Compumedics has received FDA approval for its Falcon HST device. Pic via Getty Images.
Health & Biotech
Special Report: Compumedics has received US Food and Drug Administration (FDA) approval to market its second home sleep testing (HST) solution Falcon in the US with potential to substantially boost the company’s revenue.
Compumedics Limited (ASX:CMP) said the FDA clearance for Falcon HST further underpins its US sleep business growth strategy, with the device set to complement its proprietary Somfit technology platform, which is currently gaining commercial traction in the US HST market.
The global medical device company develops, manufactures and commercialises diagnostic technology for sleep, brain and ultrasonic blood-flow monitoring.
Compumedics said the HST market in the US, which the Somfit and now the Falcon HST were primarily targeted at, is estimated to be up to four million studies per annum.
Given market research activities undertaken by the company, Compumedics said this represents a potential new addressable market of between US$100m and US$200m a year in new and incremental software as a service (SaaS) revenues.
The company said the revenue assumption is based on market research activities with existing HST providers in the US market, which includes potential pricing for the Somfit and Falcon HST platforms, should they switch to the Compumedics solutions.
The company said the revenue assumption is for the full market opportunity of about four million studies annually, using differing pricing points based on volumes of studies achieved.
Compumedics is currently targeting to achieve between 10% and 30% of the addressable market over the next 24 months and has already commenced sales of Somfit in the US, where initial sales in the last six months were ~$1m.
Somfit is a wearable device for collecting patients’ physiological data, primarily for use in assisting medical professionals to diagnose sleep disorders.
Compumedics said the fully integrated and connected end-to-end Falcon HST offered a more clinically based technology platform that captures more data points.
The company said Falcon HST was still very much a scalable product, offering a clinical grade technology for use in the home, greater convenience and ease of use for the patients, along with an overall reduced cost.
Compumedics has already built a high-performance sales team in the US focused on selling its Somfit HST platform, with the Falcon HST to be added to the product offering.
The Falcon HST was released in Australia in October 2024 and has quickly gained traction selling more than 100 devices with ~$1 m in total revenues.
The further 100 to 200 Falcon HST devices expected to be sold by end of FY25.
Compumedics is now also testing the Falcon HST in Australian markets that are adjacent to sleep, such as cardiac disease, offering potentially significant and highly complementary markets to grow.
The company said early success in Australia bodes well for the much larger US market, which is more than 10 times bigger than the Australian market, based on population.
Executive chairman, CEO and founder Dr David Burton said following the FDA clearance for the Falcon HST device in the US Compumedics can further accelerate its HST commercialisation strategy to capitalise on this high-growth sleep market segment.
“The Falcon HST has already been on sale in the Australian market for six months now and we can take from our experience here that the product is highly regarded by both our existing and new customers, and this augurs well for the much larger USA market,” said Burton.
Compumedics has reaffirmed FY25 guidance of revenue of at least $55m and EBITDA of about $5m.
This article was developed in collaboration with Compumedics, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
