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BOSTON – At the 2018 AGA Tech Summit, this year’s Shark Tank line up included an automated system for video capture of endoscopy, a feeding tube that prevents aspiration in intubated patients, a tool to accurately measure polyps captured on colonoscopy, a device that targets gastrointestinal cancers with electrical pulses, and a new method for real-time stool testing of infectious pathogens.
In each case, the presenting entrepreneur vowed to the Shark Tank panel of experts that their innovation is addressing an important clinical need. In announcing the winner, V. Raman Muthusamy, MD, who is the chair of the AGA Center for GI Innovation and Technology (CGIT) and director of interventional endoscopy and general GI endoscopy, David Geffen School of Medicine at UCLA, Los Angeles, said, “We have rarely had such a strong group of candidates.”
New for 2018, both the Sharks and AGA Tech Summit attendees voted on a winner. The unanimous winner was Chang-Hee Kim, PhD, who presented a new rapid test for identifying infectious pathogens in stool. The sharks were looking for 1. Novelty/immediate patient impact, 2. Business plan, and 3. Pitch. While all of the participants were close, the immediate patient impact for Dr. Kim’s innovation gave him a leg up on his competitors.
New device permits real-time stool sample analysis
A new tool for rapid analysis of stool for pathogens may be revolutionary in that it can provide results within 15 minutes rather than the days normally required when stool samples are sent to a laboratory, according to Dr. Chang-Hee Kim, chief executive officer of GoDx, Inc. The patent-pending methodology developed at Dr. Kim’s company permits real-time analysis “at the point of need and without the need for a lab.” In addition to the efficiency, the paper-based test, which Dr. Kim compared to a pregnancy test in that there is a color change with positive results, has the potential to improve outcomes.
Real-time testing “will decrease the loss of patients to follow-up and accelerate the time to treatment,” Dr. Kim asserted. “The test is also likely to reduce the spread of nosocomial pathogens if rapid infection control reduces spread.”
The test, which Dr. Kim expected to be made available at a cost of $100, will also be substantially cheaper than current laboratory analyses. In experimental studies, the accuracy has been at least as accurate as polymerase-chain reaction (PCR) testing, according to Dr. Kim. He sees applications not only in hospitals but at sites where ordering laboratory studies are not normally available, such as on cruise ships, in nursing homes, or in the military.
In the Shark Tank session, the main concerns expressed were about how this test will fit with Clinical Laboratory Improvement Amendments (CLIA) compliance. Herb Lerner, MD, a former officer in the Food and Drug Administration (FDA) and now senior director of medical and regulatory affairs at Hogan Lovells, a Washington, D.C.–based law firm, urged Dr. Kim to approach the FDA as soon as possible for advice on how to address this and other potential obstacles to a commercial product.
GI endoscopy capture, storage, and sharing
In introducing an automated method of capturing videos taken during colonoscopy, Matthew Z. Schwartz, the cofounder of Virgo Surgical Video Solutions, Inc. said, “There is currently no low-cost, user-friendly way to systematically capture GI endoscopy video.” Relative to existing products that “require complicated formatting and time-consuming setup for each procedure recording,” the plug-and-play system developed at Virgo “works with any existing endoscopy system that has a video output.” The videos are designed for cloud storage.
“Our long-term vision is to create the largest and highest quality repository of GI endoscopy videos,” said Mr. Schwartz, who added that support tools, including clinical decision-making aided by artificial intelligence, are being developed to provide even more value for quality control, research, and training.
Several Sharks, including Tom Shehab, MD, managing director, Arboretum Ventures, Ann Arbor, Mich., asked for more information about the value proposition for a proposed cost of $500 per month for the system. The answer was that this value would differ for settings, such as in an academic center that might apply the system for training relative to a community setting where the main purpose might be quality improvement.
New NG tube addresses aspiration risk
Pulmonary aspiration, along with symptomatic gastric reflux, is a common clinical challenge in intubated patients on a feeding tube, but a novel nasogastric (NG) tube equipped with a dual balloon system is designed to solve this problem, according to Talal Sharaiha, MD, the founder of Aspisafe Solutions. He said that reducing the risk of aspiration is important because it is associated with pneumonia, erosive inflammation, and upper GI bleeding. He called it the most common cause of upper GI bleeding in intensive care units.
Of the two balloons, one serves as an anchor and sits in the esophagus. The other serves as an anti-aspiration reservoir and sits in the stomach. The anti-aspiration balloon, inflated after it is inserted in the stomach, blocks reflux of gastric contents. Contending that there is a large market for this device, Dr. Sharaiha said, “having a feeding tube in intubated patients that prevents gastric reflux and aspiration will dramatically reduce complications and likely help reduce length of ventilation time, ICU time, and length of hospitals stay.”
More than one Shark requested more information about safety. Michael L. Kochman, MD, the Wilmott Professor of Medicine and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, Philadelphia, noted that there have been adverse experiences in the past with other types of balloon devices introduced into the GI tract. He indicated that this may be a potential bar to clinician comfort, so a comprehensive approach to safety analyses should be a priority in clinical development.
Virtual tape measure for colonoscopy measures polyp size
There are risks from the current practice of estimating polyp size, according to Avishay Sidlesky, founder of VTM Technologies, Ltd. He called these estimates “inherently inaccurate” and asserted that they “lead to erroneous diagnoses, suboptimal treatment and follow-up.” He believes that a “virtual tape measure” dependent on an endoscopic laser emitter solves this problem and cited a published paper that confirmed the accuracy of polyp measurements conducted with this device in an animal model.
“Employing dedicated software that analyzes the laser curves in the endoscopic image, the system enables reporting of the size of lesions, diameter and profile of polyps, longitudinal cross-section of lumens and more,” Mr. Sidlesky reported, specifying that the tool can be used alone or integrated into third party endoscopes. He believes applications can eventually be developed for a variety of endoscopic procedures in addition to colonoscopy.
Of Shark comments, several regarded concern about how this measuring tool would be integrated with existing endoscopic systems. Even though the measuring tool can be introduced in an unused channel of available scopes, the image is displayed separately. Michael J. Docktor, MD, clinical director of innovation, Boston Children’s Hospital, cautioned that devices that add steps to the workflow in the endoscopy suite may not be as rapidly accepted as one in which the tool is totally integrated with existing systems.
New device treats esophageal cancers with electroporation
There are a variety of tools to treat upper GI cancers endoscopically, including with radiofrequency ablation, cryotechnology, and photodynamic therapy, but morbidity rates are high, according to Declan Soden, founder of Mirai Medical. He described the attributes of a new technology based on electroporation in which electrical pulses painlessly target neoplastic tissue while preserving adjacent healthy tissue. He said that the treatment is performed in a matter of minutes on an outpatient basis.
“Clinical results to date have demonstrated the benefit of the technology in the treatment of late-stage esophageal and colorectal disease,” Mr. Soden said. He believes that the “unique selling point” of this electroporation treatment, which is part of a complete treatment regimen, “is that it renders tumor tissue leaky or porous, allowing absorption and uptake of drugs.” Relative to current standards, the treatment has multiple advantages, not least of which is preservation of quality of life, he believes.
The Sharks posed many technical questions about this strategy that might narrow the applicability of this device. For example, Trey Reed, MD, medical director, Humana Inc., posed questions about the depth of penetration of the electoral pulses and where they can be adjusted for tumors of different sizes. He also questioned whether the device will be too large to penetrate lumens obstructed by tumor. Although Mr. Soden believes that the device will be versatile, he acknowledged that its role might be better understood when phase 2 trials begin later this year.
A moderator at the Shank Tank session and a previous CGIT Chair, Dr. Kochman reported that he was impressed with the crop of entries. As one of the creators of the AGA Tech Summit, Dr. Kochman has the experience to recognize good ideas when he hears them.
“It is gratifying to see the high quality of the Shark Tank presenters. Over the past years, a number of the presenting companies have gone on to obtain additional funding, be acquired, and on to successful launches,” Dr. Kochman observed. “We hope the same successes await this year’s group.”
BOSTON – At the 2018 AGA Tech Summit, this year’s Shark Tank line up included an automated system for video capture of endoscopy, a feeding tube that prevents aspiration in intubated patients, a tool to accurately measure polyps captured on colonoscopy, a device that targets gastrointestinal cancers with electrical pulses, and a new method for real-time stool testing of infectious pathogens.
In each case, the presenting entrepreneur vowed to the Shark Tank panel of experts that their innovation is addressing an important clinical need. In announcing the winner, V. Raman Muthusamy, MD, who is the chair of the AGA Center for GI Innovation and Technology (CGIT) and director of interventional endoscopy and general GI endoscopy, David Geffen School of Medicine at UCLA, Los Angeles, said, “We have rarely had such a strong group of candidates.”
New for 2018, both the Sharks and AGA Tech Summit attendees voted on a winner. The unanimous winner was Chang-Hee Kim, PhD, who presented a new rapid test for identifying infectious pathogens in stool. The sharks were looking for 1. Novelty/immediate patient impact, 2. Business plan, and 3. Pitch. While all of the participants were close, the immediate patient impact for Dr. Kim’s innovation gave him a leg up on his competitors.
New device permits real-time stool sample analysis
A new tool for rapid analysis of stool for pathogens may be revolutionary in that it can provide results within 15 minutes rather than the days normally required when stool samples are sent to a laboratory, according to Dr. Chang-Hee Kim, chief executive officer of GoDx, Inc. The patent-pending methodology developed at Dr. Kim’s company permits real-time analysis “at the point of need and without the need for a lab.” In addition to the efficiency, the paper-based test, which Dr. Kim compared to a pregnancy test in that there is a color change with positive results, has the potential to improve outcomes.
Real-time testing “will decrease the loss of patients to follow-up and accelerate the time to treatment,” Dr. Kim asserted. “The test is also likely to reduce the spread of nosocomial pathogens if rapid infection control reduces spread.”
The test, which Dr. Kim expected to be made available at a cost of $100, will also be substantially cheaper than current laboratory analyses. In experimental studies, the accuracy has been at least as accurate as polymerase-chain reaction (PCR) testing, according to Dr. Kim. He sees applications not only in hospitals but at sites where ordering laboratory studies are not normally available, such as on cruise ships, in nursing homes, or in the military.
In the Shark Tank session, the main concerns expressed were about how this test will fit with Clinical Laboratory Improvement Amendments (CLIA) compliance. Herb Lerner, MD, a former officer in the Food and Drug Administration (FDA) and now senior director of medical and regulatory affairs at Hogan Lovells, a Washington, D.C.–based law firm, urged Dr. Kim to approach the FDA as soon as possible for advice on how to address this and other potential obstacles to a commercial product.
GI endoscopy capture, storage, and sharing
In introducing an automated method of capturing videos taken during colonoscopy, Matthew Z. Schwartz, the cofounder of Virgo Surgical Video Solutions, Inc. said, “There is currently no low-cost, user-friendly way to systematically capture GI endoscopy video.” Relative to existing products that “require complicated formatting and time-consuming setup for each procedure recording,” the plug-and-play system developed at Virgo “works with any existing endoscopy system that has a video output.” The videos are designed for cloud storage.
“Our long-term vision is to create the largest and highest quality repository of GI endoscopy videos,” said Mr. Schwartz, who added that support tools, including clinical decision-making aided by artificial intelligence, are being developed to provide even more value for quality control, research, and training.
Several Sharks, including Tom Shehab, MD, managing director, Arboretum Ventures, Ann Arbor, Mich., asked for more information about the value proposition for a proposed cost of $500 per month for the system. The answer was that this value would differ for settings, such as in an academic center that might apply the system for training relative to a community setting where the main purpose might be quality improvement.
New NG tube addresses aspiration risk
Pulmonary aspiration, along with symptomatic gastric reflux, is a common clinical challenge in intubated patients on a feeding tube, but a novel nasogastric (NG) tube equipped with a dual balloon system is designed to solve this problem, according to Talal Sharaiha, MD, the founder of Aspisafe Solutions. He said that reducing the risk of aspiration is important because it is associated with pneumonia, erosive inflammation, and upper GI bleeding. He called it the most common cause of upper GI bleeding in intensive care units.
Of the two balloons, one serves as an anchor and sits in the esophagus. The other serves as an anti-aspiration reservoir and sits in the stomach. The anti-aspiration balloon, inflated after it is inserted in the stomach, blocks reflux of gastric contents. Contending that there is a large market for this device, Dr. Sharaiha said, “having a feeding tube in intubated patients that prevents gastric reflux and aspiration will dramatically reduce complications and likely help reduce length of ventilation time, ICU time, and length of hospitals stay.”
More than one Shark requested more information about safety. Michael L. Kochman, MD, the Wilmott Professor of Medicine and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, Philadelphia, noted that there have been adverse experiences in the past with other types of balloon devices introduced into the GI tract. He indicated that this may be a potential bar to clinician comfort, so a comprehensive approach to safety analyses should be a priority in clinical development.
Virtual tape measure for colonoscopy measures polyp size
There are risks from the current practice of estimating polyp size, according to Avishay Sidlesky, founder of VTM Technologies, Ltd. He called these estimates “inherently inaccurate” and asserted that they “lead to erroneous diagnoses, suboptimal treatment and follow-up.” He believes that a “virtual tape measure” dependent on an endoscopic laser emitter solves this problem and cited a published paper that confirmed the accuracy of polyp measurements conducted with this device in an animal model.
“Employing dedicated software that analyzes the laser curves in the endoscopic image, the system enables reporting of the size of lesions, diameter and profile of polyps, longitudinal cross-section of lumens and more,” Mr. Sidlesky reported, specifying that the tool can be used alone or integrated into third party endoscopes. He believes applications can eventually be developed for a variety of endoscopic procedures in addition to colonoscopy.
Of Shark comments, several regarded concern about how this measuring tool would be integrated with existing endoscopic systems. Even though the measuring tool can be introduced in an unused channel of available scopes, the image is displayed separately. Michael J. Docktor, MD, clinical director of innovation, Boston Children’s Hospital, cautioned that devices that add steps to the workflow in the endoscopy suite may not be as rapidly accepted as one in which the tool is totally integrated with existing systems.
New device treats esophageal cancers with electroporation
There are a variety of tools to treat upper GI cancers endoscopically, including with radiofrequency ablation, cryotechnology, and photodynamic therapy, but morbidity rates are high, according to Declan Soden, founder of Mirai Medical. He described the attributes of a new technology based on electroporation in which electrical pulses painlessly target neoplastic tissue while preserving adjacent healthy tissue. He said that the treatment is performed in a matter of minutes on an outpatient basis.
“Clinical results to date have demonstrated the benefit of the technology in the treatment of late-stage esophageal and colorectal disease,” Mr. Soden said. He believes that the “unique selling point” of this electroporation treatment, which is part of a complete treatment regimen, “is that it renders tumor tissue leaky or porous, allowing absorption and uptake of drugs.” Relative to current standards, the treatment has multiple advantages, not least of which is preservation of quality of life, he believes.
The Sharks posed many technical questions about this strategy that might narrow the applicability of this device. For example, Trey Reed, MD, medical director, Humana Inc., posed questions about the depth of penetration of the electoral pulses and where they can be adjusted for tumors of different sizes. He also questioned whether the device will be too large to penetrate lumens obstructed by tumor. Although Mr. Soden believes that the device will be versatile, he acknowledged that its role might be better understood when phase 2 trials begin later this year.
A moderator at the Shank Tank session and a previous CGIT Chair, Dr. Kochman reported that he was impressed with the crop of entries. As one of the creators of the AGA Tech Summit, Dr. Kochman has the experience to recognize good ideas when he hears them.
“It is gratifying to see the high quality of the Shark Tank presenters. Over the past years, a number of the presenting companies have gone on to obtain additional funding, be acquired, and on to successful launches,” Dr. Kochman observed. “We hope the same successes await this year’s group.”
BOSTON – At the 2018 AGA Tech Summit, this year’s Shark Tank line up included an automated system for video capture of endoscopy, a feeding tube that prevents aspiration in intubated patients, a tool to accurately measure polyps captured on colonoscopy, a device that targets gastrointestinal cancers with electrical pulses, and a new method for real-time stool testing of infectious pathogens.
In each case, the presenting entrepreneur vowed to the Shark Tank panel of experts that their innovation is addressing an important clinical need. In announcing the winner, V. Raman Muthusamy, MD, who is the chair of the AGA Center for GI Innovation and Technology (CGIT) and director of interventional endoscopy and general GI endoscopy, David Geffen School of Medicine at UCLA, Los Angeles, said, “We have rarely had such a strong group of candidates.”
New for 2018, both the Sharks and AGA Tech Summit attendees voted on a winner. The unanimous winner was Chang-Hee Kim, PhD, who presented a new rapid test for identifying infectious pathogens in stool. The sharks were looking for 1. Novelty/immediate patient impact, 2. Business plan, and 3. Pitch. While all of the participants were close, the immediate patient impact for Dr. Kim’s innovation gave him a leg up on his competitors.
New device permits real-time stool sample analysis
A new tool for rapid analysis of stool for pathogens may be revolutionary in that it can provide results within 15 minutes rather than the days normally required when stool samples are sent to a laboratory, according to Dr. Chang-Hee Kim, chief executive officer of GoDx, Inc. The patent-pending methodology developed at Dr. Kim’s company permits real-time analysis “at the point of need and without the need for a lab.” In addition to the efficiency, the paper-based test, which Dr. Kim compared to a pregnancy test in that there is a color change with positive results, has the potential to improve outcomes.
Real-time testing “will decrease the loss of patients to follow-up and accelerate the time to treatment,” Dr. Kim asserted. “The test is also likely to reduce the spread of nosocomial pathogens if rapid infection control reduces spread.”
The test, which Dr. Kim expected to be made available at a cost of $100, will also be substantially cheaper than current laboratory analyses. In experimental studies, the accuracy has been at least as accurate as polymerase-chain reaction (PCR) testing, according to Dr. Kim. He sees applications not only in hospitals but at sites where ordering laboratory studies are not normally available, such as on cruise ships, in nursing homes, or in the military.
In the Shark Tank session, the main concerns expressed were about how this test will fit with Clinical Laboratory Improvement Amendments (CLIA) compliance. Herb Lerner, MD, a former officer in the Food and Drug Administration (FDA) and now senior director of medical and regulatory affairs at Hogan Lovells, a Washington, D.C.–based law firm, urged Dr. Kim to approach the FDA as soon as possible for advice on how to address this and other potential obstacles to a commercial product.
GI endoscopy capture, storage, and sharing
In introducing an automated method of capturing videos taken during colonoscopy, Matthew Z. Schwartz, the cofounder of Virgo Surgical Video Solutions, Inc. said, “There is currently no low-cost, user-friendly way to systematically capture GI endoscopy video.” Relative to existing products that “require complicated formatting and time-consuming setup for each procedure recording,” the plug-and-play system developed at Virgo “works with any existing endoscopy system that has a video output.” The videos are designed for cloud storage.
“Our long-term vision is to create the largest and highest quality repository of GI endoscopy videos,” said Mr. Schwartz, who added that support tools, including clinical decision-making aided by artificial intelligence, are being developed to provide even more value for quality control, research, and training.
Several Sharks, including Tom Shehab, MD, managing director, Arboretum Ventures, Ann Arbor, Mich., asked for more information about the value proposition for a proposed cost of $500 per month for the system. The answer was that this value would differ for settings, such as in an academic center that might apply the system for training relative to a community setting where the main purpose might be quality improvement.
New NG tube addresses aspiration risk
Pulmonary aspiration, along with symptomatic gastric reflux, is a common clinical challenge in intubated patients on a feeding tube, but a novel nasogastric (NG) tube equipped with a dual balloon system is designed to solve this problem, according to Talal Sharaiha, MD, the founder of Aspisafe Solutions. He said that reducing the risk of aspiration is important because it is associated with pneumonia, erosive inflammation, and upper GI bleeding. He called it the most common cause of upper GI bleeding in intensive care units.
Of the two balloons, one serves as an anchor and sits in the esophagus. The other serves as an anti-aspiration reservoir and sits in the stomach. The anti-aspiration balloon, inflated after it is inserted in the stomach, blocks reflux of gastric contents. Contending that there is a large market for this device, Dr. Sharaiha said, “having a feeding tube in intubated patients that prevents gastric reflux and aspiration will dramatically reduce complications and likely help reduce length of ventilation time, ICU time, and length of hospitals stay.”
More than one Shark requested more information about safety. Michael L. Kochman, MD, the Wilmott Professor of Medicine and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, Philadelphia, noted that there have been adverse experiences in the past with other types of balloon devices introduced into the GI tract. He indicated that this may be a potential bar to clinician comfort, so a comprehensive approach to safety analyses should be a priority in clinical development.
Virtual tape measure for colonoscopy measures polyp size
There are risks from the current practice of estimating polyp size, according to Avishay Sidlesky, founder of VTM Technologies, Ltd. He called these estimates “inherently inaccurate” and asserted that they “lead to erroneous diagnoses, suboptimal treatment and follow-up.” He believes that a “virtual tape measure” dependent on an endoscopic laser emitter solves this problem and cited a published paper that confirmed the accuracy of polyp measurements conducted with this device in an animal model.
“Employing dedicated software that analyzes the laser curves in the endoscopic image, the system enables reporting of the size of lesions, diameter and profile of polyps, longitudinal cross-section of lumens and more,” Mr. Sidlesky reported, specifying that the tool can be used alone or integrated into third party endoscopes. He believes applications can eventually be developed for a variety of endoscopic procedures in addition to colonoscopy.
Of Shark comments, several regarded concern about how this measuring tool would be integrated with existing endoscopic systems. Even though the measuring tool can be introduced in an unused channel of available scopes, the image is displayed separately. Michael J. Docktor, MD, clinical director of innovation, Boston Children’s Hospital, cautioned that devices that add steps to the workflow in the endoscopy suite may not be as rapidly accepted as one in which the tool is totally integrated with existing systems.
New device treats esophageal cancers with electroporation
There are a variety of tools to treat upper GI cancers endoscopically, including with radiofrequency ablation, cryotechnology, and photodynamic therapy, but morbidity rates are high, according to Declan Soden, founder of Mirai Medical. He described the attributes of a new technology based on electroporation in which electrical pulses painlessly target neoplastic tissue while preserving adjacent healthy tissue. He said that the treatment is performed in a matter of minutes on an outpatient basis.
“Clinical results to date have demonstrated the benefit of the technology in the treatment of late-stage esophageal and colorectal disease,” Mr. Soden said. He believes that the “unique selling point” of this electroporation treatment, which is part of a complete treatment regimen, “is that it renders tumor tissue leaky or porous, allowing absorption and uptake of drugs.” Relative to current standards, the treatment has multiple advantages, not least of which is preservation of quality of life, he believes.
The Sharks posed many technical questions about this strategy that might narrow the applicability of this device. For example, Trey Reed, MD, medical director, Humana Inc., posed questions about the depth of penetration of the electoral pulses and where they can be adjusted for tumors of different sizes. He also questioned whether the device will be too large to penetrate lumens obstructed by tumor. Although Mr. Soden believes that the device will be versatile, he acknowledged that its role might be better understood when phase 2 trials begin later this year.
A moderator at the Shank Tank session and a previous CGIT Chair, Dr. Kochman reported that he was impressed with the crop of entries. As one of the creators of the AGA Tech Summit, Dr. Kochman has the experience to recognize good ideas when he hears them.
“It is gratifying to see the high quality of the Shark Tank presenters. Over the past years, a number of the presenting companies have gone on to obtain additional funding, be acquired, and on to successful launches,” Dr. Kochman observed. “We hope the same successes await this year’s group.”
REPORTING FROM 2018 AGA TECH SUMMIT