OrbusNeich® Announces Japan Approval for COMBO® Plus Coronary Stent

Hong Kong (ots/PRNewswire) - OrbusNeich Medical K.K. of Tokyo
Japan has announced that the Japan Ministry of Health, Labour, and
Welfare (MHLW) has granted Shonin market approval for the COMBO Plus
Coronary Stent. The COMBO Plus Coronary Stent is the first
drug-eluting stent [DES] to combine the proprietary endothelial
progenitor cell [EPC] capture technology with an abluminal sirolimus
drug elution delivered from a biodegradable matrix polymer that
achieves full and complete dissipation by 90 days. OrbusNeich's
patented immobilized antibody promotes the capture of EPCs
circulating in the blood to the device surface. EPCs have been shown
to promote the formation of a functional endothelial layer that
provides protection against thrombosis and modulates restenosis.

The pivotal randomized, multi-center HARMONEE (Harmonized
Assessment by Randomized, Multi-center Study of OrbusNEich's COMBO
StEnt) [NCT02073565] was conducted as a global clinical
"proof-of-concept" project under the joint Japan PMDA-US FDA
Harmonization by Doing initiative and the study provided the pivotal
clinical data used to support the Shonin approval. A total of 572
patients were enrolled at 50 sites in Japan and the U.S. to support
the company's application for Shonin approval in Japan and to meet
the Pilot trial requirements in the U.S. Patients presenting with
ischemic coronary disease and non-ST segment myocardial infarction
(NSTEMI) were randomized one-to-one to treatment with a COMBO Plus
Stent or an everolimus-eluting stent (EES) comparator. The study's
primary endpoint was met in a comparison of clinically driven target
vessel failure (TVF), defined as cardiac death, target vessel
myocardial infarction (MI) or ischemia- driven target vessel
revascularization (TVR) by percutaneous or surgical methods. The
COMBO Plus stent was found to be non-inferior in 1-year TVF compared
to the EES comparator. Additionally, the COMBO Plus stent was found
to have superior healthy stent strut coverage compared to the EES
control as determined by an independent OCT Core Laboratory analysis
of serial optical coherence tomography [OCT] imaging at 6- and
12-months. (European Heart Journal 2018; 39:2460-2468)

Dr Mitchell Krucoff, Duke University Medical Center, Durham, N.C,
USA, and the Global Co-Principal Investigator for the HARMONEE trial,
stated "The OrbusNeich Combo DES with endoluminal biologic
endothelial progenitor cell capture technology has just become the
first coronary device approved for clinical use in Japan based on the
HARMONEE study which enrolled both Japanese and US human subjects in
a single prospective randomized trial protocol. Not only is this a
huge success for the COMBO DES, but it is also a first-in-kind proof
of concept for the Japan-USA Harmonization By Doing program (HBD)."

The COMBO Plus stent is designed to address the risk of stent
thrombosis associated with delayed healing found with conventional
DES. The unique dual therapy stent design combines anti-restenotic
effectiveness by abluminal sirolimus elution from a bioresorbable
polymer matrix with pro-healing antibody surface coating for enhanced
EPC capture from the circulating blood, resulting in more complete
healing and endothelial functionality. The COMBO Plus stent clinical
program now has over 9,500+ subjects included in clinical trials with
the COMBO stent. The CE-marked COMBO Plus Dual Therapy stent has
claims based upon clinical results from this extensive clinical
program, including indications to allow for flexibility in
dual-antiplatelet therapy [DAPT] if needed, with a recommended
minimum one-month DAPT in stable patients and three-months DAPT in
acute coronary syndrome [ACS] patients.

"The market approval of the COMBO Plus Coronary Stent in Japan is
a tremendous achievement for the entire OrbusNeich organization" said
David Chien, OrbusNeich Medical President and CEO. "A
well-coordinated global effort was required to obtain the Japan
market approval of a unique product such as the COMBO Plus Coronary
Stent. We expect this approval to allow OrbusNeich build on our
strong market position in the Japan percutaneous interventional
market."

About the COMBO Plus Coronary Stent

The COMBO Plus Coronary Stent is the first stent to combine a
proprietary endothelial progenitor cell [EPC] capture technology on
the luminal stent surface with an abluminal sirolimus drug elution
delivered from a biodegradable matrix polymer that is completely
dissipated within 90 days. OrbusNeich's patented EPC capture
technology consists of an immobilized antibody surface coating that
captures EPCs circulating in the blood to the device surface.

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 COMBO PLUS Coronary Stent, together with stents and balloons
marketed under the names of AZULE®, SCOREFLEX®, SCOREFLEX® NC,
SAPPHIRE® II, SAPPHIRE® II PRO and SAPPHIRE® II NC, and the TELEPORT®
microcatheter, as well as products to treat peripheral artery
disease: the JADE® and SCOREFLEX® PTA balloons. 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 physicians in
more than 60 countries. For more information, visit
www.OrbusNeich.com

ots Originaltext: OrbusNeich
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Contact:
Alain Khair +31332541150

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