For immediate release |
7 May 2013 |
ANGLE plc
("ANGLE" or "the Company")
PARSORTIX REGULATORY APPROVAL UPDATE
ANGLE plc (AIM: AGL), the specialist medtech company, is pleased to announce the appointment of a specialist regulatory company, Medical Device Management (MDM), to manage the process of obtaining regulatory authorisations for the clinical use of the Parsortix cell separation system.
MDM is focused entirely on the medical devices sector and has expertise worldwide in quality assurance systems, regulatory submissions and compliance. Its clients range from small innovative companies to international medical devices businesses.
In the European Union (EU), marketing authorisation will be via a CE Mark, which will give approval for clinical sales throughout the EU. In the US, the process requires the submission of a 510(k) application to the FDA. Authorisation under 510(k) will allow the Company to make the product available throughout the US for use in treating patients.
MDM's initial analysis has confirmed ANGLE's expectation of securing regulatory authorisation in the EU by the end of the current calendar year and making a regulatory submission to the FDA in the US in early 2014.
Although ANGLE has not yet started to market Parsortix, there has been a stream of potential users expressing interest in the product, particularly in its harvesting capability. These include major hospitals, leading research groups and several commercial companies. Geographically, interest has come from across the UK as well as several international locations including the US, Canada and Australia.
ANGLE's Founder and Chief Executive, Andrew Newland, commented:
"We are very pleased to have put in place a plan for securing regulatory authorisations in Europe and the United States. MDM are experts in this field and it is reassuring that they have expressed confidence in our ability to secure the authorisations needed to enter the multi-billion dollar market for the clinical use of our cell separating technology."
For further information:
ANGLE plc |
01483 685830 |
Andrew Newland, Chief Executive Ian Griffiths, Finance Director |
|
Cenkos Securities Stephen Keys, Adrian Hargrave (Nominated adviser) Andy Roberts, Christian Hobart (Sales) |
020 7397 8900 |
Buchanan Mark Court, Fiona Henson, Sophie Cowles |
020 7466 5000 |
