Gelesis Receives Approval to Market PLENITY in Europe as a Weight Loss Treatment
Gelesis, 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 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.
“Seventy percent of the western world is affected by overweight or obesity and there are few non-invasive, non-systemic solutions without major risks,” says John Wilding, M.D., FRCP, a clinical researcher Obesity, Diabetes and Endocrinology at the University of Liverpool and the incoming president of the World Obesity Federation. “Through my participation in the clinical trial, I saw firsthand the impact Plenity can have. The CE mark will further broaden access to a weight loss option that can impact tens of millions of patients globally.”
The CE mark indicates that Plenity has been assessed to meet health and safety standards for products sold within the European Economic Area (EEA), as required by the European Medical Device Directives. Gelesis will now be able to market Plenity throughout the EEA and in other countries that recognize the CE mark.
“Obesity is a global public health crisis, and too many individuals have struggled to lose weight on their own, without an effective therapeutic intervention to help them. We believe Plenity is a highly differentiated option for this serious public health issue,” said Yishai Zohar, founder and chief executive officer of Gelesis. “Receiving the CE mark is an important milestone for the Gelesis team and for our hydrogel technology platform.”
Gelesis plans to bring Plenity to the U.S. first, where it is now available by prescription to a limited extent while the company ramps up its commercial operations and inventory for a broad launch in 2021.
Neha writes articles on sectors including medicine, food, materials, and science & technology. A qualified statistician, she has the ability to observe and analyze the trends in global markets and write compelling articles that help CXOs in decision making. She is a bookworm and loves to read fiction, lifestyle, science and technology. Neha comes with 6 years of experience in content writing and editing that involves blog writing, preparation of study materials and OERs.