller to navigate around the stomach. The procedure requires no anesthesia.

The company expects to apply for Food and Drug Administration approval in 2025 or 2026. Mr. Smith is hoping the agency will approve it quickly because the robot pills are similar enough to passive camera pills that have been on the market for years.

But he also sees it as a crucial step forward because controlling the robot with three electric motors squirting water in six directions will allow physicians to point it at what they really need to see, not just hope to get a lucky shot of a problem area as the device floats by.

The most immediate technical challenge is improving the quality of the pill’s video. “We’re evaluating different cameras but we know we can’t be inferior on the imaging side,” Mr. Smith said.

Attention from the AGA is crucial because the team of engineers wants physicians to help it improve the robot pill, Mr. Luebeke said. “We can build anything, but we need guidance about what the market needs. Doctors have to say, ‘We need you to tweak it this way or that way.’ ”

The business opportunity is large, Mr. Smith said, with 7.5 million upper endoscopies out of 223 million endoscopic procedures done per year in the United States.

Endiatx figures the gross margin on procedures with the robot pills is 90%-95% because the manufacturing cost is about $50 per pill, but physicians can bill $500 for them using existing CPT codes for passive pill cameras.

Dr. Sethi said the robot pill stood out among other contenders because of the dire need for improved endoscopy technology.

Endiatx will represent AGA at the 2023 Digestive Disease Week® (DDW) Shark Tank pitch competition.

 

 

Four other finalists

The choice that received the most votes from the audience was Ezalife’s Button Huggie, a device for securing gastrostomy and cecostomy buttons. It includes a reusable, child-proof lid with a disposable, biodegradable, gauze sponge and a base layer held in place with a long-wearing adhesive. This prevents button movement in the tract, which can delay wound healing and lead to complications. In addition, the Button Huggie is much easier to put in place. “Our device is novel, with no direct competitors,” said CTO/COO Tyler Mironuck.

Currently patients are advised to fasten gastrostomy and cecostomy buttons with tape, but the buttons are dislodged 7% of the time, he said. The company estimates that patients spend an average of $100 a month on tape and gauze. The Button Huggie can be manufactured for $56, and the company envisions selling them for $300.

The device is exempt from needing a 510K FDA approval, so it can get to the market quickly. Nevertheless, the company is conducting a clinical trial with 200 patients at five children’s hospitals, Mr. Mironuck said.

NovaScan was a finalist for nsCanary, a device that uses electrical impedance to detect cancer. The device hinges on the company’s discovery that the Cole relaxation frequency is orders of magnitude different for cancerous and benign tissue, yet not affected by mass. By measuring this frequency, the nsCanary can find cancer in tissue acquired through biopsy forceps, snare polypectomy, mucosal resection, and endoscopic ultrasound-guided fine needle biopsy. It works in seconds without the need to interpret images.

Atlas Endoscopy was recognized for REN, a robotic colonoscopy system. The operator uses an external actuating magnet above the patient to guide a disposable ultracompliant endoscope through the colon. The company says this form of navigation prevents looping, reduces pain, and minimizes tissue stress.

Limaca Medical was recognized for Precision, a motorized, automated, rotational cutting and coring needle for endoscopic ultrasound biopsy. Manual biopsy needles now on the market require repeat passes in and out of the endoscope to obtain fragments of tissue, but Precision obtains larger intact samples of tumor tissue in a single pass.

Dr. Sethi has served as a consultant for Boston Scientific, Medtronic and Olympus; as a board member for EndoSound and has received grant support from FUJIFILM.
 

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Should GI own the obesity field?

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Mon, 03/27/2023 - 12:35

Gastroenterologists are uniquely positioned to treat obesity, according to a panel of experts convened by the American Gastroenterological Association.

“We see this as a field that GI should own,” said Naresh T. Gunaratnam, MD, a gastroenterologist at Huron Gastro in Ypsilanti, Mich., who has made obesity treatment an important part of his practice.

Gastroenterologists are uniquely qualified in endoscopic sleeve gastroplasty and in the placement of intragastric balloons and can also bring their internal medicine training to bear in patient education and medical prescription, Dr. Gunaratnam said in an interview.

He and three colleagues spoke about innovation in obesity and metabolism at the 2023 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Significant hurdles remain to launching new endoscopic devices for treating obesity, but evidence shows that the existing treatments are effective when combined with medication and other treatments, said panelist Reem Z. Sharaiha, MD, MSc, a gastroenterologist with expertise in obesity at Weill Cornell Medicine in New York. “You can never find just one cure for obesity, you should always think about a combination.”

Obesity rates continue to spiral worldwide, with over 100 million adults in the United States weighing in at over 30 kg/m2, said Dr. Sharaiha, but less than 5% per year receive adequate treatment. The condition is driving upticks in diabetes and nonalcoholic fatty liver disease and contributing to cancer, heart disease, stroke, and COVID-19 infections.

Even small reductions in body weight can significantly improve these conditions, she said. Less than a 5% in total body weight on average results in significant reductions in HbA1c, triglycerides, blood pressure and steatosis.

In recent years, the Food and Drug Administration has several devices that gastroenterologists can use to treat obesity, Dr. Sharaiha said, including three brands of intragastric balloon used to reduce appetite by filling the stomach. The AGA now recommends such an intragastric balloon for people with obesity who have “failed a trial of conventional weight-loss strategies.”



But many devices have been withdrawn from the market, including two of the balloon systems. Why do so many devices fail? Sometimes the FDA demands trials that are too expensive, Dr. Sharaiha said. The COVID-19 pandemic put financial pressure on some companies that have already secured FDA approval. Some insurance companies are not willing to pay for the devices, even after the FDA has approved them. Some are not cost effective.

And sometimes patients don’t accept them. That may have been one challenge with Aspire’s AspireAssist, which allowed patients to empty their stomachs into the toilet using a surgically implanted tube, though the company cited “the financial impact of the COVID-19 pandemic” when it withdrew the device from the market last year.

More devices are in the pipeline, but they face an uncertain path forward, Dr. Sharaiha said. “Device companies are usually startups that need funding. With the economic downturn, venture capital funding is hard to get.”

In the meantime, patients with class 3 obesity in particular may benefit from surgery, she said.

For others, medications are playing a more important role in the obesity epidemic, with an average 10%-15% body weight loss, Dr. Sharaiha said. Injections with semaglutide (Ozempic), a glucagon-like peptide 1 (GLP-1) receptor agonist that is approved to improve glycemic control in adults with type 2 diabetes mellitus, is leading the charge.

Tirzepatide (Mounjaro) may be even more effective, Dr. Sharaiha said. The FDA approved the drug last year to improve blood sugar control in adults with type 2 diabetes and was fast-tracked in October for the treatment of adults with obesity, or who are overweight with weight-related comorbidities.

Medications provide add-on benefits to many patients who have been treated with intragastric balloons or endoscopic sleeve gastroplasty, Dr. Sharaiha said.

Also lifestyle and education should not be neglected, said Dr. Gunaratnam, who lost 50 pounds by changing his diet. He urged gastroenterologists to take on the challenge of treating obesity. It’s not the part of his practice with the best reimbursement, but it is the most satisfying. “I get more hugs, cards, and tears by doing this because when you change weight, you’re impacting every part of their lives,” he said.

Dr. Gunaratnam is the founder of Lean Medical LLC and Satya Health Sciences. Dr. Sharaiha has served as a consultant for Boston Scientific Corporation and Cook Medical Inc.

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Gastroenterologists are uniquely positioned to treat obesity, according to a panel of experts convened by the American Gastroenterological Association.

“We see this as a field that GI should own,” said Naresh T. Gunaratnam, MD, a gastroenterologist at Huron Gastro in Ypsilanti, Mich., who has made obesity treatment an important part of his practice.

Gastroenterologists are uniquely qualified in endoscopic sleeve gastroplasty and in the placement of intragastric balloons and can also bring their internal medicine training to bear in patient education and medical prescription, Dr. Gunaratnam said in an interview.

He and three colleagues spoke about innovation in obesity and metabolism at the 2023 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Significant hurdles remain to launching new endoscopic devices for treating obesity, but evidence shows that the existing treatments are effective when combined with medication and other treatments, said panelist Reem Z. Sharaiha, MD, MSc, a gastroenterologist with expertise in obesity at Weill Cornell Medicine in New York. “You can never find just one cure for obesity, you should always think about a combination.”

Obesity rates continue to spiral worldwide, with over 100 million adults in the United States weighing in at over 30 kg/m2, said Dr. Sharaiha, but less than 5% per year receive adequate treatment. The condition is driving upticks in diabetes and nonalcoholic fatty liver disease and contributing to cancer, heart disease, stroke, and COVID-19 infections.

Even small reductions in body weight can significantly improve these conditions, she said. Less than a 5% in total body weight on average results in significant reductions in HbA1c, triglycerides, blood pressure and steatosis.

In recent years, the Food and Drug Administration has several devices that gastroenterologists can use to treat obesity, Dr. Sharaiha said, including three brands of intragastric balloon used to reduce appetite by filling the stomach. The AGA now recommends such an intragastric balloon for people with obesity who have “failed a trial of conventional weight-loss strategies.”



But many devices have been withdrawn from the market, including two of the balloon systems. Why do so many devices fail? Sometimes the FDA demands trials that are too expensive, Dr. Sharaiha said. The COVID-19 pandemic put financial pressure on some companies that have already secured FDA approval. Some insurance companies are not willing to pay for the devices, even after the FDA has approved them. Some are not cost effective.

And sometimes patients don’t accept them. That may have been one challenge with Aspire’s AspireAssist, which allowed patients to empty their stomachs into the toilet using a surgically implanted tube, though the company cited “the financial impact of the COVID-19 pandemic” when it withdrew the device from the market last year.

More devices are in the pipeline, but they face an uncertain path forward, Dr. Sharaiha said. “Device companies are usually startups that need funding. With the economic downturn, venture capital funding is hard to get.”

In the meantime, patients with class 3 obesity in particular may benefit from surgery, she said.

For others, medications are playing a more important role in the obesity epidemic, with an average 10%-15% body weight loss, Dr. Sharaiha said. Injections with semaglutide (Ozempic), a glucagon-like peptide 1 (GLP-1) receptor agonist that is approved to improve glycemic control in adults with type 2 diabetes mellitus, is leading the charge.

Tirzepatide (Mounjaro) may be even more effective, Dr. Sharaiha said. The FDA approved the drug last year to improve blood sugar control in adults with type 2 diabetes and was fast-tracked in October for the treatment of adults with obesity, or who are overweight with weight-related comorbidities.

Medications provide add-on benefits to many patients who have been treated with intragastric balloons or endoscopic sleeve gastroplasty, Dr. Sharaiha said.

Also lifestyle and education should not be neglected, said Dr. Gunaratnam, who lost 50 pounds by changing his diet. He urged gastroenterologists to take on the challenge of treating obesity. It’s not the part of his practice with the best reimbursement, but it is the most satisfying. “I get more hugs, cards, and tears by doing this because when you change weight, you’re impacting every part of their lives,” he said.

Dr. Gunaratnam is the founder of Lean Medical LLC and Satya Health Sciences. Dr. Sharaiha has served as a consultant for Boston Scientific Corporation and Cook Medical Inc.

Gastroenterologists are uniquely positioned to treat obesity, according to a panel of experts convened by the American Gastroenterological Association.

“We see this as a field that GI should own,” said Naresh T. Gunaratnam, MD, a gastroenterologist at Huron Gastro in Ypsilanti, Mich., who has made obesity treatment an important part of his practice.

Gastroenterologists are uniquely qualified in endoscopic sleeve gastroplasty and in the placement of intragastric balloons and can also bring their internal medicine training to bear in patient education and medical prescription, Dr. Gunaratnam said in an interview.

He and three colleagues spoke about innovation in obesity and metabolism at the 2023 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Significant hurdles remain to launching new endoscopic devices for treating obesity, but evidence shows that the existing treatments are effective when combined with medication and other treatments, said panelist Reem Z. Sharaiha, MD, MSc, a gastroenterologist with expertise in obesity at Weill Cornell Medicine in New York. “You can never find just one cure for obesity, you should always think about a combination.”

Obesity rates continue to spiral worldwide, with over 100 million adults in the United States weighing in at over 30 kg/m2, said Dr. Sharaiha, but less than 5% per year receive adequate treatment. The condition is driving upticks in diabetes and nonalcoholic fatty liver disease and contributing to cancer, heart disease, stroke, and COVID-19 infections.

Even small reductions in body weight can significantly improve these conditions, she said. Less than a 5% in total body weight on average results in significant reductions in HbA1c, triglycerides, blood pressure and steatosis.

In recent years, the Food and Drug Administration has several devices that gastroenterologists can use to treat obesity, Dr. Sharaiha said, including three brands of intragastric balloon used to reduce appetite by filling the stomach. The AGA now recommends such an intragastric balloon for people with obesity who have “failed a trial of conventional weight-loss strategies.”



But many devices have been withdrawn from the market, including two of the balloon systems. Why do so many devices fail? Sometimes the FDA demands trials that are too expensive, Dr. Sharaiha said. The COVID-19 pandemic put financial pressure on some companies that have already secured FDA approval. Some insurance companies are not willing to pay for the devices, even after the FDA has approved them. Some are not cost effective.

And sometimes patients don’t accept them. That may have been one challenge with Aspire’s AspireAssist, which allowed patients to empty their stomachs into the toilet using a surgically implanted tube, though the company cited “the financial impact of the COVID-19 pandemic” when it withdrew the device from the market last year.

More devices are in the pipeline, but they face an uncertain path forward, Dr. Sharaiha said. “Device companies are usually startups that need funding. With the economic downturn, venture capital funding is hard to get.”

In the meantime, patients with class 3 obesity in particular may benefit from surgery, she said.

For others, medications are playing a more important role in the obesity epidemic, with an average 10%-15% body weight loss, Dr. Sharaiha said. Injections with semaglutide (Ozempic), a glucagon-like peptide 1 (GLP-1) receptor agonist that is approved to improve glycemic control in adults with type 2 diabetes mellitus, is leading the charge.

Tirzepatide (Mounjaro) may be even more effective, Dr. Sharaiha said. The FDA approved the drug last year to improve blood sugar control in adults with type 2 diabetes and was fast-tracked in October for the treatment of adults with obesity, or who are overweight with weight-related comorbidities.

Medications provide add-on benefits to many patients who have been treated with intragastric balloons or endoscopic sleeve gastroplasty, Dr. Sharaiha said.

Also lifestyle and education should not be neglected, said Dr. Gunaratnam, who lost 50 pounds by changing his diet. He urged gastroenterologists to take on the challenge of treating obesity. It’s not the part of his practice with the best reimbursement, but it is the most satisfying. “I get more hugs, cards, and tears by doing this because when you change weight, you’re impacting every part of their lives,” he said.

Dr. Gunaratnam is the founder of Lean Medical LLC and Satya Health Sciences. Dr. Sharaiha has served as a consultant for Boston Scientific Corporation and Cook Medical Inc.

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