FDA registration opens US market to British insomnia device

An innovative, UK-designed sleep therapy solution has taken a major step towards capturing a share of the global $80bn sleep aid market after securing US regulatory registration. SleepCogni, a data-supported device for people suffering from insomnia, has now been registered for medical use by the US Food & Drug Administration (FDA).

Following a successful clinical trial at Sheffield Hallam University, preliminary analysis has shown that SleepCogni reduces insomnia – as measured by Insomnia Severity Index -  in just seven days.* FDA registration opens up immediate access to an estimated 70m sleep sufferers living in the US.

Co-founded by Sheffield-based entrepreneur Richard Mills, who has personally suffered from sleeping disorders, and Dutch chronobiologist and sleep expert, Dr Maan van de Werken, SleepCogni is a hand-held sleeping aid which enables users to self-manage their insomnia. The device, which collects data to provide informed insights for clinical intervention, has secured 11 patents including ones for its wind down technology, Active-Biofeedback, which uses haptic feedback to help insomnia sufferers break cognitive cycles preventing sleep.

Since it was founded in 2015, SleepCogni has raised almost £1.8m to support technology development, including investment from venture capitalists Mercia and other private sources, and has secured three research and development grants through the UK’s innovation agency, Innovate UK.

The company is now about to begin beta testing its device at four sites, two in the UK and two in the US, one of which is a world-leading healthcare system. Upon successful testing, SleepCogni is set to be rolled out to 130 clinics of one of the largest sleep care management groups in the US.

The company’s chairman is Richard di Benedetto, President of Aetna International health insurance, and a leading figure in the global healthcare sector. Its medical advisers include Dr Donn Posner, the US-based Founder and President of Sleepwell Consultants. 

Richard Mills, SleepCogni’s co-founder and CEO said: “FDA registration is a major development for the company, giving us access into the American market where, according to the Centres for Disease Control and Prevention, one in three people suffer with insomnia at some point in their lives. This coincides with an agreement to roll out our device in 130 US sleep clinics following the successful completion of its final testing.”

Leading the SleepCogni clinical trials were Dr Antonia Ypsilanti, Associate Professor of Cognitive Psychology and Dr Lambros Lazuras, Associate Professor in Social Psychology at Sheffield Hallam University. Dr Ypsilanti said: “The SleepCogni trials produced extraordinary results, reducing clinical insomnia to subthreshold insomnia in just seven days for those using the device. It’s ground-breaking to see such a drastic improvement on insomnia severity, and therefore unsurprising that the participants found the device more effective than other sleep improvement approaches they’d used in the past.”

Richard di Benedetto, SleepCogni’s chairman, said: “SleepCogni is an innovative, self-managing solution for insomnia sufferers with huge global market potential. The successful trials in collaboration with Sheffield Hallam University, FDA registration and our partnership with one of the biggest sleep care management providers in the US further underlines its strong commercial prospects going forward.”