BAROnova launched a first-in-class novel design, non-surgical treatment device to treat obesity.
TransPyloric Shuttle device is a non-surgical weight loss treatment for individuals suffering from obesity. The device is approved for 12 months of treatment, under which the patients undergo lifestyle modification counselling to develop and maintain healthier habits.
The TPS device is retrieved endoscopically and relies on its mechanical structure to maintain its shape to keep it in the stomach as an intragastric balloon.
The device TPS is the size of a small peach (~5.6 cm in diameter), 85-90 per cent smaller than the fluid-filled balloons. Once in the 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.
The TPS's primary mechanism of action is delayed gastric emptying which is a known mechanism of weight loss.
FDA approved TPS based on a trial data, a randomised, double-blind and sham-controlled study that enrolled 302 patients from 9 investigational centres across the U.S. TPS helped patients to lose 3.4x more weight than the sham control group (9.5 per cent for the TPS group and 2.8 per cent for the control, p<0.0001) at the 12-month follow up.