LIFETECH SCI(01302): The ICS Elpis Absorbable Peripheral Balloon-Expandable Covered Stent System Enters the Innovative Medical Management Device Special Review Program
LIFETECH SCI (01302) announced that on October 19, 2026, the Company received official written notification from the National Medical Products Administration confirming that the ICS Elpis Absorbable Peripheral Balloon-Expandable Covered Stent System, independently developed by the Company's subsidiary Yuanxin Technology (Shenzhen) Co., Ltd., has entered the National Medical Products Administration's Special Review Program for Innovative Medical Devices. The product is indicated for the treatment of atherosclerotic stenosis or occlusive lesions of the common iliac artery and external iliac artery, and is the Company's twentieth product to enter this program of the National Medical Products Administration.
LIFETECH SCI (01302) announced that on October 19, 2026, the Company received an official written notice from the National Medical Products Administration confirming that the ICS Elpis Absorbable Peripheral Balloon-Expandable Covered Stent System, independently developed by the Company's subsidiary Yuanxin Technology (Shenzhen) Co., Ltd., has entered the National Medical Products Administration's Innovative Medical Management Device Special Review Program. The product is indicated for the treatment of atherosclerotic stenosis or occlusive lesions of the common iliac artery and external iliac artery, and is the Company's twentieth product to enter this program of the National Medical Products Administration.
ICS ElpisTM has completed all clinical enrollment for its first-in-human (FIM) trial. Study results showed that both the device success rate and the procedure success rate reached 100%, with vessels remaining patent post-operatively and during follow-up, preliminarily validating the safety and efficacy of the product.
The Group owns the independent intellectual property rights to this product. Currently, the product has obtained clinical trial approval from the National Medical Products Administration and is about to commence a randomized controlled clinical trial. As subsequent clinical trials progress steadily, more high-quality evidence-based medical data will further confirm the safety and efficacy of the product.
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