Fraunhofer Institute for Toxicology and Experimental Medicine
Fraunhofer Institute for Toxicology and Experimental Medicine

Innovation for preterm neonates: breath-triggered delivery of medical aerosols

Challenges in the care of preterm infants

Die am Fraunhofer ITEM patentierte Technologie »Inhale+« soll Frühgeborenen mit einem schweren Atemnotsyndrom helfen.
© Fraunhofer ITEM
Preterm infants with severe respiratory distress syndrome require effective treatment at an early stage. Traditionally, this treatment is administered systemically and invasively, placing significant strain on these fragile patients. The patented “Inhale+” technology developed by Fraunhofer ITEM aims to change this.

In today’s medical landscape, the care of preterm infants faces significant challenges, particularly concerning respiratory diseases and lung injuries. Global statistics indicate that approximately 14.8 million babies are born prematurely each year, with around 34% suffering from severe respiratory conditions. This issue is particularly critical for extremely premature infants (born before the 23rd week of gestation), with studies from the U.S. reporting mortality rates as high as 43%.

It is well established that early systemic administration of corticosteroids (before the 7th postnatal day) can reduce the incidence of bronchopulmonary dysplasia (BPD) and mortality. However, this approach is associated with an increased risk of adverse effects such as hyperglycemia, hypertension, gastrointestinal bleeding, gastrointestinal perforations, and growth impairments. The link between early (<7 days of life) systemic corticosteroid administration and negative effects on neurological development has ultimately led to a reduction in the use of corticosteroids in ventilated preterm infants.

An alternative to systemic administration is early, localized delivery via inhalation directly into the lungs. Evidence suggests that when effectively administered, local inhalation can successfully reduce the incidence of BPD and mortality without the associated systemic side effects.

 

Innovative inhalation technology and its benefits

The introduction of technologies for non-invasive inhalation therapy, developed and patented under the leadership of Dr. Gerhard Pohlmann at Fraunhofer ITEM, offers a gentle and effective treatment option for the underdeveloped lungs of preterm infants. This innovative approach enables a unique alternative method for very early, preventive treatment of respiratory diseases, helping to prevent lung damage and long-term complications while reducing mortality rates. The technology provides significant advantages over the current invasive, intravenous drug delivery methods, which are often associated with severe side effects.

This groundbreaking technology revolutionizes the efficiency of inhalation therapy for preterm infants by enabling precise and sufficiently high drug dosages during respiratory support. It is universally compatible with various ventilator settings. The core product of this technology already achieves efficacy levels that meet the threshold for pulmonary delivery of many drugs, particularly corticosteroids. Additional efficiency improvements through breath-synchronized drug release are currently under development.

 

Increased efficiency of the inhaled dose in comparison between Inhale Standard and Inhale+
© Fraunhofer ITEM
The efficiency enhancement of the inhaled dose achieved through the innovative technology was successfully measured using a preterm infant test bed developed from the EU Horizon 2020 project MDOT [1]. The test bed realistically simulates the breathing profiles of preterm infants. The following parameters were used: Breathing rate: 50 breaths/min; Tidal volume: 8 ml; Inhalation-to-exhalation ratio: 1:1.5; Continuous Positive Airway Pressure (CPAP): 6 L/min; Positive End-Expiratory Pressure (PEEP): 5 mbar

Outlook and technology transfer

Group photo with Felix Wiegandt at the Life Science Factory 2024 in Göttingen.
© Marco Buehl
Dr. Wiegandt in discussion with Dr. Robert Habeck, the German Vice Chancellor and Federal Minister for Economic Affairs and Climate Action, on the challenges of founding new companies and the political framework conditions during the Life Science Factory event in Göttingen on April 30, 2024.

As part of the treatment for preterm infants with respiratory diseases, the innovative technology has the potential to set a new standard in neonatal care. To bring this technology to market, it is being spun off into Inhale+ GmbH.

There are significant opportunities for further development of the technology, particularly in its scalability for additional applications, including for adults. In this context, additive manufacturing methods provide flexible customization options for the individualized production of therapeutic accessories.

During the course of the spin-off efforts, several successes have already been achieved:

  • Best Industry Poster Award at The Drug Delivery to the Lungs Conference
  • Hannoverimpuls Future Health Lab (Incubator)
  • Fraunhofer AHEAD Phase I + II (Accelerator), AHEAD Pitch Night Award (2x)
  • ELSA (Entrepreneurial LifeScience Accelerator), ELSA Pitch Bowl Award
  • Startup prize “Wegbereiter” from the Börsenclub Hannover (engl. stock exchange club)
  • Discussion with Dr. Robert Habeck, Federal Minister for Economic Affairs and Climate Action, on the startup landscape as part of the Life Science Factory in Göttingen.
 

© Marco Buehl

InhalPlus funding

Two separate grants have been successfully acquired: the EXIST funding and a grant from IBT Niedersachsen, each supporting a specific development phase.

InhalPlus

EXIST Research Funding

With support from EXIST, the current prototype will be further developed at Fraunhofer ITEM and optimized for usability in close collaboration with nursing staff and neonatologists.

Additionally, this phase will address critical regulatory steps by preparing documentation and processes for CE certification - an essential milestone for market entry.

Funding amount: 1.5 million euros
Start of funding: December 2024

 

IBT Lower Saxony

Thanks to funding from IBT Lower Saxony, clinical partners at Hannover Medical School (MHH) and University Hospital Schleswig-Holstein (UKSH) will conduct a clinical proof-of-concept study. This study will, for the first time, validate the efficiency advantage of the inhalation technology in clinical practice.

This funding is much more than just financial support - it is a strong vote of confidence in the vision to sustainably improve neonatal care.

Funding amount: 1.3 million euros

Start of funding: April 2025

Go to Inhale+

Contact

Ulrich Froriep

Contact Press / Media

Dr. Ulrich Froriep

Division Co-Director of Safety Assessment and Toxicology & Head of Department of Biomedical Engineering

Phone +49 511 5350-294

Felix Wiegandt

Contact Press / Media

Felix Wiegandt

Division Safety Assessment and Toxicology

Phone +49 511 5350-287