A lung biopsy can collapse the lung it samples, when air leaks along the needle path. According to Selio Medical's EIC report, a third of lung biopsy patients suffer this pneumothorax, and a third of those need hospital admission. Selio, a Trinity College Dublin spin-out, developed a biodegradable hydrogel that is injected along the needle path to seal it before the biopsy is taken.
The European Innovation Council granted €2,499,999 towards a €3.7 million project from October 2022 to September 2024 for the "development and commercialisation" of the system. The final report lists manufacturing scale-up, preclinical studies and completed regulatory files. The US Food and Drug Administration cleared the Pre-B Seal Lung Biopsy Plug System on 8 April 2025, according to its 510(k) database. In August 2026 the company said the device would be used in patients for the first time in Q4 2026, while it raises a €5 million Series A, according to TechCentral.ie.
Company file
- Legal entity
- Selio Medical Limited, Dublin, Ireland
- Origin
- Trinity College Dublin spin-out; EIT Health BioInnovate fellowship
- CEO and co-founder
- Colm McGarvey
- Product
- Pre-B Seal Lung Biopsy Plug System, pre-filled hydrogel syringe
- FDA
- 510(k) K243722, cleared 8 April 2025
- EIC project
- Selio System, 1 Oct 2022 to 30 Sep 2024, closed
- EIC funding
- Grant only
Where Selio Stands Now
Selio says it has raised more than €15 million to date. Its Series A is meant to fund a US launch, and it plans to hire five people in sales, marketing and operations over two years. It forecasts sales of 100,000 devices and $30 million in revenue by 2031. The FDA cleared the device through the 510(k) route, as "substantially equivalent" to a product already on the market. The published evidence for its effect is a preclinical study: in a head-to-head comparison with the Biosentry plug, Selio's technology reduced pneumothorax cases by 70%, according to MedCity News.
"Pneumothorax has been an accepted risk of lung biopsy for decades, but it doesn't have to be. We have built a patented device that seals the lung before a biopsy is even carried out."
Colm McGarvey, co-founder and CEO, Selio Medical, August 2026The Technology: Sealing Before Sampling
Earlier approaches to the problem "have all been post-biopsy", Selio's CEO said. Selio's sealant is delivered through a single-use pre-filled syringe along the biopsy route first, adding about two minutes to the procedure, its CEO told MedCity News. The EIC project objective called it the "world's first system specifically designed to prevent PTX occurring before biopsy even takes place".
What the EIC Project Promised, and What CORDIS Shows
By September 2024 the report lists over 5,000 pre-filled syringes produced and sterilised, R&D and GLP preclinical studies, usability testing with clinicians, design verification, sterilisation validation, biocompatibility tests, three patent filings and complete regulatory submission documents. The FDA received the submission in December 2024. The commercialisation half of the project title has not happened yet: no device has been used on a patient or sold.
- Manufacturing scale-upDelivered5,000+ syringes.
- Regulatory clearanceDeliveredFDA, April 2025.
- Human clinical evidenceNone yetFirst use Q4 2026.
- CommercialisationNot startedLaunch pending funding.
The Money
Beyond the EIC grant, EIT Health lists its fellowship, Headstart and innovation project funding among Selio's backers. The company does not publish accounts or name its equity investors, and it has no revenue from sales.
What Cannot Be Checked
Questions for the EIC
The preclinical study data, the predicate device the FDA compared it with, whether a CE Mark has been sought for Europe, and who has invested are not public.
Why Europe Should Care
The EIC paid most of the development of an Irish device that reached FDA clearance fast. Its first market is the US; the company has announced no European approval or launch.
What the project promised
Development and commercialisation of the first system to prevent pneumothorax before a lung biopsy.
What the record shows
A finished, FDA-cleared product with animal data, no patient use yet and a Series A still being raised.
The Verdict
Ready to launch, not launched
Selio did the development work the EIC paid for and cleared the FDA quickly. Whether its plug prevents collapsed lungs in people is still untested, and the launch depends on money it has yet to raise.
Selio Medical and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.
