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Product approval

BAROnova gains FDA Approval for TransPyloric Shuttle Device

Non-surgical solution for obesity approved for one-year of device treatment, offering patients potentially more durable weight loss and health benefits

BAROnova has announced FDA approval for its the TransPyloric Shuttle (TPS) Device, a non-surgical weight loss solution for adult individuals with obesity with a BMI35.0-40.0 or a BMI of 30.0-34.9 with one or more obesity-related comorbid conditions and is intended to be used in conjunction with a diet and behaviour modification programme. 

TransPyloric Shuttle (TPS) 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 TransPyloric Shuttle's primary mechanism of action is delayed gastric emptying which is a known mechanism of weight loss.  Once in place, the TransPyloric Shuttle may cause a patient’s stomach to fill up faster, stay full longer, and potentially delay gastric emptying, which is a known mechanism of action for weight loss. The device is approved for up to 12 months of treatment, during which time patients undergo lifestyle modification counselling 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 (~5.6cm 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 US. 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,” 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. “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."

The approval of the TPS is based on data from its pivotal trial (ENDObesity II study), a randomised, double-blind, and sham-controlled study that enrolled 302 patients from nine investigational centres across the US. Patients treated with the TPS device on average lost 3.4 time more weight when compared to the sham-control group (9.5% for the TPS group and 2.8% for the control group, p<0.0001) at the 12-month follow up.

"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,” added 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.     “The TPS device design addresses some of the limitations with the first-generation intragastric devices and offers longer treatment duration which is clinically attractive."

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.”

"FDA approval is a significant milestone for the company," said Dr Lian Cunningham, 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."

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