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---A First-in-Class, Non-Surgical Solution for Obesity Approved for One-Year of Device Treatment, Offering Patients Potentially More Durable Weight Loss and Health Benefits
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SAN CARLOS, Calif., April 23, 2019 /PRNewswire/ -- BAROnova, Inc., a medical device company focused on the development of first-in-class non-surgical solutions for the treatment of obesity, announced today that the U.S. Food and Drug Administration (FDA) has approved the TransPyloric Shuttle® (TPS®) Device, a non-surgical weight loss solution for adult individuals suffering from obesity with a body mass index (BMI) of 30 to 40 kg/m2. The device is approved for up to 12 months of treatment, during which time patients undergo lifestyle modification counseling to help develop and maintain healthier habits. The TPS device is delivered and retrieved endoscopically and relies on its mechanical structure to maintain its shape to keep it in the stomach as opposed to traditional inflatable intragastric balloons. The constructed TPS is the size of a small peach (~5.6 cm in diameter), 85-90% smaller than the fluid-filled balloons. Once in stomach, it is designed to slow the passage of food so patients feel full sooner and stay full longer. The 12-month treatment duration is twice as long as intragastric balloons currently approved in the U.S. The longer treatment duration potentially allows patients the opportunity to achieve more durable lifestyle changes and health benefits. "Those of us who participated in the pivotal trial have the firsthand experience with the TPS device and were pleased with its patient outcomes. In addition to the clinically meaningful weight loss seen in the study group who received the device, we also observed cardio-metabolic improvements in that cohort. We are excited to see that the device is approved by the FDA and look forward to using it in our clinical practice," said Dr. Richard Rothstein, the Joseph M. Huber Professor and Chair of Medicine for the Dartmouth Geisel School of Medicine, and the lead investigator for the ENDObesity II study. Obesity is one of the biggest drivers of the healthcare costs in the U.S., currently estimated as much as $210 billion annually. Effectively treating this condition will have a substantial impact on controlling ever-increasing healthcare costs. "The vast majority of patients with obesity are left untreated today. Endoscopically delivered intragastric devices can help close the obesity treatment gap and offer alternative options for qualified patients who are not eligible, or unwilling, to undergo metabolic and bariatric surgery. The TPS device design addresses some of the limitations with the first-generation intragastric devices and offers longer treatment duration which is clinically attractive," commented Dr. Wayne English, Associate Professor of Surgery, Clinical Trial Research Director at Vanderbilt University Weight Loss Center, and a principal investigator for the ENDObesity II study. "FDA approval is a significant milestone for the company," said Lian Cunningham, M.D, PhD, Senior Vice President of Clinical Affairs and Regulatory Affairs of BAROnova Inc. "The TPS device is unique in its treatment efficacy and duration. Further validation of potential comorbidity benefits, like cardiometabolic improvement observed in the pivotal study, during the post-market phase may translate to important advantages in achieving healthcare coverage for the TPS device in the future. We look forward to bringing this new technology to patients and physicians." The approval of the TPS is based on data from its pivotal trial (ENDObesity® II study), a randomized, double-blind, and sham-controlled study that enrolled 302 patients from nine investigational centers across the United States. Patients treated with the TPS device on average lost 3.4x more weight when compared to the sham-control group (9.5% for the TPS group and 2.8% for the Control, p<0.0001) at the 12-month follow up. Approximately 67% of people treated with TPS lost 5% or more of their body weight, exceeding the study endpoint target of 50% (p<0.0001). Forty percent (40%) of people treated with TPS lost 10% or more weight (vs. 14% in sham-treated controls). A weight loss of 5% or more is considered clinically meaningful for achieving important health benefits. Improvements in blood pressure and other cardiometabolic risk factors as well as quality of life were also observed with TPS treatment. The most common adverse events among people treated with the TPS device were gastrointestinal events, such as stomach pain, nausea, vomiting, and dyspepsia, as expected with an intragastric device designed to treat obesity through delayed gastric emptying. About Obesity
Obesity is defined as a Body Mass Index (BMI) >30 kg/m2. Individuals with obesity are at increased risk of developing over 70 comorbid conditions including hypertension, hyperlipidemia, and type 2 diabetes. Obesity is a worldwide epidemic that has placed a major burden on healthcare systems globally. There are currently over 75 million adults in the United States with a BMI between 30-40 kg/m2 and over 600 million adults worldwide who are candidates for a safe and effective non-surgical therapy. About the TransPyloric Shuttle
The TransPyloric Shuttle is a novel device that is designed to be inserted and removed trans-orally using standard endoscopic techniques. It is mechanically constructed using solid silicone components and is not subject to inflation or deflation risks. The TPS/TPS Delivery Device is indicated for weight reduction in adult patients with obesity with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more obesity-related comorbid conditions and is intended to be used in conjunction with a diet and behavior modification program. The device is intended to reside in the stomach for 12 months. The TransPyloric Shuttle's primary mechanism of action is delayed gastric emptying which is a known mechanism of weight loss. About BAROnova, Inc.
BAROnova is a private medical device company that has developed a first-in-class non-surgical solution for obesity. BAROnova is headquartered in San Carlos, CA. For more information about the company, please visit  www.BAROnova.com . BAROnova, Inc., Contact:

BAROnova Announces FDA Approval of the TransPyloric Shuttle® (TPS®) Device

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Dive Brief:
FDA has granted premarket approval to BaroNova for a device to treat obesity that is inserted into the stomach, where it delays gastric emptying. It is removed after 12 months. The device, called the TransPyloric Shuttle system, is placed and removed through the mouth in an endoscopic procedure. Approval was based on the company's 270-patient pivotal study in which people treated with the device lost three times more weight on average than patients who had a sham procedure in the control group. Dive Insight:
Despite obesity prevalence at 39.8% in 2015-16, affecting about 93.3 million U.S. adults, according to the Centers for Disease Control and Prevention , therapeutic options have not made a dent. Stubbornly high rates globally show the need for an effective treatment, despite substantial public health efforts to address the problem. Optimism at the start of the decade about progress has been tempered, according to a 2018 editorial in the Journal of the American Medical Association. The AMA recognized obesity as a disease in 2013. Conditions linked to obesity include heart disease, stroke, Type 2 diabetes and some forms of cancer. When lifestyle modifications are not enough, physicians may prescribe weight-loss medications or suggest weight-loss surgery. BaroNova's system offers a non-surgical option. The device is indicated to treat obesity in patients with a body mass index of 30-40 kg/m2. The company's clinical study met its primary endpoints for percent total body weight loss 12 months after the procedure and the proportion of subjects in the treatment group achieving 5% total body weight loss. Approximately 67% of people treated with the device lost 5% or more of their body weight, exceeding the pre-specified performance target of 50%. Forty percent (40%) of those treated with the device lost 10% or more of their weight. The Mayo Clinic lists several surgical options to treat obesity. They include gastric bypass, in which the surgeon creates a pouch at the top of the stomach that is connected to the small intestine, allowing food and liquid to bypass most of the stomach. Other surgical approaches include gastric banding, where bands are placed at the top of the stomach to leave a small portion available for food. Biliopancreatic diversion and gastric sleeve procedures both involve removing part of the stomach. In 2015, FDA approved an implantable, vagus nerve blocking neuromodulation device from EnteroMedics, now known as ReShape Lifesciences. A pulse generator implanted under the skin in the abdomen sends electrical signals via wire leads and electrodes to the vagus nerve. Also in 2015, FDA approved two intragastric balloon devices sold by manufacturers ReShape and Apollo Endosurgery. In 2016, FDA approved a third balloon system, made by Obalon, that delivers three balloons in a swallowable capsule that are filled with air. In 2017, FDA alerted the public to complications with the liquid-filled devices, including four deaths tied to the Orbera balloon made by Apollo and one death linked to the ReShape balloon. Other device-based treatments on the market include Aspire Bariatrics' AspireAssist  that uses a surgically placed tube to drain some stomach contents and PureTech's edible hydrogel capsule, called Plenity , intended to create a feeling of fullness. Recommended Reading:

Obesity device to slow stomach emptying approved

MassDevice
BaroNova touts TransPyloric Shuttle pivotal study data
November 19, 2018
BaroNova  late last week released the primary results from the pivotal ENDObesityII study of its TransPyloric Shuttle device intended to treat obesity. Results from the trial were presented at the Obesity Week 2018 conference’s scientific sessions, the San Carlos, Calif.-based company said. “Obesity is a worldwide epidemic with up to 40% of adult Americans suffering from obesity and its associated co-morbidities. We need effective solutions that are safe and acceptable by physicians and by people who live with this chronic condition. The TransPyloric Shuttle represents the next generation of intragastric devices that was designed to address some of the undesirable side effects with the first-generation devices and offer longer treatment duration. Based on the successful results from this study, this treatment will likely find a very meaningful role in clinical practice, if approved by the FDA,” ENDObesity II lead investigator Dr. Richard Rothstein of the Dartmouth Geisel School of Medicine, who presented the results, said in a prepared statement. Investigators in the 302-patient ENDObesity II trial analyzed the safety and effectiveness of the TransPyloric Shuttle Device in treating obesity in patients with a body mass index of between 30-40kg/m2. The trial had primary endpoints of the percent of total body weight loss at one year follow-up post-procedure and the proportion of people in the treatment group who achieved 5% total body weight loss or more at one year, BaroNova said. Results indicated that patients treated with the investigational TPS device lost an average of three times more weight compared to the sham-control group at 9.5% versus 2.8%, respectively, at twelve months. Data also indicated that 67% of patients treated with the TPS system lost 5% or more of their body weight, which exceeded the pre-specified 50% target for the trial, BaroNova said. A total of 40% of people treated with TPS lost 10% or more weight, the company said, and those in the TPS arm of the study showed greater improvement in blood pressure and other cardiometabolic factors and improvements in their quality of life as compared with the control group. The most common adverse events in the trial were gastrointestinal events including stomach pain, nausea, vomiting and dyspepsia. “We are pleased to see the magnitude of weight loss and significant clinical benefit demonstrated in the study. Based on the positive pivotal study results, we have submitted the PMA application to the FDA. We would like to thank all our clinical investigators and their staff for their contribution to the success of this trial. We look forward to bringing this new technology to patients and physicians if approved by the FDA,” clinical & regulatory affairs senior VP Dr. Lian Cunningham said in a press release. Intuitive Surgical enjoyed a nearly two-decade monopoly in the robot-assisted surgery space. At DeviceTalks West, we'll delve into that history as longtime CEO Gary Guthart tells us how he got his start in medtech, how Intuitive came to enjoy such a commanding lead and what the future holds for medical robotics. In case you missed it
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BaroNova touts TransPyloric Shuttle pivotal study data

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BAROnova is a clinical-stage medical technology company developing endoscopically-delivered devices for the chronic treatment of obesity. The BAROnova technology focuses on slowing gastric emptying, a known mechanism of action for weight loss.

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Perseus Medical Technologies is an early-stage medical device company that is providing a portable endoscopic visualization solution for physicians

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