A discreet lid, an enhanced emptying system, and connected digital tools, supported by an enabling implant. Being evaluated in a pivotal clinical study (N=224), with 3,000+ expressions of patient interest and 60+ granted patents.
The Opportunity
People living with a stoma have had limited choice in daily management. An estimated 3 to 4 million worldwide manage a stoma using adhesive bags often associated with skin complications, infections, and a heavy psychological burden. The average patient spends EUR 2,500 to 3,000 per year on consumables (figures to be supported with cited sources).
OstomySecure is developing a patient-controlled system, a discreet lid and an enhanced bag system supported by an enabling implant, designed to reduce dependence on continuous pouch wear.
Twenty-five years of clinical insight, engineered into a system patients control.
The element patients use every day. Designed to seal the stoma site interface between emptying. Discreet and low-profile under clothing. Equipped with sensors connected to the OstomySecure digital application for real-time monitoring and patient-clinician communication.
Enhanced emptying system for controlled, on-demand drainage. Designed for discreet daily use, it puts the timing of evacuation back in the hands of the patient. Proprietary interface, built to work with the TIES port.
Collection bag for continuous overnight and extended wear. Designed for hands-free use during sleep and longer stretches between emptying. The same proprietary interface keeps every component locked to the TIES port.
Connected lid with biosensors under development. Mobile app for monitoring. Expected launch: 2027. Regulatory classification: under assessment (may follow Software as Medical Device pathway, separate from TIES implant Class IIb classification under EU MDR).
The enabling technology behind the system. A medical-grade titanium and mesh implant, 3D-printed, that integrates with the body through tissue ingrowth. Placed during standard stoma surgery, it forms the stable interface every patient-facing component connects to.
Discreet on the outside.
Intelligent on the inside.
The established players manage the bag. OstomySecure is designing for patient control.
Business Model
Built on what clinicians at the bedside
have been asking for since 1998.
Leadership
Milestones
OstomySecure AS is seeking EUR 12.5M in equity financing to complete clinical studies, achieve regulatory approvals, and prepare for market launch in the UK, EU, and US.