PR84740

TIANJIN, China, July 13, 2020 /PRNewswire=KYODO JBN/--

SINOMED, a developer of innovative neuro- and cardiovascular technologies,

announced the completion of the 1-year follow-up in the PIONEER-III, randomized

global trial evaluating the BuMA Supreme Drug-Eluting Coronary Stent (DES).

Once completed, the company plans to submit the data to the U.S. Food and Drug

Administration and Japanese Pharmaceuticals and Medical Devices Agency for the

device approval.  

"Despite the problems of managing the COVID pandemic, everyone involved in the

study has made a tremendous effort to finish the necessary clinical follow-up,"

said Martin B. Leon, MD, Columbia University Medical Center, USA, and Chairman

of the Executive Committee of the PIONEER III study. "We can now focus on

analyzing the data and planning the presentation and publication of the

findings in the second half of 2020. The completion of this study could help

lead SINOMED to become the first Chinese company to gain FDA approval of a

drug-eluting stent."

The PIONEER III trial completed follow-up of 1,631 patients at 74 sites in

North America, Europe and Japan. Patients presenting with symptomatic heart

disease were randomized 2:1 to receive the BuMA Supreme DES or any commercially

available durable polymer everolimus-eluting stent. The clinical trial's

endpoint is target lesion failure (TLF) at twelve months and patients will be

followed-up for five years post study enrollment. Additionally, the trial is

powered for a long-term landmark analysis of TLF between one and five years;

looking for superiority of the BuMA Supreme over the control arm.

The BuMA Supreme is a new evolution of DES, developed to maximize functional

healing of the blood vessels after a stent implantation. Its innovative design

utilizes a combination of a novel drug release kinetic and proprietary coating

technology to allow for a quicker return of natural cellular functionality, in

comparison to other commercially available DES. This healthy restoration is

believed to contribute to better long-term clinical outcomes.

The BuMA Supreme with a new cobalt chromium platform and delivery system is CE

approved and available for distribution in select regions. BuMA Supreme is an

investigational device in the United States and Japan.

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.

For more information, visit: www.sinomed.com

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Contact:

SINOMED B.V

Cindy Zheng

Wilhelminakade 173

3072AP Rotterdam

The Netherlands

T: +31-10-307-6295

E: cindy.zheng@sinomed.com  

SOURCE: SINOMED