PulmoBioMed Receives CE Mark for First Deep Lung Breath Sampling Device, Addressing 40-Year Clinical Challenge
Key Insights
PulmoBioMed (search) Ltd, a Northumbria University spinout, has received CE marking for its PBM-Hale (search)™ platform, the first breath sampling device proven to reliably collect saliva-free exhaled breath condensates from the deep lung.
The non-invasive device addresses a 40-year challenge in respiratory medicine by providing an alternative to expensive, high-risk invasive procedures like bronchoscopy and bronchoalveolar lavage.
The CE-marked and US FDA-registered device can now be deployed across clinical and research settings in Europe and the USA, marking a significant advancement in lung disease diagnosis.
PulmoBioMed (search) Ltd, a medical device company spun out of Northumbria University, has achieved a significant regulatory milestone with CE marking for its PBM-Hale (search)™ platform, a non-invasive breath sampling device that represents the first technology of its type to reliably collect saliva-free exhaled breath condensates (EBC) from the deep lung. The CE-marked and US FDA-registered device can now be deployed across clinical and research settings in Europe and the USA.
Addressing a Four-Decade Clinical Challenge
The technology tackles a problem that has frustrated clinicians for more than 40 years: obtaining reliable samples from the deep lung without resorting to expensive, high-risk invasive procedures. Existing gold-standard techniques such as bronchoscopy and bronchoalveolar lavage are reserved for the most seriously ill patients and cannot be repeated routinely or used at scale in community settings. As a result, clinicians are often left treating the symptoms of lung disease rather than its underlying causes.
PBM-Hale (search)™ changes this paradigm by enabling the collection of exhaled breath condensates originating from the deep lung, while eliminating contamination from the mouth, upper airways, and the environment. The device has been successfully tested in both hospital and primary care settings and is designed to work with existing diagnostic test workflows.
From University Research to Commercial Reality
The technology was developed during Professor Sterghios Moschos's tenure at Northumbria University, where his research into breath-based diagnostics laid the foundations for what has become a commercially viable medical device. PulmoBioMed (search) was subsequently established as a Northumbria spinout company, supported by Northern Accelerator (search)—a research commercialisation partnership between the North East's universities—whose Proof-of-Concept funding enabled the development of the first functional prototype, with rapid prototyping carried out using 3D printers within Northumbria's own engineering labs.
"Achieving CE marking represents an important milestone for PulmoBioMed (search)," said Professor Sterghios A. Moschos, Founder and Chief Executive Officer of PulmoBioMed and Visiting Professor at Northumbria University. "Our goal has been to address a 40-year challenge in respiratory medicine—obtaining reliable samples from the deep lung without invasive methods or complex instrumentation. With regulatory clearance now in place, we look forward to working with specialist respiratory centres, researchers, and pharmaceutical companies developing respiratory therapeutics. Our objective is to empower clinically actionable diagnoses that realise personalised respiratory medicine."
Manufacturing Partnership and Market Introduction
The device is manufactured under contract by Sanner GmbH (search), a USFDA-registered contract development and manufacturing organisation (CDMO) based in Germany, whose expertise accelerated PulmoBioMed (search)'s journey from prototype to market-ready device.
"At Sanner, we are proud to help turn bold ideas into tangible healthcare solutions—advancing from first device concepts to a robust, frozen design and high-quality prototypes," said Stefan Verheyden, CEO at Sanner. "This milestone reflects the power of collaboration and innovation in shaping the future of respiratory diagnostics. Congratulations to PulmoBioMed (search) on achieving CE marking for this groundbreaking, reliable, and non-invasive deep lung sampling device."
Clinical Implementation Strategy
PulmoBioMed (search) will now begin introducing PBM-Hale (search)™ through structured collaborations with lung transplant centres, diagnostic test manufacturers, research institutions, and biotech and pharmaceutical companies across Europe and the USA, with early programmes focusing on settings where consistent access to deep lung samples could support more informed clinical decision-making.
Jenny Taylor, Executive Director of Research and Innovation Services at Northumbria University, emphasized the significance of this achievement: "PulmoBioMed (search) is a wonderful example of what happens when world-class research is given the support it needs to reach its full potential. The CE marking of PBM-Hale (search)™ is a proud moment for Northumbria—from Professor Moschos's early research in our labs, through Northern Accelerator (search)'s proof-of-concept support, this is genuinely a North East success story. We look forward to seeing the technology make a real difference for patients and researchers across Europe and beyond."