Good News! Tongee Medical's Gastric Bypass Stent System Has Obtained the Medical Device Registration Certificate in Brazil!

Recently, the self-developed Gastric Bypass Stent System of Tongee Medical was officially approved for market launch in Brazil. As the largest, most populous, and economically strongest country in South America, this approval not only reaffirms the clinical value and technological reliability of the system, but also marks Tongee Medical's completion of its core strategic footprint in South America—following Southeast Asia and the Middle East—establishing a cross-continental, systematic global business presence.

Brazil currently faces a heavy burden of obesity and metabolic diseases, with over 60% of the population being overweight. Related healthcare expenditures rank among the highest globally, creating an urgent clinical demand for endoscopic minimally invasive weight-loss therapies that lies between drug treatment and surgical intervention. The Gastric Bypass Stent System offers unique advantages: it is super minimally invasive, easy to use, repeatably implantable, and preserves anatomical structures. It can provide a brand-new treatment option for the vast number of local patients suffering from obesity and metabolic diseases.

Prior to this, Tongee Medical had already obtained market access in Ecuador and Colombia, achieving coverage of the core northwestern region of South America. With the Brazilian approval, a triangular strategic linkage among Ecuador, Colombia, and Brazil has now taken shape. Through mutual recognition of regional regulations, shared clinical experience, and joint distribution channels, the three markets can create synergistic effects and significantly reduce the cost of market expansion in neighboring countries. South America has thus become, after Southeast Asia, one of the core regions in the global expansion of Tongee Medical, with the most complete overseas layout and the largest coverage of the population.

From a global development perspective, Tongee Medical relies on its independently developed technological barriers to build a distinctive internationalization pathway featuring “domestic first launch, global simultaneous registration, and multi-regional clinical implementation”. In the future, Tongee Medical will simultaneously advance the iterative refinement of a diversified product pipeline, including the DTx digital chronic disease management platform and degradable intragastric balloon, providing safe, efficient, inclusive and accessible integrated solutions for obese and metabolic disease patients worldwide.