London, UK - July 1 - Imperial Innovations Group plc (AIM: IVO; ‘the Group’, ‘Innovations’) is pleased to note that portfolio company Veryan Medical (‘Veryan’ or the ‘Company’) has today announced the enrolment of the first subject in its MIMICS-2 study, which has been designed to provide data to support a US Premarket Approval Application (PMA) of the Company’s BioMimics 3D Stent System in the USA. Veryan has already gained a CE Mark enabling sales of its BioMimics 3D™ stent within the European Economic Area (EEA).
Following on from the Company’s successful European study, MIMICS-2 is a single-arm, multi-centre clinical trial of Veryan’s BioMimics 3D® stent technology being conducted under US Investigational Device Exemption (IDE) approved by FDA. The study will enrol 280 subjects in up to 40 sites in the US and Germany and will evaluate the BioMimics 3D stent against performance goals for the safety and effectiveness of Nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery. The first subject was enrolled today at Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany by the European Principal Investigator (PI), Professor Thomas Zeller, who was also the PI of Mimics, the company’s previous randomized controlled study.
Veryan is Innovations’ third largest portfolio company by value and as of 31 January 2015 the Group had a 48.2% interest in the Company with a fair value of £20.9 million.
Nigel Pitchford, Chief Investment Officer of Imperial Innovation said:
"Approval of the IDE and the commencement of the clinical trial is an important milestone for Veryan."
“We are excited by the prospect that MIMICS-2 study will provide further evidence that BioMimics 3D stent offers significant benefits in femoropopliteal use, ultimately leading to approval in the US, thereby expanding the market beyond its current European approval.”
About Imperial Innovations - www.imperialinnovations.co.uk
Imperial Innovations Group plc creates, builds and invests in pioneering technologies developed from the academic research within the ‘Golden Triangle’ broadly bounded by London, Cambridge and Oxford, which is home to the UK’s four leading research-intensive universities.
This area is home to many new technology companies through its proximity to the academic communities of Imperial College London, the University of Cambridge, the University of Oxford and University College London, as well as other leading research institutions.
Imperial College London, the University of Cambridge, the University of Oxford and University College London collectively have research income of £1.4 billion per annum and are ranked as four of the top ten Universities in the world (source: QS World University Rankings 2014/15).
Innovations supports scientists and entrepreneurs in the commercialisation of their ideas through the licensing of intellectual property, by leading the formation of new companies, providing facilities in the early stages, providing investment and encouraging co-investment to accelerate development, providing operational expertise and recruiting high-calibre management teams. It also runs an incubator in London that is the initial home for many of its technology spin-outs.
Since admission of its shares to trading on AIM in 2006, Innovations has raised more than £346.0 million of equity from investors, which has enabled it to invest in some of the most exciting spin-outs to come out of UK academic research. In addition, the Group has a £30.0 million loan facility from the European Investment Bank (EIB) for investment in biotech and therapeutics businesses.
During the period from admission on AIM up until 31 January 2015, Innovations has invested a total of £198.3 million across its portfolio companies, which have raised collectively investment of £926.8 million rising to £1.0 billion including post period end investments and commitments.
About Veryan Medical Ltd - www.veryanmed.com
Veryan is developing innovative solutions to improve the performance of vascular stents using the principles of biomimicry. Veryan’s BioMimics 3D® stent technology involves adapting traditional straight stent designs to a patented three-dimensional helical shape, which more closely mimics the natural geometry of the human vascular system. BioMimics 3D technology is designed to enhance clinical performance by improving flow conditions in, and biomechanical performance of, stented vessels. The advanced, biomimetic design of the BioMimics 3D stent is intended to provide more flexibility, kink and fracture resistance than other laser-cut nitinol tube stents, making its unique design of particular importance in the hostile environment of the femoropopliteal artery. Veryan’s Research & Development facility is located in Galway, Ireland.
BioMimics 3D, a Nitinol stent with unique three-dimensional helical geometry, has been developed by Veryan, based on pioneering research by Prof Colin Caro at Imperial College London into the link between blood flow mechanics and vascular disease. The BioMimics 3D stent has unique helical curvature to impart natural curvature to the diseased artery, promoting secondary (swirling) flow and elevated wall shear stress, which has a protective effect on the endothelium. The helical geometry of the BioMimics 3D femoropopliteal stent is also designed to enable coil-spring shortening of the stented segment during knee flexion and mitigate the risk of stented segment compression causing localized strains that in a straight stent may lead to stent fracture and chronic vascular injury.
BioMimics 3D is a registered trademark of Veryan Medical Ltd.
Issued for and on behalf of Imperial Innovations by Instinctif Partners.
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Melanie Toyne-SewellManaging Partner