The Somnus Sleep™ app turns any smartphone into a sensor via BSA™, our on-device acoustic breathing and snoring engine — zero hardware, zero cost to enter the funnel. The Somnus Index™ is a composite wellness score that tracks progression across the platform. Both operate under the FDA General Wellness Policy and are positioned in wellness terms.
Not a device gap. It's an infrastructure gap. The market keeps shipping better open-loop products into a problem that only a closed loop can solve.
We're building the infrastructure layer for upper airway dysfunction (UAD).
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. At its May 7, 2026 FDA Pre-Submission meeting, FDA confirmed the 510(k) pathway and our predicate device. Clinical study is next, as planned. A clinical study evaluating safety and effectiveness supports the change in implant material; design, sample size, and protocol are set in a supplemental Q-submission, and the 510(k) submission follows study completion. CRO partners are in final selection. That's the near-term commercial story.
Every treated patient sharpens routing for the next.
Sensors → Bedside Node → Somnus Index™ → Provider Directory → Therapy → Outcomes → Re-scoring & Re-routing → back to Sensors. We are building the loop.
Palatal implant for snoring and mild-to-moderate OSA. 510(k) pathway via our predicate device; manufactured by Voltas Medical (ISO 13485). Passive structural device; AI/ML decision layer in the surrounding software. Pre-Sub complete (May 7) — FDA confirmed the pathway and predicate; safety-and-effectiveness clinical study is next, as planned; CRO selection in final evaluation; submission follows study.
$2,500 ASP · 88% GM · ~2,000 unitsA smart oral device with on-device airway analytics, supported by an AI/ML clinical decision layer. Ships in three regulatory stages so each stage funds the next; supports clinical decision-making and does not diagnose independently.
V1 MAD → V2 wellness → V3 diagnosticTurns 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.
Pre-launch · FDA General Wellness Policy-alignedComposite wellness score that tracks progression across the platform. Patient-facing in the app, provider-facing in the Directory. Operates under the FDA General Wellness Policy and is positioned in wellness terms.
Core of the defensible moatLaunch: patient-browsable directory of sleep-health providers from public registry data (NPPES). Neutral, informational — no credentialing claim, no selective routing — in the wellness context.
Roadmap (V3): predictive, selective routing layer and provider worklist is a roadmap capability on the device-software track; pathway under counsel review.
Premium-tier bedside hardware with mmWave radar and beamforming mics. Extends BSA™ and the Somnus Index™ beyond the phone, and pairs with the MORPHEX AI V3 diagnostic tier when that stage activates. Multi-modal sensor fusion with graceful degradation.
Roadmap — aligns with MORPHEX AI V3The post-therapy outcome data nobody else captures is our training set.
The seven pieces are the components; the loop that connects them — sense, score, route, treat, re-score — is the durable asset. We are building the loop. As one connected system it does not exist in the market today, and it 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.
Maturity reflects build status, not accumulated usage.Use of proceeds. First-close capital funds HYPNARA™ through the FDA-required clinical study and 510(k) submission, the Somnus Sleep™ launch, IP-portfolio expansion, and provider-network seeding. The full round adds the MORPHEX AI V1 MAD 510(k) workstream.
Use of funds — first close ($2.5M), 18-month runway to clearance & Series A readiness
Series A readiness at month 18: HYPNARA™ cleared, MORPHEX AI V1 in flight on full-round capital, the closed-loop data network moat validated, and a 25-provider network live.
An F-reorganization (IRC §368(a)(1)(F)) to a destination jurisdiction is planned pre-Series A and is investor-contingent; the destination is open. The HoldCo + two-subsidiary structure (Somnus Medical Devices, Inc. + Somnus Digital Health, Inc.) is a Phase-2, pre-Series A event.
"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." — Agustin J. Arrieta, MD
HYPNARA™ and MORPHEX™AI are not yet FDA cleared or approved and are not yet available for sale or commercial distribution. 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. Confidential; not an offer to sell or a solicitation to buy any security.
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