Veryan’s BioMimics 3D Nitinol Stent With Helical Curvature Shows Improved Patency at 2-Year Follow-Up in Mimics Randomized Controlled Study

Las Vegas, 4th November 2014 – Two-year data from the Mimics study,
presented at today’s  Late-Breaking Clinical Trials session at the VIVA
Symposium, have confirmed that the BioMimics 3D stent provides a significant
improvement in long-term primary patency compared to a straight nitinol
control stent in patients undergoing femoropopliteal artery intervention.
A new 12-month landmark analysis presented today reinforces the longer
term benefit of Veryan’s helical stent technology and showed a
statistically significant improvement in the Kaplan Meier estimate of
survival from clinical-driven TLR through 24 months, compared to the
control stent (P<0.05).

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 nitinol stent has
unique helical centerline geometry to mimic natural vascular curvature
that promotes secondary (swirling) flow and elevated hemodynamic 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 in a straight stent that may lead to stent fracture and chronic
vascular injury.

The Mimics study is a prospective, randomized, multicenter controlled
trial conducted at eight German investigational centers and supported by
an independent core lab. A total of 76 patients were enrolled and
randomized 2:1 (50 BioMimics 3D vs 26 Control) in subjects undergoing
femoropopliteal artery intervention. Mimics’ investigators compared the
safety, efficacy and vascular hemodynamics of the BioMimics 3D stent to
straight nitinol stents (24/26 control subjects were treated with
LifeStent (CR Bard)).

Mimics data were presented during the VIVA session by Principal
Investigator Professor Thomas Zeller, Universitäts-Herzzentrum,
Freiburg-Bad Krozingen, Germany. 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.

An improvement of one or more Rutherford categories was observed in 87% of
BioMimics 3D patients at 24-months compared to baseline. A core lab review
of straight and flexed knee X-rays did not detect any stent fractures in
any BioMimics 3D Stent. Bi-planar X-ray imaging data indicate the ability
of the femoropopliteal artery to adopt the three-dimensional curvature of
the BioMimics 3D stent and computational fluid dynamic modelling provided
evidence of secondary (swirling) flow within the stented segment and
predicted zones of elevated wall shear stress.

Mimics Study data indicate a correlation between primary patency and stent
curvature. BioMimics 3D stented segments showed significantly greater
curvature (P= 0.02) compared with the control, providing swirling blood
flow and elevated wall shear, which may explain the longer term patency
protective effect seen with BioMimics 3D. Across all patients, stent
curvature was greater for BioMimics 3D stents compared to the straight
control stents and no loss of patency was observed in patients with mean
straight leg stent curvature above 0.02 mm-1.

“These data suggest the existence of a patency protective effect provided
by the biomimetic characteristics of the BioMimics 3D nitinol stent
resulting in hemodynamic and biomechanical performance advantages over
straight nitinol stents”, commented Professor Zeller.

“We are very grateful to Professor Zeller and the Mimics’ Investigators
for enabling Veryan to complete this benchmark evaluation of the unique
BioMimics 3D helical stent technology. We believe this advanced stent
design offers outstanding benefits in femoropopliteal use and has
potential for innovation in many other areas of endovascular intervention.
Presentation of the full two-year Mimics’ results represents a major step
forward in this endeavour”, added Veryan Chief Executive Chas Taylor.

Veryan has received CE Mark approval for the BioMimics 3D stent and is
planning commercialization through an international distributor starting
in the first quarter of 2015.