Recently, the Equipment Review Center of the National Medical Products Administration released the results of the special review application for innovative medical devices (No. 8 of 2024), intending to approve 5 innovative medical device projects to enter the special review process.

1. Human homologous recombination repair defect detection kit (high-throughput sequencing method): Xiamen Aide Biomedical Technology Co., Ltd
Xiamen Aide Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as Aide Biotechnology) was established in 2008. It has long been deeply involved in the field of tumor gene testing, focusing on tumor drug co diagnosis. Relying on powerful bioinformatics algorithms, it has laid out detection reagents, software, and supporting instruments for various technology platforms, and provides detection services and drug clinical research services.

In terms of products, Eide Biological Products has a wide range of products, which can detect the mutations of EGFR, KRAS, BRAF and other common genes, covering the disease field, including non-small cell lung cancer, breast cancer and other cancers. At the same time, Eide Biological Products is also the first to be approved overseas. On September 6th of this year, ADx ARMS, a multi-target rapid detection technology developed by Edbio, was introduced ®） The innovative product, the PCR-11 gene companion diagnostic kit, has been approved by the National Medical Products Administration (NMPA) and is currently being approved in China, Japan, and Europe.

Based on its self-developed nucleic acid molecule detection technology (ADxARMS), EdBio has launched multiple detection products. Currently, 27 tumor gene detection products have obtained NMPA Class III registration certificates. The technology platform covers mainstream PCR, NGS, immunohistochemistry, in situ fluorescence hybridization, etc., and is equipped with matching instruments.

Based on this, Ed Biotech's products include a comprehensive solution for precise tumor detection, from upstream sample processing/nucleic acid extraction to downstream automatic reporting/data management systems. Currently, Edbio has ADx ARMS ®、 Core technologies such as Super ARMS, ddCapture, and ADx HANDLE have collaborated with top pharmaceutical companies such as AstraZeneca, Johnson&Johnson, and Hengrui to develop diagnostic reagents for their targeted drug therapies, demonstrating strong research and development capabilities.

2. Disposable peripheral vascular plaque resection catheter: Avig Corporation
Avinger, Inc. is a commercial medical equipment company focused on developing and commercializing innovative intravascular image guidance systems for the diagnosis and treatment of vascular diseases. The company's product line includes image-guided catheter systems for the diagnosis and treatment of peripheral and coronary artery diseases.

It is worth mentioning that Avig Corporation has developed the world's only peripheral vascular therapy device and product with optical coherence tomography (OCT) imaging capabilities. This groundbreaking innovative technology can provide real-time intravascular imaging during the treatment of peripheral arterial disease (PAD), helping doctors better distinguish the affected area and reduce damage to healthy blood vessels.

Its product family includes the following series: Pantheris OCT image-guided plaque resection catheter; Ocelot and Tigereye OCT image-guided chronic total occlusion (CTO) vessel opening catheter; LightBox 3 OCT imaging console, etc. Avig's products have been proven safe and effective through multiple clinical trials, including VISION Study, INSIGHT Study, and CONNECT Study. The Avig product family has been launched and clinically applied in the United States and Europe for many years.

3. Magnetic positioning balloon pulse ablation device: St. Jude Medical
St. Jude Medical, founded in 1976 and headquartered in St. Paul, Minnesota, USA, is a pioneer in the field of cardiovascular medical technology. St. Jude Medical has developed from an initial heart valve manufacturer to a global leader in cardiovascular medical technology through independent innovation and strategic acquisitions.

At present, St. Jude Medical's product line covers five major fields: cardiac rhythm management, cardiac electrophysiology, cardiac surgery, cardiovascular intervention diagnosis and treatment, and neural regulation. It provides products and services to customers in more than 100 countries worldwide, with an annual turnover of $5.5 billion and over 18000 employees.

In 2016, Abbott acquired St. Jude Medical for $25 billion, which added breakthrough products in the cardiovascular and neuroregulatory fields and further consolidated its position in the global medical device market.

In addition, St. Jude Medical also has a presence in China. St. Jude Medical (Shanghai) Co., Ltd. was established in June 2003 and is a subsidiary of St. Jude Medical in China, responsible for sales and services in the Chinese market.

4. Xinnopu Medical Technology (Beijing) Co., Ltd.: Cryoablation System
Synaptic Medical, founded in 2005, is committed to becoming a provider of comprehensive solutions for cardiac electrophysiology, focusing on this field for nearly 20 years and continuously leading industry technological innovation. Xinnopu's existing products cover dozens of types in three major categories: atrial septal puncture instruments, diagnostic instruments, and therapeutic instruments, and have established a complete business system covering research and development, manufacturing, and sales. Among them, atrial septal puncture instruments have entered nearly 2000 hospitals in China, the United States, Japan, Europe, and other countries due to their performance advantages. Xinnopu has become the market leader in atrial septal puncture in China.

Xinnopu is actively promoting revolutionary innovation projects such as cryoablation system (Nordica), 3D mapping system (Meridian), intracardiac ultrasound (ICE) diagnostic catheter and equipment (enVision) with the innovation research and development center in the United States as the engine, comprehensively improving surgical outcomes, continuously enhancing the safety and effectiveness of atrial fibrillation surgery, continuously improving the clinical operation experience of operators, and benefiting the vast number of cardiovascular disease patients.

In June 2024, Nordica's animal experiment results were first released in the United States, demonstrating the safety and effectiveness of Nordica in the treatment of atrial fibrillation. The Nordica cryoablation system has improved the design of the cryoballoon and circular mapping catheter. The balloon is designed with a single-layer polyurethane, and its size can be adjusted. During the freezing process, the balloon maintains low pressure and constant pressure.

It is reported that Nordica has conducted clinical trials in the United States and is expected to complete full enrollment by September 2024. It will be launched in multiple global markets such as China, the United States, Japan, and Europe from 2024 to 2025.

5. Human leukocyte antigen (HLA) genotyping test kit (fluorescence PCR method): Jiangsu Weihe Biotechnology Co., Ltd
Jiangsu Weihe Biotechnology Co., Ltd. (hereinafter referred to as Weihe Biotechnology) was established in Taizhou, Jiangsu in April 2014. It is a company that focuses on the development, production, sales, and service of molecular diagnostic products in the fields of transplantation, blood transfusion, and immune genetics. It assists in the "import substitution" of transplantation diagnostic products and the implementation of the national "precision blood transfusion" strategy.

In addition, Weihe Biotechnology adopts a dual wheel drive development model of "product+service", promoting the two strategic development directions of "import substitution" for transplant diagnostic products and "molecular and precision" for transfusion medical diagnosis, and participating in the formulation of multiple national standards and standard products in the industry.

Weihe Biotechnology has a standard laboratory of approximately 2000 square meters, including multiple standard PCR laboratories. It also has a 10000 level and 100000 level purification plant of approximately 1000 square meters (including one set of Class III nucleic acid and Class II protein in vitro diagnostic reagent production lines), as well as production and operation licenses and import and export licenses for Class II and Class III in vitro diagnostic reagents.

Moreover, Weihe Biotechnology has established a third-party medical laboratory called Jianxin Medical Testing in Taizhou, Jiangsu. We have a comprehensive quality management system and experienced personnel in research and development, registration, clinical practice, and production. At the same time, Weihe Southwest Center and Medical Inspection Institute were established in Yibin, Sichuan. At present, Weihe Biotechnology has completed the research and development of more than 30 products, which have been used or tested in clinical and research institutes; Multiple products have obtained Class I, II, III and EU CE registration certificates; Completed an investment of over 100 million yuan.

Source: https://news.yaozh.com/archive/44235.html