IBS Angel™ Iron-Based Bioresorbable Stent System Completes First U.S. Implant Under FDA Compassionate Use

Shenzhen, March 28, 2022 /PRNewswire/ -- On March 24, 2022, U.S. time, the innovative product independently developed by Biotyx Medical (Shenzhen) Co., Ltd., a subsidiary of Lifetech Scientific (01302.HK),Iron-Based Bioabsorbable Stent System("IBS Angel™")At the Children's Hospital of Wisconsin in West Allis, USASuccessfully completed its first implant in the United States. The product passed the United StatesFDA "Compassionate Use"(Compassionate Use) Approval: The second product under Lifetech Scientific's iron-based bioabsorbable materials platform to achieve successful implantation in the United States.

The patient who received the IBS Angel™ implant was only 7 months old and suffered from Tetralogy of Fallot, having previously undergone surgical repair. The infant recently developed right ventricular outflow tract obstruction, necessitating timely surgical intervention. Given the patient's medical history and age, another open-heart surgery would cause significant surgical trauma and pose extremely high risks. Therefore, stent implantation was considered the most suitable treatment option for this child. However, there is currently no dedicated stent specifically designed for the right ventricular outflow tract available in the North American market. Additionally, for very young patients, permanent stent implantation could restrict normal growth of the right ventricle and increase the complexity of potential future surgical interventions.

IBS Angel™ is a bioresorbable stent specifically designed and developed for pediatric pulmonary vessels, used to improve the luminal diameter of pulmonary vessels in children who require stent treatment.World's FirstFully degradable pulmonary vascular stent made from iron-based materials.The mechanical properties and clinical handling performance of IBS Angel™ are comparable to mainstream cobalt-chromium alloy permanent stents on the market, with stent diameters covering the full range of pulmonary vessel diameters. The stent is made from high-strength and highly ductile high-purity nitrided iron tubing, featuring a thin strut wall yet strong radial force, and is compatible with a minimum 4F sheath.（Inner diameter approximately 1.35 millimeters）, which can easily access the tiny blood vessels of newborns and infants. After implantation, IBS Angel™ can provide effective support to the blood vessels during the vascular remodeling period, preventing vascular elastic recoil. Subsequently, the stent begins to gradually degrade and be absorbed, relieving radial constraint on the blood vessels without affecting their normal growth, thus offering an ideal disease solution for newborns and young pediatric patients.

After fully understanding and evaluating the clinical advantages of IBS Angel™ for pediatric patients, the attending physician applied to the U.S. FDA for"Compassionate Use"(Compassionate Use), and was officially approved on March 11, 2022.Setting off immediately, crossing mountains and seas. The iron-based bioresorbable scaffold, representing a breakthrough in the current field, has brought hope to young American patients in the shortest possible time.

AsThe Only One in the WorldIBS Angel™, an Iron-Based Bioresorbable Scaffold for Children, Receives U.S. FDA Approval"Compassionate Use"(Compassionate Use) and successful implantation were achieved, demonstrating the full recognition by clinical experts in the North American core market of the innovative product's technical advantages.""Medicine knows no borders," China's innovative medical technology once again brings positive significance to addressing clinical gaps.Currently, the IBS Angel™ has obtained registration in Malaysia, and both the EU CE registration and clinical trial enrollment in China are proceeding steadily. It is expected to become the first commercially available iron-based bioresorbable scaffold in the EU and China, offering a groundbreaking new treatment option for a wide range of patients.

About Lifetech Scientific:

Lifetech Scientific  (01302.HK) It is a leading enterprise in the field of minimally invasive interventional medical devices for cardiovascular, cerebrovascular, and peripheral vascular diseases. Established in Shenzhen, China in 1999, it is a national high-tech enterprise. The company’s products under development and on sale cover areas such as structural heart disease, peripheral vascular disease, cardiac rhythm management, oncology, and respiratory diseases. It also owns the world's first iron-based bioabsorbable material platform, achieving independent technological breakthroughs in multiple niche fields. A total of 14 products have been approved for entry into China’s "Special Review Procedure for Innovative Medical Devices." Currently, the company's sales network covers more than 100 countries and regions worldwide, making it one of the few highly internationalized Class III interventional medical device enterprises in China.