On December 16th, the National Medical Products Administration's Device Review Center released the results of the special review application for innovative medical devices (No. 11 of 2024), intending to approve 5 innovative medical device projects to enter the special review process.

1. Hot steam ablation system: Shanghai Lixiao Medical Technology Co., Ltd
Lixiao Medical was founded in January 2019 by Dr. Cheng Lifei, Global Vice President of Business Development at Medtronic. It is an innovative medical technology platform that focuses on the introduction of advanced medical technologies from overseas, local research and development, and industrialization. It specializes in the research and development of medical devices for the treatment of chronic diseases such as cardiovascular, urinary, and respiratory diseases. As of now, Lixiao Medical has completed two rounds of financing of nearly one billion US dollars, led by well-known investment institutions such as Eli Lilly Asia, Sequoia Capital, and WuXi AppTec.

At present, Lixiao Medical's technology platform covers cutting-edge directions in multiple medical technology fields, including high-precision catheter intervention, neural regulation, next-generation energy ablation, etc. Its technology platform closely aligns with clinical needs and academic development, contributing its own research and development strength to the progress of medical technology in China, and targeting the gap between domestic and foreign advanced technologies, striving to seek breakthroughs in domestic technology, in order to enable domestic patients to use world-class medical technology as soon as possible.

2. Absorbent polymer tissue sealer: Bao'aikang Co., Ltd
Ethicon is a subsidiary of Johnson&Johnson that focuses on developing innovative laparoscopic and minimally invasive surgical products, including cardiovascular surgery, general surgery, breast surgery, plastic surgery, spinal surgery, wound closure surgery, and ligation. LoveKang's suture products also have a high market share globally, rising from 15% to over 70% since World War II. In the US market, their market share exceeds 80%, making them the world's most comprehensive suture manufacturer in terms of variety.

Cherish Kang has made significant contributions to surgical procedures over the course of more than 100 years, from creating the first batch of sutures to revolutionizing surgery with minimally invasive techniques. At present, Aicaikang has launched Puliling ® Polypropylene suture, Vicho ® Suture, Pudisi ® Absorbable suture, single Qiao ® Absorbable sutures, multiple application sticks ® Multiple medical suture related products such as skin adhesives.

On May 29, 2024, iCon announced the launch of its first linear surgical stapler, Echelon, in the United States. This product is the first linear surgical stapler that combines 3D binding technology and surface clamping technology (GST), aiming to improve safety, reduce surgical risks, and enhance treatment outcomes.

Moreover, Johnson&Johnson has made plans for brands such as iQikang this year. On September 10th, Johnson&Johnson announced that Ethicon, DePuy Synthes, Biosense Webster, Abiomed, and Cerenovus brands under the Future Group will all operate under the name Johnson&Johnson MedTech, with iCon being one of them. This strategic initiative is another important milestone after Johnson&Johnson announced its overall brand renewal in September 2023, which will further demonstrate Johnson&Johnson's leadership position in medical technology products such as cardiovascular, orthopedic, surgical, and eye health.

3. Interventional pulmonary valve and delivery system: Beijing Bairen Medical Technology Co., Ltd
Bairen Medical was founded in 2005 and successfully listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange in December 2019. It is a high-tech enterprise dedicated to the research and production of high-value medical devices for animal derived plant-based interventions. Our products cover three major fields: heart valve replacement and repair, interventional treatment for congenital heart disease, and surgical soft tissue repair.

The SalusTM interventional pulmonary valve and delivery system, developed by the team of Professor Su Junwu from Bairen Medical and Anzhen Hospital after years of cooperation, adopts a self expanding stent design and valve leaflets made of bovine pericardium. It is processed using mature surgical bovine pericardium valve manufacturing and processing techniques, achieving effective anti calcification and excellent blood flow, comprehensively improving the durability of the valve. It is the first innovative device for thoracic interventional pulmonary valve to enter clinical trials in China.

The intervention of pulmonary valve and delivery system is mainly aimed at patients who have undergone right ventricular outflow tract repair and reconstruction in the early years, especially those who have survived after surgery for Tetralogy of Fallot. The vast majority of them suffer from right heart failure due to a large amount of tricuspid regurgitation caused by pulmonary valve loss, and require thoracotomy of the main pulmonary artery and catheterization of the product to reconstruct the artificial pulmonary valve again.

4. Drug eluting peripheral arterial stent system: Beijing Xinlitai Medical Equipment Co., Ltd
Xinlitai Medical was established in 2009, focusing on the research and development, production, and sales of high-end interventional medical devices. Its product pipeline covers key areas of interventional therapy such as cardiovascular and cerebrovascular diseases, peripheral blood vessels, structural heart disease, electrophysiology, and cardiac rhythm management. It is committed to becoming a leading global platform enterprise for innovative cardiovascular and cerebrovascular devices.

Among the various products of Xinlitai Medical, the particularly outstanding one is its Maurora rapamycin drug-eluting vertebral artery stent. This product was approved for sale in China on July 17, 2020. It is a ball expanding cobalt chromium alloy rapamycin drug-eluting stent suitable for the dilation of symptomatic extracranial stenosis of the vertebral artery. It is reported that this product has been admitted to nearly 700 hospitals between 2021 and 2022, and its cumulative sales revenue has exceeded 100 million yuan since its launch. It is one of the products with good single product sales in the field of neural intervention, supporting the revenue banner of Xinlitai Medical.

In addition to the drug-eluting peripheral arterial stent system that has entered the special review process, Xinlitai Medical also has products under development such as the rapamycin drug-eluting coronary balloon catheter, rapamycin drug-eluting peripheral balloon catheter, vena cava filter system, and iliac vein stent system.

5. Biological bone hollow screw: Jiangxi Silk Biotechnology Co., Ltd
Founded in 2016, Silk Biotechnology has a research and development center located in Shanghai. The company currently has a production scale of 2500 square meters, including a 400 square meter GMP factory and an 800 square meter research and development area. It has established an intellectual property patent system around silk protein biomedical materials, including silk protein material technology, bone fixation products and instruments, dental inlay materials, and plastic surgery prosthetic materials.

In terms of silk fibroin hard materials, Silk Biotechnology has currently developed two products: large-sized bone nails for orthopedics and silk fibroin plastic materials. Both products have been tested for many years and are expected to obtain product registration certificates in 2025 and 2026, respectively.

It is reported that the bio based bone hollow screw that has entered the special review process this time is the world's first absorbable silk protein bone fixation product, and is also a high-performance, low-cost biotechnology material independently developed by China from traditional silk, breaking through the technical barriers of hard silk protein materials and achieving the world's first. It has the advantages of biodegradability, good bio-compatibility, and high mechanical performance, and can be widely used in various biomedical scenarios such as orthopedics and plastic surgery.

Source: https://news.yaozh.com/archive/44701.html