CE-Marked PBM-Hale™: A Non-Invasive Leap for Lung Diagnostics

The diagnosis of lung diseases, from chronic obstructive pulmonary disease (COPD) to interstitial lung diseases and lung cancer, has long relied on invasive, costly, and high-risk procedures such as bronchoscopy or bronchoalveolar lavage. These methods, while effective, are reserved for the most severe cases, leaving a significant gap in routine or repeat testing. The result is often underdiagnosis, delayed treatment, and a focus on symptoms rather than root causes.

This paradigm may soon shift. On April 23, 2026, Sanner, a device design specialist and contract development and manufacturing organization (CDMO), and PulmoBioMed Ltd, a UK-based medical device company, announced that their PBM-Hale™ platform had secured CE marking, the first non-invasive technology capable of obtaining saliva-free, deep distal lung samples. Approved for clinical and research use across Europe and the U.S., PBM-Hale™ promises to make lung diagnostics safer, more accessible, and more scalable than ever before.

A Breakthrough in Breath Sampling

At the heart of PBM-Hale™’s innovation is its ability to reliably collect exhaled breath condensate (EBC) from the distal lung, the deep regions where many respiratory diseases originate, while minimizing contamination from the mouth, upper airways, or environment. Unlike traditional methods, which require sedation, hospitalization, or specialized equipment, PBM-Hale™ is designed to integrate seamlessly into standard diagnostic workflows, making it suitable for both clinical and research settings.

“Current diagnostic procedures for lung diseases are not only invasive but also logistically complex and expensive,” explains Dr. Sterghios A. Moschos, founder and CEO of PulmoBioMed. “This often means that patients only undergo testing when their condition is already advanced. With PBM-Hale™, we’re offering a non-invasive, repeatable, and patient-friendly alternative that could enable earlier detection and better disease management.”

The device’s potential applications are vast. In clinical practice, it could facilitate the monitoring of chronic conditions like asthma or cystic fibrosis, where regular sampling is critical. For research, it opens doors to studying biomarkers in EBC, which could lead to new diagnostic tests or therapeutic targets for diseases like lung cancer or idiopathic pulmonary fibrosis (IPF).

From Prototype to Production: The Power of Partnership

Developing a medical device from concept to market is a high-stakes, highly regulated process, one that PulmoBioMed did not navigate alone. The company partnered with Sanner, leveraging the CDMO’s expertise in design, regulatory support, and cleanroom manufacturing to transform the PBM-Hale™ prototype into a market-ready product.

Sanner’s role was comprehensive. Their UK-based development team guided the design through rigorous risk analyses, prototype testing, and tolerance assessments to ensure reliability under an ISO 13485-certified Quality Management System. Early involvement of Design Transfer experts allowed for a smooth transition to scaled production, with 3D data and mold-flow simulations optimizing the 17-part device for injection molding and assembly.

“Sanner’s integrated approach was instrumental in accelerating our path to commercialization,” says Dr. Moschos. “The handover from design for manufacture to scaled production was seamless, and their ability to address both functional and regulatory needs while keeping our SME constraints in mind was impressive.”

The first 3,500 units of PBM-Hale™ were manufactured in Sanner’s Class 7 cleanroom, meeting the highest standards for medical device production. Beyond the device itself, Sanner also developed the primary packaging, branded secondary cartons, and tertiary multi-packs required for shipping, ensuring that PBM-Hale™ was ready for global distribution from day one.

Market Potential and the Road Ahead

With CE marking secured, PulmoBioMed is now poised to introduce PBM-Hale™ in clinical trials and collaborationswith diagnostic test manufacturers, as well as pharma and biotech companies across the U.S. and Europe. The long-term ambition is to democratize lung diagnostics, making them less risky and more accessible to a broader range of patients.

The implications of this innovation are far-reaching. Non-invasive sampling could reduce the burden on patients and healthcare systems by enabling earlier and more frequent monitoring of lung diseases. For researchers, EBC samples could provide novel insights into disease mechanisms, potentially accelerating the development of personalized treatments. As the first device of its kind to achieve CE marking, PBM-Hale™ could also set a new standard for respiratory diagnostics, challenging the dominance of invasive methods that have long been the norm.

Yet, challenges remain. Clinicians may be hesitant to adopt a new technology without robust data demonstrating its accuracy, reproducibility, and cost-effectiveness compared to traditional methods. Additionally, while the CE mark allows for commercialization in Europe, FDA approval will be critical for the U.S. market, a process that can be lengthy and resource-intensive.

A Glimpse into the Future of Lung Diagnostics

The collaboration between Sanner and PulmoBioMed exemplifies how partnerships between innovators and CDMOs can accelerate the translation of groundbreaking ideas into tangible solutions. For PBM-Hale™, the next steps involve scaling production, expanding clinical validation, and forging strategic alliances to bring the device to patients worldwide.

As Dr. Moschos concludes: “We’re not just launching a product; we’re redefining what’s possible in respiratory diagnostics. With Sanner’s support, we’re ready to conquer the market and establish a global supply chain for PBM-Hale™.”

For patients and clinicians alike, the hope is that this innovation will breathe new life into the fight against lung diseases, one non-invasive sample at a time.