In June this year we reported that we were working with Australian company BioAnalytics on a new device for sleep apnoea sufferers. We’re delighted to announce that BioAnalytics has completed final changes to their device that will allow the company to undertake a six-month clinical trial for FDA certification.
Romar specialises in advanced medical manufacturing and innovative solutions to manufacturing challenges. So, it was the ideal choice for Owen Morgan, CEO of Australian start-up BioAnalytics.
Owen worked closely with our leading engineers through initial development and Romar will continue to be involved at every step of production.
With sleep apnoea, the walls of the throat constrict. This airway blockage may stop an individual’s breathing for 10 to 60 seconds or until the brain registers it and sends a wake-up call, usually accompanied by a snort or snore. The pattern can occur hundreds of times per night, leaving the afflicted – and their partner – exhausted.
Untreated sleep apnoea may contribute to the onset of other medical conditions including diabetes, heart disease and fatty liver disease. Crucially, it affects 10% of the global population.
Many patients find current treatments unsuitable due to physical and psychological discomfort. The new device is 1/10 the cost of current therapies and more comfortable to use. It will monitor patients’ sleep quality and is an ideal option for up to 40% of patients who can’t use traditional therapies.
Romar is manufacturing the device for trial and into the future for its global product release. Read more about our partnership and the potential of this extraordinary innovation. See more articles about medical device manufacturing, and contact us to start the conversation.
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