BAROnova® Announces the Results of ENDObesity® I Clinical Trial
New Non-Surgical Medical Device Achieves Surgical-Level Weight-Loss Results and Has the Potential to be Safer and More Cost-Effective than Bariatric Surgery
Goleta, Calif., April 22, 2013 /PRNewswire/ — BAROnova, Inc., recently presented data from their ENDObesity I clinical trial at the annual Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) meeting. During the study, which was conducted in Sydney, Australia, obese subjects with a BMI ranging from 30-50 kg/m2 were treated with BAROnova’s weight-loss device, the TransPyloric Shuttle® (TPS®). After six months, patients achieved an average excess weight loss (EWL) of 50%, while subjects in the BMI range of 30-40 kg/m2 achieved an even greater average EWL of 58%.
“The device was well tolerated and subjects were discharged home from an outpatient setting within two hours of TPS insertion without the nausea and discomfort that are typically experienced with intragastric therapies. The weight loss associated with the treatment was substantial and progressive, without a plateau, throughout the six-month study. The absence of a plateau in the treatment suggests that longer-term results may be comparable to surgical interventions,” said Dr. George Marinos, who was the primary investigator in the ENDObesity I clinical study and is currently a gastroenterologist at the Gastric Balloon & Lapband Australia clinic and the Prince of Wales Hospital, as well as a senior lecturer at the University of New South Wales. “The non-surgical placement and removal of the TPS device was straightforward and our patients expressed a high level of satisfaction with their weight-loss results and their overall experience.”
“We are extremely pleased with the weight-loss results from the ENDObesity I clinical trial,” said Hugh Narciso, Founder, President and CEO of BAROnova. “In addition, one participant entered the trial classified as an obese subject and six months later, at the time of TPS removal, this subject had a BMI of 24.9 kg/m2, which falls within the BMI range that is categorized as normal/healthy. The TPS device is a potent technology that has the capability to give a subject the power to hit the reset button in his or her life.”
BAROnova recently closed its Series C financing, raising more than $27.3M to fund further clinical studies.
About BAROnova, Inc.
BAROnova is a clinical-stage medical-technology company developing endoscopically-delivered devices for the chronic treatment of obesity. BAROnova is headquartered in Goleta, CA. For more information about the company, please visit www.BAROnova.com.
About the TransPyloric Shuttle
BAROnova’s novel weight-loss device, the TransPyloric Shuttle (TPS), is inserted and removed entirely through the mouth using standard endoscopic techniques. While in place, the device results in delayed gastric emptying, which may enable an overall reduction in caloric intake and weight loss by helping the subject feel full sooner (early satiation) and/or feel full longer (prolonged satiety/reduced hunger). The BAROnova TransPyloric Shuttle is not approved for sale by the US FDA or the Australian TGA. The data presented were obtained via an approved clinical study conducted in Australia.
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