BAROnova, Inc. issued the following announcement on April 23.
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 billionannually. 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.
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.
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