SAN CARLOS, Calif., Jan. 25, 2017 /PRNewswire/ -- BAROnova, Inc., announced completion of its randomized cohort enrollment in the ENDObesity II Study, a multicenter randomized pivotal clinical trial designed to test the safety and effectiveness of the TransPyloric Shuttle® (TPS®), which treats obesity.
Richard Rothstein, MD, the lead investigator of the study and the Joseph M. Huber Professor and Chair of the Department of Medicine at the Geisel School of Medicine at Dartmouth in Hanover, NH and a gastroenterologist and Chief Academic Officer at the Dartmouth-Hitchcock Medical Center, said, "This is the first non-surgical weight-loss device inserted into the stomach for a year-long residence time in US pivotal studies. The TPS device is easily endoscopically placed and removed. The pilot data showed that this device was well tolerated by individuals who received it with impressive weight loss results. We await the full analysis of this randomized trial to verify its safety and efficacy. The TPS device has great potential for widespread clinical use."
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 ShuttleBAROnova'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+1-650-638-9796 [email protected]
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Richard Rothstein, MD, the lead investigator of the study and the Joseph M. Huber Professor and Chair of the Department of Medicine at the Geisel School of Medicine at Dartmouth in Hanover, NH and a gastroenterologist and Chief Academic Officer at the Dartmouth-Hitchcock Medical Center, said, "This is the first non-surgical weight-loss device inserted into the stomach for a year-long residence time in US pivotal studies. The TPS device is easily endoscopically placed and removed. The pilot data showed that this device was well tolerated by individuals who received it with impressive weight loss results. We await the full analysis of this randomized trial to verify its safety and efficacy. The TPS device has great potential for widespread clinical use."
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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 ShuttleBAROnova'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+1-650-638-9796 [email protected]
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SOURCE BAROnova, Inc.
