Compumedics has secured a $2.15 million placement to fast-track commercialisation of its Somfit D device following early FDA approval, positioning the company for significant growth in the US home sleep testing market.
- Early FDA approval of Somfit D accelerates US market entry
- Placement raises $2.15 million at $0.285 per share
- Somfit pipeline now exceeds US$20 million
- OrionMEG brain imaging platform sees strong demand from China
- FY26 guidance reaffirmed with revenue above $70 million
Early FDA Approval Spurs Capital Raise
Compumedics Limited (ASX – CMP), a global medical technology company specialising in sleep diagnostics and brain imaging, has announced a $2.15 million placement to accelerate the commercial rollout of its Somfit D device. This follows an early FDA approval granted three months ahead of schedule, a significant regulatory milestone that underscores the device’s readiness for the US home sleep testing market.
The placement was conducted at $0.285 per share, representing a modest discount to recent trading prices, and attracted support from both existing and new institutional investors. The capital injection is earmarked primarily for scaling up manufacturing and tooling capabilities to meet the burgeoning demand reflected in a Somfit pipeline now exceeding US$20 million.
Strategic Growth Pillars Driving Expansion
Compumedics is entering a pivotal phase of commercial expansion, anchored by three strategic pillars. First, Somfit® is positioned to capture a growing slice of the US home sleep testing market, estimated at around US$250 million annually and expanding at up to 25% per year. The company’s partnerships with independent diagnostic testing facilities, pharmacies, and CPAP suppliers signal a transition from pilot programs to full-scale commercial deployment.
Second, the OrionMEG® platform, a breakthrough in functional brain imaging validated by the University of California San Diego, is gaining traction globally. With approximately $15 million in orders forecast for FY26 and over $20 million in early demand from China, OrionMEG® is preparing for entry into the US and European markets. Its advanced temporal resolution targets significant neurological conditions, offering potential to disrupt a $13.6 billion market.
Third, Compumedics continues to leverage its SaaS platforms, such as Nexus 360®, which have processed over 770,000 studies to date. These platforms contribute recurring revenue streams and improved margins, enhancing the company’s overall financial profile.
Outlook and Market Positioning
With FY26 underway, Compumedics has reaffirmed its guidance of revenue exceeding $70 million and EBITDA around $9 million. The company’s strengthened US sales leadership and ongoing board renewal efforts aim to support not only operational execution but also a structural valuation re-rating relative to peers.
CEO Dr. David Burton highlighted the significance of the FDA clearance and the capital raise, noting that Somfit D is transitioning from clinical trials to revenue-generating commercialisation. The funds will also support OrionMEG® capacity expansion to meet global demand, particularly in China, and prepare for anticipated sales in the US and Europe.
As Compumedics moves from pilot adoption to full-scale rollout, the company is well-positioned to capitalize on expanding markets in sleep diagnostics and neuroscience, leveraging regulatory wins and strategic partnerships to drive growth.
Bottom Line?
Compumedics’ early FDA win and capital raise set the stage for a transformative growth phase in sleep and brain diagnostics.
Questions in the middle?
- How quickly can Somfit D scale production to meet the US pipeline demand?
- What are the timelines and challenges for OrionMEG’s US and EU market entry?
- Will the company’s SaaS platforms sustain margin expansion amid rapid growth?