Guinness Enterprise Centre-based medtech innovator aims to bring FDA-cleared lung biopsy device to major US hospitals as first patient procedures begin later this year.
Dublin medtech company Selio Medical is launching a €5 million Series A fundraising round to support the commercial rollout of its FDA-cleared lung biopsy technology in the United States, following more than €15 million already raised by the company.
The Guinness Enterprise Centre (GEC)-based business has developed a biodegradable hydrogel sealant designed to reduce the risk of pneumothorax, or collapsed lung, one of the most common and costly complications associated with lung biopsy procedures.
“We have built a patented device that seals the lung before a biopsy is even carried out, rather than reacting to a complication once it has happened”
The fundraising marks a significant milestone for the company as it prepares for the first use of its device in patients during the fourth quarter of 2026 and begins scaling operations for entry into the US healthcare market.
Pre-launch agreements
More than 400,000 lung biopsies are performed annually in the US, which is Selio Medical’s primary target market. Pneumothorax occurs in up to 35% of those procedures and accounts for more than $750 million in annual treatment costs for healthcare providers.
Selio Medical’s solution, the Pre. B Seal Lung Biopsy Plug System, is designed to create a sealing plug before a biopsy takes place, helping prevent air leaks during the procedure. The single-use device is delivered through a pre-filled syringe and is compatible with existing biopsy equipment.
The company believes the addressable US market opportunity exceeds $450 million annually. It has already secured pre-launch agreements with major hospitals in New York and expects annual US sales to reach 100,000 devices by 2031, generating projected revenues of $30 million.
Manufacturing in Dublin
A key part of Selio Medical’s growth strategy is its manufacturing operation at the Guinness Enterprise Centre in Dublin.
The company operates a custom-built clean room facility, the first of its kind within the GEC, allowing it to manufacture devices under the stringent quality and regulatory standards required for the medical technology sector.
All products destined for the US market will be manufactured at the Dublin facility.
To support commercialisation efforts, Selio Medical plans to hire five new employees over the next two years across sales, marketing and operations functions. The positions will be split between Dublin and the US.
The company also intends to expand development of its platform technology into other cancer-related applications.
Commenting on the fundraising and upcoming market launch, Selio Medical co-founder and chief executive Colm McGarvey said the company is reaching a defining moment after a decade of development work.
“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, rather than reacting to a complication once it has happened. That single shift has the potential to make biopsies safer for patients, more efficient for clinicians and more financially sustainable for hospitals.
“With FDA clearance secured and our first human cases planned for later this year, we are at an exciting point in our 10-year journey as we prepare to witness the real-world impact of our device. Along with the vital base and support provided by the Guinness Enterprise Centre ecosystem, this funding will let us bring that to US hospitals at the scale the problem demands.”
The Guinness Enterprise Centre has played a central role in supporting Selio Medical’s growth from an early-stage venture to a commercial-stage medical device company.
A design for life sciences
Clare Meehan, Operations Manager at the Guinness Enterprise Centre, said the company’s progress demonstrates the value of providing specialised facilities and support to ambitious life sciences start-ups.
“Selio Medical is a great example of what can happen when a life sciences company is given the space and support to grow at home. At the Guinness Enterprise Centre, we are dedicated to giving start-ups the best chance of success. For Selio Medical, this included building a dedicated clean room as the company’s manufacturing needs evolved.
“We are extremely proud to be on this journey with Selio Medical and look forward to seeing the company’s hard work pay off.”
Founded in 2016 as a spin-out from BioInnovate Ireland and Trinity College Dublin, Selio Medical has steadily built an international profile within the medtech sector. The company was the first organisation outside the United States to gain access to the National Science Foundation’s I-Corps accelerator programme and has won accolades including MedTech Innovator’s international pitch competition and the Ireland-France Business Awards Rising Star Award.
With FDA clearance secured, manufacturing established in Dublin and commercial agreements already in place, the company is now focusing on turning years of research and development into widespread clinical adoption across the US healthcare system.
Top image: Clare Meehan, Operations Manager, Guinness Enterprise Centre; and Colm McGarvey, co-founder and CEO, Selio Medical
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