Summary: ProSomnus has advanced multiple strategic initiatives, including FDA registration of its HWO2 buccal mucosal wellness oximeter, launch of the EVO Guided oral appliance, and additional growth financing.
Key takeaways:
- HWO2, an intraoral oximeter, tracks SpO₂, pulse rate, and device use time, with data viewable via smartphone.
- The buccal mucosal measurement site may reduce common oximetry errors due to high vascularity, stable temperature, reduced ambient light interference, and lower melanin content.
- EVO Guided is engineered to optimize airway patency, jaw stabilization, and nasal breathing, with high post-market provider and patient satisfaction.
- ProSomnus secured growth capital from existing investors to support new device rollouts and appointed Jason Orchard as CFO.
- The company achieved EU-U.S., UK Extension, and Swiss-U.S. Data Privacy Framework certifications for compliant cross-border personal data transfers.
- At World Sleep 2025, ProSomnus will present the new devices, host a symposium, and feature at least seven scientific abstracts.
ProSomnus Sleep Technologies today announced significant progress on strategic programs, including the US Food and Drug Administration registration of HWO2, a buccal mucosal wellness oximeter.
HWO2 Wellness Oximeter
The ProSomnus HWO2 Device enables patients to monitor their nightly health and wellness during sleep, specifically, blood oxygen saturation, pulse rate, and overall use time, from their smartphones. Available to a limited customer base for now, patients can order HWO2 directly through ProSomnus providers. (Providers can inquire with their local rep.)
In a controlled desaturation study, HWO2 demonstrated a root mean squared error (RMSE) of 2.94% over the range of 70-100% SaO2 collected from 325 matched SpO2/SaO2 data pairs. Performed at the University of Calgary’s Cumming School of Medicine, the test also confirmed pulse rate accuracy with a RMSE of 2.08 bpm collected from 346 matched pulse rate/electrocardiogram data pairs.
Testing provided initial confirmation that intraoral oximetry may offer several meaningful benefits as the buccal mucosal region has qualities that mitigate known confounding variables for oximetry. The buccal mucosal region is highly vascular, not prone to contamination from ambient light, temperature stable, and appears to contain less melanin than skin.
“The HWO2 Device makes it easy, comfortable, and economical to monitor nightly health and wellness. The user simply wears the device, as one might wear a retainer or orthodontic aligner. Upon removal, the device transfers the nightly data to the user’s smartphone app, where the patient can monitor and visualize their nightly health and sleep,” says Edward T. Sall, MD, DDS, MBA, in a release.
“We have been waiting years for a truly accurate SpO₂ monitor embedded in an oral device, and after months of wearing the ProSomnus HWO2 Device, I believe we are finally here,” says Kent Smith, DDS, D-ABDSM, ASBA, in a release. “It is comfortable, reliable, and consistently delivers actionable data—I am sold.”
EVO Guided
HWO2 comes on the heels of introducing ProSomnus EVO Guided, which is bioengineered to dilate the velopharynx and the oropharynx. Each EVO Guided device is custom-fabricated directly from the prescribing provider’s digital records—without prefabricated elements or alterations to the original prescription.
According to ProSomnus, this enables EVO Guided to offer more room for the tongue to stay forward; a novel titration mechanism to stabilize the mandible and prevent jaw drop; and an optimized, minimalistic, anatomical design to minimize tooth separation, facilitate mouth closure, and encourage nasal breathing. The company’s post-market surveillance data indicates high levels of patient and provider satisfaction.
“When we first began using the ProSomnus EVO Guided Device in early 2025, its thinner design and extended mandibular post gave me pause. After delivering more than 1,000 devices, my concerns are gone. EVO Guided is now my oral appliance of choice,” dentist Smith says.
Growth Capital
ProSomnus has secured additional growth capital to support EVO Guided, the HWO2 program, and other strategic initiatives. The financing was led by existing investors Spring Mountain Capital, LP, Littlejohn & Co, and Masters Special Situations.
ProSomnus also welcomes Jason Orchard as chief financial officer, who brings over two decades of investment, financial, and operating expertise to the role.
DPF Certification
In acknowledgement of the growing importance of personal health information in the field of sleep medicine, ProSomnus announced certification under the EU-U.S. Data Privacy Framework (DPF), the UK Extension to the EU-U.S. DPF, and the Swiss-U.S. DPF, enabling compliant cross-border transfers of personal data from Europe to the United States.
World Sleep 2025
At the 2025 World Sleep Congress, where ProSomnus is a bronze sponsor, the company expects to feature the new EVO Guided and HWO2. It also has a symposium, Beyond Mandibular Advancement: Science, Innovation and Outcomes, on September 8 at 12:45 pm in room #326. The company also reports at least seven scientific abstracts that evaluate the merits of the ProSomnus EVO and HWO2 devices.
“At ProSomnus, our mission is enabling more patients to breathe better during sleep, with devices that make OSA treatment safe, effective, patient preferred, and economical,” says Len Liptak, CEO for ProSomnus, in a release. “The progress made on these strategic initiatives demonstrates the impressive contributions of ProSomnus team members worldwide, guidance from dental sleep medicine providers, and support from our investors.”
