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 inhalers do not inhale correctly – some with critical errors that compromise their therapy.1,2 For children with asthma, many of these errors happen in moments parents and care teams cannot see.

Choose your perspective

Choose the perspective that matters to you.

Explore CAELIA through the lens of everyday care or long-term platform potential. You can switch perspectives at any time.

For children, parents, and families

Care should not have to guess.

When a child lives with asthma, inhalation therapy becomes part of family life — before school, after sports, when symptoms appear, and before bedtime. Yet one essential question often remains unanswered: did the medication reach the lungs?

Parents remember the medication, guide the routine, watch for symptoms, and stay calm when things feel uncertain. Yet even the most attentive parent cannot see whether dose, timing, breath, and technique came together as intended.

SereneAir is designed to turn everyday inhalations into clear, understandable feedback — giving families more confidence, helping children learn gently, and giving care teams more context between visits.

Guidance, not surveillance.

SereneAir is designed to bring visibility into therapy moments — not to monitor children, but to support the people who care for them.

8%

Even with a spacer, inhalation is hard to get right: in one study, only 8% of parents of young children used a newly prescribed spacer correctly with the standard picture instructions.3 Up to 90% of people using inhalers do not inhale correctly.1,2

What goes wrong The most common errors with metered-dose inhalers
  1. No breath-hold after inhaling 46% 46% of patients · Sanchis et al. 20162
  2. Actuation and breath not coordinated 45% 45% of patients · Sanchis et al. 20162
  3. Breathing in too fast or not deeply enough 44% 44% of patients · Sanchis et al. 20162
  4. Actuation before breathing in (critical error) 24.9% 24.9% of patients · Price et al. 20174

Share of patients making each error; multiple errors possible, values do not add up. A spacer makes coordination easier – but errors remain common.

Parents

Confidence without added worry.

Clear feedback after an inhalation could help parents understand whether it was performed as intended — without creating unnecessary anxiety.

Children

Guidance without blame.

Simple, encouraging feedback could turn a difficult routine into a supported learning moment and help children build confidence step by step.

Care teams

More context between visits.

Structured insights into inhalation could give care teams more context about everyday therapy patterns and help them support families more precisely.

A supported care moment

From invisible routine to shared understanding.

Make dose, timing, flow, and technique easier to understand.
Support children with gentle, age-appropriate guidance.
Help parents feel more confident in everyday therapy moments.
Give clinicians a clearer view between appointments.
Build a shared understanding between child, family, and care team.

SereneAir is designed to support children — not monitor them.

It is about making care more visible, understandable, and supportive — for the people who live with asthma every day.

Explore how SereneAir supports families →
For investors and strategic partners

From a focused clinical wedge to a respiratory intelligence platform.

CAELIA is building the respiratory intelligence layer for inhalation therapy. We are starting with pediatric asthma and SereneAir — a smart pMDI spacer designed to capture dose, timing, flow, technique, and longitudinal respiratory patterns.

Inhalation therapy is widely used, yet its most important moment remains largely unmeasured. SereneAir creates a structured data point at the moment of use. Over time, validated inhalation events can strengthen coaching, therapy monitoring, evidence generation, and future risk models — while building a defensible real-world respiratory data foundation.

Pediatric asthma is the entry point. Respiratory intelligence is the platform.

A focused first use case, multimodal sensing, and a scalable longitudinal data layer.

01 · WEDGE

A clear unmet need

Children, families, and care teams need objective feedback in therapy moments that happen beyond the clinic.

02 · PRODUCT

A multimodal capture point

SereneAir is designed to understand how an inhaler was used — not merely whether it was used.

03 · PLATFORM

A compounding intelligence layer

Structured real-world inhalation data creates a learning loop across technique, adherence, response, and risk signals.

CAELIA Health at a glance

Company
CAELIA Health – deep-tech MedTech startup in formation, Munich, Germany
Origin
Research transfer project anchored at Fraunhofer EMFT
Funding
EXIST Research Transfer (German Federal Ministry for Economic Affairs and Energy and ESF Plus)
First product
SereneAir – smart spacer for standard pMDI inhalers
First indication
Pediatric asthma
Measures
Dose, timing, inhalation flow, technique and respiratory patterns over time
Sensing
Ultrasonic flow, optical aerosol detection, acoustic monitoring, IMU orientation sensing
Regulatory status
In development; developed along EU MDR, FDA pathway under validation; not CE-marked, not FDA-cleared, not commercially available
Network
Fraunhofer Venture, Fraunhofer AHEAD, Life Science Factory, Science4Life, TUM Venture Labs Healthcare
Contact
hello@caelia-health.com
Market problemSereneAirIntelligence layerTechnologyRegulationTeam & network
The Wedge

For parents, uncertainty often begins after the inhalation.

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

In pediatric asthma, therapy often happens at home, at school, or when symptoms suddenly appear. Parents need more than reminders: they need objective feedback on how the inhalation was performed. Care teams need a clearer view of everyday therapy than memory, self-reporting, and occasional check-ups can provide.

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 often fails in the moment no one measures.

Inhalation therapy is one of the most widely used treatments in respiratory care. Yet its critical moment rarely happens in the clinic. It happens in everyday life — where dose delivery, breathing technique, and therapy response remain 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 use: dose, timing, flow, technique, and respiratory patterns over time.

Meet SereneAir

Understand what happens during an inhalation.

SereneAir is a smart spacer for standard pMDI inhalers. It is being designed to make dose, timing, breathing flow, and technique easier to understand — and to provide clear, supportive feedback for children, families, and care teams.

SereneAir smart spacer connected to a standard pMDI inhaler with swappable mouthpiece
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 more than a device. It is a capture point for structured real-world inhalation data — designed to create a privacy-preserving learning loop across technique, adherence, therapy 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 for moments a single signal cannot explain.

Most digital inhaler solutions focus on whether an inhaler was used. CAELIA is designed to understand how it was used — and whether the inhalation 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 strategy is built into SereneAir from day one.

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 emerged from the Fraunhofer environment and is 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 built for a hard problem.

CAELIA brings together venture building, ultrasonic sensing, medical hardware, healthcare operations, software architecture, and regulatory execution — the capabilities needed to turn everyday 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
Ervin Hasko
CDO · Data & AI

Ervin Hasko

Data strategy, statistics, machine learning, data pipelines, and AI-driven respiratory insights.

FAQ

Questions we are often asked.

For parents and families

What is SereneAir?

SereneAir is a smart spacer being developed by CAELIA Health for standard pMDI inhalers (metered-dose inhalers). It is designed to show whether an inhalation worked as intended – whether the dose was released, and whether timing, breathing flow and technique were right – and to give children, parents and care teams clear, supportive feedback.

Why do inhalation errors matter for children with asthma?

Up to 90% of people using inhalers do not inhale correctly – some with critical errors that compromise their therapy (Chrystyn et al. 2017; Sanchis et al. 2016). A spacer helps, but does not solve the problem: in one study, only 8% of parents of young children used a newly prescribed spacer correctly with the standard picture instructions (Topal et al. 2020). For children, inhalation often happens at home, at school or when symptoms appear suddenly – moments parents and care teams cannot see. If the medication does not reach the lungs, the therapy cannot work as intended.

Which inhalers will SereneAir work with?

SereneAir is designed as a device-agnostic smart spacer for standard pMDI inhalers (metered-dose inhalers), with a swappable mouthpiece.

Can I buy SereneAir or use it for my child today?

Not yet. SereneAir is in development and is not CE-marked, FDA-cleared or commercially available. Please continue your child's therapy exactly as agreed with your doctor.

Will SereneAir monitor my child?

SereneAir follows the principle “guidance, not surveillance”. It is designed to make therapy moments understandable and to support the people who care for a child – not to control children.

What happens to my child's data?

Data is stored and processed according to the highest data protection standards and in line with the EU General Data Protection Regulation (GDPR). Data protection is part of SereneAir's development from the very beginning – because the goal is to support families and care teams, not to monitor children.

How can parents help shape SereneAir?

Parents, patients and caregivers can share their everyday experience with inhalation therapy in an informal conversation via hello@caelia-health.com. This is not a product trial and not medical advice.

For investors and partners

What problem does CAELIA Health solve?

Inhalation therapy is one of the most widely used treatments in respiratory care, yet its critical moment – the inhalation itself – is largely unmeasured. Up to 90% of people using inhalers do not inhale correctly, some with critical errors (Chrystyn et al. 2017; Sanchis et al. 2016). Critical errors such as actuating the inhaler before breathing in are associated with uncontrolled asthma and exacerbations (Price et al. 2017; Usmani et al. 2018), and even with a spacer, technique often remains poor (Topal et al. 2020). CAELIA makes dose delivery, technique and therapy response measurable in everyday life, starting with pediatric asthma.

How is CAELIA different from other digital inhaler solutions?

Most digital inhaler solutions focus on whether an inhaler was used. SereneAir is designed to understand how it was used, combining ultrasonic flow measurement, optical aerosol detection, acoustic monitoring and IMU orientation sensing in one device-agnostic smart spacer.

What is the platform thesis?

Pediatric asthma is the entry point; respiratory intelligence is the platform. Each validated inhalation event becomes a structured real-world data point that can strengthen coaching, therapy monitoring, evidence generation and future risk models – building a longitudinal respiratory data foundation.

What is the regulatory pathway?

SereneAir is being developed along the European MDR framework with support from medical-device regulatory experts, while the appropriate FDA pathway for the United States is being validated. The product is not yet CE-marked or FDA-cleared.

Who is behind CAELIA Health?

Björn Götzfried (CEO, venture & product), Rinaldo Persichini (CTO, hardware & ultrasonic sensing), Vanessa Torres Gangoo (CPO, clinical operations) and Ervin Hasko (CDO, data & AI). The project is anchored at Fraunhofer EMFT, funded by EXIST Research Transfer and supported by Fraunhofer Venture, Fraunhofer AHEAD, Life Science Factory, Science4Life and TUM Venture Labs Healthcare.

How can investors and partners engage?

CAELIA is preparing pediatric asthma pilots, regulatory pathway validation and clinical evidence generation. Investors, clinicians, regulatory advisors and strategic partners can request the investor brief or start a conversation via hello@caelia-health.com.

SereneAir is in development and not yet CE-marked, FDA-cleared or commercially available. This information does not replace medical advice.

Help shape SereneAir from the beginning

Your experience can help shape SereneAir.

We want to listen before we decide. If you live with asthma, care for a child, or support inhalation therapy at home, we would value an open conversation about the moments that feel difficult, uncertain, or overlooked. Your perspective can help us design SereneAir around real life.

An informal conversation — no product trial and no medical advice. SereneAir is still in development and not yet commercially available.

Work With Us

Help us make inhalation therapy visible.

We are preparing CAELIA for its next stage: pediatric asthma pilots, regulatory pathway validation, clinical evidence generation, and the continued development of a scalable 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

Get in touch

No medical advice. SereneAir is in development.