Compumedics welcomes FDA clearance for Somfit
Melbourne, Victoria
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December 07, 2023 11:30 AM Eastern Standard Time
Compumedics Ltd (ASX:CMP) chairman Dr David Burton and CFO David Lawson speak with Proactive following news the US Food & Drug Administration (FDA) has cleared the company’s Somfit device to be marketed in the USA. They say it marks the achievement of another significant strategic milestone for the Somfit technology platform in one of the world’s largest sleep markets. The home sleep testing (HST) market in the USA, which the Somfit is primarily targeted at, is estimated to be about two million studies per year.
Compumedics Ltd CFO and executive director David Lawson and executive chairman and CEO David Burton sat down with Proactive’s Andrew Scott to discuss the major milestone surrounding its Somfit technology platform. Somfit® has received FDA clearance for the device to be marketed in the USA.
There is a significant addressable market in the USA between US$110 million to US$180 million in potential revenue, which Compumedics will target 10% to 30% of within the next 24 months. Compumedics can now begin its commercialisation activities in the key USA market, following the initial successful validation and commencement of sales activities for Somfit in the Australian market, since the beginning of the 2024 financial year.
In commenting on this significant milestone for Compumedics, David Burton said when the announcement came out, “Following FDA clearance for the Somfit device in the USA, 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.”
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