Respiratory Intelligence for Inhalation Therapy

Making every inhalation visible.

CAELIA Health is building the respiratory intelligence layer for inhalation therapy — starting with children living with asthma.

Our first product, SereneAir, is a smart pMDI spacer designed to measure whether medication was taken with the right dose, timing, flow, and technique — turning everyday inhalation moments into actionable respiratory insight.

The Silent Epidemic

Up to 90% of people using inhaled therapies make critical errors — and for children with asthma, many of these errors happen in the moments parents and care teams cannot see.

The Wedge

For parents, the hardest question comes after the dose.

The medication was prescribed. The inhaler was used. The child breathed in. But the decisive question remains unanswered: did the medication actually reach the lungs?

In pediatric asthma, the therapy moment often happens at home, at school, or during an acute symptom episode. Parents need more than reminders. They need objective feedback that the inhalation was performed correctly — and clinicians need better real-world insight than memory, self-reporting, and occasional check-ups.

Parents

Parents need certainty

Objective feedback after each inhalation can reduce uncertainty around dose delivery, timing, flow, and technique.

Children

Children need guidance

Immediate, child-friendly feedback can turn a difficult daily routine into a guided therapy moment.

Clinicians

Clinicians need context

Structured inhalation data can help care teams understand what happens between visits — not only what is remembered during them.

The Problem

Inhalation therapy fails in the moment nobody measures.

Inhalation therapy is one of the most common treatments in respiratory care. Yet the critical moment does not happen inside the clinic. It happens in everyday life — where dose delivery, breathing technique, and therapy response are largely invisible.

Did the dose actually reach the lungs?
Was the timing right?
Was the inhalation too fast, too shallow, or incomplete?
Was the device held correctly?
Is therapy response changing over time?
Are early warning signals being missed?
“You cannot optimize what you cannot see. CAELIA makes everyday inhalation therapy measurable.
Our First Product

SereneAir sees the full inhalation event.

SereneAir is a device-agnostic smart spacer for standard pMDI inhalers. It is designed to capture the signals that matter during inhalation: dose, timing, flow, technique, and longitudinal respiratory patterns.

SereneAir smart spacer — gold technical lineout SereneAir Smart Spacer
01

Compatible with all standard pMDI-Inhalers

02

Smart Spacer

Dose · Technique · Feedback · Tracking

03

Swappable Mouthpiece

01pMDI-Inhaler
02Smart Spacer
03Mouthpiece
Dose

Dose

Detect whether actuation happened and whether aerosol was present during the inhalation event.

Flow

Flow

Measure inhalation flow and volume to understand whether breathing supported effective delivery.

Timing

Timing

Connect dose release and breath phase to detect coordination errors.

Technique

Technique

Combine sensor signals to identify application errors and guide better use.

Response

Response

Track respiratory patterns over time to support therapy monitoring and future warning-signal detection.

The Intelligence Layer

Every inhalation strengthens the respiratory intelligence layer.

SereneAir is not only a device. It is the first capture point for structured real-world inhalation data — creating a privacy-preserving learning loop across therapy technique, adherence, response, and risk signals.

1

Measure

Dose, timing, flow, technique, and respiratory patterns are captured during everyday use.

2

Structure

Each inhalation event becomes a structured data point instead of an invisible therapy moment.

3

Learn

Longitudinal patterns help improve coaching, therapy monitoring, and future risk models.

4

Guide

Patients, parents, and clinicians receive clearer feedback and more actionable insight.

5

Scale

As usage grows, CAELIA builds a respiratory intelligence layer for precision respiratory care.

The wedge is pediatric asthma. The platform is respiratory intelligence.

Why CAELIA

Multimodal sensing where single-signal tracking is not enough.

Most digital inhaler solutions focus on whether an inhaler was used. CAELIA is built to understand how it was used — and whether the inhalation event supported effective delivery.

Sensing

Multimodal sensing

Ultrasonic flow, optical aerosol detection, acoustic monitoring, IMU orientation sensing, and real-time feedback in one smart spacer architecture.

Foundation

Deep-tech foundation

Built on Fraunhofer engineering, protected IP, and a hardware architecture designed for medical-grade respiratory sensing.

Software

AI-native development

CAELIA is built AI-native from the start — using modern software, simulation, data workflows, and intelligent prototyping to accelerate development in a highly regulated environment.

Moat

Respiratory data moat

Each validated inhalation event contributes to a growing longitudinal understanding of real-world respiratory therapy.

Regulatory Strategy

Regulatory thinking is built into SereneAir from the start.

CAELIA works with leading medical-device regulatory experts to shape a robust and internationally relevant pathway. Our development currently follows the European MDR framework, while we validate the appropriate FDA pathway for the United States.

Expertise

Experienced guidance

Regulatory experts support our strategy, development priorities, and evidence planning.

Europe

MDR-oriented development

SereneAir is being developed with the European MDR framework in mind.

United States

FDA pathway validation

In parallel, we are validating the appropriate regulatory pathway for the US market.

SereneAir is currently in development and is not yet CE-marked, FDA-cleared, or commercially available.
Network

Backed by deep-tech, health, and venture-building ecosystems.

CAELIA is built in the Fraunhofer environment and supported by a growing network of partners, programs, and advisors across MedTech, digital health, venture building, and clinical respiratory care.

We are actively expanding our network of pediatric asthma pilot partners, regulatory advisors, strategic health partners, and venture investors who share our vision of making inhalation therapy measurable.

Logos shown for programs, networks or institutions supporting CAELIA Health. No clinical endorsement or product approval implied.

Founding Team

An interdisciplinary team for a hard problem.

CAELIA brings together venture building, ultrasonic sensing, medical hardware, healthcare operations, software architecture, and regulatory execution — the combination required to turn respiratory therapy into measurable intelligence.

Björn Götzfried
CEO · Venture & Product

Björn Götzfried

Strategy, venture building, fundraising, go-to-market, reimbursement, and investor relations.

LinkedIn
Rinaldo Persichini
CTO · Hardware & Sensing

Rinaldo Persichini

Ultrasonic sensing, embedded hardware, industrialization, IP strategy, and medical-grade device engineering.

LinkedIn
Vanessa Torres Gangoo
CPO · Clinical Operations

Vanessa Torres Gangoo

Product strategy, healthcare systems, usability, clinical operations, and regulatory preparation.

LinkedIn
S/W
Software Architecture · Embedded & Data

To be announced

Firmware, connectivity, app architecture, data pipeline, cybersecurity, and software lifecycle.

Work With Us

Help us make inhalation therapy visible.

We are preparing CAELIA for the next stage: pediatric asthma pilots, regulatory pathway validation, clinical evidence generation, and a venture-scale respiratory intelligence platform.

Pediatric Asthma Pilots

For clinicians, pediatric pneumologists, clinics, and care teams interested in early feedback, pilot design, or clinical validation.

Discuss a pediatric asthma pilot →
Regulatory & FDA Advisors

For experts in FDA, 510(k), MDR, SaMD, clinical claims, usability, and medical device strategy.

Validate the regulatory pathway →
Strategic & Industry Partners

For pharma, device, payer, clinical research, and respiratory care partners exploring real-world inhalation data and therapy support.

Explore strategic partnership →
Investors & Venture Partners

For deep-tech, MedTech, digital health, and AI investors interested in the future infrastructure layer for precision respiratory medicine.

Request the investor brief →

Talk to us at hello@caelia-health.com