3D stent developer, Veryan Medical, has received a cash injection that might see its biomimetic 3D vascular stent over the regulatory line.
Veryan Medical (Horsham, UK) has received additional £13.5m funding in the form of both equity from its existing investors, and debt provided by Silicon Valley Bank in the form of a €5m capital term loan.
A frequent visitor to our pages, Veryan’s BioMimics 3D stent features unique three-dimensional helical geometry which promotes secondary (swirling) flow, which in turn leads to elevated wall shear stress. This so-called biomimetic curvature of the vessel has a protective effect on the endothelium and has the additional feature of shortening during knee flexion, which mitigates the risk of stented segment compression causing localised strains that in a straight stent may lead to stent fracture and chronic vascular injury.
The new funding follows the achievement of several significant milestones in 2016, including: the completion of enrolment into the MIMICS-2 IDE study in the US, Germany and Japan; the publication of the results from the Mimics Randomised Controlled Trial in Circulation: Cardiovascular Interventions; the first 50 subjects enrolled into the MIMICS-3D Registry; and continued strong commercial adoption in European markets.
In the Mimics trial, the Kaplan Meier (KM) survival estimate of freedom from loss of primary patency at two years was 72% for BioMimics 3D subjects vs. 55.0% for the control arm. The difference in survival estimate between the two groups by log rank test was significant (P<0.05). Importantly, there was no increase in the KM estimate of clinically driven target lesion revascularization (CDTLR) rate in the BioMimics arm between 12 and 24 months (9% at both time-points) compared to a 3-fold increase (8% at 12 months and 24% at 24 months) in the straight stent control arm.
Veryan Medical’s CEO Chas Taylor said: “This funding round is reflective of growing excitement in BioMimics 3D and the benefits of swirling flow. Veryan is developing an important clinical dataset of approximately one thousand patients in both primary stenting and bail-out procedures in conjunction with drug coated balloons. This investment will allow the Company to continue its progress towards US and Japanese regulatory approvals.”
Source: Veryan Medical Ltd.