Seluna Initiates Pediatric Sleep Trial

Medtech firm Seluna has launched a major childhood sleep disorder study in partnership with the Royal Hospital for Children in Glasgow, Scotland, in preparation for its anticipated expansion into the U.S. market.

The 500-patient study (all subjects are younger than 18), will run through the end of 2025. It aims to validate Seluna’s diagnostic software as a medical device (SaMD), which automatically interprets sleep studies through machine learning algorithms. The technology will help 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.

“What makes Seluna’s approach so compelling is its focus on explainable AI,” said principal study investigator Dr. Ruth Hamilton, a consultant clinical scientist at Royal Hospital for Sick Children in Glasgow. “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.”

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. The current gold standard pathway relies on manual interpretation of complex sleep study data—a slow and labor-intensive approach that creates significant bottlenecks in an already strained healthcare system.

“Right now, we simply don’t know if we’re operating on the right children, and we’re missing many who genuinely need treatment,” stated principal study investigator Dr. Haytham Kubba, a pediatric ENT surgeon at Royal Hospital for Children. “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 has secured more than $860,000 in recent funding from Gabriel Investment Syndicate, the University of Strathclyde, STAC Invest, and Scottish Enterprise. This will be used to initiate its U.S. Food and Drug Administration (FDA) pre-submission process, optimize the diagnostic machine learning algorithms, and launch the first U.K. 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.

“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,” Seluna Co-Founder/CEO Dr. Scott Black said. “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.”

The company also 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 U.K.-based investors are expected to follow on in support of the company’s international growth and mission to address this gap in children’s health.

“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,” stated Alex Lusty at Gabriel Investment Syndicate. “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 U.K. and U.S.”

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. The 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.

“Seluna represents exactly the kind of investment opportunity STAC Invest is looking for—a 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,” STAC Investment Head Angus Macfadyen said. “Seluna has all the ingredients for international success: exceptional founders, differentiated technology, clear regulatory pathway, and substantial market opportunity in both U.K. and U.S. markets.”

The Glasgow study marks the first phase of a broader, multi-site validation program, with other National Health Service 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.

“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,” commented Anne Henderson, head of Investment at the University of Strathclyde. “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.”

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.

“Scottish Enterprise has supported Seluna’s ambition to improve the diagnosis and management of childhood sleep disorders over several years,” added Derek Shaw, director of Entrepreneurship & Investment at Scottish Enterprise. “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.”

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. Black and Dr. Yola Jones, 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 the ways in which conclusions are reached, helping to minimize the ‘black box’ problem often associated with artificial intelligence-based tools.

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 £150,000, with valuations under £1.5 million. Gabriel is a co-investment partner of Scottish Enterprise, and aims to co-invest in all new investments.

STAC is Scotland’s industry-led accelerator for smart, connected, and deep tech startups. Founded in 2021, STAC delivers an 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 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 that provide capital and access to technology, market intelligence, supply chains, and global networks. Through STAC Invest, its investment syndicate with almost 50 members, the organization provides capital alongside comprehensive support to help Scottish startups scale globally.

The University of Strathclyde is an international technological university based in Glasgow. Its 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 research capabilities, academic resources, and an industry engagement program. 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 U.K. 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.

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 internationalization.