REG - CelLBxHealth PLC - Aligning Regulatory Approach with Commercial Needs

CellbxhealthAnnouncement

13/02/2026 07:00

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RNS Number : 8324S  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                                 +44 (0) 1483 343434

 Peter Collins, Chief Executive Officer          investor@cellbxhealth.com

 Jan Groen, Executive Chairman

 Cavendish (NOMAD and Broker)

 Geoff Nash / Isaac Hooper (Corporate Finance)   +44 (0) 20 7220 0500

 Sunila de Silva (Corporate Broking)

 Nigel Birks (Life Science Specialist Sales)

 FTI Consulting

 Simon Conway, Ciara Martin, Sam Purewal         +44 (0) 203 727 1000

 

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/
(https://cellbxhealth.com/) .

 

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