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About Selio

  • Selio Medical is a biomaterial medical device company based in the Guinness Enterprise Centre, in the heart of Dublin.

  • Selio has developed a patented, platform biomaterial technology to improve outcomes in minimally invasive access and interventional procedures.

  • The company was founded through BioInnovate Ireland and Trinity College Dublin.

  • Our first product, the Pre. B Seal Lung Biopsy Plug System, is FDA cleared for use in lung biopsy procedures to reduce a common, costly and dangerous complication, pneumothorax, and to mark biopsy locations for surgical follow-up.

  • We are developing this platform technology for new indications to meet other large market opportunities.

  • Conducted Pre-Clinical Study: Demonstrated device safety and performance in a relevant biological environment to support biocompatibility and functional claims.

  • Executed Usability Engineering Process: Ensured the device is safe and effective for intended users through formative and summative human factors evaluations.

  • Completed Design Verification and Validation Testing: Confirmed that the device meets all specified user and design requirements through rigorous testing and analysis.

  • Validated Sterilization Process: Provided evidence of effective sterilization and maintenance of sterility through packaging validation and shelf-life testing.

  • Prepared and Submitted Comprehensive 510(k) Dossier: Included all required administrative, technical, and performance data to demonstrate substantial equivalence to a legally marketed predicate device. Refer to K243722

Clinical Need

  • Lung cancer is leading cause of cancer death worldwide & lung biopsy is the gold standard method of diagnosis.

  • Early diagnosis has been proven to save lives making lung biopsy a vital armament in the battle against lung cancer.

  • Approximately, 1 in 3 patients undergoing a lung biopsy suffer from a collapsed lung, known as pneumothorax.

  • This dangerous complication converts a routine outpatient procedure to one requiring hospitilisation, for up to a week, for invasive treatment & follow-up.

  • This results in healthcare costs in excess of $20,000 per patient making it the No. 1 hospital cost & complication post lung biopsy.

Technology

  • Platform technology comprising a novel biodegradable hydrogel sealant and precision delivery device.

  • Received FDA clearance for the first indication – the reduction of pneumothorax associated with lung biopsy procedures and the marking of the biopsy location for subsequent surgery.

  • The Pre. B Seal Lung Biopsy Plug System is the first device designed to proactively seal the biopsy access route into the lung before the biopsy takes place.

  • This unique prophylactic protects the lung both during and after the procedure.

  • Our proven, patented technology seamlessly integrates with the current biopsy standard of care.

  • The Pre. B Seal Lung Biopsy Plug System provides pneumothorax protection for the patient, enabling the patient to safely return home on the same day as their biopsy procedure. This significantly improves the patient’s quality of care while preventing further in-patient treatment and associated costs.

  • Developing this platform technology for new indications to meet other large market opportunities.

News

April 2025: Selio Medical receive FDA 510(k) Clearance for the Pre. B Seal Lung Biopsy Plug System.

December 2024: After years of hard work, problem solving and a dedication to improving patient safety, Selio Medical have completed their FDA 510(k) submission.

August 2024: Selio Medical have completed their final GLP Pre-Clinical Study.

July 2024: Selio Medical have concluded executing their usability engineering studies with a final study in New York-Presbyterian Hospital.

June 2022: Selio Medical has been awarded €2.5 million funding from the European Innovation Council (EIC) Accelerator programme. This latest funding will support growing the team in Ireland and further technical development as it prepares for market launch. Read More.

March 2022: Ireland’s Health Innovators: Selio Medical is one of the three start-ups making impact internationally. Read More.

November 2021:  Delighted to receive the prestigious Rising Star Award at the Ireland-France Business Awards presented by An Taoiseach Micheal Martin and French Minister Franck Riester. Read More.

November 2021: Selio Medical proud to be included in the Sunday Business Post list of 2021 ‘Hot 100 Start-ups’.

August 2021: Selio Medical very proud to welcome a large delegation as part of President Macron visit to Ireland. This delegation included a number of dignitaries including French Finance Minister Bruno Le Maire and Irish Minister for Finance Paschal Donohoe. Read More.

August 2021: Selio Medical delighted to welcome new CEO of Enterprise Ireland Leo Clancy and Chairman of GEC, David Varian to our facility.

August 2020: Selio Medical delighted to welcome Tanaiste Leo Varadkar and Enterprise Ireland CEO Julie Sinnamon, to the new Selio Medical facility in the Guinness Enterprise Centre. Read More.

January 2018: Selio Medical, Headstart/Proof-of-Concept Winner 2017 : EIT Health UK-Ireland @ Oxford University. Read more.

October 2017: Selio Medical, Winner at Medtech Innovator in San Jose, US, out of over 600 medical device start-up companies. Read more.

Setembro 2017: Selio Medical wins Medtech Innovator International Pitch Competition.

September 2017: Selio Medical selected as first international company to take part in prestigious National Science Foundation Icorps accelerator program. Completed in Gerogia Tech, Atlanta 2017. Read more.

August 2017: Selio lung biopsy device exemplifies medtech growth and scale. Colm McGarvey and Garrett Ryan are eliminating collapsed lung complications. Read more.

July 2017: Selio Medical chosen in top 10 of Enterprise Ireland Big Ideas Competition 2017.

May 2017: Selio Medical highlighted as one of 5 Irish big ideas that can transform medical treatment. Read more.

The Team

Colm McGarvey, Co-Founder & CEO

An ambitious, dynamic and visionary professional with over 22 years commercial experience, national and international, within the medical device and pharmacy sectors. Colm holds a BSc Degree in Pharmacy from Queens University Belfast and a MSc in Bio-Innovation from University College Cork.

 

Careers

We are always looking for exciting talent. Please contact us for further information. CVs can be provided to: admin@seliomedical.com

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