7 May 2013 – regulatory approval
In another positive development, ANGLE has announced that it has appointed a specialist regulatory company, Medical Device Management (MDM) to manage the process of obtaining the relevant regulatory approvals for its Parsortix blood separation device. MDM has worldwide experience in regulatory submissions and is focused entirely on the medical devices sector. Initial analysis by MDM has confirmed ANGLE’s expectation of securing EU regulatory authorisation in the EU by the end of 2013 with a submission to the US FDA likely in early 2014. It is reassuring that MDM have expressed confidence in the Parsortix device and we retain our recommendation of BUY.