Seluna Introduced a Pediatric Sleep Trial, Intending to Attract US Investment and Partnership

Announcement

Scotland-related leading medtech company Seluna is encouraged to enhance the management and diagnosis of childhood sleep disorders, with the introduction of a crucial clinical validation study in collaboration with the Royal Hospital for Children in Glasgow, Scotland. With this upcoming progressive initiative, the industry is paving the way and securing its position in the extensive US market.

Pediatric Sleep Trial

The study includes 500 anonymised patients under the age of 18, will be in operation until the end of 2025. It focuses on the validation of Seluna’s diagnostic software as a medical device (SaMD). This is introduced to instantly interpret sleep studies through a streamlined process of machine learning algorithms. This will contribute to the registered polysomnographic technologists (RPSGTs) and doctors in managing and diagnosing pediatric sleep apnea. Recently, Seluna has been on the right track and leading as the first-ever SaMD on the market, mainly developed for pediatric sleep diagnostics.

Extreme of Apnea

Sleep apnea impacts approximately 96 million children globally, and 80% are yet undiagnosed. The untreated sleep apnea in children can reflect ADHD, elevate long-term risk of chronic neurological, metabolic disease, and cardiac and also impair neurocognitive development. The gold standard pathway depends on manual analysis of complex sleep study data, which is a labour-intensive and slow approach, generating prominent bottlenecks in an already filtered healthcare system. Learning these extremes, Seluna has raised $860,000 in current funding from Gabriel Investment Syndicate, the STAC invest, the University of Strathclyde, and Scottish Enterprise.

This will help the company to fuel their FDA pre-submission process, to fuel their diagnostic machine learning algorithms, and introduce their first UK clinical validation trial. The company is engaged in seeking collaboration with the US pediatric hospitals and sleep clinics to provide a collective data licensing agreement and sharing that contribute largely to the collaborative development, and also international multi-site validation. Seluna is also getting ready to introduce its seed round this year and intends to lead US investors with excellent insights into the sleep medicine sector.

Views and Statements from the Company Leaders

Co-founder and CEO of Seluna, Dr. scott black said, “Pediatric sleep diagnostics has been undiscovered for too long. The critical challenge was the reason no tools were introduced for children. Our validation study will elaborate on the clinical change and make a precise statement: Seluna is here to raise standards, compete globally, and innovate in the field. We’re seeking a US-based lead investor who sees the potential of the pediatric healthcare market.”