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.
Dr. Richard Rothstein, Dartmouth Geisel School of Medicine