(Yicai) Aug. 7 -- Shares of Sino Medical Sciences Technology surged by their daily trading limit after the Chinese company said the US Food and Drug Administration granted Breakthrough Device Designation to two of its medical devices, including the world's first stent system for the treatment of intracranial atherosclerotic stenosis, bringing hopes to millions of patients recovering from a stroke worldwide.

SinoMed [SHA: 688108] closed 20 percent higher at CNY17.03 (USD2.37) a share today, reaching a new high since November 2020. The Shanghai Stock Exchange Star 50 Index fell 0.2 percent.

SinoMed's COMETIU self-expanding intracranial drug-coated stent system and COMEX balloon microcatheter got the Breakthrough Device Designation on Aug. 4, the Tianjin-based company announced yesterday.

COMETIU is for patients with intracranial atherosclerosis, with over 70 percent of those with intracranial vascular stenosis not curable by drugs, SinoMed said, noting that the device expands the lumen diameter of patients' intracranial blood vessels to improve cerebral ischemia and can shorten the time needed for surgeries, reducing corresponding risks.

Breakthrough Device Designation is the FDA's 'green channel' to speed up innovative medical device development and review processes. The agency offers preferential services, including review priority for product development and clinical trials, reviewer support, and product-launching assistance.

Devices with a Breakthrough Device Designation must be original, currently no approved products of similar efficacy or alternative solutions, or they should have prominent advantages in clinical uses compared with the existing ones. 

Securing the designation will strongly facilitate SinoMed's positioning of its innovative neurological intervention products worldwide, the company said, adding that it will also significantly improve its global brand recognition and image.

SinoMed has made significant progress in innovative new products development recently, just before the Breakthrough Device Designation, the company’s HT Supreme™ Drug Coated Coronary Stent System received the FDA's conditional approval on July 25, becoming China's first domestically developed coronary stent product got such approval.

Editor: Martin Kadiev