Aligning Regulatory Approach with Commercial Needs

CelLBxHealth PLC

13 February 2026

 

CelLBxHealth plc ("the Company")

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

Guildford, UK and Plymouth Meeting, US - 13 February 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	[phone] [e-mail]
Cavendish (NOMAD and Broker) Geoff Nash / Isaac Hooper (Corporate Finance) Sunila de Silva (Corporate Broking) Nigel Birks (Life Science Specialist Sales)	[phone]
FTI Consulting Simon Conway, Ciara Martin, Sam Purewal	[phone]

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the EU Market Abuse Regulation (596/2014) as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018, as amended. Upon the publication of this announcement via a regulatory information service, this information is considered to be in the public domain.

Notes for editors 

About CelLBxHealth plc

CelLBxHealth plc is a CTC intelligence company specializing in innovative circulating tumor cell (CTC) solutions for use in research, drug development and clinical oncology. Its patent-protected Parsortix® platform harvests CTCs from blood and can be integrated with existing laboratory instruments for comprehensive downstream analysis - including whole-cell imaging, proteomic profiling and full genomic workflows.

Commercial activities center on (1) Product Sales: Accelerating Parsortix platform adoption and consumable sales through CROs and clinical lab partnerships. (2) Laboratory services: Clinical trial support and assay development (3) Lab Developed Tests (LDTs): Strategic partnerships combined with a focused in-house development program.

The product portfolio comprises the Parsortix® platform with associated consumables and assays. Laboratory services are delivered from CelLBxHealth's GCLP compliant UK laboratory, providing bespoke clinical-trial support and assay development.

For more information, visit https://cellbxhealth.com/.

 

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