GDS

Project "GDS" data sheet

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 Project objective

With nearly 15% of the current population over 18 years old obese, obesity is on the verge of becoming a global pandemic. Obesity can lead to serious health issues, like diabetes, coronary heart diseases and several types of cancers. Each year obesity related conditions cost globally over €1.7 trillion and cause almost 2.8 million deaths a year. It is estimated that the EU spends almost 7% of their GDP in obesity treatments. Current gold standard for weight loss is effective, but extremely expensive and has life-threating side-effects. The GDS is an innovative non-surgical procedure for weight loss, that is reversible, it is 7 times cheaper than the golden standard (RYGB) and almost 4 times cheaper than alternative procedures, and can be done in 30 minutes without hospitalization time or the need of big surgical team. The GDS is composed of a polymeric flexible sleeve inserted in the duodenum with a patented anchoring system to stop the sleeve from migrating to the small intestine. The sleeve prevents weight gain through malabsorption of calories and the anchor increases the satiety sensation in the user. Allevetix has already performed successful pre-clinical trials on animals. Within the overall innovation project Allevetix requires to miniaturize the GDS; conduct a First in Human safety clinical trial, and safety and efficacy Pivotal Clinical trial; setup a production line with an external CMO; obtain the CE mark; and prepare a sound commercialization and got-to-market strategy.