Company Interview / Compumedics' dream US approval

Key Points

Compumedics (ASX:CMP) receives US FDA clearance for the Somfit D disposable home sleep testing device New approval doubles the US addressable market, valued at up to $250 million Company anticipates global market opportunity surpassing $1 billion Diversified revenue streams from devices, consumables, and SaaS subscriptions drive growth

Compumedics has secured US FDA clearance for its latest sleep testing device, Somfit D, marking a significant milestone for the company in the burgeoning American home sleep testing market. David Burton states that Somfit D, a disposable version of the existing home sleep system, now allows for web-based studies conducted in patients’ homes across the US. This system uniquely provides both sleep apnoea screening and insomnia measurement at a competitive price. Burton notes that with the introduction of this disposable model, Compumedics’ addressable market has instantly doubled, with initial sales of the reusable Somfit having already reached $2 million.

Lawson adds that the US home sleep testing market now comprises around 4 million tests annually, growing up to 25% per year. The company estimates the local addressable market for their devices is between $240 million and $250 million, with global potential reaching over $1 billion. Compumedics is capitalising on this rapid expansion, with a $10–20 million sales pipeline for Somfit D and a 20-strong salesforce geared towards accelerating new deals.

The company’s business model spans device sales, consumables, and SaaS subscriptions. In addition to its sleep diagnostics division, Compumedics’ neurodiagnostics and vascular businesses are experiencing swift growth, particularly with innovative products such as its brain scanner and Doppler AI system. Compumedics expects revenue to lift to $70 million and EBITDA to rise from $3 million to $9 million by FY26.