GI Therapies’ technology relates to the use of transcutaneous abdominal gastrointestinal stimulation (TAGS®) to deliver interferential electrical stimulation to the abdomen. The first indication for the product (Rhythm IC®) is to treat chronic constipation. The technology has been developed over more than seven years at the Murdoch Childrens Research Institute in Melbourne.
Rhythm.IC is a dedicated non-invasive electrical stimulation device and electrode positioning garment specifically designed for the treatment of chronic constipation. Rhythm.IC incorporates an electrical stimulation unit and the patented neXus® electrode positioning cable.
The product is simple to use, taking only a few minutes to locate on the lower abdomen after which the user is free to walk around or undertake daily tasks while the treatment is in session (30-60 minutes/day for 1-3 months).
After 1-3 months of using TAGS over the abdomen, a majority of patients show a clinically significant improvement in bowel function and quality of life measures. For many patients, the treatment has the prospect of being able to eliminate or significantly reduce their long-term dependence on laxatives or drugs, well after the treatment has stopped.
While the initial clinical trials were undertaken in children, the technology has been shown to be equally effective in adults. The technology is based on applying a comfortable level of electrical stimulation with a non-invasive medical device that is used by a patient at home.
Currently, GI Therapies is finalising the design, testing and preliminary production validation of a purpose designed device. The Company received CE Mark in 2016 and will be undertaking a number of post marketing trials in several European countries in 2017. A larger pivotal trial will be undertaken in the US in order to be able to seek marketing approval by the FDA within two years.
The technology is subject to patent applications either granted or pending in all major markets.