Imperial Innovations Group plc has announced that portfolio company Veryan, a vascular disease specialist, has received CE Mark approval for the BioMimics 3D™ Stent.
Its unique design mimics the natural helical geometry of the human vascular system, improving blood flow and reducing kinking and deformation of the stent during movement of the leg, to protect the vessel from damage.
CE Mark approval follows on from meeting the primary endpoints of the MIMICS study, a prospective randomized controlled trial comparing the safety and efficacy of the BioMimics 3D stent with a standard nitinol stent.
Follow up assessments of patients involved in the trial have already demonstrated an excellent safety profile and clinical performance at both 6 and 12 months, and will continue for two years.
Prevalence of PAD is increasing due to an aging population with a rising incidence of risk factors such as diabetes and obesity.
The multibillion pound global PAD market represents a major opportunity for innovative products enabling minimally invasive endovascular intervention.
Veryan is planning to commercialize the BioMimics 3D stent system both in Europe and other global markets where CE Mark approval may expedite the registration process.
Veryan completed a £5 million funding round in October 2011, co-led by Innovations and Seroba Kernal Life Sciences, to progress the company towards a clinical study in the USA to achieve FDA approval. To date, Innovations has invested £9.1 million and has a 46.8% stake in the business.
Susan Searle, Chief Executive Officer, Imperial Innovations, said: “We are delighted that Veryan, one of our leading assets, has achieved this key milestone in the development of its technology. The results of the MIMICS trial are promising and the CE Mark is an important step towards commercialization for Veryan.”
Chas Taylor, Chief Executive Officer of Veryan, said: “CE Mark is an important milestone for Veryan. In conjunction with the encouraging data from the MIMICS study recently presented at the prestigious VIVA conference in Las Vegas, we are greatly encouraged that the unique geometry of the BioMimics 3D stent will be highly competitive against conventional straight nitinol stents. We believe the ability to take this differentiated platform technology to market may contribute significantly to fulfilling the need for more durable clinical outcomes in patients with PAD undergoing endovascular intervention.”