Date: 08-Jul-2020

Sinomed Completes Enrollment In PIONEER-III Pivotal US & Japanese Trial Of The BuMA Supreme Coronary DES

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 US 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. “With the completion of follow-up, 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 for 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 trials 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 DES over the control arm.

BuMA Supreme is Sinomed's second-generation DES with eG Coating, biodegradable polymer and sirolimus drug. The therapeutic coating has been formulated for a targeted drug-release that allows the vessel to regain its natural healing ability sooner than other DES. After two months, the biodegradable polymer is completely absorbed leaving an inert environment for better healing to occur.

The BuMA Supreme stent is CE approved and available for distribution in select regions. BuMA Supreme is an investigation device in the United States and Japan.