Imperial Innovations Group Regulatory News (IVO)

30 May 2014

Imperial Innovations Group plc

Veryan announces results on two-year Mimics study

Imperial Innovations Group plc (AIM: IVO, "Innovations", "the Group") is pleased to note that Veryan Medical ("Veryan") the Group's third largest portfolio company by value will today publish the full two-year data from the Mimics randomized controlled study of its BioMimics 3D™Stent System at the 15th Annual New Cardiovascular Horizons (NCVH) Conference in New Orleans. The results have confirmed that BioMimics 3D provides a significant improvement in long-term patency compared to a straight nitinol control stent in patients undergoing femoropopliteal artery intervention. 

Veryan was formed in 2003 as the result of a technology spin out from Imperial College, London, UK. The company's BioMimics 3D technology is based on pioneering research by Professor Colin Caro into the link between blood flow mechanics and vascular disease. Innovations first invested in Veryan in 2004 and as at 31 January 2014, the Group had a 44.3 per cent. interest in the company.

Veryan's innovative biomimetic peripheral stents feature a three-dimensional helical shape, which closely mimics the natural geometry of the human vascular system and promotes natural swirling blood flow to elevate wall shear stress in the stented segment. Preclinical studies have shown this to significantly reduce the formation of neointimal hyperplasia, potentially conferring a patency-protective effect.

The helical curvature of the BioMimics 3D stent is also designed to help the stented vessel mimic the natural biomechanical performance of the femoropopliteal artery during knee flexion, thereby mitigating the risk of stent fracture and vessel kinking, which are common problems with traditional straight stents.

The Mimics study is a multicentre, randomised, controlled trial conducted at eight German investigational centres that compared the safety, efficacy and vascular hemodynamics of the BioMimics 3D stent to those of a best-in-class straight nitinol stent.

The full two-year data from Mimics will be presented by Principal Investigator Professor Thomas Zeller, Universitäts-Herzzentrum, Freiburg-Bad Krozingen, Germany.

Professor Zeller said:

"The final 24-month data for the BioMimics 3D stent confirm that the flow effects produced by its helical design are contributing to an improved outcome compared to that achieved with the straight control stents."

The results of this trial provide evidence for a patency-protective effect in patients treated with BioMimics 3D and a clear separation favouring BioMimics 3D over control stents in the two-year Kaplan Meier survival estimates for freedom from clinically driven target lesion revascularization (TLR) an important outcome marker of the need for re-intervention to treat restenosis in the vessel.

Chas Taylor, Chief Executive of Veryan, said:

"The results from this two year trial are the first independent evaluation of our biomimetic 3D helical stent technology and confirm our belief that this advanced stent design offers outstanding benefits in terms of improved hemodynamics and vascular compatibility. It is ideal for use in the hostile environment of the femoropopliteal artery, but also has potential for use in many other areas of endovascular intervention."

Russ Cummings, CEO of Imperial Innovations, said:

"These are very encouraging data that continue to show the BioMimics 3D stent in a positive light compared to other market-leading stent solutions and suggests a favourable and competitive foundation for commercialisation in the US and Europe.

"In the light of these results, we will revisit our strategic options for commercialising Veryan's novel 3D helical stents, which could range from completing strategic partnerships around the technology platform to building a further funding round with the aim of taking the product through pre-market approval PMA in the US."

Veryan has received CE Mark approval for the BioMimics 3D stent and plans to launch the stent in Europe later this year.

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Notes to editors

About Imperial Innovations - www.imperialinnovations.co.uk 

Imperial Innovations creates, builds and invests in pioneering technologies developed from the academic research of the UK's four leading Universities. The Group supports scientists and entrepreneurs in the commercialisation of their ideas and 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.

Originally formed as the Technology Transfer office for Imperial College - a role it still carries out today, Innovations also invests in opportunities arising from intellectual property developed at, or associated with, Cambridge University, Oxford University and University College London. These are the top four research intensive universities in Europe with a research income of over £1.3 billion per annum.

Innovations invests in the most promising opportunities from whichever technology sector they arise, but has built particular expertise in the key sectors of: therapeutics, medtech, engineering and materials, and ICT.

During the period from the admission of its shares to trading on AIM in 2006 to 31 January 2014, Innovations has invested a total of £160.9 million across its portfolio companies, which have raised collectively investment of over £750.0 million.

About Veryan Medical Ltd.

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 is a registered trademark of Veryan Medical Ltd.

CAUTION: The BioMimics 3D stent is not available for sale or investigational use in the United States.

For further information, please visit: www.veryanmed.com