Parsortix FDA Submission

RNS Number : 4304C

Angle PLC

17 March 2014

 



For immediate release

17 March 2014

ANGLE plc

("ANGLE" or "the Company")

PARSORTIX FDA SUBMISSION

ANGLE plc (AIM: AGL), the specialist medtech company, is pleased to announce it has made a submission to the United States Food and Drug Administration ("FDA") for authorisation of its Parsortix cell separation system for sale as an in vitro diagnostic device in the United States. 

The submission has been made under the FDA's 510(k) programme, one of the regulatory pathways for medical devices in the United States.

ANGLE anticipates that the Parsortix system will receive FDA clearance by the end of Q3 this year, although no guarantees can be made around the exact timing of authorisation.          

FDA regulatory clearance would allow sale of the Parsortix system to hospital pathology laboratories and other clinical customers in the United States for the harvesting and molecular analysis of large cells such as circulating tumour cells (CTCs) from patient blood ("liquid biopsy").  

There are currently no systems for harvesting CTCs for molecular analysis with FDA clearance for use with patients in the United States.  There is the prospect therefore that ANGLE's Parsortix system may be the first such system cleared by the FDA.  This would give ANGLE a market lead in the United States as new CTC based treatments for personalised cancer care emerge into mainstream medical practice.

ANGLE's Parsortix system is designed as an open system and has major commercial advantages:

·     The Parsortix system is intended for use with all existing authorised molecular analysis systems (i.e. systems which can analyse cancer cells to identify mutations and other important medical information).  ANGLE is thus positioning its product to collaborate with existing major medtech platforms rather than compete with them. 

·     When authorised by the FDA, ANGLE's Parsortix system may be used for the capture and harvesting of cells in relation to many cancer types without the requirement for separate time-consuming and costly FDA authorisations for each cancer type.    

·     As ANGLE's Parsortix system is a high performance laboratory instrument, capturing cells and presenting them for analysis, it will not require ANGLE to secure new designated US reimbursement codes.  Instead it can be purchased by hospital laboratories under their existing laboratory budgets, avoiding the challenging process to secure US reimbursement codes, which can take years and be very costly. 

ANGLE's ultimate objective is the widespread adoption of the Parsortix system in the diagnosis and treatment of cancer patients.  According to statistics from the World Health Organisation, there were 14 million new cancer cases worldwide in 2012, a marked rise on the 12.7 million cases in 2008.  ANGLE estimates that this represents a potential market for the Parsortix system worth in excess of £8 billion per annum worldwide.

ANGLE's Founder and Chief Executive, Andrew Newland, commented:

"We are pleased to have submitted our FDA application and are excited about the potential of having an FDA authorised system that can harvest cancer cells from blood for mutational analysis.  We believe the simplicity of our approach provides strong competitive advantages in the major emerging market of personalised cancer care."

For further information:

ANGLE plc	01483 685830
Andrew Newland, Chief Executive Ian Griffiths, Finance Director
Cenkos Securities Stephen Keys, Christopher Golden (Nominated adviser) Andy Roberts, Christian Hobart (Sales)	020 7397 8900
Buchanan Mark Court, Fiona Henson, Sophie Cowles	020 7466 5000

 

END

 

 

RAPSFMEEMFLSEED