Portfolio company Veryan Medical announces the completion of subject enrolment into the MIMICS-2 clinical study
Imperial Innovations Group plc (AIM: IVO or ‘the Group’, ‘Innovations’) notes that portfolio company Veryan Medical (‘Veryan’ or the ‘Company’) has completed enrolment into the MIMICS-2 clinical study of its BioMimics 3D® Self-Expanding Stent System (BioMimics 3D).
The MIMICS-2 study is a prospective, multicentre, interventional study designed to evaluate the safety and effectiveness of Veryan’s patented three dimensional helical stent in the treatment of patients with symptomatic femoropopliteal disease. The study is being conducted under a USA Food and Drug Administration (FDA) Investigational Device Exemption (IDE), with Japanese Pharmaceuticals and Medical Devices Agency (PMDA) concurrence under the “Harmonisation By Doing” initiative, in order to provide safety and effectiveness data that are intended to support future marketing applications for BioMimics 3D in both the USA and Japan. BioMimics 3D has previously been awarded the CE Mark and is actively being sold across Europe.
Enrolment in the MIMICS-2 study concluded with a total of 271 patients enrolled across 47 investigational sites in Germany, the USA and Japan.
As at 31 July 2016, Innovations had a 46.1% interest in the issued share capital of Veryan with a net investment carrying value of £26.5 million.
Dr Nigel Pitchford, Chief Investment Officer, Imperial Innovations, said:
“Completion of enrolment into the MIMICS-2 is an important milestone for Veryan on its path to the global commercialisation of its unique stent technology.
“We are very pleased with the speed at which enrolment has been completed, which is a testament to the investigating physicians’ enthusiasm for recruiting patients and the efficiency of the Veryan team.”