Somnus is an airway platform company. We treat obstructive sleep apnea as a chronic condition, not a one-time surgical event — and we built the company to match that reality.
We're building the infrastructure layer for upper airway dysfunction.
The clinical wedge is HYPNARA™, a palatal implant with strong unit economics: $2,500 ASP, $300 COGS, 88% gross margin, break-even at two thousand units. FDA Pre-Submission meets May 7, 510(k) filed late 2026 using Pillar as predicate, clearance targeted Q1/Q2 2027 with limited launch. That's the near-term commercial story.
The platform is what makes the company durable. Somnus Sleep™ turns any smartphone into a sensor through BSA™, our on-device acoustic breathing and snoring engine — zero hardware, zero cost to enter the funnel. MORPHEX™AI is a smart oral device that pairs with HYPNARA post-procedure, shipping in three regulatory stages — standard MAD, wellness-grade sensors, diagnostic clearance — so each stage funds the next. The Somnus Bedside Node™ sits at the premium tier with mmWave radar and beamforming mics. The Somnus Index™ is the composite score that tracks progression across all of it, and the Somnus Provider Directory™ routes flagged users to Somnus-trained™ surgeons.
That's the flywheel: a patient monitored on the Index today becomes a referral for HYPNARA tomorrow.
Our defensible moat is the closed-loop data network. Twelve patent applications filed, growing to roughly nineteen applications and three hundred ninety-plus claims over the next twelve months. The patents cover closed-loop titration driven by small language models on-device, multi-node sensor fusion including thermostats and mattresses, and a privacy-partitioned social sleep network. None of that is duplicable from hardware alone.
Somnus is a closed-loop AI/ML platform for upper airway dysfunction. Multi-modal sensor fusion — phone acoustics, ambient bedside sensing, and post-procedure outcome capture — feeds a machine-learned acoustic classification stack and a patient-level scoring engine that supports clinical decision-making rather than replacing it. The Somnus Index™ scores each patient continuously, and the Somnus Provider Directory™ uses AI/ML routing to match flagged users to Somnus-trained™ surgeons by phenotype, geography, and the outcome history of similar patients. HYPNARA™ itself is a passive structural palatal implant; the surrounding software is the AI/ML layer that turns a one-time procedure into a closed loop. The platform is the subject of multiple patent-pending applications across the closed-loop architecture, scoring, routing, and sensor-fusion claim families.
We're not selling a device. We're building the infrastructure layer for upper airway dysfunction.
Three sensing streams feed the Somnus Index. The Index scores each patient and routes them through the Provider Directory to the right therapy — HYPNARA, MORPHEXAI, or another pathway the clinician selects. Post-procedure outcomes feed back into the Index. Every loop makes the next routing smarter.
Palatal implant for snoring and mild-to-moderate OSA. 510(k) via Pillar predicate, manufactured at Voltas Medical (ISO 13485). Passive structural device; supported by the AI/ML clinical decision layer in the surrounding Somnus platform.
Smart oral device pairing with HYPNARA post-procedure. Ships in three regulatory stages so each stage funds the next.
Turns any smartphone into a sensor via BSA, our on-device acoustic breathing and snoring engine. Zero hardware, zero cost to enter the funnel. Machine-learned acoustic classification with per-patient calibration.
Composite score that tracks airway progression across every product. Patient-facing in the app, provider-facing in the Directory, outcomes framework for both devices. ML-based multi-factor scoring engine; continuous re-calibration as new sensor data lands.
Routes flagged users from the app to Somnus-trained surgeons. Subscription revenue engine for the data-network side. AI/ML routing matches patients to providers by phenotype, geography, and the outcome history of similar patients; clinician review and selection determine final treatment path.
Premium-tier bedside hardware with mmWave radar and beamforming mics. Extends BSA and the Somnus Index beyond the phone, and pairs with the MORPHEXAI V3 diagnostic tier when that stage activates. Multi-modal sensor fusion with graceful degradation when individual sensors are missing.
"On any full clinic day, I see three to five patients presenting with snoring concerns — sometimes more. The demand for a single-procedure palatal solution is steady and underserved by today's options."
Matthew Cronin · Founder & CEO
mcronin@somnustech.ai · 920.284.9099
HYPNARA and MORPHEXAI are not yet FDA cleared or approved and are not available for sale or commercial distribution. Product names, regulatory pathways, and timelines described on this page reflect current development plans and are subject to change. Somnus Sleep and the BSA acoustic engine are intended to operate within the FDA General Wellness Policy and are not diagnostic devices. The Somnus Index™ and the AI/ML decision layer support clinical decision-making by licensed clinicians; they do not make diagnoses or treatment decisions independently.
This page is confidential and intended solely for recipients invited by Somnus Technologies, Inc. It is not an offer to sell or a solicitation of an offer to buy any security. Any such offer will be made only to qualified investors through definitive offering documents.