Wellosophy Biotechnology and Eladiet S.A today announced the receipt of CE Mark 1254 authorizing the sale of SWELL - marketed as a Class IIa Medical Device under the tradename HydroSlim in all 27-member European Union countries.
Clearwater Beach, FL (PRWEB) March 13, 2017
SWELL is a multi-patented, ingestible, superabsorbent hydrogel technology specifically designed for weight loss. The approval comes on the heels of the successful, SHORT-1 Pivotal Trial (Superabsorbent Hydrogel for Obesity Reduction & Treatment) - an 8-week, Pivotal, Phase III, randomized, prospective, double-blind, placebo-controlled trial that evaluated 126 overweight and obese, otherwise healthy volunteers (38 men and 88 women) between the ages of 18 and 70. The SHORT-1 Trial is the largest clinical trial of its kind; and was led by Dr. Rafael Guerrero, Professor of Clinical pharmacology, nutrition and dietetics, University of Extremadura; University Center of Mrida. SHORT-1 demonstrated highly statistically significant and clinically relevant improvement in all three of the study's primary endpoints: Total Body Weight, Body Mass Index, and Abdominal Girth; with a mean placebo-adjusted weight loss of 13 lbs. in 8 weeks (p<0.0001) without the addition of diet, exercise, or other behavioral modifications. Of Note: all 63 participants (100%) in the HydroSlim group lost weight during the study period. No significant side effects or adverse events were reported.
Lior Sher, JD, Wellosophy's Founder, Chairman and CEO stated: "HydroSlim is an unprecedented scientific achievement spanning eleven years of development with SHORT-1 being our eleventh clinical trial. No other hydrogel for weight loss has been studied as extensively. The CE Mark culminates five years of intense pre-clinical and clinical development - working with some of the most highly-respected physicians and scientists in Europe. HydroSlim has demonstrated superior safety and effectiveness as a simple, sustainable, non-pharmaceutical, non-invasive solution to promote early satiety - the essential missing piece in the weight loss puzzle for most people struggling to lose weight. We believe that these important features will encourage physicians and their patients alike to adopt HydroSlim as the new standard for a first-line therapeutic option in their battle of the bulge.' SWELL is a category-creator.' It is currently sold under private labels in both Russia and Chile as a Class IIa Medical Device, and as a dietary supplement in other jurisdictions. We are privileged to work with an outstanding partner like Eladiet to expand our marketing efforts throughout the European Union."
Eladiet's CEO, Carla Gaya Boix, LLM, MBA, added: "We are proud to partner with Wellosophy in this venture. We loved the SWELL technology from the moment we saw it; and are honored to be the exclusive European Manufacturer of such a great product. Its clinical performance has exceeded all of our expectations. There really is nothing like it in the world. At long last, there appears to be a simple, safe and effective means for people to safely lose weight without feeling hungry. HydroSlim provides an elegant solution for a critical unmet medical need. Patients now have a clear choice that bridges the gap between side-effect laden drugs and expensive invasive surgery."
Dr. Richard Davis, MD, Wellosophy's President and Chief Science Officer explained: "SWELL is an ingestible, ultrapure, bioinert, hydrogel material that has been specifically designed to rapidly absorb hundreds of times its weight in water in the stomach. When consumed with a sufficient amount of pure water, 30 to 60 minutes prior to meals, the thousands of microbeads of SWELL in each capsule expand in the stomach to form what looks like a slurry of tiny caviar particles which collectively occupy a volume about the size of a large apple. As the microbeads expand, they trigger gastric stretch receptors in the stomach lining to engage the Leptin and Ghrelin hormone cascade which causes the brain to signal gastric fullness thus providing a sense of early satiety at mealtime. Our multiple international studies have consistently shown that patients from all cultures and dietary traditions can comfortably and reliably reduce their meal portions by anywhere from 35% to 50% without feeling deprived. This allows people to eat less without feeling hungry, so they sustainably lose weight slowly, safely and naturally. SWELL is indigestible and non-absorbable; which eliminates the potential for any significant side effects or adverse events. The soft slippery microbeads pass gently and naturally with the meal through the GI tract just like lentils, corn or other common indigestible foods. We are delighted that the EU regulators have provided their citizens with a powerful new tool to combat the obesity epidemic."
Wellosophy (Clearwater Beach, Florida) is a privately-held, US-based biotechnology company developing novel therapies that safely promote weight loss in overweight and obese patients. For more information, visit http://www.Wellosophy.com
Eladiet (Barcelona, Spain) is a leading European cGMP and CE-certified maker of Nutraceuticals and Medical Devices. For more information, visit cm.Eladiet.com
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Wellosophy and Eladiet Announce Receipt of the CE Mark for SWELL:A Proprietary, First-to Market, Ingestible ... - Benzinga
