Epitomee Medical Announces FDA Clearance of its Capsule, Weight Management Device

Caesarea, Israel (ots/PRNewswire) - Epitomee's Ingestible Capsule, Offers a Safe
and Effective Prescription Solution for Adults with BMI of 25-40 looking for
Alternative Drug Free Solutions for Their Weight Management Needs alongside diet
and exercise.

Epitomee Medical Ltd. (https://epitomeemedical.com/) (TASE: EPIT), announced
that the United States Food and Drug Administration (FDA) has officially cleared
the Epitomee® Capsule, a cutting-edge ingestible medical device designed to
support weight management in adults with a Body Mass Index (BMI) of 25-40 kg/m²
alongside diet and exercise. This novel, drug-free treatment provides a new
option for millions of health-conscious individuals in the U.S.

The Epitomee® Capsule represents an innovative prescription option in weight
management solutions, offering a drug-free alternative that differs from
injectable treatments. With FDA clearance extending to adults with a BMI
starting at 25, Epitomee® Capsule is accessible to a broader range of patients
looking for tolerable and easy to use weight management solutions. The Epitomee®
device is encased in a standard size, self-administered ingestible capsule. Once
the Epitomee® Capsule is swallowed, and reaches the stomach it absorbs water in
the stomach and creates a three-dimensional matrix designed to occupy volume in
the stomach creating a sensation of fullness, enabling weight loss. The
Epitomee® Capsule mechanism of action is purely mechanical and does not involve
any chemical activity. The capsule works directly in the gastrointestinal (GI)
tract.

Epitomee® Capsule was cleared by the U.S. FDA following the RESET study: A
prospective, randomized, double-blind, placebo-controlled, multi-canter trial.
The study enrolled 279 overweight and obese adults with and without prediabetes.
All 9 sites enrolled in the study were in the US, located across 9 different
states. Eligible subjects were randomized to test or placebo arms. Subjects were
to take one capsule of the investigational device or placebo twice daily ,
alongside diet and exercise, for a period of 24 weeks. The study demonstrated
that both co-primary endpoints were successfully met. The RESET study
demonstrated significantly better weight loss among the device group compared to
the control group (P<0.0001). The co-primary endpoint of treatment responders
was also achieved: the rate of Epitomee treatment group subjects whose total
body weight was reduced by at least 5% at 24-weeks post randomization was 55.5%
(CI; 46.1-64.6), significantly exceeding the threshold of >35% (P<0.0001).

The study demonstrated a favourable safety profile of Epitomee® treatment
throughout the study duration. Epitomee® treatment was well tolerated, with
fewer patient dropouts in Epitomee® group than the control group. There were no
serious adverse device effects (SADEs) in the study. In addition, subjects
treated with Epitomee® showed better improvement in quality of life in several
items of the IWQOL-Lite-CT questionnaire.

The company also performed an additional study in 3 out of the 9 sites that
participated in the RESET study, the ELECT study. In this study subjects from
both the device group and the placebo group kept on taking the Epitomee® capsule
for an additional 24 week period. The study demonstrated a favourable safety
profile of Epitomee® treatment throughout the 48 weeks of the study duration for
subjects in the device group.

Shimon Eckhouse PhD co-founder and chairman of the board, commented on the
approval: "The FDA clearance of the Epitomee® Capsule marks a significant
milestone in the field of weight management. Its innovative approach offers a
safe and effective option for patients. The ability to manage weight through a
simple, drug free capsule opens up new possibilities for those seeking to
improve their health and quality of life."

Dan Hashimshony PhD, CEO of Epitomee Medical Ltd., commented: "We are proud to
have received FDA clearance for our Epitomee® weight management Oral, Drug-Free
solution. This achievement is the result of the innovative approach we have
taken to tackle the global obesity epidemic. Our capsule offers a safe,
effective, and drug-free solution to the many millions of individuals struggling
with weight management. As we move forward, we are eager to bring this
groundbreaking product to the U.S. market and seek strategic partnerships to
fully realize its commercial potential."

About Epitomee Medical Ltd. Epitomee Medical Ltd, a public company (TASE: EPIT),
co-founded in 2005 by Shimon Eckhouse, PhD and led by CEO Dan Hashimshony PhD.
Shimon co-founded Syneron Medical Ltd. (Nasdaq: ELOS), Lumenis (formally ESC
Medical) and co-founded Ventor Medical Technologies, which was acquired by
Medtronic. Dan was the founding CEO of Dune Medical Devices, a surgical oncology
company (acquired by Dilon Technologies). Prior to that, Dan was with
X-Technologies (acquired by Guidant in 2003) and Sela Semiconductor (acquired by
Camtek).

The company is a pioneering health solutions company, committed to advancing
innovative therapies. With focus on safety, efficacy, and improving quality of
life, Epitomee Medical strives to be at the forefront of transformative
healthcare solutions.

The company is advancing two major fields: weight management and biologic drug
delivery. In addition to its flagship weight management solution, Epitomee
Medical is developing a cutting-edge platform focused on the oral delivery of
biologics. This innovative platform is designed to transport drugs to the
absorption site with enhanced bioavailability.

For more information about Epitomee Medical Ltd., please visit Epitomee Medical
(https://epitomeemedical.com/) ( https://epitomeemedical.com/ )

For partnership inquiries and more information about the Weight-management
capsule - contact:

Mr. Alon Heth

VP Sales and Marketing

mailto:[e-mail]

Photo - https://mma.prnewswire.com/media/2506355/Epitomee_Medical.jpg

Logo - https://mma.prnewswire.com/media/2506356/Epitomee_Medical_Logo.jpg

View original content: https://www.prnewswire.co.uk/news-releases/epitomee-medic
al-announces-fda-clearance-of-its-capsule-weight-management-device-302249169.htm
l

Contact:

[phone]

Additional content: http://presseportal.de/pm/173166/5865806
OTS: Epitomee Medical