CelLBxHealth PLC (AIM:CLBX, OTCQB:ANPCF, FRA:DWV) has decided to discontinue maintenance of its United States Food and Drug Administration establishment licence and device listing for the Parsortix system as it seeks to strengthen cost discipline and match its regulatory approach with current commercial priorities.
The Guildford-based group, which provides circulating tumour cell intelligence tests and services to support research, drug development and clinical oncology, said the decision reflected its 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, the company said.
Streamlining these expenses will allow CelLBxHealth to reallocate resources to areas that directly support revenue growth, customer support and product development.
The company said it 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.
The change has no impact on CelLBxHealth’s sales pipeline, market forecasts, customer support or ongoing partnerships.
Peter Collins, chief executive of CelLBxHealth, said: “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 optimising 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.”
The company said it would continue to expand its research, contract research organisation and clinical laboratory collaborations, advance laboratory developed test development programmes and strengthen its position in circulating tumour cell solutions.