CelLBxHealth PLC - Aligning Regulatory Approach with Commercial Needs

CelLBxHealth strengthens cost discipline by aligning FDA regulatory approach with current commercial needs

GUILDFORD, SURREY / ACCESS Newswire / February 13, 2026 / CelLBxHealth plc (AIM:CLBX), a leader in circulating tumor cell (CTC) intelligence, with tests and services supporting research, drug development and clinical oncology, announces that it has decided to discontinue maintenance of its FDA establishment license and device listing for the Parsortix system, which aligns its regulatory strategy with the Company's current operational and commercial priorities and strengthening cost discipline.

This decision reflects the Company's revised business model and customer usage patterns. More than 97% of Parsortix platforms in the field are deployed for in-house translational research and assay development activities, where an active device listing provides no commercial benefit. By streamlining these expenses, CelLBxHealth can reallocate resources to areas that directly support revenue growth, customer support, and product development.

Importantly, the Company retains the flexibility to reinstate the device listing at any time through payment of the applicable annual fees should commercial opportunities make it advantageous to do so.

This change has no impact on CelLBxHealth's sales pipeline, market forecasts, customer support, or ongoing partnerships.

Peter Collins CEO of CelLBxHealth commented:
"Our decision to discontinue the current FDA establishment license and device listing is a practical step that reflects how our customers are using the Parsortix platform today. With most platforms supporting translational research and assay development, maintaining this listing does not presently add commercial value. By optimizing our cost structure, we can invest more directly in revenue generation while retaining the option to reinstate the regulatory listing when it supports future revenue opportunities. We remain confident in our growth trajectory and excited about the expanding role of the Parsortix platform within the precision oncology market."

CelLBxHealth continues to focus on expanding its research, CRO and clinical laboratory collaborations, to advance LDT development programs, and strengthening its position as a leader in CTC solutions.

For further information:

CelLBxHealth plc Peter Collins, Chief Executive Officer Jan Groen, Executive Chairman

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