Propofol is the default sedative in modern hospitals. It is used to keep patients calm and comfortable in intensive care, and to enable procedures such as colonoscopy and surgery.

It is one of the most administered drugs in modern hospitals, used in ICUs every day, and in procedural settings millions of times each year worldwide.

Propofol is one of the most widely used drugs in modern hospitals.

It is given continuously in ICU and daily in procedural care, yet clinicians cannot measure its concentration at the bedside.

All dosing of propofol is estimated, not measured.

Why does this matter:

When a drug like propofol is administered without measurement it has profound downstream effects which contribute to prolonged ventilation, delirium, and extended length of stay. In procedural care, discharge is conservative because residual drug levels are unknown.

When a drug is used millions of times each year without real-time measurement, small inaccuracies compound into systemic cost and risk, costing an estimated $1.1bn annually in the UK and US alone.

Somnus has developed the first rapid, point-of-care system to measure blood propofol concentration at the bedside.

ProSed® delivers a quantitative result from a drop of blood in minutes, enabling clinicians to personalise sedation in real time.

ProTIVA™, in development, will provide continuous propofol monitoring during anaesthesia, enabling fully controlled, gas-free sedation.

Together, they transform propofol from an estimated therapy into a measurable, controllable one.

Measurement turns sedation from judgement into precision.

For decades, clinicians have managed propofol sedation without being able to measure it. They have relied on observation, scoring systems, and clinical judgement, doing their best with incomplete information.

That is no longer acceptable, and the profession knows it.

Clinical guidelines now mandate light, personalised sedation. Patients are living longer with the consequences of over-sedation, delirium, cognitive impairment, PTSD. ICU nurses cite sedation management as a leading cause of burnout. The standard of care is shifting, but the tools haven't kept pace.

At the same time, environmental pressure is accelerating the move away from anaesthetic gases toward propofol-based TIVA, a transition that requires real-time monitoring to scale safely and confidently.

ProSed arrives at the moment when clinical ambition, patient outcomes, staff wellbeing, and environmental responsibility are all pointing in the same direction.

The measurement gap is finally being closed.

ICU is a £2.5bn market globally.

• UK ICU addressable market ≈ 1.8m tests per year
• US ICU addressable market ≈ 31.7m tests per year

(Four tests per ICU patient per day, at ~75% gross margin) - Matching standard procedures

Procedural sedation adds another ~£3bn.

Colonoscopy and day-case procedures effectively double the ICU opportunity.

(19m colonoscopies per year in the US alone)

General anaesthesia takes the total platform to roughly £7bn.

• ICU sedation: ~£2.5bn global
• Procedural sedation: ~£2.8–3.0bn global
• General anaesthesia (TIVA opportunity): ~£2.2bn global

Somnus operates a high-margin diagnostic consumables model.

Revenue is generated through the placement of ProSed® readers in ICU units and the recurring sale of single-use test cartridges required for each blood propofol measurement.

Modelled gross margins reach approximately 75% from launch.

The initial focus is ICU sedation, followed by expansion into procedural sedation and total intravenous anaesthesia workflows. Each stage increases utilisation frequency and deepens clinical integration.

Distribution is delivered through specialist in-territory partners, maintaining capital efficiency while scaling internationally.

The proprietary propofol antibody and sensor platform also create optional licensing opportunities within laboratory diagnostics, adding further strategic leverage.

Somnus has completed a five-year R&D programme and established proprietary propofol measurement technology protected by three patent families, including a granted UK patent.

Key achievements to date include:

• World-first recombinant monoclonal antibody to propofol
• Functional ProSed® system with cartridge + reader workflow
• Quantitative testing completed using human blood samples
• ISO 13485-certified Quality Management System in place
• UK and US regulatory strategies defined with external advisors
• Clinical usability and validation studies underway at leading UK ICU sites
• Multiple national innovation awards and government-backed programmes
• Distributor discussions initiated across UK and international markets

Somnus is now focused on completing analytical validation, regulatory submission, and first commercial deployment.

ISO 13485 certified, UK clinical validation is underway, MHRA submission targeted for 2026, and we’re running a structured 510(k) pathway with FDA Q-Sub in 2025 for US clearance in 2027.

UK First Strategy (2026 Launch)

• ISO 13485 certified

• NHS validation sites active

• MHRA pathway defined

• Technical file in preparation

US 510(k) Strategy (2027 Clearance)

• FDA Q-Sub scheduled 2025

• Regulatory consultants appointed

• Major US clinical sites aligned

Five-Year Base Case (UK-First Launch)

• UK ICU annual addressable test volume: ~2.98 million tests
• UK cartridge price: £31 per test

Adoption assumptions are based on historical penetration rates observed in NICE-supported medical technologies, reaching ~37% by Year 5.

Under this staged diffusion model:

• FY27 (Year 1 @ ~1.5% Market): ~£1.1m
• FY28 (Year 2 @ ~3% Market): ~£2.7m
• FY29 (Year 3 @ ~8% Market): ~£7m
• FY30 (Year 4 @ ~19% Market): ~£17m
• FY31 (Year 5 @ ~37% Market): ~£34m

EBITDA break-even is targeted in FY28, subject to regulatory timing.

This base case reflects:

• Gradual NHS adoption patterns
• Protocol-driven recurring usage
• Expansion beyond early clinical champion sites

The model does not assume full-market penetration. It reflects controlled clinical diffusion consistent with comparable NHS device rollouts.

The £2m raise is structured to reach regulatory clearance and first commercial revenue, the primary value inflection point that enables this scaling phase.

£2 million bridge to first UK commercial sales and US launch set-up

• EIS eligible
• £8m pre-money valuation
• £600k already committed from existing shareholders

• UK regulatory approval (MHRA pathway)
• First UK ICU launch (2026 target)
• Clinical validation dataset
• Initial distributor rollout
• Platform for US FDA submission (2027)

1. Analytical Validation

Risk: Achieving precise quantitative detection of a hydrophobic molecule like propofol at point-of-care is technically demanding.

Mitigation:

• Proprietary monoclonal antibody and immunoassay platform developed in-house.
• Parallel electrochemical and immunoassay sensor pathways to reduce single-platform dependency.
• Validation against laboratory gold standards (LC-MS / HPLC).
• Lot-to-lot reproducibility and stability testing built into development plan.

Status:

• ISO 13485 quality system in place.
• Independent laboratory validation underway.
• Granted UK patent on core sensor platform.
• Multi-family IP estate protecting assay, displacer and sensor technologies

2. Regulatory Timing

Risk: UK (MHRA) and US (FDA) approval timelines could extend, impacting launch and revenue timing.

Mitigation:

• UK-first launch strategy to achieve earlier regulatory inflection.
• Early engagement with MHRA.
• FDA Q-Sub pathway initiated with specialist US regulatory advisors (RQM+).
• Documentation aligned to FDA-grade standards from inception.
  

Status:

• ISO 13485 certification achieved.
• NHS clinical sites engaged.
• Regulatory consultants retained in both UK and US.
• Q-Sub planned ahead of US submission timeline

3. Hospital Procurement Cycle

Risk: Hospital purchasing processes are multi-stakeholder, evidence-heavy, and slow.

Mitigation:

• KOL-led entry into early adopter sites.
• “Test-drive → protocol summit → SOP adoption” structured rollout model.
• Health-economic modelling built at individual ICU level (UK) and adapted for US systems.
• Distributor partnerships in key territories to accelerate local access
• 
  Status:
• Clinical champions already embedded.
• International distributors expressing interest.
• Benefit model developed per ICU in England.
• Early engagement with major strategic MedTech players.

4. Adoption Speed

Risk: Even after approval, uptake may be gradual if clinical practice does not change.

Mitigation:

• Positioning ProSed® within established ICU sedation guidelines and ABCDEF framework.
• Data generation focused on measurable endpoints:

1. Ventilation duration
2. ICU length of stay
3. Delirium incidence
4. Discharge timing

• Peer-reviewed publications and conference dissemination.
• Building a “Community of Practice” around precision sedation.

Status:

• Prospective outcome datasets planned.
• Conference presentations underway.
• Clinical publications emerging.
• Clear pathway from ICU → procedural sedation → TIVA expansion.

Target trade sale to a global MedTech or diagnostics major following regulatory validation and protocolised ICU adoption.

Early strategic discussions have already been held with two major international MedTech groups active in relevant clinical markets.