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April 23, 2026 – Device design specialist and CDMO Sanner and medical device company PulmoBioMed Ltd have teamed up to achieve CE marking for PBM-HaleTM, a deep-lung breath sampling platform. As the first technology to obtain saliva-free, deep distal lung samples non-invasively, the solution is now approved for clinical and research purposes across Europe and the U.S. Together, Sanner and PulmoBioMed co-developed the pioneering device from prototype to market entry and are now ready for series production.
Obtaining representative deep-lung samples today involves invasive, costly, and high-risk procedures, reserved for the critically ill and unsuitable for routine or repeat testing. This often results in root causes of lung disease going untreated, with clinicians focusing on the symptoms instead. UK-based medical device company PulmoBioMed made it its mission to challenge invasive clinical diagnostic procedures and instead advance respiratory research and future diagnostic development. This led to the development of the PBM-HaleTM, a non-invasive, deep-lung breath sampling device. It reliably collects saliva-free exhaled breath condensate from the distal lung while minimizing contamination from the mouth, upper airways, and the environment, and is designed to integrate into standard diagnostic workflows.
Development expertise from prototype to production
To develop the prototype into a market-ready device, receive regulatory support, and have cleanroom manufacturing capabilities at their disposal from a single source, PulmoBioMed joined forces with Sanner. Development experts of Sanner UK guided the design through a rigorous product development process, including risk analyses, prototype and design-iteration testing, and tolerance analyses to predict performance and ensure reliability under an ISO 13485-certified Quality Management System.
The team also involved Design Transfer experts at an early stage to provide PulmoBioMed with the benefits of a full-service CDMO. 3D data and mold-flow simulations were used to optimize the design of the 17 parts for subsequent manufacture by injection molding and for assembly at scale, while manufacturing teams made sure that material choices and tool design met functional, regulatory, and as well as assembly needs.
Cleanroom manufacture to the highest standards
After verification, installation and operational qualification (IQ/OQ), the PBM-HaleTM was ready for its first builds. Sanner produced the initial 3,500 units in a class 7 cleanroom to meet product requirements. “We were impressed with Sanner’s professionalism from the get-go and the quality of workmanship as we saw our 3D printed prototype mature into a robust, high-quality, injection-molded product,” Dr. Sterghios A. Moschos, founder and CEO of PulmoBioMed remarks. In addition to the device itself, Sanner also developed the primary packaging concept, the branded secondary cartons, and the tertiary multi packs required for shipping the PBM-HaleTM.
Successful co-development for device accessibility
Sanner’s integrated full-service CDMO approach proved crucial in enabling PulmoBioMed to efficiently transition from development to commercialization and bring the PBM-HaleTM to market. As Dr. Moschos says, “The process handover from design for manufacture to scaled production was smooth and the partnership progressed productively in the context of SME needs vis-à-vis stringent quality and regulatory criteria.” With CE marking now secured, PulmoBioMed plans to introduce the PBM-HaleTM in clinical trials and collaborations with diagnostic test manufacturers as well as pharma and biotech companies across the U.S. and Europe, supporting its long-term ambition to make diagnostics for lung disease less risky and more accessible to a wider range of patients. “We look forward to conquering the market and establishing global supply for PBM-HaleTM together with Sanner,” Dr. Moschos concludes.
About Sanner
Sanner GmbH was founded in 1894. Headquartered in Germany with best-in-class manufacturing facilities across Germany, France, Hungary, China, and the U.S. Sanner has successively developed from a global market leader for desiccant closures and effervescent tablet packaging into a sought-after provider of customized solutions in the areas of medical devices and diagnostics, pharmaceuticals, and consumer healthcare. Today, Sanner supplies its products to more than 150 countries globally and has more than 820 employees. In November 2021, GHO Capital, Europe’s leading specialist investor in healthcare, acquired a majority stake in Sanner to partner with the fourth generation of the Sanner family to continue to support the growth of the company with a specific focus on transforming Sanner into a global MedTech CDMO.
About PulmoBioMed
PulmoBioMed Ltd is headquartered in Newcastle upon Tyne, UK, and develops and sells technologies designed to enable reliable, non-invasive access to deep lung samples. PBM-Hale™ is a CE-marked and US FDA-registered medical device. It is listed on the US FDA Medical Device database under operator number 10091222, and the EUDAMED database under UDE-DI: 05070003246106, reflecting the company’s ambitions beyond the European market. The company’s platform aims to disrupt invasive clinical diagnostic procedures for lung diseases, support advances in respiratory research, and future diagnostic development. With the product development phase completed, the company is raising investment to support its commercial growth phase.
Media contact
Commha Consulting GmbH & Co. KG
Annette Crowther
Tel. +49 6221 18779-27
sanner@commhaconsulting.com