Epitomee® announces the filing of a novel Weight Loss Capsule for FDA clearance
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
"The Epitomee® capsule represents a significant enhancement to the arsenal for weight management" said Prof.
"We are excited to announce the filing of our Weight Loss Capsule data for FDA," said Dr.
This announcement follows the company's announcement (
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@epitomeemedical.com
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