A medical device company spun out from Northumbria University has reached a key milestone. Receives CE Mark for an exhaled breath sampling platform that has been demonstrated in peer-reviewed studies to reliably collect saliva-free exhaled breath condensate (EBC) from deep within the lungs, making it the first technology of its kind to achieve this distinction.
PulmoBioMed Ltd has been awarded the CE mark for its PBM-Hale™ platform, a non-invasive breath sampling device developed based on research carried out at Northumbria University in Newcastle. The CE-marked and US FDA-registered device is now available for deployment in clinical and research settings in Europe and the US, marking a major step forward in the global effort to make lung disease diagnosis faster, safer and more accessible for patients.
The technology addresses a challenge that has plagued clinicians for more than 40 years: how to reliably collect samples from deep in the lungs without resorting to expensive and risky invasive procedures. Existing gold standard techniques such as bronchoscopy and bronchoalveolar lavage are reserved for the most critically ill patients and cannot be routinely repeated or used on a large scale in the community. As a result, clinicians often end up treating the symptoms of lung disease rather than the underlying cause of the disease.
PBM-Hale™ changes this situation by allowing collection of exhaled breath condensate originating from deep within the lungs while eliminating contamination from the mouth, upper respiratory tract, and environment. The device has been successfully tested in both hospital and primary care settings and is designed to work with existing diagnostic testing workflows.
The technology was developed when Professor Stergios Moskos was a professor at Northumbria University, where his work on breath-based diagnostics laid the foundations for what has become a commercially viable medical device. PulmoBioMed was then established as a spin-out company in Northumbria, with support from the Northern Accelerator, a research commercialization partnership between universities in the North East. The Northun Accelerator’s proof of concept funding enabled us to carry out rapid prototyping using 3D printers within Northumbria’s own engineering laboratory and develop the first functional prototype.
Sterghios A., Founder and Chief Executive Officer of PulmoBioMed and Visiting Professor at Northumbria University. Professor Moschos said: “Achieving the CE mark is an important milestone for PulmoBioMed. Our goal was to address a 40-year-old challenge in respiratory medicine: obtaining reliable samples from the deep lungs without invasive methods or complex equipment. Now that regulatory approval is in place, we look forward to collaborating with pulmonologists.” Our aim is to partner with centers, researchers, and pharmaceutical companies developing respiratory treatments to enable clinically actionable diagnostics that enable personalized respiratory care. ”
Jenny Taylor, Executive Director of Research and Innovation Services at Northumbria University, said: “PulmoBioMed is a great example of what happens when world-class research receives the support it needs to reach its full potential. CE marking for PBM-Hale™ is a proud moment for Northumbria. Our laboratory From Professor Moskos’ initial research at Northern Accelerator to its proof-of-concept support, this is truly a success story in the North East. We look forward to seeing this technology make a real difference to patients and researchers across Europe and beyond.”
The device is manufactured under contract with Sanner GmbH, a Germany-based USFDA-registered contract development and manufacturing organization (CDMO) whose expertise accelerated PulmoBioMed’s transition from prototype to market-ready device.
At Sanner, we’re proud to help turn bold ideas into tangible healthcare solutions, progressing from initial device concepts to robust, frozen designs and high-quality prototypes. This milestone reflects the power of collaboration and innovation in shaping the future of respiratory diagnostics. Congratulations to PulmoBioMed on receiving the CE mark for this innovative and reliable non-invasive deep lung sampling device. ”
Stefan Verheiden, Sanner CEO
PulmoBioMed is now beginning to implement PBM-Hale™ through structured collaborations with lung transplant centers, diagnostic test manufacturers, research institutions, biotechnology and pharmaceutical companies in Europe and the United States, with initial programs focused on environments where consistent access to deep lung samples can support more informed clinical decision-making.
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Northumbria University, Newcastle
