Compumedics eyes US market with Somfit sleep diagnostic device

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By Colin Hay - 
Compumedics ASX CMP Somfit sleep testing FDA approval

Brain research technology specialist Compumedics (ASX: CMP) has achieved a major breakthrough with the planned distribution of its Somfit sleep assist system, with the Food & Drug Administration (FDA) clearing the device to be marketed in the United States.

Compumedics is targeting the multi-million dollar sleep market in the US with the Somfit technology, which has been designed to include a number of market-specific and disorder-specific products that offer several advantages to organisations operating in the sleep diagnostic space.

Executive chair and chief executive officer Dr David Burton said the green light from the FDA marks another significant strategic milestone for the Somfit technology platform in one of the world’s largest sleep markets.

Implementing a commercialisation strategy

“Following FDA clearance for the Somfit device in the US, Compumedics can now begin executing their commercialisation strategy to capitalise on the under-penetrated sleep market with an initial focus on home sleep testing (HST), before addressing other opportunities,” Dr Burton said.

Compumedics announced the initial commercialisation of Somfit in Australia in July, with the system already receiving $1.2 million of sales orders to date.

The company is now looking to commence commercialisation activities in the key US market from the beginning of the 2024 financial year.

Massive US market opportunity

According to research undertaken by Compumedics, the HST market in the US is estimated to be about two million studies per annum, with a potential addressable market of between $166 million and $270 million a year in potential new and incremental software as a service revenues for Compumedics.

Compumedics, which is looking to achieve between 10% and 30% of the addressable market over the next 24 months, has pre-emptively appointed a number of new sales staff in the US to commence initial commercialisation activities.

The company said it will also be actively pursuing several focused opportunities available to it following the FDA clearance.

Clear competitive advantage

Based on its own assessment, Compumedics believes the Somfit technology platform offers a clear competitive advantage and superior value to alternative technologies on the market in the US due to it being highly scalable while offering a clinical-grade technology for use in the home.

This includes the capacity to obtain clinical-grade data in an at-home monitoring device that removes the need for patients to travel to a hospital or sleep clinic.

Compumedics says Somfit can also reduce patient costs, as the at-home monitoring is less expensive than hospital monitoring because it eliminates the need for hospital staff and facilities.

The Somfit technology products have now received regulatory clearance for sale in Australia, New Zealand, the EU and the US.