Business
Gelesis Approved to Market Plenity in Europe
Gelesis Approved to Market Plenity in Europe.
About this update from Puretech Health Plc
[{"type":"text","content":"\n \n \n RNS Number : 6078O\n PureTech Health PLC\n 02 June 2020\n \n \n \n \n 2 June 2020\n \n \n PureTech Health plc\n \n \n \n \n \n PureTech Founded Entity Gelesis Receives Approval to Market PLENITY™ in Europe as a Weight Loss Treatment\n \n \n \n \n \n CE Mark enables Gelesis to market Plenity™throughout the European Economic Area \n \n \n \n \n \n \n \n PureTech Health plc\n \n \n (LSE: PRTC) (\"PureTech,\" or the \"Company\"), a clinical stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, \n is pleased to note that its Founded Entity, Gelesis, today announced that it has received \n approval to market Plenity™, a novel weight loss treatment, in Europe. Gelesis received a Conformité Européenne (CE) mark for Plenity as a class III medical device indicated for weight loss in overweight and obese adults with a Body Mass Index (BMI) of 25-40 kg/m2, when used in conjunction with diet and exercise. Gelesis will now be able to market Plenity throughout the European Economic Area and in other countries that recognise the CE mark. Gelesis previously received clearance for Plenity from the US Food and Drug Administration and plans to bring Plenity to the US first, where it is now available to a limited extent while the company ramps up its commercial operations and inventory for a broad launch in 2021.\n \n \n \n \n \n Eric Elenko, PhD, chief innovation officer at PureTech, said: \"This is an important milestone for Gelesis and for the millions of adults across Europe who are seeking to manage their weight. We look forward to continued progress from Gelesis' novel hydrogel platform and to the broad launch of Plenity across of the world.\"\n \n \n \n \n The full text of the announcement from Gelesis is as follows:\n \n \n Gelesis Receives Approval to Market PLENITY™ in Europe as a Weight Loss Treatment\n \n \n \n \n \n CE Mark enables Gelesis to market Plenity™throughout the European Economic Area \n \n \n \n \n BOSTON, \n \n \n June 2, 2020 \n \n - \n \n \n Gelesis\n \n \n , a biotechnology company developing a novel hydrogel platform technology to treat obesity and other chronic diseases related to the gastrointestinal (GI) tract, announced today that it has received approval to m...