FDA Breakthrough Device · 2025

Every breath.
Accounted for.

The pocket pulmonologist that turns every inhaler puff, peak-flow reading, and midnight wheeze into a personalized action plan — delivered before breakfast.

🩺 Respiratory Nurses🏥 Health-System CTOs📊 Pharma Med Affairs
Healthcare professional reviewing patient respiratory data on a tablet in a clinical setting

200+

patients per nurse

14 days

to Epic live

34%

fewer ER visits

Diagnostic Intake

Your organization at a glance

Patient VolumeYour RoleContact

How many asthma patients does your organization actively manage?

1.8M preventable ER visits annually$56B annual asthma burden in the US34% fewer ER visits with Breathe73% adherence improvement14-day Epic deployment200+ patient panels managed per nurse41% fewer weather-triggered exacerbationsFHIR R4 Certified · HIPAA Compliant · SOC 2 Type II1.8M preventable ER visits annually$56B annual asthma burden in the US34% fewer ER visits with Breathe73% adherence improvement14-day Epic deployment200+ patient panels managed per nurse41% fewer weather-triggered exacerbationsFHIR R4 Certified · HIPAA Compliant · SOC 2 Type II

Unmanaged asthma costs more than
you can afford to ignore.

0M

ER visits annually from asthma attacks that were preventable

$0B

Annual economic burden of asthma in the US healthcare system

0%

Of patients report non-adherence to their prescribed inhaler regimen

Average symptom spike intensity by hour — 10,000 patients, 90-day cohort

Peak 11 PM – 4 AM
12a
6a
12p
6p
Low
Moderate
Critical
Source: Breathe clinical dataset, 2025
47% of patients

Medication Non-Adherence

miss at least 3 inhaler doses per week, with no clinical visibility until an ER visit confirms it.

68% of exacerbations

Invisible Triggers

correlate with pollen, AQI, or humidity spikes that no current EHR captures in real time.

4.2 systems average

Fragmented Data Silos

per patient across inhaler apps, spirometry devices, and the EHR — none of them talking.

Every clinical pain point.
A specific answer.

The Problem

Medication Non-Adherence

Nurses call patients reactively. By the time a missed dose is caught, the patient is already symptomatic.

Breathe's Answer

Smart Inhaler Sync

Bluetooth inhaler sensors log every puff in real time. Missed dose? Breathe flags it in the nurse dashboard within 4 hours — not 4 weeks.

Digital health dashboard showing inhaler usage tracking data on a tablet screen
73% adherence improvement in 90-day trials
The Problem

Missed Environmental Triggers

AQI spikes, pollen surges, and cold fronts silently drive 68% of ER visits. No EHR captures this data.

Breathe's Answer

Environmental API Overlays

Real-time AQI, pollen, humidity, and mold data layered over each patient's symptom timeline. Predictive alerts fire 6 hours before forecast spikes.

Weather and air quality monitoring data visualization with environmental triggers dashboard
41% reduction in weather-triggered exacerbations
The Problem

Fragmented Data Silos

Spirometry in one app. Inhaler data in another. EHR in Epic. None of it unified into a single clinical picture.

Breathe's Answer

FHIR-Native Integration

Breathe writes directly to Epic via HL7 FHIR R4. Every inhaler puff, peak-flow reading, and trigger correlation appears in the patient's existing chart — automatically.

Medical data integration dashboard showing FHIR-compatible patient health records and analytics
Live in Epic in 14 days or less
FHIR R4 Certified

Live in Epic in 14 days.
Not 14 months.

Breathe was built FHIR-native from day one. No middleware. No custom connectors. No six-month integration sprint.

Certified integrations

Ep

Epic

FHIR R4 native

Ce

Cerner

HL7 certified

Pr

Propeller

Smart sensor sync

Ai

AirNow

AQI real-time API

Sa

Salesforce Health

Care coordination

Az

Azure Health

HIPAA-compliant

HIPAA CompliantSOC 2 Type IIHL7 FHIR R4ONC Certified21st Century Cures Act

Deployment timeline

Day 1

FHIR Handshake

API credentials provisioned, Epic sandbox connected, test data flowing.

Day 3

Patient Import

Asthma patient cohort mapped from Epic. Risk stratification running.

Day 7

Inhaler Sync Live

Smart sensors paired. First real-time adherence data in the dashboard.

Day 14

Go Live

Full production deployment. Nurses triaging from Breathe. Epic charts updated.

No 6-month integration sprint

Our implementation team has completed 47 Epic go-lives. Median deployment: 11 days. Your CTO will not need to write a single line of custom code.

Not a promise.
A published result.

34%

reduction in asthma-related ER visits

n=2,847, 12-month RCT

NEJM Evidence, 2025

73%

improvement in controller medication adherence

n=1,200, 90-day trial

Chest Journal, 2024

41%

fewer weather-triggered exacerbations

n=4,100, 6-month observational

Lancet Digital Health, 2025

2.4×

faster time-to-triage for remote nurse panels

n=312 nurses, 8 systems

JAMIA, 2025

I manage 240 asthma patients. Before Breathe, I was flying blind between appointments. Now I triage by risk score every morning before my first patient call. Three hospitalizations prevented last month alone.

Smiling female nurse in blue scrubs, professional healthcare setting

Rachel Okonkwo, RN

Respiratory Nurse Specialist

Northwestern Medicine, Chicago

We evaluated six asthma platforms. Breathe was the only one that could write back to Epic without a custom integration layer. We were live in 9 days. Our CMIO called it the smoothest health-tech deployment he'd seen in 15 years.

Professional male executive in business attire, healthcare technology leader

James Whitfield

Chief Technology Officer

Piedmont Healthcare, Atlanta

Our post-market adherence study needed real-world data from 5,000 patients across three health systems. Breathe's FHIR API gave us deidentified, structured data in a format our biostatisticians could actually use.

Female medical professional with stethoscope, pharmaceutical research setting

Dr. Priya Nair

VP Medical Affairs

AstraZeneca Respiratory

Download the Clinical Evidence Pack

4 peer-reviewed studies, 3 health-system case studies, FDA de novo pathway summary. Shareable internally — no sales call required.

Your numbers.
Your return.

Your Organization

patients
$

US average: $2,800 · Adjust for your market

Assumptions (peer-reviewed)

Unmanaged ER visits / patient / year1.8
Breathe ER reduction (34% — NEJM Evidence, 2025)34%
Breathe platform cost$18 / pt / mo

Annual Impact Projection

Net Annual ROI

$1.8M

6.9× return on Breathe investment

ER visits prevented annually734
Annual ER cost savings$2.1M
Annual Breathe platform cost-$259K

Conservative estimate based on published clinical outcomes. Actual ROI varies by cohort complexity.

See $1.8M in savings.
In your patient panel. Today.

Personalized demo environment · Synthetic data at your scale · No commitment

Takes 90 seconds · Pre-filled from your intake