David Thrower, CEO of BAROnova added, "With the completion of pivotal trial enrollment, BAROnova has achieved an important milestone. Based upon our pilot clinical results, we are optimistic that the BAROnova TPS device will prove to be a safe, effective, non-surgical treatment for obese individuals with significant advantages in efficacy and duration of treatment. We look forward to bringing this important advancement in the treatment of obesity to market."
The ENDObesity II Study completed enrollment of 270 patients in 9 sites in the United States in December of 2016. The results from this study will be used to support an FDA application for TransPyloric Shuttle approval and subsequent domestic commercialization of the device.
About the TransPyloric Shuttle
BAROnova's novel weight-loss device, the TransPyloric Shuttle (TPS), is inserted and removed trans-orally using standard endoscopic techniques. In a previous feasibility study of the TPS, patients with a BMI of 30-40 kg/m2 demonstrated an average total body loss of 14.7% after six months. Over 100M people in the United States are classified as medically obese. If approved, the TransPyloric shuttle will be the first intra-gastric device with a twelve-month dwell time in the stomach, potentially leading to additional efficacy and duration of weight-loss.
About BAROnova, Inc.
BAROnova is a clinical-stage medical technology company developing devices for the treatment of obesity. BAROnova's technology focuses on slowing gastric emptying, a known mechanism of action for weight loss. BAROnova is headquartered in San Carlos, CA. For more information about the company, please visit www.BAROnova.com.
BAROnova, Inc., Contact:
David Thrower, CEO
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SOURCE BAROnova, Inc.