We have a completed 10-patient clinical trial of GERD patients. This trial showed promising safety and efficacy outcomes for our technology:
- No adverse events. No dysphagia (trouble swallowing). Post-operative pain medications were not prescribed or needed in any patients;
- 9 patients completed 12-month follow up. All 9 patients reported clinically significant improvement in symptoms, as evidenced by 50% or more improvement in their GERD-HRQL score (a standard validated questionnaire-based measure of GERD-related quality of life), at their last follow-up at 12 months;
- The mean heartburn score reduced from 20.6 to 3.1 (p-value <0.001) and the mean regurgitation score reduced from 9.3 to 0.9 (p-value 0.002);
- All 9 patients were able to reduce PPIs by more than 50%, and 7 out of 9 patients (78%) completely discontinued the use of PPIs.
Results of clinical study were published in the peer-reviewed journal Gastrointestinal Endoscopy.
In addition, our proprietary bulking agent has been successfully used in humans for over 15 years for other indications. The FDA first approved it in 1999 for the treatment of female stress urinary incontinence. Since then it has shown exceptional biocompatibility and a strong safety track record in many patients worldwide.
 Source: “A new injectable agent for the treatment of GERD”, Gastrointestinal endoscopy, Vol 69, 2009