STOMAID ADAPTIVE CONTINENCE SYSTEM

Redefining life after stoma.

A new adaptive continence device that restores dignity and control — designed for comfort, discretion, and freedom from the external bag.

The Problem with Current Ostomy Care

Millions live with permanent ostomies. The current standard is a passive collecting bag. It can be bulky, visible under clothes, and psychologically limiting. Patients ask for control, discretion, and the ability to move freely.


The StomAid Solution

StomAid is an adaptive continence device featuring an inflatable toroidal sealing balloon and a precision spigot valve. It provides a secure, atraumatic seal and enables odor‑free, controlled release when the user decides.

Freedom from the external bag in daily life*

Discreet, comfortable, and secure under clothing

Planned evacuation for true continence and autonomy

Biocompatible interface; disposable inner core

Designed for compatibility across stoma diameters

Technology Highlights

Adaptive Seal

Inflatable toroidal balloon conforms to stoma anatomy, providing a gentle but secure seal designed to reduce leakage and skin irritation.

Precision Microvalve

Manually controlled spigot permits on‑demand evacuation, enabling continence and scheduling around daily activities.

Biocompatible Materials

Skin‑friendly contact layer and disposable inner core engineered for safety, hygiene, and straightforward replacement.

Clinical & Regulatory Pathway

  • Pre‑market clinical studies in preparation (EU / FDA pathways).
  • Target CE marking in the EU, followed by FDA submission in the U.S.
  • Human factors & usability validation as part of risk management.
  • Post‑market surveillance plan for continuous safety monitoring.

Development Status

Technology Readiness Level (TRL): 6 — functional prototype validated in lab settings; clinical pilot next.

Manufacturing options under evaluation (dip‑molding vs. blow‑molding) for the inflatable component; supply chain partners under assessment.

For Investors

Medicea Medica Srl is an Italian Innovative SME focused on biomedical devices for patient dignity and for care in remote/critical environments. StomAid addresses a large unmet need with a defendable design and clear clinical value proposition.

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Market

Ostomy population in EU+US in the millions; strong willingness to adopt solutions that restore continence and privacy.

IP & Moat

Novel sealing geometry and valve architecture; pathway for patents, trade secrets, and clinical data moat.

Business Model

Device + consumable core; reimbursement strategy by indication; direct‑to‑specialist and KOL‑led adoption.