Can SomnoMed Sustain Growth After FDA Clearance and Operational Overhaul?
SomnoMed Limited reported a robust FY25 with revenue surpassing guidance and a landmark FDA clearance for its Rest Assure® oral device, setting the stage for sustained growth in oral appliance therapy.
- FY25 revenue of $111.5 million, 22% growth exceeding guidance
- EBITDA improved to $9.2 million with margin rising to 8%
- FDA clearance for Rest Assure® compliance monitoring system
- Manufacturing capacity increased by over 50%, backlog eliminated
- FY26 guidance reaffirmed with revenue of $119–126 million and EBITDA of $10–12 million
Strong Financial Performance
SomnoMed Limited has delivered a standout FY25, posting revenue of $111.5 million, a 22% increase compared to the previous year and comfortably above its guidance of $105 million. This growth was matched by a significant turnaround in profitability, with EBITDA rising to $9.2 million from just $0.6 million in FY24, lifting the margin from 1% to 8%. The company also achieved positive operating and free cash flow, underpinning a more sustainable financial footing.
Operational Transformation
Behind these numbers lies a concerted effort to strengthen operational foundations. SomnoMed expanded its manufacturing capacity by over 50%, resolving previous constraints that had hampered supply. Turnaround times improved markedly across all regions, and the backlog that had affected customers in FY24 was effectively eliminated. These operational improvements have enhanced reliability and positioned the company to meet growing global demand for oral appliance therapy.
Leadership and Strategic Focus
The company’s transformation was supported by a refreshed leadership team, with key hires across finance, operations, product development, and regulatory affairs. Notable appointments include Jonathan Vowels as VP of Manufacturing and Operations and Keshan Gunasinghe as Chief Product Officer, bringing decades of industry experience. This leadership upgrade has accelerated execution and improved organizational discipline.
Regulatory Milestone – FDA Clearance
A highlight of FY25 was the FDA clearance of SomnoMed’s Rest Assure® system, the first oral appliance globally with built-in compliance monitoring. This technology integrates an oral device with a software platform, including patient and physician apps and cloud systems. The company is now preparing for US clinical trials to support efficacy monitoring, with the Clayton Sleep Institute confirmed as a clinical site. This innovation is poised to redefine oral appliance therapy by providing clinicians and payors with meaningful data and enhancing patient engagement.
Outlook and Guidance
Looking ahead, SomnoMed reaffirmed its FY26 guidance, targeting revenue between $119 million and $126 million and EBITDA of $10 million to $12 million. Capital expenditure is expected to be $6 million to $8 million, focused on Rest Assure® development and manufacturing expansion. The company aims to continue embedding operational gains while advancing its clinical program and broadening the adoption of oral appliance therapy as a mainstream treatment for obstructive sleep apnea.
Bottom Line?
SomnoMed’s FY25 momentum and FDA breakthrough set a promising course, but clinical trial outcomes will be pivotal for future growth.
Questions in the middle?
- How will the upcoming Rest Assure® clinical trials influence FDA approval timelines and market adoption?
- What impact will increased manufacturing capacity have on global market share and competitive positioning?
- How sustainable is the company’s margin improvement amid ongoing investments and market expansion?
