Epitomee Capsule: the new biodegradable device for weight loss without surgery

Epitomee is an oral medical device designed to reduce appetite by increasing satiety, promoting weight loss. Its key features differentiate it from other options:

• Non-pharmacological: contains no hormones or medications.
• Non-systemic: acts mechanically only in the stomach and does not enter the bloodstream.
• Biodegradable: naturally eliminated, without the need for removal.

For exclusive use with medical prescription, indicated for adults with overweight or obesity (BMI of 25 to 40).

How it works, in 4 steps

Each capsule contains a polymer blend (superabsorbent hydrogel) that mimics the effect of food. Its mechanism is purely mechanical:

1. Ingestion: swallow a capsule with two 250 ml glasses of water, 30 minutes before lunch and/or dinner.
2. Expansion: in the stomach, it absorbs water and expands to form a soft triangular structure.
3. Satiety: gently presses the stomach walls and sends a satiety signal to the brain, helping to eat smaller portions without feeling deprived.
4. Disintegration: after several hours, it completely breaks down in the small intestine and is naturally eliminated.

Why the Epitomee capsule is an advancement

What makes Epitomee an advancement is not just the result, but how it achieves it: it combines material science with a simple and reversible mechanism that avoids surgery, endoscopy, and drugs. This makes it an especially attractive option for those seeking a non-invasive approach or wanting an alternative after a medication-based treatment.

What makes Epitomee a breakthrough is not just the result, but how it achieves it: it combines material science with a simple and reversible mechanism that avoids surgery, endoscopy, and drugs. This makes it an especially attractive option for those seeking a non-invasive approach or wanting an alternative after a medication-based treatment.

The clinical advances supporting the Epitomee capsule

• RESET Study (randomised, double-blind, 24 weeks, n=279)
• Average weight loss: −6.6% with Epitomee versus −4.6% with placebo (p<0.0001).
• 56% of patients achieved a loss of at least 5%.
• Waist reduction of 6 cm (≈2 trouser sizes) on average in 24 weeks.
• In early responders (≥2% at week 8), the average loss reached 9.3%.
• Increased satiety: participants reported feeling full sooner and with less need to snack.

Metabolic benefits in prediabetes

• Significant reduction in insulin resistance (HOMA-IR, p<0.007) and fasting insulin (p<0.003).
• 38.6% reverted to normoglycaemia, compared to 22% with placebo.

Results in metabolic syndrome

• Weight loss: −8.3% versus −5.2% with placebo (p<0.0004).
• 40.7% achieved a loss ≥10%, compared to 6.5% with placebo.

Safety and adherence

• Zero serious adverse events related to the device.

Side effects similar to placebo.

• Adherence over 96%.
• Long-term maintenance: ELECT study (48 weeks)
• Maintenance of an average weight loss of −11.2%.
• Persistence of metabolic improvement and quality of life.
• Favourable safety profile also in prolonged use.

As a guide, this table summarises how the Epitomee capsule compares to the gastric balloon, another known non-surgical option:

It is indicated for adults (18+) with overweight or obesity and a BMI of 25 to 40 kg/m², with or without comorbidities, according to medical criteria. It is especially suitable for:

• People seeking a non-pharmacological and non-surgical approach.
• People with difficulty controlling portions or who feel late satiety.
• People looking for other options as a complement or after a medication-based treatment.

Important aspects:

• It is used only under medical prescription and within clinical follow-up.
• It is assessed and prescribed in consultation, individually, along with diet and exercise.
• It should not be used during pregnancy or in people with a known allergy to any of its components.

The Epitomee capsule at Instituto de Benito

At Instituto de Benito, we incorporate the Epitomee capsule within a comprehensive approach to overweight and obesity, always with prior assessment, medical prescription, and continuous follow-up. Each case is studied individually to determine if this option is the most suitable and how to integrate it with the rest of the treatment.

If you want to know if the Epitomee capsule is an option for you, request an assessment with our medical team.