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Investment Opportunity

The investment case forContinent stoma care

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.

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Patent families
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Patient inquiries received
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Pivotal study participants
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Equity round
Five Pillars

Investment Highlights

01

Unmet Need

People living with a stoma have had limited choice in daily management. An estimated 3 to 4 million worldwide, with approximately 225,000 stoma procedures annually (figures to be supported with cited sources).

02

Proprietary Platform

A patient-facing platform: discreet lid, enhanced bag system, and connected digital tools, locked together by a proprietary interface and supported by an enabling implant. 12 patent families, 60+ granted patents.

03

Recurring Revenue

Targeting recurring patient-facing revenue of approximately EUR 2,000 per patient per year (forward-looking, see disclaimer). Estimated lifetime value and long-term market-share targets are detailed in the investor deck.

04

IP Protection

12 patent families. 60+ national patents granted across US, EU, UK, and key markets.

05

Regulatory Pathway

A clear value-inflection ladder, each step subject to regulatory review: 2027 e-TIES digital launch, 2027 pivotal trial readout, targeting UK clearance in 2028, EU MDR in 2028, and US FDA De Novo in 2029.

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Business Model

Recurring, patient-facing platform economics

Each patient gains access through a single procedure, then engages a recurring, patient-facing platform: lid, enhanced bag system, and digital tools. Standard ostomy supplies are generally covered by payers, and OstomySecure positions reimbursement around these patient-facing components (source to be confirmed). Projected regional revenue milestones (forward-looking, see disclaimer):

United Kingdom
2028
EUR 6M
Projected revenue
European Union
2029
EUR 37M
Projected revenue
United States
2031
EUR 207M
Projected revenue
Global Target
2038
EUR 1,175M
Projected revenue
2038 Target Revenue
EUR 0M
Projected annual revenue
2038 Target EBIT
EUR 0M
Projected EBIT
EUR 120M+
3,000+ patient inquiries received represent an estimated EUR 120M in potential lifetime consumable revenue.
Projected figures based on internal projections for UK, EU, US markets. All figures are forward-looking estimates and subject to the risks described in the Forward-Looking Statements disclaimer. Actual results may differ materially.
Regulatory Pathway

Clear path to market

*All dates are forward-looking estimates and subject to the risks described in the Forward-Looking Statements disclaimer.

UK
EU
US
Digital
United Kingdom
N=224 StudyPivotal multi-center clinical studyCompleting Q3 2027*
UK ClearanceMarketing authorizationTargeted Q1 2028*
UK LaunchCommercial availabilityTargeted Q1 2028*
European Union
MDR CE MarkEU Medical Device RegulationTargeted Q3 2028*
EU ExpansionMarket launch across EUTargeted Q1 2029*
United States
FDA De NovoRegulatory submissionTargeted Q3 2029*
US LaunchCommercial availabilityTargeted Q1 2031*
Digital Platform
e-TIES LaunchConnected digital platformExpected 2027*
Current Shareholders

Institutional backing

Kistefos69.01%
Canica18.21%
Other (42 shareholders)12.78%
The Ask
EUR 12.5M
Equity financing
EUR 5M
Clinical studies, regulatory approvals, R&D
EUR 4M
Digital lid, app, connected product development
EUR 3.5M
Operations, distribution preparation, path to first revenues
Balanced View

Key Risks and Mitigants

Experienced medtech investors expect balanced information. Each concern is paired with a concrete mitigant.

Regulatory

Regulatory delays

Marketing authorizations in UK, EU, and US are subject to regulatory timelines that may extend beyond current projections.

Mitigant: N=224 pivotal study underway across 5 countries. Experienced regulatory team. Parallel submission strategy across regions.
Clinical

Clinical outcomes

Pivotal study results may differ from earlier observations. Endpoints must meet predefined statistical thresholds.

Mitigant: Study design informed by prior clinical experience. Independent DSMB oversight. Multi-center design reduces site-specific variability.
Market

Competitive developments

Established stoma care companies may develop competing approaches or alternative technologies.

Mitigant: 12 patent families providing broad IP protection. Proprietary interface creating accessory lock-in. First-mover advantage in continent stoma care category.
Commercial

Reimbursement uncertainty

Payer coverage decisions may impact adoption rates and revenue projections in each market.

Mitigant: Health economic analysis underway. Projected cost savings vs. lifetime adhesive bag costs. 3,000+ patient inquiries demonstrating demand signal.
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Take the Next Step

Interested in the Investment Opportunity?

OstomySecure AS is seeking EUR 12.5M in equity financing to complete clinical studies, achieve regulatory approvals, and prepare for market launch.

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Download Presentation

Full investor deck with projections, clinical status, team.

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