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Shares of Sino Medical Sciences Technology took a sharp decline following regulatory rejection of their new stent system designed for treating intracranial atherosclerotic stenosis. The company’s stock fell 17.2%, reaching CNY20.86 (approximately USD2.94) per share around 1:15 p.m. in Shanghai today. This followed a 9.4% drop yesterday prior to the news.
The company’s subsidiary, Sinomed Neurovita Technology, was informed by the National Medical Products Administration that their application for the COMETIU self-expanding intracranial drug-coated stent system did not receive approval, according to the parent company based in Tianjin.
COMETIU is renowned as the world’s first innovative device aimed at treating intracranial atherosclerotic disease. It works by enlarging the diameter of blood vessels in the brain to enhance blood flow and potentially improve cerebral ischemia. The device also aims to shorten surgical procedures and lower associated risks, according to the company.
Despite the setback, SinoMed plans to continue discussions with the NMPA’s Center for Medical Device Evaluation to proceed with the registration process for COMETIU in China. The company has not disclosed the specific reasons behind the initial rejection but intends to push forward with efforts to commercialize the product globally.
Additionally, the U.S. Food and Drug Administration designated COMETIU as a Breakthrough Device on August 4, allowing the device to undergo pivotal clinical trials and be initially marketed through the FDA’s premarket approval pathway, SinoMed noted.
The company has scheduled an investor conference via the Shanghai Stock Exchange’s online platform at 3:30 p.m. tomorrow. Key executives, including the Chairman and General Manager, will address questions regarding the rejection of the stent system.
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