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

Rhea-AI Summary

Epitomee Medical (TASE: EPIT) has received FDA clearance for its Epitomee® Capsule, a novel ingestible weight management device for adults with a BMI of 25-40 kg/m². This drug-free prescription solution works mechanically by creating a 3D matrix in the stomach, promoting a feeling of fullness. The FDA clearance follows the successful RESET study, a randomized, double-blind, placebo-controlled trial involving 279 participants across 9 U.S. sites. Key findings include:

• Significantly better weight loss in the device group (P<0.0001)
• 55.5% of subjects achieved ≥5% weight loss at 24 weeks
• Favorable safety profile with no serious adverse device effects
• Improved quality of life for treated subjects

The company is now seeking strategic partnerships to bring this innovative product to the U.S. market.

Positive

• FDA clearance received for Epitomee® Capsule, expanding treatment options for weight management
• RESET study showed significantly better weight loss in the device group compared to control (P<0.0001)
• 55.5% of subjects achieved ≥5% weight loss at 24 weeks, exceeding the >35% threshold (P<0.0001)
• Favorable safety profile with no serious adverse device effects reported
• Improved quality of life observed in several items of the IWQOL-Lite-CT questionnaire
• Additional ELECT study demonstrated continued safety over 48 weeks

Negative

• None.

Insights

Medical Device Expert

The FDA clearance of Epitomee's ingestible capsule is a significant development in the weight management market. This drug-free, mechanical solution offers a novel approach for adults with BMI 25-40, addressing a broader patient population than many existing treatments. The capsule's mechanism, creating a 3D matrix in the stomach to induce fullness, is innovative and non-invasive.

The RESET study results are promising, with 55.5% of subjects achieving ≥5% weight loss at 24 weeks. The favorable safety profile and improved quality of life metrics are encouraging. However, long-term efficacy and safety data beyond 48 weeks will be important for widespread adoption. The potential market impact is substantial, offering an alternative to pharmaceutical interventions in the growing obesity treatment landscape.

Market Research Analyst

Epitomee's FDA clearance represents a strategic market entry in the competitive weight management sector. The capsule's positioning as a prescription, drug-free alternative to injectables could capture a significant market share, especially among patients seeking non-pharmacological options. The broad BMI range (25-40) targeted expands the potential user base considerably.

However, market success will hinge on pricing strategy, insurance coverage and physician adoption. The company's search for strategic partnerships suggests a focus on leveraging established distribution channels. The weight management market is projected to grow substantially and Epitomee's unique offering could disrupt current treatment paradigms if it can demonstrate long-term efficacy and cost-effectiveness compared to existing solutions.

Clinical Trial Analyst

The RESET study's design and execution appear robust, with its multi-center, randomized, double-blind, placebo-controlled approach enhancing result credibility. The 279-patient sample size across 9 U.S. states provides a good initial dataset, though larger studies may be needed to confirm findings. The statistically significant weight loss (P<0.0001) and high responder rate are impressive.

The 48-week ELECT study offers valuable extended safety data, a important factor for regulatory bodies and clinicians. However, the study's limitation to 3 sites may reduce its generalizability. Future research should focus on long-term efficacy, potential for weight regain after discontinuation and comparisons with other weight management approaches to establish Epitomee's place in treatment algorithms.

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.

CAESAREA, Israel, Sept. 16, 2024 /PRNewswire/ -- Epitomee Medical Ltd. (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/)

For partnership inquiries and more information about the Weight-management capsule - contact:
Mr. Alon Heth
VP Sales and Marketing
alon@epitomeemedical.com

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SOURCE Epitomee Medical

FAQ

What is the Epitomee® Capsule and what did it receive from the FDA?

The Epitomee® Capsule is an ingestible weight management device that received FDA clearance for use in adults with a BMI of 25-40 kg/m², to be used alongside diet and exercise.

How does the Epitomee® Capsule work for weight management?

The Epitomee® Capsule works mechanically by absorbing water in the stomach and creating a 3D matrix, which occupies volume and creates a sensation of fullness, enabling weight loss without any chemical activity.

What were the key results of the RESET study for Epitomee® Capsule (EPIT)?

The RESET study showed significantly better weight loss in the device group compared to control (P<0.0001), with 55.5% of subjects achieving ≥5% weight loss at 24 weeks. It also demonstrated a favorable safety profile with no serious adverse device effects.

How long was the Epitomee® Capsule (EPIT) tested in clinical trials?

The Epitomee® Capsule was tested in the RESET study for 24 weeks, and an additional ELECT study demonstrated continued safety over a 48-week period for some participants.