Epitomee Medical
Developer of ingestible therapeutic device platforms that operate in the gastrointestinal tract for weight management and oral biologics delivery. The company designs pH-triggered, shape‑shifting hydrogel devices and mucoadhesive matrix patches to provide transient, targeted mechanical stimulation or controlled API release. Activities include preclinical and clinical development, regulatory submissions, scale-up of a dedicated production line, and commercial partnerships for global distribution.
Industries
Nr. of Employees
small (1-50)
Epitomee Medical
Patents
Retentive devices and systems for in-situ release of pharmaceutical active agents
US-11129793-B2
View Details
Retentive devices and systems for in-situ release of pharmaceutical active agents
US-11129793-B2
View DetailsProducts
Ingestible weight-management capsule (drug‑free)
A standard-size swallowable capsule containing a pH-activated, swellable hydrogel scaffold that expands in the stomach to create a transient space-occupying structure intended to induce early satiety and reduce meal size and snacking.
Ingestible therapeutic device platform for oral biologics delivery
A platform that deploys mucoadhesive matrix patches from an ingestible scaffold to deliver biologics and other APIs directly to the small intestine, with formulation options to protect APIs from enzymatic degradation and enhance absorption.
Epitomee weight management capsule
A swallowable capsule that expands in the stomach into a semi rigid scaffold creating a natural sense of fullness, dissolves completely and leaves the body naturally within several hours, taken twice a day before meals to induce early sensation of fullness and lower daily caloric intake resulting in weight loss.
Epitomee device (ED)
A novel, orally self-administered biodegradable device for weight loss in patients with overweight and obesity. The device self-expands in the stomach to create a pH-sensitive super absorbent gel structure that promotes satiety and weight loss.
Epitomee Ingestible Therapeutic Device
A self-administered, safe, and efficient swallowable capsule made from two hydrogel layers, designed to deliver active pharmaceutical ingredients (API) through the oral route and GI tract by targeting the small intestine with mucoadhesive patches for controlled release and maximal absorption.
Epitomee Capsule (EC)
An oral, self-use, biodegradable device for weight management composed of absorbent polymers that self-expands in the stomach to create a triangular shape, space-occupying super-absorbent gel structure.
Ingestible weight-management capsule (drug‑free)
A standard-size swallowable capsule containing a pH-activated, swellable hydrogel scaffold that expands in the stomach to create a transient space-occupying structure intended to induce early satiety and reduce meal size and snacking.
Ingestible therapeutic device platform for oral biologics delivery
A platform that deploys mucoadhesive matrix patches from an ingestible scaffold to deliver biologics and other APIs directly to the small intestine, with formulation options to protect APIs from enzymatic degradation and enhance absorption.
Epitomee weight management capsule
A swallowable capsule that expands in the stomach into a semi rigid scaffold creating a natural sense of fullness, dissolves completely and leaves the body naturally within several hours, taken twice a day before meals to induce early sensation of fullness and lower daily caloric intake resulting in weight loss.
Epitomee device (ED)
A novel, orally self-administered biodegradable device for weight loss in patients with overweight and obesity. The device self-expands in the stomach to create a pH-sensitive super absorbent gel structure that promotes satiety and weight loss.
Epitomee Ingestible Therapeutic Device
A self-administered, safe, and efficient swallowable capsule made from two hydrogel layers, designed to deliver active pharmaceutical ingredients (API) through the oral route and GI tract by targeting the small intestine with mucoadhesive patches for controlled release and maximal absorption.
Epitomee Capsule (EC)
An oral, self-use, biodegradable device for weight management composed of absorbent polymers that self-expands in the stomach to create a triangular shape, space-occupying super-absorbent gel structure.
Services
Establishing strategic partnerships for global commercialization, licensing and distribution of ingestible device platforms.
Design and operation of a dedicated production line (gel film production, component assembly, automated final packaging) to support mass production of swallowable devices.
Management and execution of multi-center randomized controlled trials including safety monitoring and endpoint analysis to support regulatory filings.
Establishing strategic partnerships for global commercialization, licensing and distribution of ingestible device platforms.
Design and operation of a dedicated production line (gel film production, component assembly, automated final packaging) to support mass production of swallowable devices.
Management and execution of multi-center randomized controlled trials including safety monitoring and endpoint analysis to support regulatory filings.
Expertise Areas
- Ingestible therapeutic devices
- Oral biologics delivery
- Clinical trial design and execution
- Biopolymer and hydrogel materials
Key Technologies
- Mucoadhesive matrix patches
- pH-triggered swellable hydrogel scaffolds
- Swellable biopolymer films
- Directional controlled-release formulations
News & Updates
Built a three-step production line (gel film production, component assembly, automated packaging) and invested in tooling and space to support scale-up; step one operational mid‑2022.
Randomized, double-blind, placebo-controlled pivotal RESET trial completed and primary endpoints met showing statistically significant weight loss and favorable safety profile.
Regulatory submission of clinical and safety data for FDA clearance via the 510(k) pathway to enable US marketing by prescription.
U.S. FDA cleared the ingestible capsule for weight management (BMI 25–40) following review of RESET trial data.
Received CE marking enabling commercialization in the European Economic Area as a medical device for weight loss in overweight and obese adults.
Entered an agreement for global development and commercialization of the weight‑management product through a strategic partner with global distribution rights.
Built a three-step production line (gel film production, component assembly, automated packaging) and invested in tooling and space to support scale-up; step one operational mid‑2022.
Randomized, double-blind, placebo-controlled pivotal RESET trial completed and primary endpoints met showing statistically significant weight loss and favorable safety profile.
Regulatory submission of clinical and safety data for FDA clearance via the 510(k) pathway to enable US marketing by prescription.
U.S. FDA cleared the ingestible capsule for weight management (BMI 25–40) following review of RESET trial data.
Received CE marking enabling commercialization in the European Economic Area as a medical device for weight loss in overweight and obese adults.
Entered an agreement for global development and commercialization of the weight‑management product through a strategic partner with global distribution rights.