CE Mark Authorisation

For immediate release

17 December 2013

 

 

ANGLE plc

("ANGLE" or "the Company")

 

PARSORTIX IN VITRO DIAGNOSTIC DEVICE CE MARK AUTHORISATION

 

ANGLE plc (AIM: AGL), the specialist medtech company, is delighted to announce the CE Mark authorisation of its Parsortix cell separation system for use as an in vitro diagnostic device in the European Union.

 

Achievement of this key milestone confirms that the Parsorter PC1 clinical system meets the Essential Requirements of the European Union In Vitro Device Directive (98/79/EC), a pre-requisite for the product's use in clinical applications (i.e. with patients) throughout Europe.

 

ANGLE is preparing an FDA 510(k) submission for clinical use of the Parsortix system in the United States.  This builds on the work completed for the CE Mark and is on track for submission to the FDA by the end of Q1 2014.   

 

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

 

To achieve widespread market adoption, ANGLE needs to establish the use of Parsortix in clinical practice through (i) identifying key clinical applications with medical utility, (ii) securing positive clinical data demonstrating the medical utility of those applications in patient trials and (iii) obtaining Key Opinion Leader support for the adoption of Parsortix in the routine medical care of cancer patients. 

 

CE Mark authorisation of the Parsortix system for clinical use throughout Europe is a major step forward as it enables ANGLE to drive commercialisation of the system on three fronts:

 

1)  Expansion of the market from the existing research use market to the much larger clinical use market. 

 

As evidence of the medical utility of circulating tumour cell (CTC) analysis is developed, ANGLE will have a product that can be sold eventually for the routine treatment of cancer patients throughout the whole of Europe.    

 

2)  Engagement with major medtech companies to combine the Parsortix system with their molecular analysis platforms.

 

ANGLE is working on demonstrating the compatibility of the Parsortix CTC harvesting capability with the established molecular analysis platforms deployed by some of the world's largest medtech companies.  The aim is that CTCs harvested from patient blood by the Parsortix system (the "liquid biopsy") are able to be analysed for mutations and other important medical information on the medtech companies' existing platforms thereby greatly expanding their market application.  Now that ANGLE has achieved CE Mark authorisation for the Parsortix system, ANGLE can progress discussions with these medtech companies for the combination of the Parsortix system with their platforms. 

 

3)  Engagement with major pharmaceutical companies to use the Parsortix system. 

 

Pharmaceutical companies are under increasing pressure to demonstrate the medical benefit of their new cancer drugs for individual patients.  Now that ANGLE has achieved CE Mark authorisation for the Parsortix system, ANGLE can progress discussions with major pharma companies to utilise the Parsortix system in their extensive clinical trials programmes. Subsequently Parsortix could be approved as a companion diagnostic test to be used first to determine whether the drug is suited to the patient's cancer allowing personalised cancer medicine and secondly to assess how effective the drug has been in treating the patient's cancer.    

 

ANGLE's ability to deliver on these key work streams is significantly strengthened by the disposal of its shareholding in Geomerics, announced on 13 December 2013, which provides the Company with up to £6.2 million of non-dilutive funding to support the commercialisation of the Parsortix system, demonstrates financial strength to commercial partners, and underlines ANGLE's re-focusing as a specialist medtech company.

 

 

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

"The successful CE Marking of the Parsortix system as an in vitro diagnostic device not only provides ANGLE with regulatory authorisation for clinical sales in Europe but also gives us a platform to explore the potential for key commercial relationships with major medtech and pharma companies."

 

 

 

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