Northern Accelerator is delighted that PulmoBioMed Ltd, a spinout from Northumbria University, has achieved CE marking for its pioneering deep lung breath sampling platform. Peer‑reviewed research shows the device can reliably collect saliva‑free exhaled breath condensates (EBC) from the deep lung. Making it the first technology of its kind to achieve this distinction.
PulmoBioMed has received CE marking for its PBM‑Hale™ platform. A non‑invasive breath sampling device developed from research at Northumbria University in Newcastle. The CE‑marked and US FDA‑registered device can now be deployed across clinical and research settings in Europe and the USA. This achievement marks an important step forward in global efforts to make lung disease diagnosis faster, safer and more accessible to patients.
Addressing a long‑standing clinical challenge
For more than 40 years, clinicians have faced a major challenge. How to obtain 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™ directly addresses this problem. The device enables the collection of exhaled breath condensates 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 medical device
The technology was developed during Professor Sterghios Moschos’s time at Northumbria University. His research into breath‑based diagnostics laid the foundations for a commercially viable medical device. PulmoBioMed was later established as a Northumbria University spinout to translate this research into real‑world clinical impact.
Professor Sterghios A. Moschos, Founder and Chief Executive Officer of PulmoBioMed and Visiting Professor at Northumbria University, said:
“Achieving CE marking represents an important milestone for PulmoBioMed. 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 and market readiness
The PBM‑Hale™ device is manufactured under contract by Sanner GmbH, a USFDA‑registered contract development and manufacturing organisation based in Germany. Sanner’s expertise helped accelerate PulmoBioMed’s journey from prototype to market‑ready device.
Stefan Verheyden, CEO at Sanner said: “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. This milestone reflects the power of collaboration and innovation in shaping the future of respiratory diagnostics. Congratulations to PulmoBioMed on achieving CE marking for this groundbreaking, reliable, and non-invasive deep lung sampling device.”
PulmoBioMed will now introduce PBM‑Hale™ through structured collaborations with lung transplant centres, research institutions, diagnostic test manufacturers and biotech and pharmaceutical companies across Europe and the USA. Early programmes will focus on settings where consistent access to deep lung samples could support more informed clinical decision-making.
How Northern Accelerator supported PulmoBioMed
Northern Accelerator played a vital role in supporting PulmoBioMed from early development through to company formation and growth.
The business received Pre-incorporation funding, which enabled product and business development of the technology. This support made it possible to bring together a dedicated team to create a prototype of the device. Rapid prototyping was carried out using 3D printing facilities within Northumbria University, with Northumbria graduate Saqib Ali appointed as Design Engineer.
Professor Moschos also took part in Northern Accelerator’s Future Founders programme. This provides academics with essential commercial knowledge and skills to support the creation of a successful university spinouts or licencing opportunities.
In addition, PulmoBioMed worked closely with Northern Accelerator‑funded technology transfer professionals at Northumbria University and benefited from Executives into Business support. This helped the company recruit and shape its management team.
Jenny Taylor, Executive Director of Research and Innovation Services at Northumbria University, said: “PulmoBioMed 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™ is a proud moment for Northumbria — from Professor Moschos’s early research in our labs, through Northern Accelerator’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.”
