Somnus

The Somnus Flywheel · Technical Scoping Briefing

Closed-Loop Sleep Health — Where the Work Is

A flywheel where each treated patient improves the routing of the next.

The hardware is in motion. The IP is filed. This briefing maps the software platform that turns those into a flywheel — and where senior software, cloud, mobile, and security work moves the needle most.

Flywheel components
7
IP portfolio
~15 applications · ~300 claims

v1.0 · April 30, 2026  ·  Matthew Cronin, Founder & CEO  ·  mcronin@somnustech.ai  ·  920.284.9099

Confidential — for authorized recipient review only. See "Important Notices" below for regulatory disclosures, IP status, and confidentiality terms.

The problem in front of the category

Sleep health is a closed-loop problem solved by open-loop systems.

~103 million U.S. adults live with upper airway dysfunction — 83.7M with obstructive sleep apnea, ~20M primary snorers. The category is enormous and undertreated.

The sleep diagnostics and therapy market is built around discrete events. A sleep study. A device prescription. A nightly compliance check. Each step lives in its own data silo. None of them talk to the next.

The result is a market where ~80% of obstructive sleep apnea remains undiagnosed (Benjafield et al., Lancet Respir Med 2019), CPAP non-adherence sits at 46% by ninety days (Patil et al., JCSM 2019), and the patients who fall off therapy are not routed anywhere — they simply disappear from the funnel.

What is missing is the loop. A platform that ingests sleep data continuously, scores it consistently, routes patients to the right therapy, captures outcomes after the procedure, and re-routes when the outcomes don't improve. That loop does not exist anywhere in the market today.

Somnus is building it. The hardware tracks (MORPHEX™ AI oral appliance, HYPNARA™ palatal implant) and the IP portfolio (~15 applications, ~300 claims) are advancing. The software platform that closes the loop is partway built.

Sources: Sönmez et al., Respir Med 2025 (US OSA prevalence, n=83.7M, 2024 data); Benjafield et al., Lancet Respir Med 2019 (undiagnosed rate); Patil et al., JCSM 2019 (CPAP adherence); primary-snorer estimate informed by Deliwala et al., npj Digital Medicine 2024 and internal analysis.

HYPNARA™ and MORPHEX™ AI are in development. Patent-pending. Not yet FDA cleared. Not available for sale.

The platform

Seven components. Each turn improves the next patient's routing.

Somnus closed-loop sleep health flywheel — three sensing streams (Phone Acoustic + BSA, Bedside Node, Therapy Outcomes) feed the Somnus Index hub, which routes through the Provider Directory to HYPNARA, MORPHEX AI, or Partner therapies, with dashed feedback arrows returning post-procedure outcomes to the data pipeline.
Sensors → Bedside Node → Somnus Index™ → Provider Directory → Therapy → Outcomes → Re-scoring & Re-routing → back to Sensors.

Somnus Index™ is a wellness metric under FDA General Wellness Policy. Not a medical device.

State of play

What's built. What's partial. What's open.

# Component Status State of play Skills that fit
1 Sensors — Phone Acoustic + BSA Partial Expo / React Native app live on Cloudflare Pages. Acoustic capture works in the browser. Native iOS recording, HealthKit live build, and battery-resilient overnight capture are not production-grade yet. Mobile (iOS / Expo)
2 Bedside Node — Thermostat / Ambient Open Patent filed — smart thermostat as ambient sleep sensing node, no prior art found. The software does not exist. Needs IoT pairing, secure handshake to common thermostat platforms, normalized ingestion, and an N-source fusion pipeline that degrades gracefully when nodes are missing. Cloud / IoT / Security
3 Somnus Index™ — Composite Score Partial Algorithm fully specified — sleep-dominant weighting, sleep-gated metrics, FDA General Wellness compliant. Reference engine partial. Needs production scoring service, weight provenance audit chain, and per-metric contribution display running on real user data. Cloud / Backend
4 Provider Directory — Algorithmic Routing Open Static UI mockup only. The patentable invention is the routing engine itself — rank providers by phenotype, comorbidity, geography, insurance, and outcome history of similar patients. Filing planned. No working code yet. Cloud / ML / Backend
5 Therapy Modalities — MORPHEX™ AI / HYPNARA™ / Partner Partial Hardware tracks advancing. Software bridge to therapy state is not — device pairing, prescription delivery, compliance telemetry, partner-pathway adapters for CPAP, HGNS, EPAP. FHIR R4 dual-output architecture spec'd but not implemented. Mobile / API / FHIR
6 Therapy Outcomes — Post-procedure Capture Open No closed-loop outcome data path yet. Pre / post-treatment scoring needs longitudinal ingestion, treatment-tagged sessions, provider annotation surface, and PDF / FHIR export. This is the data asset that compounds — and the foundation of a clinical study with HYPNARA™. Cloud / Data Eng.
7 Re-scoring & Re-routing — Feedback Loop Open The closed-loop master claim that ties the flywheel together. Needs an outcomes-aware retraining pipeline aligned with FDA's Predetermined Change Control Plan, an audit trail for every model update, and a re-routing service that flags patients whose Index is not improving. Architecturally absent today. Cloud / ML / Compliance

Status legend: Built / IP filed · Partial — needs work · Open territory

Patent-pending across the family. Some filings are anchored; others are queued for filing through Q2/Q3 2026. Specific filing status available under separate cover with EIP (Amy Salmela, Partner).

Cross-cutting

One layer runs through all seven.

Beyond the seven components, there is one cross-cutting layer that everything downstream depends on — HIPAA Security Rule compliance, SOC 2 readiness, BAAs with every cloud vendor, audit logging, breach notification, and de-identification pipeline integrity.

It is not a single component on the flywheel. It is the spine. Standing this layer up correctly clears the path for a clinical study, an investor close, and an FDA submission for the device side. It matters more than any one of the seven.

HIPAA
Security Rule compliance
SOC 2
Readiness posture
BAAs
Every cloud vendor
Audit logging
Breach notification path
De-identification
Pipeline integrity

Where the leverage is

Five entry points. Ranked.

1
Closed-loop architecture (components 6 + 7)

Highest leverage in the portfolio. The outcomes data pipeline plus the re-scoring and re-routing service is the single piece that turns a stack of patent claims into a working flywheel. Done right — FDA PCCP-aligned, audit-ready — it is also what unlocks a clinical study with HYPNARA™. If the HYPNARA™ study moves to front and center, this is the critical path.

2
AI Referral Engine (component 4)

The provider routing engine is its own filing. A working prototype, even a thin one, turns a paper claim into something demonstrable. This piece is also licensable on its own — a hospital system could license routing without licensing the rest of the platform — so it is a separate commercial asset.

3
Bedside Node IoT integration (component 2)

Smart thermostat as an ambient sleep sensing node has no prior art. The patent is filed. The software is open. Pairing, secure ingestion, and N-source fusion with graceful degradation is a clean greenfield project. Small enough to be a sixty-day deliverable, defensible enough to stand on its own as a demo.

4
Security spine (cross-cutting)

HIPAA architecture, SOC 2 readiness, encryption at rest and in transit, key management, BAA inventory. Not glamorous. Blocks everything downstream — investor diligence, IRB approval for a clinical study, FDA submission for the device side. The right person on this layer is hard to overvalue.

5
Mobile production hardening (component 1)

Native iOS overnight acoustic capture, HealthKit live integration, signed builds, TestFlight pipeline. Less novel, but it is what gets the BSA app past being a web demo. Right fit for someone deep in iOS.

How the work gets done

Hybrid setup. Fast workflow. Clean audit trail.

Strategy, IP coordination, attorney communication, and document production happen through Claude in the Somnus project. Code, builds, source-tree audits, Cloudflare deployments, and anything that needs authenticated access to the Somnus environment happen through Claude Code in the local development tree. Findings flow between the two.

A senior contributor working on any of the components above plugs into both surfaces. Fast workflow. Clean audit trail.

Clinical & Strategic Advisors

Agustin J. Arrieta, MD — Otolaryngology / Sleep Medicine — clinical advisor and HYPNARA™ candidate-evaluation reference.

Mike Kremkau — Strategic Advisor — industry veteran.

Counsel of record

Patent / IP — Amy Salmela, Partner (EIP) — prosecution, USPTO assignments, freedom-to-operate.

Regulatory — Jeffrey K. Shapiro, Partner (King & Spalding) — FDA Life Sciences, 510(k), GWP.

Corporate — John R. McDonald, Shareholder (Godfrey & Kahn) — corporate, financing.

Engagement

Two ways in. Not mutually exclusive.

Next step

A short scoping conversation.

The five ranked areas are the live work. The right place to start depends on the contributor's depth.

30-min scoping call
This week
Mutual NDA · scope memo · access to source tree
Deliverables
Sixty-day bounded engagement on chosen entry point
First work

mcronin@somnustech.ai  ·  920.284.9099  ·  sleep.somnustech.ai

Important notices

Important Notices

Confidentiality. This briefing and its contents are the confidential and proprietary information of Somnus Technologies, Inc. ("Somnus"). It is provided to the named recipient for the purpose of evaluating a potential engagement with Somnus, and may not be reproduced, distributed, or disclosed to any third party without the prior written consent of Somnus. Disclosure to advisors or third parties in the recipient's professional network requires those parties to be bound by comparable confidentiality obligations.

Trademarks. HYPNARA™, MORPHEX™ AI, Somnus Index™, and Somnus-trained™ are trademarks of Somnus Technologies, Inc. All other trademarks referenced are the property of their respective owners.

Patent-pending status. The Somnus IP portfolio comprises approximately fifteen applications and three hundred claims, in various stages of filing and prosecution as of April 2026. References in this briefing to "patent filed" describe applications anchored at the USPTO; references to "filing planned" describe applications drafted and queued for filing through Q2 and Q3 2026. Specific application numbers, filing dates, and prosecution status are available under separate cover from Somnus patent counsel.

Regulatory status. HYPNARA™ and MORPHEX™ AI are in development. Patent-pending. Not yet FDA cleared and not available for commercial sale in the United States. The Somnus Index™ is a wellness metric positioned under the FDA General Wellness Policy and is not a medical device, not for clinical diagnosis or treatment decisions. References to indications, regulatory pathways, and timelines reflect the company's current plans and are subject to FDA review, classification, and clearance.

Inventorship and assignment. Any inventive technical contribution arising from the engagement evaluation described in this briefing is intended to be assigned to Somnus Technologies, Inc., with the contributor named as a co-inventor on the relevant filing(s) under standard inventor assignment terms. The recipient is asked to confirm in advance any prior employment or affiliation agreements that could affect ownership of such contributions.

Forward-looking statements. This briefing contains forward-looking statements regarding regulatory milestones, technical roadmaps, and engagement timelines. Such statements involve known and unknown risks, uncertainties, and assumptions. Actual results may differ materially. These statements are based on management's current expectations and are not guarantees of future performance.

Not an investment offering. This briefing is a technical scoping document. It is not an offer or solicitation to sell securities of Somnus Technologies, Inc., and shall not constitute the basis of any contract or commitment.

Copyright. © 2026 Somnus Technologies, Inc. All rights reserved.

Contact. Matthew Cronin, Founder & CEO  ·  mcronin@somnustech.ai  ·  920.284.9099