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Shares of a Chinese medical technology company soared to their maximum daily trading limit after announcing that the U.S. Food and Drug Administration had granted Breakthrough Device Designation to two of its medical devices. Among these is the world’s first stent system designed specifically for treating intracranial atherosclerotic stenosis, offering renewed hope to millions worldwide who are recovering from strokes.
The company’s stock closed the day 20% higher at 17.03 yuan (approximately $2.37), marking a new high since November 2020. Meanwhile, the Shanghai Stock Exchange Star 50 Index dipped slightly by 0.2%.
The two devices to receive the designation are the COMETIU self-expanding intracranial drug-coated stent system and the COMEX balloon microcatheter, which were announced as awarded on August 4. Headquartered in Tianjin, the company explained that the COMETIU system is designed for patients with intracranial atherosclerosis, a condition where more than 70% of patients with intracranial vascular narrowing cannot be effectively treated with medication alone. The device works by expanding the blood vessel lumen to enhance cerebral blood flow, potentially reducing the duration and risks associated with surgical procedures.
The Breakthrough Device Program is the FDA’s expedited pathway intended to accelerate the development and review of innovative medical technologies. It provides benefits such as priority review for clinical trials and product development, dedicated reviewer support, and assistance with launching new products.
To qualify for this designation, a device must represent an original advancement with no similar existing products or alternatives, or it must demonstrate significant clinical advantages over current solutions.
Gaining this recognition is expected to enhance the company’s global strategic positioning for its neurological intervention products, boosting its international brand recognition and reputation. Just prior to receiving the designation, the company achieved a major milestone with its HT Supreme™ Drug-Coated Coronary Stent System, which received FDA conditional approval on July 25. This marks the first domestically developed coronary stent from China to attain such an approval.
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