Key Takeaways
- Seluna initiates a clinical validation study to enhance diagnosis of childhood sleep disorders at the Royal Hospital for Children.
- The study aims to validate Seluna’s machine-learning software for diagnosing paediatric sleep apnoea, targeting Class I medical device classification by 2026.
- Funding of nearly £650,000 has been secured to support the project, indicating strong investment interest in innovative paediatric healthcare solutions.
Seluna’s Innovative Approach to Childhood Sleep Disorders
Glasgow-based MedTech firm Seluna has launched a clinical validation study in partnership with the Royal Hospital for Children, aimed at improving the diagnosis and management of childhood sleep disorders, particularly sleep apnoea. Clinicians currently face challenges in determining which children will benefit from treatments, sometimes leading to unnecessary surgery or missed opportunities for other patients who could gain from surgery.
Seluna’s diagnostic software, which falls under the category of software as a medical device (SaMD), employs machine-learning algorithms to enhance the interpretation of sleep studies. By collaborating with registered polysomnographic technologists and doctors, the software aims to provide better insights into children’s sleep patterns.
Dr. Scott Black, co-founder and CEO of Seluna, expressed that the field of paediatric sleep diagnostics has not received adequate attention until now. He emphasized the importance of this validation study, stating it will not only demonstrate the clinical impact but will also set a new standard in the industry. Backed by investors who recognize the potential of this market, Seluna is poised to innovate and compete on an international scale.
The validation study is set to involve 500 anonymised patients under 18 years of age and will continue until the end of 2025. Seluna is optimistic that the validation studies will lead to a Class I medical device classification in the UK by the end of 2026. This classification would facilitate wider adoption of the technology within the NHS and private healthcare sectors, and also serve as a foundation for international expansion, particularly targeting Class II FDA approval in the US by the end of 2027.
The company’s machine learning pipeline is designed to automatically score paediatric sleep studies by identifying and classifying digital biomarkers associated with sleep-disordered breathing. Dr. Ruth Hamilton, a consultant clinical scientist at the Royal Hospital for Sick Children and principal investigator of the study, highlighted the significance of Seluna’s focus on explainable AI. This approach ensures that clinicians can understand the reasoning behind the technology’s recommendations, fostering trust for its use in clinical settings. The technology is expected to alleviate pressure on overstretched departments, helping to address lengthy wait lists.
Seluna’s initiative follows a successful round of funding, securing nearly £650,000 with backing from existing investors, including the Gabriel Investment Syndicate, Scottish Enterprise, and the University of Strathclyde, along with new investor STAC Invest. Angus Macfadyen, head of investment at STAC, noted that Seluna exemplifies a prime investment opportunity—led by a world-class founding team addressing a crucial global health challenge with innovative technology.
In July 2024, The Royal Hospital for Children in Glasgow had also launched a trial for another device from PneumoWave, a digital therapeutics company, aimed at diagnosing respiratory and sleep conditions in infants and young children, indicating a growing focus on this area of healthcare.
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