Ostoform and the EIC Accelerator: A Pouch That Keeps Skin Dry
Ostoform, an Irish company led by its founder Kevin Kelleher, makes products for people with a stoma, an opening created in surgery that empties into a pouch. Its patented FlowAssist design adds a non-absorbent spout to the usual hydrocolloid adhesive, so that output is directed into the pouch instead of eroding the adhesive and the skin. After developing a FlowAssist seal with an earlier EU grant, it asked the EIC to fund a full pouch, because "the ostomy pouch market is larger than the seal market", according to CORDIS.
The European Innovation Council granted €2,499,901 towards a €3.57 million project in 2023 and 2024. The final report says a new manufacturing method allowing three-dimensional designs was developed, a FlowAssist pouch was "developed to regulatory approval" and bench tests showed it lasts longer than industry-standard products. It said the pouch would be sold in the US in 2024 with reimbursement codes assigned, and that "a clinical study will take place". In the US, Ostoform won purchasing contracts with Vizient and Premier. Its CEO told the Business Post the first product is "on market in eight countries". Revenue is not published.
Company file
- Legal entity
- Ostoform Limited, Mullingar, Co. Westmeath (per CORDIS)
- CEO and co-founder
- Kevin Kelleher
- Products
- FlowAssist Seal, FlowAssist 2-Piece Pouch, Crest mouldable barrier
- Investors
- BGF (lead, 2021) and earlier seed investors
- US distribution
- Medline; Vizient and Premier purchasing agreements
- Earlier EIC project
- OSTOFORM, EIC SME Instrument Phase 2 (Horizon 2020), 1 Apr 2019 to 31 Oct 2021, €1.29M grant
- EIC project
- 1 Jan 2023 to 31 Dec 2024, closed
- EIC funding
- Grant only in practice ("non-dilutive")
Where Ostoform Stands Now
Ostoform's website now sells a FlowAssist 2-piece pouch alongside the seal. The Vizient Innovative Technology contract, awarded in 2024, followed a recommendation by hospital experts on one of Vizient's councils, and in February 2025 Premier gave FlowAssist a "Breakthrough Technology" designation. Kelleher said sales were building in the US and Europe, that it would expand to South America in early 2026, and that Ostoform was raising a €2.1 million round qualifying for Ireland's EIIS tax relief.
The record
From ostomy seal to ostomy pouch
Ostoform used its EIC grant to develop a FlowAssist pouch to regulatory approval and scale up its seal. It won US purchasing contracts and says its first product sells in eight countries.
- 2018Seed roundFirst outside investment€1.1M
- Apr 2019EIC SME Instrument Phase 2OSTOFORM: seal trial and manufacturing line, to Oct 2021€1.29M grant
- 2021Growth roundLed by BGF€3M
- Jun 2022EIC Accelerator cut-offFlowAssist pouchgrant first
- Jan 2023EIC project starts€3.57M project€2.50M grant
- May 2024Vizient contractUS Innovative Technology contract
- Dec 2024EIC project endsPouch developed to regulatory approval
- Feb 2025Premier agreementUS Breakthrough Technology designation
- Early 2026South AmericaPlanned expansion; €2.1M round being raised
CORDIS, Ostoform and Business Post.
"Our first product is now on market in eight countries, and we have recently developed a new ostomy pouch, which significantly expands our market opportunity."
Kevin Kelleher, CEO, Ostoform, to the Business PostThe Technology: A Spout in the Seal
The project says standard hydrocolloid adhesive absorbs stoma output and breaks down, leading to leaks and skin complications. FlowAssist's non-absorbent spout sits below the stoma and channels output into the pouch. Ostoform says the technology has been supported by five peer-reviewed clinical studies. For the pouch, the report cites bench testing only; the clinical study it announced has not been published.
The market
Where FlowAssist is sold or listed
Countries where the first product is on the market, per the company, and the number of US group purchasing agreements announced.
Business Post; Ostoform news.
What the EIC Project Promised, and What CORDIS Shows
The EIC project
The EU paid 70% of a €3.6M project
The FlowAssist Pouch project ran from January 2023 to December 2024. CORDIS lists it as closed.
CORDIS project 190160729. Values in € millions.
The pouch project built on an earlier EIC grant. At the 9 January 2019 cut-off of the EIC SME Instrument Phase 2, part of the Horizon 2020 EIC pilot, Ostoform was selected for OSTOFORM, which ran from 1 April 2019 to 31 October 2021 with an EU contribution of €1,285,060.88 towards a total cost of €1,835,801.25, to run patient trials of the seal and set up a full manufacturing line. The final report says a multi-site clinical investigation was completed, a high-volume manufacturing line was set up and the seal went on sale in the Netherlands, Denmark and the US, with reimbursement in each. Ostoform announced the trial's publication in Advances in Skin & Wound Care in March 2021 and a US distribution agreement with Medline in May 2021.
The project promised the FlowAssist pouch and wider availability of the technology. The pouch reached regulatory approval and is on sale, and the report said the seal would be on sale in countries including the Czech Republic, Germany, France and Spain before the project ended. A clinical study of the pouch and its European launch are described as future steps and are not documented as done. CORDIS lists the project as closed.
- FlowAssist pouchDeliveredRegulatory approval.
- New manufacturing methodDelivered3D designs.
- Pouch clinical studyNot publishedAnnounced as future.
- US market accessDeliveredVizient, Premier.
The Money
Ostoform raised €1.1 million in 2018 and €3 million in 2021, led by BGF, and says it received about €6 million in grants from EU Horizon programmes and Ireland's Disruptive Technologies Innovation Fund. It described the EIC award as "€2.5M in non-dilutive grant funding". Its revenue is not published.
The money
Equity and grants, as Ostoform describes them
In € millions. The grant total covers EU Horizon programmes, including the EIC grant, and Ireland's Disruptive Technologies Innovation Fund. The €2.1M round was being raised, not closed.
Business Post; CORDIS.
What Cannot Be Checked
Questions for the EIC
Ostoform's revenue, how many pouches it has sold, whether the pouch clinical study started and whether the €2.1 million round closed are not public.
Why Europe Should Care
The EIC grant helped a small Irish company extend a patented idea from a niche accessory into the larger pouch market, and to reach US hospital buyers. It is a modest, practical medtech story; the scale it reaches depends on sales that are not yet visible.
What the project promised
A FlowAssist pouch that brings the seal's skin benefits to a wider group of ostomy patients.
What the record shows
An approved pouch on sale, two US purchasing agreements, eight countries and no published sales or pouch trial.
The Verdict
Product delivered, scale unknown
Ostoform built and launched the pouch the EIC paid for. How widely it is used, and whether the clinical evidence promised for it arrives, remain to be seen.
Ostoform and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.
Sources
- CORDIS, OSTOFORM fact sheet and final report
- European Commission, EIC SME Instrument Phase 2 selected companies, 2019
- CORDIS, FlowAssist Pouch fact sheet and report
- Business Post, Ostoform profile
- Ostoform, Vizient contract
- Ostoform, Premier agreement
- Ostoform, clinical study published, March 2021 and Medline agreement, May 2021
- Ostoform, news
Industry
HealthMedical devices
- Focus
- Gastrointestinal devices
- Technologies
- Medical adhesives
- Keywords
- Ostomy care
- Stoma care
- Skin protection
- Leak prevention