PR86604

TIANJIN, China Nov. 17, 2020 /PRNewswire=KYODO JBN/--

SINOMED(R) today announced that Prof. Alexandra Lansky from the Yale School of

Medicine, USA, presented data from its first inter-continental PIONEER III

study comparing the safety and efficacy of the Supreme HT (Healing-Targeted)

Drug-Eluting Stent, to the Xience or Promus Durable Polymer Drug-Eluting Stent

(DP DES).  One-year results, revealed at the 2020 American Heart Association

Scientific Late-Breaking Trials Session, showed equivalent clinical performance

of the Supreme HT to the market-leading DES and will be used to support U.S.

Food and Drug Administration and Japanese regulatory approvals.

The PIONEER III study enrolled 1,629 patients (randomized 2:1 experimental to

control) from North America, Europe and Japan and had a primary composite

endpoint of target lesion failure (TLF) at one-year.  The TLF outcomes showed

that the Supreme HT met the non-inferiority endpoint at 5.4% compared to 5.1%

from the DP DES (p=0.002). A grouped analysis of secondary endpoints showed a

numerically better result for Supreme HT in cardiac death or target-vessel

myocardial infarction (TV MI) with 3.5% in the Supreme HT arm compared to 4.6%

in the control arm (p=0.27).  Lower late stent thrombosis data (Supreme HT 0.1%

compared to DP DES 0.4%, p=0.22) also suggested exceptional safety for the HT

DES.  A powered, landmark TLF analysis evaluating the healing superiority of

Supreme HT between 1 and 5 years is ongoing.

"I am very pleased that Japanese patients will benefit from the most advanced

DES in the US, Europe and Japan," said Shigeru Saito, MD, Shonan Kamakura

General, Japan and primary investigator of the Japanese cohort of the PIONEER

III study . "The results combined with the safety measurement of cardiac death,

target vessel MI and late stent thrombosis favor the Supreme HT, supporting the

early endothelial healing concept."

Contemporary DES have emphasized delay healing through prolonged drug delivery

to suppress the body's response to injury, hypersensitivity, or progression of

disease.  The Supreme HT development was based on the "wound-healing window"

concept originally proposed in 2013 and represents a novel class of DES that

highlight the importance of early, timely healing.  Through patented designs

and proprietary processes, the Supreme HT was tailored to help patients

accelerate their wound-healing process and restore their natural endothelial

function.  This healing-targeted mechanism may help overcome the long-standing

problem of tradition-DES implantation, allowing for safer long-term results.

"We are very grateful to the extraordinary group of medical professionals and

all the patients who have endured through this difficult pandemic and completed

this study milestone in such a timely and professional manor," said Jianhua

Sun, PhD., Chairman & Chief Executive Officer of SINOMED.  "The results have

been extremely encouraging and if we reach superiority in the landmark

analysis, we could revolutionize the understanding of healing and the future of

implantable devices,"

More information on the PIONEER III study is available at

www.clinicaltrials.gov, identifier: NCT03168776.

About SINOMED

Sino Medical Science Technology Inc. (SINOMED), a global medical device company

engaged in research, development, production, and commercial distribution of

interventional devices. We are focused on developing breakthrough technologies

to target unmet clinical needs in the interventional treatment of coronary,

neurovascular and structural heart disease. Our mission is to expose more

patients to the benefits of our medical innovations, increasing patient

longevity and quality of life.

For more information, visit: www.sinomed.com

SINOMED B.V

Cindy Zheng

T:  +31-10-307-6295

E:  cindy.zheng@sinomed.com

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Source: SINOMED