Scottish Medtech Seluna Launches Pediatric Sleep Trial Ahead of U.S. Entry

Seluna seeks US collaborations and investment to transform childhood sleep disorder diagnosis globally

Glasgow, UK, Aug. 28, 2025 (GLOBE NEWSWIRE) --       Scottish Medtech Seluna Launches Pediatric Sleep Trial Ahead of U.S. Entry

Seluna seeks US collaborations and investment to transform childhood sleep disorder diagnosis globally

Scotland-based medtech company Seluna is poised to advance the diagnosis and management of childhood sleep disorders, starting with the launch of a major clinical validation study in partnership with the Royal Hospital for Children in Glasgow, Scotland. With this milestone underway, the company is now setting its sights on expansion into the U.S. market.

The study, involving 500 anonymised patients under the age of 18, will run from now until the end of 2025. It aims to validate Seluna's diagnostic software as a medical device (SaMD), which is designed to automatically interpret sleep studies via a pipeline of machine learning algorithms. This will support Registered Polysomnographic Technologists (RPSGTs) and doctors in diagnosing and managing pediatric sleep apnea. Currently, Seluna is on track to be the first SaMD on the market specifically developed for pediatric sleep diagnostics.

Sleep apnea affects an estimated 96 million children globally, yet up to 80% remain undiagnosed. Left untreated, sleep apnea in children can impair neurocognitive development, mimic ADHD, and increase long-term risks of chronic neurological, cardiac, and metabolic disease. Currently, the gold-standard pathway relies on manual interpretation of complex sleep study data – a slow and labour-intensive approach that creates significant bottlenecks in an already strained healthcare system.

Seluna has secured over $860,000 in recent funding from Gabriel Investment Syndicate, the University of Strathclyde, STAC Invest and Scottish Enterprise. This will be used to initiate their FDA pre-submission process, optimize their diagnostic machine learning algorithms, and launch their first UK clinical validation trial. The company is now actively seeking partnerships with U.S. sleep clinics and pediatric hospitals to enable collaborative data sharing and licensing agreements that support collaborative development, and international multi-site validation.

In addition, the company is preparing to launch its seed round later this year and is seeking a lead U.S. investor with strategic insights within the sleep medicine sector. The company’s UK-based investors are expected to follow on in support of the company’s international growth and mission to address this critical gap in children’s health.

Dr. Scott Black, co-founder and CEO, positions the commercial opportunity:

“Pediatric sleep diagnostics has been underserved for too long. It’s a complex challenge, which is why existing tools weren’t built for children - until now. Our validation study will demonstrate clinical impact and make a clear statement: Seluna is here to set a new standard, innovate in the field, and compete internationally. We’re now looking for a U.S-based lead investor who recognizes the potential of the pediatric healthcare market.”

Dr. Haytham Kubba, Pediatric ENT Surgeon at Royal Hospital for Children, Glasgow, and principal investigator, explains:

"Right now, we simply don’t know if we’re operating on the right children, and we’re missing many who genuinely need treatment. It’s frustrating, because there’s no reliable way to predict which children will benefit most from surgery. Seluna is developing a solution that could significantly improve our ability to identify and prioritize those most in need. This technology has the potential to advance the way we diagnose and manage pediatric sleep disorders."

Seluna’s machine learning pipeline automatically scores pediatric sleep studies by identifying and classifying digital biomarkers of sleep-disordered breathing. Designed to reduce clinical workload and support objective, data-driven decisions, the system streamlines and standardizes the diagnostic pathway. Their algorithms are designed to be interpretable and transparent, to support, not replace, clinical judgement. This will yield a more efficient, standardized, and objective diagnostic pathway that reduces the manual workload on staff, increases patient throughput, and improves accuracy. The result is better, faster, and more cost-effective diagnostics for pediatric sleep apnea.

Dr Ruth Hamilton, Consultant Clinical Scientist at Royal Hospital for Sick Children, Glasgow, and principal investigator, added:

"What makes Seluna's approach so compelling is its focus on explainable AI. As clinicians, we need to understand why the technology is making certain recommendations. Seluna's focus on interpretability builds the trust we need to confidently use this technology in clinical practice. It will help take pressure off busy departments and allow us to accurately diagnose more children.”

Alex Lusty at Gabriel Investment Syndicate confirmed:

"Gabriel was delighted to lead this second round investment into Seluna, recognizing the company’s exceptional progress in building the product, commercial partnerships and internal team capability. It’s been great to see the strong clinical engagement with the company’s ethical AI-based diagnostic pathway. We look forward to continuing to support Seluna as the company transitions to helping children in the UK and US."

Angus Macfadyen, head of investment at STAC, said:

"Seluna represents exactly the kind of investment opportunity STAC Invest is looking for - a world-class founding team tackling a significant global challenge with genuinely innovative technology. With 80% of childhood sleep apnea cases going undiagnosed worldwide and 96 million children affected by sleep disorders, there's a compelling commercial opportunity for a solution that delivers better patient outcomes while reducing healthcare costs. Seluna has all the ingredients for international success: exceptional founders, differentiated technology, clear regulatory pathway, and substantial market opportunity in both UK and US markets."

Anne Henderson, Head of Investment at the University of Strathclyde, said:

“We are committed to addressing societal challenges through innovation, and Seluna is an excellent example of how cutting-edge research and technology can be used to transform paediatric healthcare.

“We are proud to have been an early investor in Seluna and look forward to continuing our partnership with further support through our Strathclyde Inspire Entrepreneurs Fund and Stephen Young Entrepreneurship Awards.”

Derek Shaw, Director Entrepreneurship & Investment at Scottish Enterprise, said:

“Scottish Enterprise has supported Seluna’s ambition to improve the diagnosis and management of childhood sleep disorders over several years.

“The life sciences industry is a key opportunity area for growth for Scotland. Companies such as Seluna can play a vital role in transforming our economy by scaling-up, creating high value jobs and competing internationally.”

The Glasgow study marks the first phase of a broader, multi-site validation program, with other NHS sites expected to join by the end of 2025. The company expects the validation studies to lay the groundwork for international expansion, with Class II FDA approval in the United States targeted by the end of 2027. US medical institutions interested in collaborative partnerships and investors seeking opportunities in underserved pediatric markets are invited to engage with Seluna's expanding international program: www.seluna.co.uk

ENDS

Notes to Editors

About Seluna

Seluna is a Glasgow-based MedTech company developing machine learning-enabled software to support doctors in diagnosing and managing childhood sleep disorders. Founded by Dr Scott Black and Dr Yola Jones, the company is addressing the critical gap in pediatric healthcare where doctors currently rely on inefficient, complex, labor-intensive, and time-consuming diagnostic pathways. The company is developing a pediatric-specific Software as Medical Device (SaMD) designed to automate sleep study scoring, identify novel digital biomarkers, and provide clinical decision support to help physicians prioritize care for children who need it most. Seluna's technology features transparent, interpretable outputs that clearly explain how conclusions are reached, helping to minimize the 'black box' problem often associated with AI-based tools. For more information, visit www.seluna.co.uk

About Pediatric Obstructive Sleep Apnea (OSA)

Pediatric obstructive sleep apnea (OSA) is a common condition affecting an estimated 96 million children worldwide. It is characterized by dysfunction of the upper airways, resulting in periodic episodes of partial or complete obstruction of breathing while the child sleeps. In children, OSA disrupts neurocognitive development, causing behavioral problems, stunted growth, poor concentration, and memory issues. Long-term, OSA increases the risk of obesity and chronic health conditions including cardiac disease, neurological disorders, metabolic abnormalities, and mental health decline. Despite being treatable through surgical procedures such as adenotonsillectomy (removal of tonsils and adenoids), 80% of pediatric OSA cases are never diagnosed, with symptoms often confused for ADHD. Without diagnosis, there is no pathway to treatment, leaving children to endure avoidable, long-term health consequences.

About Gabriel Investment Syndicate

Gabriel is a Scottish investment syndicate backing ambitious, innovative early stage companies across a range of sectors with pre seed capital and dedicated mentoring support. Members typically first invest in companies raising around £150k, with valuations under £1.5m. Gabriel is a co-investment partner of Scottish Enterprise, and aims to co-invest in all new investments. For more information visit www.gabriel-is.com

About STAC

STAC is Scotland's industry-led accelerator for smart, connected, and deep tech startups. Founded in 2021, STAC delivers an intensive 18-month program that takes companies from concept to market-ready products capable of competing internationally.

STAC is Scotland's only private business accelerator offering the complete ecosystem for tech startups: expert industry-led mentorship, co-working space in thebeyond, direct access to market through corporate partnerships, and investment through STAC Invest.

Operating from its headquarters in Glasgow, STAC supports 15-20 companies every nine months across sectors including robotics, AI, advanced materials, IoT, and deep tech applications. The accelerator's unique model provides 116 structured business ingredients over 18 months, covering everything from product development and customer acquisition to investment readiness and international scaling.

STAC is 90% funded by industry partners including major technology brands who provide not only capital but also access to technology, market intelligence, supply chains, and global networks. Through STAC Invest, its investment syndicate with almost 50 members, the organisation provides capital alongside comprehensive support to help Scottish startups scale globally.

For more information, visit https://www.stac.ac/

About University of Strathclyde

The University of Strathclyde is a leading international technological university based in the
centre of Glasgow. Inspired by our founding principle as ‘a place of useful learning’, our mission is to make a positive difference to the lives of our students, to society and to the world.
Strathclyde students benefit from an innovative and practical educational experience
enhanced by its integration with our research capabilities, high-quality academic resources
and an unparalleled industry engagement programme.

The excellence of our research is evidenced by the growth in range and scale of our
research collaborations and by our performance in the Research Excellence Framework
2021 where almost 90% was rated ‘world-leading’ or ‘internationally-excellent’.
We have redefined how we collaborate and work with industry, government and the third
sector to ensure innovation and knowledge exchange are fundamental activities that deliver
tangible impact.

Strathclyde was named Scottish University of the Year 2024 in the inaugural Daily Mail
University Guide, Sunday Times Good University Guide Scottish University of the Year
2020, Times Higher Education UK University of the Year 2019, and was awarded a Queen’s
Anniversary Prize for Higher and Further Education for its excellence in energy innovation in
2020, for excellence in advanced manufacturing in 2022 and for excellence in photonics
research in 2023.

About Scottish Enterprise

Scottish Enterprise (SE) is Scotland’s national economic development agency and a non-departmental public body of the Scottish Government. It supports businesses to innovate and scale to transform the Scottish economy by focusing on new market opportunities through targeted investment, innovation and internationalisation. Follow us on LinkedIn.

Attachment

• L-R_ Dr Yola Jones of Seluna, Dr Ruth Hamilton, Dr Scott Black of Seluna, Prof Haytham Kubba, and Innes Taylor, Commercial Manager at Seluna

Jen Richards
Media contact
jen.richards@hottinroof.co.uk

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