Insertion
The device concept is designed to be positioned by the user at the stoma, subject to validated instructions for use.
A new approach to life with a colostomy
More freedom
in everyday life.
StomAid is developing an investigational, internal, removable and reversible device designed to provide temporary control of colostomy output, with the potential for bag-free periods.
Help us understand the needs of people living with a colostomy. Take part in our short survey.
Discover StomAid →Explore the scienceAbout StomAid
Engineering a more human approach to colostomy care.
StomAid brings together device innovation, clinical insight and strategic development with a shared focus on people living with a colostomy.
Our work is guided by patient needs, scientific discipline and the recognition that meaningful medical innovation must earn trust through evidence.
Patient-centredDesigned around real-life needs
Removable and reversibleA non-surgical approach in development
Evidence-ledDevelopment guided by data and feedback
Designed for tomorrowWorking toward regulatory validation
The Need
Life with a colostomy can still be a daily challenge.
Managing output, worrying about leakage and planning around pouch changes can affect confidence, physical activity and social life.
StomAid starts from a simple premise: people deserve more choice, predictability and dignity in how they manage their day.
52%reported a high or very high impact on daily life
64%reported limitations in sports activity
84%reported fear of leakage
56%reported frequent skin irritation
Source: StomAid patient survey conducted in Spain (n = 109)
The patient perspective →
The Solution
A different approach to colostomy care.
StomAid is an investigational internal device designed for temporary use and reversibility, with the potential to support periods without an external pouch.
The concept is being developed for selected people with a colostomy. Suitability, safety and performance must be assessed through appropriate clinical and regulatory processes.
For clinicians
Designed around the user
A simple, reversible concept.
Conceptual overview only. Final instructions and use conditions will be established through design validation and regulatory review.
In place
The design aims to provide temporary retention. Comfort and usability remain to be evaluated.
Temporary control
The concept is being developed to evaluate the potential for temporary management of colostomy output.
Removal and return
The concept is designed to be removable; conditions for use and return to standard pouching remain subject to validation.
Science & Development
Evidence drives responsible innovation.
StomAid’s development combines patient feedback, design iteration, material and functional evaluation, and a planned regulatory pathway.
Human-centred design
Usability and patient experience are key inputs to ongoing design refinement.
Materials and testing
Biocompatibility, mechanical performance and product quality require appropriate verification.
Regulatory pathway
StomAid has initiated its FDA regulatory pathway. Further details are not disclosed at this stage.
Clinical Development
From early experience to broader validation.
An initial historical clinical experience involving 9 patients over 3 months was reported in a 1986 publication. This is preliminary historical information and is not a substitute for formal contemporary clinical evidence.
The next steps include further usability and safety assessment, appropriate testing and formal clinical/regulatory work.
COMPLETED
Patent portfolio and prototype
Patents granted in Europe, the United States and Hong Kong; prototype developed.
IN PROGRESS / PLANNED
Design, usability and verification
Further assessment of safety, usability, materials and functional performance.
REGULATORY MILESTONES
Regulatory planning
Further regulatory work and evidence requirements remain under development.
For Patients
More choice for what matters to you.
StomAid is being developed with the aim of supporting greater confidence and flexibility for selected people living with a colostomy.
We are interested in understanding real needs, practical concerns and usability priorities. Participation in any research or study is subject to its own eligibility and consent process.
Get in touch →
ChoiceA potential additional option to discuss with your care team.
FlexibilityDesigned around selected activities and periods of use.
ReversibilityDesigned to allow a return to standard pouching.
InvolvementPatient feedback can inform development and usability.
For Clinicians
A potential complementary option in colostomy care.
StomAid is being developed as a removable and reversible device intended to provide temporary control of colostomy output for selected patients.
Clinical input is important to patient selection, risk assessment, usability, study design and evaluation of outcomes. Current information is developmental and should not be interpreted as a clinical recommendation.
Discuss clinical collaboration →
Patient-centred evaluation
Assessing usability, comfort, acceptability and patient-reported outcomes.
Evidence and safety
Building an appropriate evidence package through verification and clinical evaluation.
Collaboration
Working with clinical and regulatory experts to define responsible next steps.
Medical & Scientific Advisory Board
Help shape the clinical development of StomAid.
We are engaging experienced healthcare professionals and clinical researchers to contribute independent expertise to the project's medical and scientific development. The Board is intended to provide scientific guidance, challenge development assumptions and help identify the evidence needed to assess the device responsibly.
Colorectal surgery and clinical safetyOstomy care and patient usabilityClinical research and study designClinical methodology and biostatistics
We welcome conversations with professionals interested in contributing their expertise to this development process.
Express interest →For Investors
A differentiated concept addressing an unmet need.
StomAid combines a differentiated device concept with a staged technical, clinical and regulatory development pathway.
The investment case depends on successful technical verification, clinical validation, regulatory clearance or approval, market access and adoption. These remain development risks, not completed outcomes.
Contact the team →
Intellectual property
Patent portfolio referenced in Europe, the United States and Hong Kong.
Development model
Product configuration, use conditions and lifecycle remain subject to engineering, usability and regulatory evaluation.
Staged milestones
Testing, clinical evidence and regulatory work are central to the path toward market access.
Development Roadmap
Milestones before market access.
TECHNICAL
Verification and biocompatibility
Complete required design, material, mechanical and functional testing.
CLINICAL
Clinical and usability evidence
Conduct appropriate studies to evaluate safety, performance and usability.
REGULATORY
FDA regulatory pathway
Advance regulatory discussions and evidence planning, with details subject to the ongoing process.
COMMERCIAL
Market access and scale-up
Subject to successful validation, regulatory authorisation and commercial readiness.
FAQ
Frequently asked questions about StomAid.
What is StomAid?
StomAid is an investigational, removable device being developed for people living with a colostomy. It is designed to be inserted into the stoma and to provide temporary control of colostomy output by means of a soft inflatable ring, with a filter intended to release intestinal gas. It is still in development.
Is StomAid available to buy?
No. StomAid is an investigational device in development. It is not available for sale and has not been cleared or approved by any regulatory authority.
Who is StomAid being developed for?
Initial development focuses on adults with a mature, stable end colostomy and formed or semi-formed stool. Whether the device is suitable for an individual will need to be assessed by healthcare professionals within appropriate clinical studies.
Does StomAid require surgery?
No. StomAid is not an implant: it is designed to be inserted into the stoma and removed by the trained user, without surgery. Training and an initial period of supervised use by a stoma-care professional are planned.
What is the regulatory status of StomAid?
StomAid has initiated its FDA regulatory pathway. Verification testing, usability evaluation and, where required, clinical evidence are still needed before any regulatory decision.
Is there any clinical evidence for StomAid?
A 1986 publication described the experience of 9 patients who used an earlier prototype of the device for up to 3 months. This is historical information on a different version of the device and is not a substitute for modern clinical evidence, which still needs to be generated.
How can I contribute to the development of StomAid?
People living with a colostomy can take part in our short survey, available in Italian, Spanish and English. Clinicians, researchers, patient organisations and investors can write to contact@stomaid.com.