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Lifeline Medical Technologies
Precision Analgesia

The Active Safety Net
for Inpatient Opioid Prescribing

A SMART on FHIR Clinical Decision Support engine that surfaces a specific, actionable, guideline-cited recommendation at the moment of prescribing — which the clinician reviews and can accept or override, with every override logged — designed to embed inside Epic and Cerner.

Enterprise B2B SaaS Self-Assessed Non-Device CDS Opioid Safety
CONFIDENTIAL — FOR INVESTOR REVIEW ONLY
Precision Analgesia
The Problem
The Inpatient Opioid Blind Spot

Hospitals are writing opioid orders without a safety net.

$78.5B
Annual U.S. economic burden of prescription opioid misuse, abuse, and dependence
Florence et al., Medical Care 2016
Litigation Risk
Opioid-dosing and monitoring failures are an active, growing category of hospital liability exposure nationally.
Illustrative framing — not a specific case citation
46%
Of monitored inpatients on continuous monitoring experienced opioid-induced respiratory depression (OIRD) events. Manual nursing checks miss the vast majority.
Khanna AK et al., Anesthesia & Analgesia, 2020;131(4):1012-1024 (PRODIGY Trial)

Alert Fatigue Is the Norm

Epic's native drug-safety warnings are dismissed 70–90% of the time (JAMIA). Clinicians have been trained to click past them. The system meant to protect patients has been optimized away.

Settlement Abatement Funds — Potentially Eligible Use

Point-of-care decision support is a potentially eligible, discretionary remediation-spend category under a hospital's Exhibit E settlement allocation — subject to that hospital's own settlement administrator and state-specific allowable-use rules. Not a designated or guaranteed funding source.

Precision Analgesia
Root Cause
Why Existing Tools Fail

The difference between reactive and proactive.

Status Quo

The Passive Calculator

Doctor must consciously remember to open MDCalc or a calculator app
Manually types in creatinine, weight, opioid doses — 45 seconds of friction
Used only 5% of the time. Used in the cafeteria, not at the bedside.
Boolean alerts ("MME > 90") dismissed in under 1 second
No pharmacogenomics, cross-tolerance, or organ-specific gating
Result
Optional. Ignored. Liability.
vs
Precision Analgesia

The Active Safety Net

Monitors CPOE in the background via CDS Hooks
Auto-pulls weight, labs, meds from FHIR — zero manual entry
Surfaces a specific recommendation at the moment of prescribing — clinician reviews and accepts or overrides, with the override logged
Returns specific, actionable guidance (not just "warning")
CYP2D6 pharmacogenomics, OIRD scoring, renal/hepatic gating
Result
Proactive. Specific. Documented.
Precision Analgesia
The Solution
How It Works

A three-layer engine embedded in every opioid order.

Layer 1 — Built

FHIR Ingestion

Patient context auto-loads via SMART on FHIR OAuth. Pulls age, weight, creatinine, active meds, allergies, genotype panel. Zero manual entry.

R4 PatientObservationMedicationRequest
Layer 2 — Built

Clinical Pipeline

10 deterministic safety rules plus OIRD risk scoring, MME thresholds, pharmacogenomic guidance, and CDC naloxone prompts — all in <100ms.

CDS HooksPRODIGYCDC 2022
Layer 3 — Scaffolded

FHIR Write-Back

1-click "Draft Order" injects safe alternative into Epic's CPOE cart. "Export to Chart" writes a billable consult note as a DocumentReference.

MedicationRequest POSTDocumentReference
The Traceability Ledger — Supporting Our Self-Assessed Criterion D Posture
Every recommendation shows the exact formula, conversion factor, and guideline citation. The clinician can independently verify the math and is not primarily relying on the software. This is designed to be legally defensible — not a black box — pending confirmatory review by regulatory counsel.
Self-Assessed Non-Device CDS
Precision Analgesia
Product
Clinical Modules

Six tools. One workflow. Zero new logins.

Risk Assessment

OME/MME calculator, OIRD risk tier (PRODIGY-aligned), organ dose gating, naloxone prompt at ≥50 MME, manual data override form.

Opioid Tapering

CDC 2022 taper schedule generator. 10%/2-week protocol. One-click copy to EHR note.

OUD Consult

BUPE/methadone/naltrexone protocols. COWS, DSM-5, aberrant behavior screening. Auto-structured consult note.

Patch Conversion

Transdermal fentanyl/buprenorphine calculators with organ-adjusted dosing. Prevents the most common ICU conversion error.

Screening Suite

DAST-10, ASSIST, ORT with sex-adjusted scoring. Reads FHIR nursing flowsheets before prompting manual entry.

IV Infusion

PCA 1-hr/4-hr limit calculator. Continuous drip converter with renal-adjusted dosing. Prevents common ICU programming errors.

Manual Override Form — "Dirty Data Defense"
Clinicians correct/supplement FHIR data in real-time. 6 sections, EHR/Manual/Missing badges.
Copy-to-Note Workflow
All outputs copy as structured clinical text. Paste into Epic note. Citrix/VDI compatible.
Precision Analgesia
Defensibility
Regulatory & Security Moats

Designed from day one to avoid the two graveyards.

The FDA Opportunity
Self-Assessed Non-Device CDS Posture

FDA's January 2026 guidance describes a "Non-Device CDS" pathway for deterministic rules a clinician can independently verify. Our Traceability Ledger is engineered to support Criterion D — but this is a self-assessment, pending confirmatory review by regulatory counsel, not a guaranteed or settled classification.

Potential to avoid ~$2M + 2 years
vs. 510(k) SaMD clearance required for AI/ML competitors — if the self-assessment holds up under counsel review
The CISO Moat
Zero-PHI Architecture

All calculations happen in-memory, discarded after the HTTP response. No database. No PHI at rest. A BAA template exists and will require counsel review and execution before any PHI-adjacent pilot. A hospital CISO's biggest fear — a data breach of stored PHI — is architecturally reduced.

Designed to ship past security review faster than a PHI-storing system
The Integration Moat
SMART on FHIR + CDS Hooks

We embed natively via Epic's published APIs. We never ask hospitals to change their workflows. Once a validated clinical system is integrated, hospital IT will never unwind it.

The Funding Angle
Settlement-Eligible Sales Motion

Point-of-care CDS is a potentially eligible, discretionary Exhibit E remediation category of National Opioid Settlement abatement funds — subject to each hospital's own settlement administrator and state rules. Not a guaranteed or designated funding source, but a conversation that can ease the capital budget objection.

Precision Analgesia
Market
Total Addressable Market

A massive, underserved acute care opportunity.

TAM (Illustrative Estimate)
$6.8B
U.S. hospital CDS / patient safety software market (2026) — modeled estimate, needs independent sourcing
SAM (Illustrative Estimate)
$1.4B
Inpatient opioid safety & analgesic stewardship software segment — modeled estimate, needs independent sourcing
SOM (Year 3 Model)
$87M
Illustrative scenario only — hospital count is still unresearched. ACV uses the comp-grounded Tier 3 figure ($100K/yr, large systems) per launch_pricing_strategy_2026-07.md §2, rather than the retired, unsourced $250K figure. Note the model contains no single-hospital price above $100K, so this scenario implies a large hospital count

Addressable Hospital Universe

Total U.S. acute care hospitals6,090
Epic-affiliated hospitals~2,800
Hospitals with opioid settlement exposure~4,100
Hospitals with a discretionary abatement allocation (illustrative estimate)~1,200

Why Now — Four Simultaneous Tailwinds

FDA Jan 2026 guidance describes a non-device CDS pathway (self-assessed, pending counsel confirmation)
Settlement abatement funds (potentially Exhibit E-eligible, discretionary) can ease budget objections
Epic Connection Hub is an established channel for SMART on FHIR CDS partners
CMS opioid quality metrics now tied to hospital reimbursement
Precision Analgesia
Competition
Competitive Landscape

We thread the needle between every incumbent.

CompetitorApproachFatal WeaknessOur Wedge
Epic / FDB Alerts
Native EHR
Boolean pop-ups on every order 70–90% dismiss rate (JAMIA). Alert fatigue is a clinical crisis. Multi-factor engine. Specific. Override-documented.
MDCalc / UpToDate
SMART calculators
Reactive reference the doctor must launch 5% usage rate. Used in the cafeteria, not the CPOE. Proactive. Monitors CPOE in the background. Surfaces guidance at the moment of prescribing.
Bamboo / NarxCare
PDMP database
Narx Score from retail pharmacy fills Outpatient only. Useless for ICU. Black-box backlash. Owns inpatient. Transparent math. Works where NarxCare doesn't.
AI/ML CDS Startups
Predictive AI
ML overdose risk models, hundreds of EHR variables Likely needs 510(k) SaMD clearance. $2M+ / 2 years. CISOs wary. Deterministic. Self-assessed non-SaMD posture. CISO-friendly design.
Precision Analgesia
SMART on FHIR CDS
Proactive CDS Hook engine, FHIR auto-population, deterministic transparent math Inpatient. Proactive. Self-assessed Non-Device CDS. CISO-friendly design. Settlement-eligible sales angle.
Precision Analgesia
Business Model
Revenue

From an iOS beta to a hospital contract priced by size — $25K, $50K or $100K a year.

Primary Revenue

Enterprise SaaS — Health System Licensing

$25K–$100K*
Annual contract per hospital system, priced by the hospital's own scale — a small fraction of the national $78.5B/yr opioid economic burden (Florence et al., Medical Care 2016) that hospitals help absorb, and priced below the category's most expensive incumbent. *Three comp-grounded tiers, all quotable today (Wolters Kluwer enterprise band; Sentri7 cost perception) — see launch_pricing_strategy_2026-07.md §2. Bed-count boundaries are a segmentation assumption, not a research finding.
Tier 1 — community, <200 beds$25K/yr
Tier 2 — regional, 200–500 beds$50K/yr
Tier 3 — large system, 500+ beds$100K/yr
Implementation & onboarding$15–20K one-time
Pharmacogenomics tier+$10–20K/yr
Settlement documentation+$10–20K/yr
Secondary Revenue

iOS App — Individual Clinicians

Currently free (TestFlight beta). Serves as top-of-funnel — a hospital's CMO downloads the app, uses it at home, champions the enterprise integration. Freemium → institutional subscription path.

Unit Economics (Per Hospital System)

National annual opioid economic burden$78.5B (Florence et al. 2016)
Annual contract value (by hospital size)$25K / $50K / $100K*
Hospital ROI framingModeled estimate — needs validation
Settlement abatement eligibilityPotentially Exhibit E — discretionary
*Comp-grounded size tiers, all quotable today (see business model card, left), plus a one-time $15–20K implementation fee. Priced by the hospital's scale, not by our sales stage.

Go-To-Market Motion

1
Epic Connection Hub → planned channel for inbound discovery across the ~2,800-hospital Epic network
2
CMIO champion path — iOS app creates awareness, targeting CMIO-requested enterprise evals
3
Settlement framing — hospital legal explores discretionary abatement funding, potentially easing the budget conversation
4
Shadow Mode — 90-day silent run proves error detection rate before go-live
Precision Analgesia
Traction
Where We Are Today

Engine built. Ready for the track.

21,000+
Lines of production code across the EHR product (frontend + backend)
25
Clinical React components (6 major workflow modules)
250+
iOS clinical validation scenarios passing (plus 120+ backend pytest tests)
15
Clinical API endpoints (rate limited + JWT auth)

Built & Verified

Full SMART on FHIR R4 patient context ingestion
10-rule Safety Engine + OIRD scoring, OME/MME, renal/hepatic, pharmacogenomics
WCAG 2.1 A accessibility (screen readers, keyboard nav, VDI-compliant)
Rate limiting + JWT token validation on every clinical route
FHIR Write-Back scaffolding (MedicationRequest + DocumentReference)
iOS app in TestFlight beta with real clinical users

Next 30 Days (Post-Seed)

Generate JWKS keys → register at fhir.epic.com
Prove FHIR R4 on Epic Sandbox synthetic patients
Wire FHIR Write-Back → live 1-click Naloxone co-prescribing
AKI trending — last 3 creatinine values, not just today's
Submit to Epic Connection Hub — activate inbound discovery channel
Target first pilot hospital for a Shadow Mode deployment (no pilot signed yet)
Precision Analgesia
The Ask
Fundraise

Seed Round — putting tires on the Ferrari.

Raising
$2.5M
Seed Round — 18-month runway to first signed hospital contracts

Use of Funds

Epic Sandbox → Production Integration$600K (24%)
Clinical Validation & Pilot Hospital$700K (28%)
Engineering (AKI, CDS Hooks, Write-Back)$750K (30%)
Enterprise Sales & CMIO Outreach$450K (18%)

18-Month Milestones

Month 3
Epic Sandbox registration, JWKS keys, FHIR R4 synthetic test passing
Month 6
Target: first pilot hospital signed. Target: Shadow Mode live. CDS Hooks on medication-prescribe.
Month 9
Target: Shadow Mode data demonstrates error-detection rate. Target: first hospital contract signed, priced by the hospital's own scale ($25K / $50K / $100K by bed count, plus a one-time $15–20K implementation fee). Epic Connection Hub listing target.
Month 18
5+ hospital contracts. Series A raise. SOC 2 Type II audit.

The Settlement-Eligible Sales Insight

Where a hospital's own settlement administrator approves point-of-care CDS as a discretionary Exhibit E remediation use, the integration may not require a separate capital budget approval — not a guaranteed or designated funding source. Where this framing applies, we believe it can compress an 18-month enterprise sales cycle to roughly 4–6 months. Our seed capital funds our first push toward settlement-eligible contracts.

The Verdict

You are not buying a calculator.
You are buying a hospital safety mandate.

Every hospital without this tool is writing opioid orders without a safety net, against a national $78.5B/yr opioid economic burden (Florence et al., 2016) and a well-documented alert-fatigue problem. The clinical engine is built. Our regulatory posture is self-assessed as favorable, pending confirmatory review by counsel. Settlement funds are a potentially eligible, discretionary funding angle — not a guarantee.

Website
precision.lifelinemedtech.org
iOS Beta
TestFlight
Company
Lifeline Medical Technologies
CONFIDENTIAL — FOR INVESTOR REVIEW ONLY · © 2026 Lifeline Medical Technologies