This significant clearance enables Epitomee to market its weight loss and weight management treatment throughout the European Economic Area
Caesarea, Israel – Epitomee Medical, a biomedical company that develops unique swallowable device therapeutic platform used for metabolic disorders, announce today that its weight loss product received a CE mark. the Epitomee capsule Product , is now approved for commercialization in the European Union (EU) as a medical device indicated for weight loss in overweight and obese adults. Most recently, on August 6, this year, Epitomee Medical and Nestle announced that they have entered a strategic partnership for the commercialization of Epitomee’s weight loss product.
The CE mark indicates that Epitomee has been assessed as having met health and safety standards for products sold within the European Economic Area (EEA), as required by the European Medical Device Directives. The product will be commercialized by Nestle Health Science. Global market launch will take place right after The US FDA clearance.
The Epitomee capsule is an easy, self-administered weight loss treatment. The patient takes the capsule orally twice a day before meal. It can be taken at home, at work, or on the road. The capsule, protected by a wide range of patents, contains an expanding shape-shifting scaffold, triggered by the stomach’s pH level, which applies direct mechanosensory stimulation to the stomach. It induces early sensation of fullness and prolonged gastric emptying, bringing about an earlier termination of every meal, which in turn results in lower daily caloric intake and subsequent weight loss. The device is biodegradable, and its impact is transitory as it dissolves completely and leaves the body naturally within several hours after swallowing it. It is intended for the overweight and obese population that seeks effective, simple, and safe assistance in losing their extra weight.
“The Epitomee capsule treatment is backed by strong evidence in the form of several preclinical and clinical studies and now has a medical device registration and CE mark. Weight management is a huge and growing issue globally, and it is great to see that evidence-based innovative solutions like Epitomee’s are now being recognized and approved for the market,” says Epitomee Medical CEO Dan Hashimshony, PhD. “We look forward to beginning the strategic partnerships around our platform in the EU and around the world.”
“We are excited about the clinical results demonstrated with our Epitomee Capsule for overweight and obese patients,” states Epitomee Medical Co-Founder and Chairman Shimon Eckhouse, PhD. The CE mark brings the solution a step closer to making the capsule available as a first treatment option for clinical use throughout the EU for weight loss and recognizing the unique platform as a vehicle for a wide range of other medical applications.”
Clinical studies on the Epitomee capsule have demonstrated effective weight loss within 12 weeks of capsule use and improvement in glycemic control of prediabetic patients and their quality of life and by significantly reducing blood pressure levels in hypertension patients with an excellent safety profile.
About the Company
Epitomee Medical Ltd. is a privately held Bio-medical company based in Israel that has developed a proprietary, device-based solutions acting along the GI tract, utilizing self-ingested, transient, shapeshifting platforms and biologics remedies to achieve significant therapeutic outcomes in highly prevalent diseases
The Epitomee platform synergistically balances ingestible devices and the body’s natural mechanism to tackle some of today’s most prevalent chronic diseases. Epitomee’s first product is drug-free, self-administered shape-shifting Capsule which aims to prevent diabetes, address obesity-related comorbidities, and establish a healthier lifestyle. The company was co-founded by Shimon Eckhouse, PhD.