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.
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.
A focused first use case, multimodal sensing, and a scalable longitudinal data layer.
A clear unmet need
Children, families, and care teams need objective feedback in therapy moments that happen beyond the clinic.
A multimodal capture point
SereneAir is designed to understand how an inhaler was used — not merely whether it was used.
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
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 need certainty
Objective feedback after each inhalation can reduce uncertainty around dose delivery, timing, flow, and technique.
Children need guidance
Immediate, child-friendly feedback can turn a difficult daily routine into a guided therapy moment.
Clinicians need context
Structured inhalation data can help care teams understand what happens between visits — not only what is remembered during them.
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.
“You cannot optimize what you cannot see. CAELIA makes everyday inhalation therapy measurable.”
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.
Dose · Technique · Feedback · Tracking
Dose
Detect whether actuation happened and whether aerosol was present during the inhalation event.
Flow
Measure inhalation flow and volume to understand whether breathing supported effective delivery.
Timing
Connect dose release and breath phase to detect coordination errors.
Technique
Combine sensor signals to identify application errors and guide better use.
Response
Track respiratory patterns over time to support therapy monitoring and future warning-signal detection.
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.
Measure
Dose, timing, flow, technique, and respiratory patterns are captured during everyday use.
Structure
Each inhalation event becomes a structured data point instead of an invisible therapy moment.
Learn
Longitudinal patterns help improve coaching, therapy monitoring, and future risk models.
Guide
Patients, parents, and clinicians receive clearer feedback and more actionable insight.
Scale
As usage grows, CAELIA builds a respiratory intelligence layer for precision respiratory care.
The wedge is pediatric asthma. The platform is respiratory intelligence.
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.
Multimodal sensing
Ultrasonic flow, optical aerosol detection, acoustic monitoring, IMU orientation sensing, and real-time feedback in one smart spacer architecture.
Deep-tech foundation
Built on Fraunhofer engineering, protected IP, and a hardware architecture designed for medical-grade respiratory sensing.
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.
Respiratory data moat
Each validated inhalation event contributes to a growing longitudinal understanding of real-world respiratory therapy.
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.
Experienced guidance
Regulatory experts support our strategy, development priorities, and evidence planning.
MDR-oriented development
SereneAir is being developed with the European MDR framework in mind.
FDA pathway validation
In parallel, we are validating the appropriate regulatory pathway for the US market.
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.
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
Strategy, venture building, fundraising, go-to-market, reimbursement, and investor relations.
LinkedIn
Rinaldo Persichini
Ultrasonic sensing, embedded hardware, industrialization, IP strategy, and medical-grade device engineering.
LinkedIn
Vanessa Torres Gangoo
Product strategy, healthcare systems, usability, clinical operations, and regulatory preparation.
LinkedIn
Ervin Hasko
Data strategy, statistics, machine learning, data pipelines, and AI-driven respiratory insights.
Questions we are often asked.
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 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.
For clinicians, pediatric pneumologists, clinics, and care teams interested in early feedback, pilot design, or clinical validation.
Discuss a pediatric asthma pilot →For experts in FDA, 510(k), MDR, SaMD, clinical claims, usability, and medical device strategy.
Validate the regulatory pathway →For pharma, device, payer, clinical research, and respiratory care partners exploring real-world inhalation data and therapy support.
Explore strategic partnership →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