Beyond One-Size-Fits-Most

Reimagining Respiratory Interfaces

Lunaris Medical is developing bespoke masks for continuous positive air pressure (CPAP) and other respiratory applications.Advances in 3D scanning, design automation systems, and additive manufacturing now enable a fundamentally different approach to creating bespoke respiratory interfaces.The Lunaris approach builds on over 20 years of experience developing comparable design systems within the bespoke orthotics sector, where fit, function, scalability and repeatability are core requirements.

THE PROBLEM

The interface is the limiting factor

CPAP therapy remains the gold standard treatment for obstructive sleep apnoea. Its clinical efficacy is well established. Long-term adherence is not.Across multiple studies, a substantial proportion of patients discontinue therapy within the first year. Mask related discomfort, pressure sores, and mask leaks are consistently reported contributors.Current respiratory interfaces — the critical boundary between device and patient — rely on predefined sizes that approximate, rather than generate, anatomical fit.

The opportunity

The size of the problem

Only 22% of OSA sufferers in the UK are diagnosed.1.6M adults in the UK have obstructive sleep apnea, half of who are on CPAP therapy.50% of those drop out within 12 months of starting the treatment.UK productivity losses linked to OSA have been estimated at £4.22 billion annually by a recent study published in Thorax.According to a study done at the University of York, untreated OSA costs the NHS £1,559 per patient over 14 years.

ENGAGEMENT

Clinical and investment partners

From the outset, our platform has been designed for high volume production — capable of scaling from pilot volumes to tens of thousands of masks per week.The system integrates:
• 3D scanning
• Automatic mask design generation
• Parametric design logic for repeatable, clinically prescribed personalisation
• Additive manufacturing compatible with existing CPAP machines
• A scalable digital-to-production pipelineThe system is being developed within a defined regulatory strategy aligned with UK MDR and EU MDR requirements, with ongoing work toward ISO 13485 certification. We are currently engaging with a limited number of clinical pilot partners as well as trategic investment partners.Professional enquiries are welcome.

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