OrbusNeich Announces Enrollment of First Patient in China Recovery Study

Hong Kong (ots/PRNewswire) -

Study to enroll 436 patients at up to 20 sites throughout China

OrbusNeich, a global company specializing in the provision of
life-changing vascular solutions, has announced that the first
patient has been enrolled in the clinical study in China of its
COMBO(TM) Dual Therapy Stent. The China Recovery Study is designed to
evaluate the COMBO Dual Therapy Stent compared to the Nano stent
(Lepu Medical Technology Co, Ltd). The first patient was enrolled by
Dr Yuan Ming at The First Affiliated Hospital of the Fourth Military
Medical University in May 2015.

The study, a multi-center, prospective, non-inferiority,
randomized controlled trial, will enroll 436 patients at up to 20
leading hospitals throughout China. "We are pleased to announce the
enrollment and treatment procedure of the first patient with the
COMBO stent and anticipate further enrollment to continue over the
coming months," said Steve Rowland, Vice President Research &
Development, OrbusNeich. "This trial will deliver significant data
that will provide physicians with valuable knowledge to make the best
treatment decisions for their patients in China and beyond."

The study will enroll patients with de novo stenotic lesions in
native coronary arteries. Patients will be randomized 1:1 to the
COMBO Dual Therapy Stent or the Nano stent, with follow up at 30
days, 6 months, 12 months and annually for up to 5 years.
Additionally, Angiographic follow-up will be performed for all
subjects at 9 months post-procedure. The principal investigator is
Professor Tao Ling from the First Affiliated Hospital of the Fourth
Military Medical University, Xian, China.

WHO figures estimate that one in five adults in China has a
cardiovascular disease with numbers predicted to increase
significantly in the coming years based on projected increased
incidence of high blood pressure, diabetes, smoking and high
cholesterol levels.
http://www.wpro.who.int/china/mediacentre/factsheets/cvd/en

Editor's notes

About the study

Primary endpoint: In-segment late lumen loss (LLL) at 9 months
post-procedure

Secondary endpoints include:

- Device, lesion and clinical success rates;
- The device-oriented target lesion failure (TLF) defined as a composite of cardiac
death, target vessel myocardial infarction (MI), and ischemia-driven target lesion
revascularization (i-TLR) at 30 days, 6 months, 12 months and annually up to 5 years
follow-up;
- The patient-oriented composite endpoint, which includes all-cause death, all MIs, or
any revascularization at 30 days, 6 months, 12 months and annually up to 5 years
follow-up;
- In-stent LLL at 9 months post-procedure;
- In-stent and In-segment binary restenosis (BR) rates at 9 months post-procedure;
- In-stent and In-segment minimal lumen diameter (MLD) at 9 months post-procedure;
- Definite and probable stent thrombosis (ST) in acute, sub-acute, late and very late
period per Academic Research Consortium (ARC) definition criteria;

About COMBO Dual Therapy Stent - Repair, Regenerate, Naturally

COMBO is the world's first and only dual therapy stent designed to
repair vessel injury and regenerate endothelium, fostering natural,
true vessel healing. It does this by accelerating endothelial
coverage and controlling neo-intimal proliferation. This is done
through a combination of the proven EPC capturing technology and a
sirolimus drug elution, delivered from a bioresorbable polymer that
is completely degraded within 90 days.

OrbusNeich's patented endothelial progenitor cell (EPC) capture
technology promotes the accelerated natural healing of the vessel
wall after the implantation of blood-contact devices such as stents.
The technology consists of an antibody surface coating that captures
EPCs circulating in the blood to the device to form an endothelial
layer that provides protection against thrombosis and modulates
restenosis.

About OrbusNeich - Pioneers in life-changing technologies

OrbusNeich is a global pioneer in the provision of life-changing
vascular solutions and offers an extensive portfolio of products that
set industry benchmarks in vascular intervention. Current products
are the world's first dual therapy stent, the COMBO Dual Therapy
Stent, and the world's first pro-healing stent, the Genous(TM) Stent.
Other products include stents and balloons marketed under the names
of Azule(TM), R Stent(TM), Scoreflex(TM), Sapphire(TM) II,
Sapphire(TM) II Pro and Sapphire(TM) II NC. OrbusNeich is
headquartered in Hong Kong and has operations in Shenzhen, China;
Fort Lauderdale, Florida, USA.; Hoevelaken, The Netherlands; and
Tokyo, Japan. OrbusNeich supplies medical devices to interventional
cardiologists in more than 60 countries. For more information, visit
http://www.OrbusNeich.com.

Learn more about our life-changing technologies on our social
media channels:

Twitter: http://www.twitter.com/OrbusNeich

LinkedIn: http://www.linkedin.com/company/orbusneich-medical

YouTube: http://www.youtube.com/user/OrbusNeichMedia

ots Originaltext: OrbusNeich
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Contact:
Global Media Contacts: Christine Lydon, +44-20-7395-7145
christine.lydon@fleishmaneurope.com
Iva Ng
OrbusNeich, +852-3109-7268, ing@orbusneich.com