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CAESAREA, Israel, March 7, 2024 /PRNewswire/ -- Epitomee® (TASE: EPIT) announced today that on February 27, 2024, it has submitted its Weight Loss Capsule for FDA clearance in the USA, reaching a significant milestone in the company's journey.
The Epitomee® capsule offers an innovative, orally administered, drug free, and clinically proven as effective and safe solution, for adults, who are looking to lose weight. The proposed indication covers the broadest Body Mass Index (BMI) range of 25 to 40 kg/m2, even without comorbidities, when used in conjunction with diet and exercise.
This submission is via the 510k regulatory pathway for medical devices. Notably, the Epitomee® capsule has already received approval in the European Union and bears a CE mark. Upon FDA approval, the capsule will become available by prescription from healthcare professionals.
"The Epitomee® capsule represents a significant enhancement to the arsenal for weight management" said Prof. Donna Ryan, former president of the World Obesity Federation. "It is an effective and safe treatment for overweight & obesity, promoting weight loss and improvement in Quality of Life. It offers a promise in prevention of progression of diabetes in persons with pre-diabetes and is associated also with improvements in blood pressure, lipids and waist circumferences. Given its outstanding safety record, the favourable risk-to-benefit ratio underscores its importance as a viable option for broad application".
"We are excited to announce the filing of our Weight Loss Capsule data for FDA," said Dr. Dan Hashimshony, CEO of Epitomee Medical. "This is another step towards commercialization in the US. We are eager to introduce this groundbreaking innovation to healthcare professionals and consumers in the near future and to expand our market reach through additional global commercial partnerships."
This announcement follows the company's announcement (January 16, 2024), on successful completion of the RESET pivotal clinical trial –randomized, placebo controlled, double blind trial, that investigated the safety and efficacy of Epitomee® capsule versus sham capsule control, alongside lifestyle interventions, for reducing body weight, in overweight or obese adults without comorbidities.
About Epitomee®:
Epitomee® is a pioneering health solutions company, committed to advancing innovative therapies. With focus on safety, efficacy, and improving quality of life, Epitomee® strives to be at the forefront of transformative healthcare solutions.
Epitomee® is a public company (TASE: EPIT)
The Epitomee® capsule is not yet available for sale.
For inquiries and partnership opportunities contact:
Safi Landskroner VP BD & Marketing
safi@epitomeemedical.com