Trial Watch: BaroNova Touts TransPyloric Shuttle Pivotal Study Data

Nov 22, 2018 | Obesity, Obesity Device, Positive Results

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Fink Densford from MassDevice reports that BaroNova, a clinical-stage medical-device venture developing non-surgical non-pharmacologic devices to induce weight loss. The San Carlos, CA-based company to date as raised over $85 million. The device clinical sponsor released primary results from its pivotal ENDObesityII trial of its TransPyloric Shuttle device intended to treat obesity.

The 302-patient trial analyzed safety and effectiveness of the TransPyloric Shuttle Device in treating obesity in patients with a body mass index of between 30-40kg/m2. The company reported that the trial 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 percent versus 2.8 percent, respectively, at twelve months. Data also indicated that 67 percent of patients treated with the TPS system lost 5 percent or more of their body weight, which exceeded the pre-specified 50 percent target for the trial. Based on the positive pivotal study results, the company has submitted the PMA application to the FDA.

Lead Research/Investigator

Dr. Richard Rothstein, Dartmouth Geisel School of Medicine

 

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