We know that early weight loss predicts long-term success, and we know that weight loss in the range of 5 to 10% is associated with multiple health benefits. We defined early responders as patients taking Epitomee^® who lost 2% or more of their weight at 8 weeks. For those responders, weight loss was 9.3% at 24 weeks¹. This allows patients and their healthcare providers to determine if Epitomee^® is likely to produce significant weight loss by providing an early marker of success.

Early response helps avoid unnecessary expenses and time investment.

Patients taking Epitomee^® lost more weight than those taking the identical-looking placebo capsule while following the lifestyle program. We found that Epitomee^® is a weight loss treatment to help patients with overweight and obesity who want to improve their lifestyle.

When patients are trying to lose weight through diet and physical activity, Epitomee^® can help support weight loss safely. Most reported side effects were mild and similar to those seen placebo. We also know that weight loss is associated with several important health benefits, including improvements in hypertension and lab results. Additionally, patients who lost weight reported enhancements in their quality of life. Furthermore, we have observed significant improvements in individuals with prediabetes, including a notable decrease in insulin and HbA1c levels. Participants at risk of metabolic syndrome achieved an average weight loss of 8.3% within 24 weeks. One significant advantage of Epitomee^® over other treatments is that it is not associated with any adverse reactions greater than those observed with placebo, making it an excellent option that won't interfere with your daily routine.

Patients treated with Epitomee^® Capsules also reported that the capsule promotes feelings of fullness, making it easier to control their appetite. Because it promotes fullness, it reduces meal size and helps reduce snacking.

No safety signal or any significant adverse events were identified. The studies demonstrated a favorable safety profile with no device-related serious adverse events (SAEs) and no significant differences in the incidence of treatment-emergent adverse events (AEs) between the Epitomee and the placebo groups.

No potential interactions between the Epitomee^® capsule and other medications commonly used by obese patients (e.g., patients who used antihypertensives, diabetes medications) were observed based on in vitro lab testing and the pivotal clinical study.

Epitomee^® Capsule offers a distinct approach in the overweight and obesity treatment landscape. While it doesn't directly compete with pharmacological or surgical interventions, it provides a unique solution addressing a different patient profile and treatment philosophy. Surgical solutions are designed for a different target audience. Key differences include its non-surgical nature and its physiological approach. Unlike chemical solutions that alter the body's natural functions, Epitomee^® works in harmony with the body's processes. In essence, Epitomee^® fills a crucial gap in the obesity treatment spectrum, offering a safe, well-tolerated option for those who may not require or desire more intensive interventions, yet seek effective weight management support. This positions Epitomee^® as a versatile solution in the continuum of care for weight management.

Because Epitomee^® is not a drug, it is not absorbed. And because it contains only a small amount of hydrogel that stimulates stomach mechano-receptors and satiety, it has a favorable safety profile. There were no differences in reported side effects (not even GI-related) between Epitomee^® and placebo groups, even with extended use (48 weeks)².

1. Low-Risk: Designed to provide effective results with low risk (similar safety profile to the control group) and with no related SAEs.
2. Safe and Reliable: Developed with the highest safety standards in mind.
3. Extended use (tested in a 48-week study)²: Even with extended use, the favorable safety profile is maintained.
4. Minimal Side Effects: Side effects are similar to those of placebo-treated patients and are generally mild.
5. Gentle on Digestion: Minimal gastrointestinal (GI) discomfort was reported, similar to placebo-treated patients, according to the product labeling.

Another study with Epitomee^® looked at what happens when we continue Epitomee® beyond 6 months. Participants who lost weight with Epitomee^® after 24 weeks of treatment, continued treatment for additional 24 weeks and maintained an 11.2% weight loss². Meanwhile, those who lost a moderate amount of weight through lifestyle changes added Epitomee^® treatment for an additional 24 weeks, resulting in further weight loss and achieving a total weight loss of 7.5%². This weight loss reduction was accompanied by improvements in waist circumference, quality of life and systolic blood pressure at week 24, improvements that were maintained through week 48². Additionally, using Epitomee^® for 48 weeks was just as safe as short-term use². It was not associated with any increased adverse reactions and had zero reported serious adverse events (SAEs).

The Epitomee^® Capsule is an ingestible, transient, space-occupying device designed as a standard capsule for oral intake. The capsule expands in the stomach into a semi-rigid triangular scaffold, imitating solid food through its interaction with the stomach wall. The scaffold stays intact for several hours, then disintegrates completely into particles that are cleared naturally from the body. The oral capsule contains thousands of particles, contained in compartments, which can each hydrate many times their original weight to form a three-dimensional matrix designed to occupy volume in the stomach. The Capsule external Material is HPMC, making it Kosher, Hallal, and Vegan. Epitomee® capsule underwent biocompatibility assessment according to ISO 10993-1 requirements for a device having permanent (> 30 days) surface contact with mucosal membranes. All the biological endpoints have been addressed by biocompatibility studies and/or rationales, as the device components have a long and documented history of safe use. Endpoints considered include Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10 Oral Mucosal Irritation Study), and Genotoxicity (ISO 10993-3 Bacterial Reverse Mutation Test). Acute Systemic Toxicity, Sub-chronic Toxicity, Chronic Toxicity, Carcinogenicity, Material Mediated Pyrogenicity, and Implantation were waived by justification.

All potential side effects and risks were assessed during the design and development of the Epitomee^® Capsule product and were shown to be clinically insignificant. During the RESET pivotal clinical study for FDA clearance, more than 100,000 devices were taken by 138 participants, with no device-related serious adverse events. Since the Epitomee^® Capsule reacts in response to the stomach pH and is excreted naturally, the potential side effects or risks are minimal and comparable to those of the placebo. The Epitomee^® Capsule does not interfere with the natural process of ingestion and absorption, similar to food. The pivotal clinical study demonstrated that the adverse reactions reported in the Epitomee^® group were similar to those of the placebo group, indicating that the Epitomee^® mechanism of action does not affect potential side effects or risks³.

Epitomee^® is a solution for adults with overweight or obesity looking to manage their weight effectively.  

From a publication led by Professor Jamy Ard, The Epitomee^® Capsule is a non-systemic weight-loss device with a mechanical mechanism of action; therefore, there is a low risk of drug interactions or systemic side effects. Therefore, it may be a suitable option for individuals with overweight or obesity as an early intervention to attain moderate weight loss or for individuals with complicated medical histories and medication regimens that create numerous contraindications or potential interactions³.

The benefits are emphasized for some groups, for example:

BMI 25-30

For patients with a BMI between 25 and 30 kg/m², who have less severe obesity and fewer obesity-related complications, this can be considered the ideal time to start their weight loss journey. Patients should act early, before more significant weight gain occurs and before potential health risks, such as diabetes, high blood pressure, or high cholesterol, arise. This is the ideal stage to make a change, when treatments like injections are not yet approved for use or when injections are not yet suitable.

Women above 50 years of age

An important insight for women over 50 who are eligible for Epitomee^® treatment: This group often seeks effective weight loss solutions due to the natural weight gain that begins in perimenopause and continues through the years. A significant proportion of women undergoing the menopause transition report weight gain of 1–2 kg per year, despite no changes in the foods they eat or in their level of physical activity (Simpson et al., 2022).  The hormonal changes during menopause bring health risks, as they shift body fat storage, which is linked to increased cardiometabolic risk. Unfortunately, treatment options have been limited, particularly in the early stages of obesity. However, the Epitomee^® Capsule offers a promising solution. In the pivotal clinical study, women over 50 with overweight or obesity lost nearly 8% of their body weight within 24 weeks when combined with lifestyle interventions. Additionally, 56% of these women saw a significant improvement in their BMI category compared to baseline, making Epitomee^® a powerful option for those seeking long-term results [unpublished data].

Patients Seeking Non-Drug Treatments

For individuals who prefer non-drug solutions or wish to avoid the chemicals and side effects associated with traditional medications (like GLP-1s). This group may also include those with contraindications to obesity medications, subject to the judgment of a healthcare provider and in accordance with the instructions for use.

Patients Prioritizing Low-Risk Treatments

For individuals who prioritize safety and are looking for treatment with minimal risk. Epitomee^® has demonstrated a safety profile similar to a placebo, including comparable rates of gastrointestinal side effects, ensuring high tolerability and compliance.

Patients Focused on Short-Term Goal Achievement

For those aiming to achieve moderate weight loss goals within a short timeframe. This could include preparing for an event, such as a wedding or summer, or recovering after holiday indulgences. Epitomee^® supports moderate weight loss to help meet these milestones.

It’s an excellent tool to have in your treatment toolbox, with favorable safety, great tolerability, and proven efficacy for weight loss, and with a significant weight loss related positive impact on quality of life. The capsule is easy to use, ensuring high patient compliance. It’s a unique, non-drug solution for those looking to take early action against obesity, paired with lifestyle changes, before facing more serious health risks and daily life burdens. Perfect for the right patients at the right time, before severe obesity and severe complications have set it.  It’s an aid for those interested in investing in lifestyle change.