The company reported a 43% increase in annual revenue for 2023, driven in part by greater adoption of its oral appliance therapy for obstructive sleep apnea.

Summary: ProSomnus Inc, specializing in oral appliance therapy for obstructive sleep apnea, reported a 43% increase in 2023 revenue to $27.7 million, marking its eighth consecutive quarter of record earnings. Growth was attributed to the adoption of its EVO product, increased sales efforts, and operational achievements including a successful pilot for a new monitoring device, a pending FDA submission for label expansion, and maintaining high satisfaction and delivery standards. The company also received ISO 13485:2016 certification, highlighting a year of significant clinical and operational advancements.

Key Takeaways:

  • ProSomnus Inc’s revenue increased by 43% in 2023, reaching $27.7 million.
  • The company submitted a 510(k) Premarket Notification to the FDA for a severe indication label expansion, which is currently under substantive review.
  • ProSomnus successfully completed a pilot study for a next-generation remote patient monitoring device, demonstrating its technical feasibility for continuous SpO2 monitoring.

ProSomnus Inc, a maker of oral appliance therapy for the treatment of obstructive sleep apnea (OSA), announced financial results for the fourth quarter and year ended Dec 31, 2023. The company’s 2023 revenue increased to $27.7 million, an increase of $8.3 million, or 43%, compared to the previous year. 

The quarter marked the eighth sequential quarter of record revenues.

The company attributed this increase to increased adoption of its oral appliances, increased sales and marketing investments, and a mix shift to the EVO Product, all of which contributed to higher unit volumes. 

“I am thrilled to announce another record revenue quarter and fiscal year for ProSomnus, as we establish the ProSomnus EVO precision intraoral technology as a truly differentiated therapy for obstructive sleep apnea,” says Len Liptak, chief executive officer of ProSomnus, in a release. “The team worked tremendously towards executing on our strategic deliverables and achieved a record number of procedures in both Q4 and the full year. 

ProSomnus EVO
ProSomnus EVO Photo credit: ProSomnus

Recent business highlights:

  • Demonstrated technical feasibility of the company’s next-generation remote patient monitoring device for OSA. Data from a recently completed pilot study demonstrated that an oximeter embedded in a precision intraoral medical device can accurately, safely, and continuously monitor SpO2.
  • Submitted 510(k) Premarket Notification to the US Food and Drug Administration for severe indication label expansion. Currently in the substantive review phase.
  • Maintained >98% on-time delivery and patient and provider satisfaction.
  • Secured ISO 13485:2016 certification of the company’s quality management system.

“2023 was an impactful year, as we continued to generate and share strong clinical data supporting the use of ProSomnus precision oral appliance therapy as a first-line therapy for obstructive sleep apnea, advanced enrollment in the Severe Obstructive Sleep Apnea study, and prepared a robust dossier to support a premarket submission to the FDA earlier this year for label expansion to include severe OSA,” says Liptak in a release. 

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