SomnoMed introduced Rest Assure, its first ever in-built technology-enabled oral appliance, at World Sleep 2022 with the aim of addressing the lack of overnight monitoring and objective data for oral appliances. Although the Rest Assure hardware and software is in prototype stage, the design is now complete, and a vendor is manufacturing the docking station and sensor components.
The second Rest Assure patient validation study has also been completed. These study results are currently being analyzed and will be submitted for publication in a scientific sleep journal later this calendar year to confirm the algorithms needed to objectively measure efficacy and compliance to ensure long-term therapy effectiveness.
Patient feedback on SomnoMed Rest Assure was also collected during this study, with 29/30 patients able to connect their device to the patient app and dock their device using simple written instructions only. All patients in the study expressed a desire to continue Continuous Open Airway Therapy (COAT) therapy with Rest Assure when the device is launched.
The Rest Assure project remains on schedule, with SomnoMed’s focus now on the preparation of documentation required for regulatory submissions to the US Food and Drug Administration, TGA (Australia), and for CE marking (Europe). Rest Assure will be commercialized once these approvals are received.
At SLEEP 2022, SomnoMed showcased its oral appliance treatment solution while also engaging in a range of collaborative interactions and meetings with various industry players. According to the company, the feedback on the Rest Assure technology was overwhelmingly positive.
SomnoMed also reports a record fourth quarter of 2022 (ending June 30), with quarterly revenue of $21.3 million, a 32% increase versus the previous corresponding period.
The record quarter reflects the impact of successful sales and marketing initiatives in all regions, with business conditions improving and the overall trend of patient activity and engagement with their medical clinician normalizing after COVID-19 impacts.
“The improving sales levels SomnoMed is experiencing have been driven by a combination of the strong underlying business activity levels across our key markets and the results of the deliberate investments we made through 2021 to expand our sales and marketing teams to focus on delivering a quality treatment solution for patients with mild to moderate OSA,” says Neil Verdal-Austin, SomnoMed’s managing director, in a release. “The sales momentum we have achieved over recent quarters continues to demonstrate the sound fundamentals of the core business and the large growth opportunity for oral appliance solutions in the treatment of obstructive sleep apnea, globally.
“These results validate our strategy and confirm, once again, that the exceptional ‘first time fit’ quality and durability of our product range is superior within the marketplace and preferred by clinicians and patients world-wide.
“We anticipate that, once launched and over time, the data collected by Rest Assure will demonstrate and establish the true clinical effectiveness of Continuous Open Airway Therapy (COAT), driving prescriptions, increased reimbursement, and ultimately greater OSA therapy market share.
“As we move into FY23 we have strong revenue momentum, an increasing rate of patient engagement, a passionate and energized global team, a strengthened balance sheet and an exciting technology development in Rest Assure, which all leave the company poised to deliver solid growth in the year ahead. I look forward to providing more formal FY23 guidance with our FY22 financial results release in August.”
SomnoMed has also secured new debt funding of $16 million, which delivers sufficient capital to support the ongoing growth within the core business and to complete the development of Rest Assure.
SomnoMed Rest Assure product is not FDA cleared for promotion or sale in the United States.