SomnoMed Q1 Revenue Hits $28.7M, Up 13.5%, FDA Supports Rest Assure Study
SomnoMed reports a strong start to FY26 with 13.5% revenue growth and confirms the Clayton Sleep Institute as the first US site for its pivotal Rest Assure clinical study, backed by FDA protocol agreement.
- Q1 FY26 revenue rises 13.5% to $28.7 million
- Clayton Sleep Institute confirmed as first US clinical site for Rest Assure study
- FDA agrees in principle with Rest Assure study protocol
- Europe and North America drive double-digit regional growth
- FY26 guidance reaffirmed with revenue target of $119m-$126m
Robust Revenue Growth Signals Momentum
SomnoMed Limited has kicked off FY26 with a solid financial performance, reporting a 13.5% increase in revenue to $28.7 million for the first quarter ended September 30, 2025. This growth was primarily driven by strong demand in Europe and North America, which posted double-digit gains, while the Asia-Pacific region experienced a slight decline. The company’s ability to exceed prior year unit sales despite last year’s backlog clearance suggests sustained market momentum for its oral appliance therapies targeting sleep-related breathing disorders.
Clinical Validation Takes a Major Step Forward
On the clinical front, SomnoMed confirmed the Clayton Sleep Institute as the inaugural US site for its Rest Assure clinical efficacy study. This milestone is significant, as the study aims to validate Rest Assure’s performance against gold-standard sleep testing methods. The involvement of such a respected institution adds considerable credibility to the trial, which is a critical step toward commercialisation in the US market.
Moreover, the US Food and Drug Administration (FDA) has indicated fundamental agreement with SomnoMed’s proposed study protocol, subject to minor modifications. This regulatory alignment is crucial, as the study’s data will support a future FDA submission for efficacy monitoring. If approved, Rest Assure would become the only oral device cleared for both efficacy and compliance monitoring, potentially setting a new standard in sleep apnea treatment.
Looking Ahead, Expansion and Guidance
SomnoMed is also in the final stages of securing a second leading US sleep clinic to participate in the Rest Assure study, with an announcement expected soon. This expansion could further strengthen the clinical evidence base and accelerate the pathway to market.
Financially, the company reaffirmed its FY26 guidance, targeting revenue between $119 million and $126 million, EBITDA of $10 million to $12 million, and capital expenditure of $6 million to $8 million. With a cash balance of $16.5 million at quarter-end, SomnoMed appears well-positioned to fund its clinical and commercial initiatives.
Co-CEOs Amrita Blickstead and Karen Borg highlighted the significance of the Clayton Sleep Institute’s involvement, emphasizing the strong clinical momentum behind Rest Assure as the company advances toward commercialisation.
Bottom Line?
SomnoMed’s clinical progress and solid revenue growth set the stage for a potentially transformative year ahead.
Questions in the middle?
- When will the Rest Assure clinical study results be available and how might they impact FDA approval timelines?
- Which US sleep clinic will be announced next to join the Rest Assure study, and what influence will it have on trial credibility?
- How will the slight decline in APAC sales affect SomnoMed’s global growth strategy moving forward?
