On October 26, the headquarters and industrialization base project of Vickor, with a total investment of 1 billion yuan, was signed and settled in Wuhan Optics Valley.According to reports, the first phase of the project plans to construct production facilities for innovative devices, modern laboratories, and office buildings. The second phase will focus on building the Central China Large Animal Center, a scientific research and teaching center, an incubation platform for minimally invasive interventional treatment devices for structural heart disease, an innovation center, and related supporting facilities. It aims to become the leading enterprise in the cardiovascular field in Central China.
It is reported that, as of now, Vickor has already advanced five products into clinical stages, four of which are the first domestically developed and original products in China, with a growth rate surpassing 80% of the companies in the industry. From initiating the development of China's first atrial shunt device at zero base to acquiring mass production capability, "from 0 to 1 and then to 100," Vickor has become the leading enterprise in the cardiovascular innovative medical device field in Central China within four years.
“Potential Unicorn Enterprises in China”
Wuhan Vickor Medical Technology Co., Ltd. ("Vickor" for short), registered in July 2018 in Wuhan's Optics Valley, is an innovative R&D enterprise focusing on cardiovascular and cerebrovascular diseases, particularly heart failure and minimally invasive interventional treatments for structural heart disease. The company is committed to building a comprehensive and integrated platform for the treatment of cardiovascular and cerebrovascular diseases. It has established branch offices in Suzhou, Beijing, Shanghai, and other locations. Since its founding, multiple products from the company have entered the "green channel" for innovative medical device reviews. In the report "Research Report on China's Potential Unicorn Enterprises in 2022" released by Great Wall Strategy Consulting, Wuhan Vickor Medical was regarded as a "Potential Unicorn Enterprise in China.""Report on China's Potential Unicorn Enterprises in 2022"The founder and chairman of the company, Shang Xiaoke, is a chief physician and professor at Wuhan Union Hospital, as well as a master's supervisor at Hubei University of Technology. The company has applied for more than 60 national patents and 1 PCT patent, and has successively received five rounds of financing totaling over 300 million RMB, led by well-known top-tier industry funds such as Blue Fountain Capital and Sequoia China. The company has been honored as one of the "Golden Seed Companies" in Hubei Province's listing reserve enterprises for 2022, a "Specialized, Precise, Unique, and Innovative" SME in Hubei Province, and has won the second prize and grand prize of the Hubei Provincial Science and Technology Progress Award.Company financing history, source: TianyanchaIn April this year, Wuhan Vickor Medical Technology Co., Ltd. successfully passed the EU International Quality Management System certification audit and obtained the certificate. This certification, named ISO 13485 Medical Device Quality Certification, is an international quality management standard specifically developed for the medical device industry. It requires companies to meet high-quality standards in all aspects, including design, development, production, sales, and after-sales service. Obtaining this certificate has laid a solid foundation for Vickor's products to enter the international market.
Vickor's ISO 13485 Certification CertificateIn addition to its cardiac occluders and delivery systems, D-shant atrial shunt, a self-developed product by Vickor, has completed multi-center clinical trials in China. Shang Xiaoke, founder of Vickor, stated: "From occluders to atrial shunts and super valves, we have accomplished the leap from the first stage to the second stage. We are currently moving towards the third stage - the layout of artificial hearts."The company plans to list on the Sci-Tech Innovation Board in the future, aiming to become a leading innovative cardiovascular medical device enterprise.”Statistics show that the mortality rate of heart failure is equivalent to that of malignant tumors, with a 5-year survival rate of only about 30%. For patients with heart failure, effective treatment in the short term and long-term chronic disease control management are both extremely important. From material processing to the integration of product technology platforms, mastering more core technologies is essential to having a strong voice in the industry. To overcome the backwardness of China-produced nickel-titanium alloy medical thin-walled tubing processing technology, after years of independent research, Vickor Medical has achieved a breakthrough in the performance and quality of nickel-titanium alloy medical thin-walled tubing, meeting and exceeding international standards for medical nickel-titanium alloy materials.Targeting heart failure monitoring devices, last year Vickor also established close cooperation with multiple universities and enterprises outside the company, officially entering the active medical device market to promote the implementation of high-end medical devices produced in Wuhan. "The company focuses on products that meet significant clinical needs within the specialized field of cardiology. We are building a comprehensive technology platform for the monitoring, management, and treatment of heart failure and structural heart diseases covering the entire life cycle," said the company's R&D-related director. According to reports, so far, Vickor has completed multiple rounds of financing exceeding 200 million yuan. After several products hit the market this year and next year, annual revenue is expected to reach hundreds of millions of yuan the following year.With multiple products,
Leader in Cardiovascular Innovative Medical Devices
On June 12, 2023, the "Cardiac Occluder Delivery System" independently developed by the company officially received registration approval from the National Medical Products Administration. This successful approval marks an important step for Vickor in formally embarking on its commercialization journey.The biggest design highlight of this occluder delivery system lies in the optimized improvement of the delivery sheath tip.
Compared with traditional products, its head-end length is shortened, allowing the overall curvature to more precisely match the anatomical shape of the atrial septum. During atrial septal defect and patent foramen ovale closure procedures, the sheath can pass through the lesion site more easily, especially under ultrasound-guided methods, significantly improving the success rate of transseptal crossing and markedly reducing operation time, demonstrating significant clinical application value. Due to the compact curvature at the head end, the operational space of the sheath within the heart chambers is increased, effectively avoiding complications such as cardiac tamponade and enhancing surgical safety.
In addition, the first "Atrial Shunt" in China for the treatment of heart failure passed the National "Special Review Procedure for Innovative Medical Devices" in June 2022. The first "Second-Generation PFO Occluder" has completed clinical validation and has been submitted to the National Medical Products Administration for registration, with approval expected by the end of this year for market release. In the future, Vickor will continue to invest heavily in technology research and development and product innovation, providing higher-quality products and better treatment solutions for patients in China and around the world.
A few months ago, Vickor announced the completion of the world's first clinical implantation of the company’s self-developed transcatheter aortic valve replacement system, “DOCS VALVE®.”This surgery was completed by the Heart Valve Center team led by Professor Nian-Guo Dong from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Wuhan Union Hospital). It successfully performed a TAVR procedure on an elderly frail patient with isolated aortic regurgitation who had a high surgical risk. Post-surgery, the patient’s cardiac structure and function significantly improved, and they were discharged smoothly.
The success of this surgery marks an important breakthrough and a milestone in the field of TAVR for aortic regurgitation in China. Vickor Medical stated that although there are currently multiple TAVR products on the market or in clinical research in China, the indications are still mainly focused on aortic stenosis, lacking dedicated percutaneous TAVR products specifically designed for high-risk patients with aortic regurgitation. As an innovative valve replacement solution, DOCS VALVE® boasts unparalleled advantages and potential.
According to the introduction, DOCS VALVE® is an artificial valve with independent intellectual property rights, designed by a team of structural heart disease doctors and developed through close collaboration between medical and engineering professionals. Its core clinical value lies in breaking through the application contraindications for large annuli and pure regurgitation. It effectively matches the characteristics of virtual annuli and outflow tracts in patients with aortic regurgitation, which constantly change during the cardiac cycle and are expandable. The valve achieves safe and stable deployment without the need for rapid pacing.
The company stated that this world-class original technology and operational concept is expected to transform TAVR from a highly difficult and high-risk specialized surgery into a routine local anesthesia procedure, bringing revolutionary changes to the implementation of TAVR surgeries.
Compared with similar products abroad, the D-Shant atrial shunt developed by the company has significant advantages in hemodynamics, manufacturing cost, delivery sheath diameter, and other aspects. This coin-sized shunt is meticulously crafted from dozens of nickel-titanium alloy wires with millimeter-level diameters. Its structural design and weaving technology not only enhance the product's stability within the body but also make it the first in the industry to be retrievable and allow for secondary intervention.
According to the product description displayed on the official website, the shunt is delivered into the heart through a cardiac interventional delivery system. Relying on its shape memory characteristics and radial support, it is implanted in the center of the atrial septum, which has been pre-punctured and balloon-dilated, effectively and stably maintaining the opening of the atrial septal shunt to achieve the therapeutic goal of atrial decompression.
Project Settlement,
Promote the High-Quality Development of Medical Devices in This Area
The medical device industry is a key development focus in Optics Valley (Guanggu), and the Guanggu medical device industry is becoming the "fourth pole" of China's medical device industry following the Bohai Rim, Yangtze River Delta, and Pearl River Delta. As of the end of 2022, the East Lake High-tech Development Zone has gathered more than 800 medical device companies, including 63 large-scale industrial enterprises, with an industrial output value of 21.9 billion yuan, representing a year-on-year increase of 79.8%.Well-known enterprises such as Mindray Medical, United Imaging Healthcare, UIH Intelligent Fusion, MGI Tech, BGI Biosciences, SonoScape Medical, and Echonova Technology have been introduced. The Wuhan headquarters base of United Imaging Healthcare has been completed and put into use, while projects like the Mindray Medical Wuhan Base and MGI Tech's Intelligent Manufacturing and R&D Base are nearing completion and will soon be operational. Self-cultivated listed companies include Medtech, the unicorn Ankon Technologies, Zhongqi Biotechnology, and Lanting Intelligence, among other well-known enterprises. In total, more than 1,200 Class II and III medical device registration certificates have been accumulated, accounting for approximately half of the province’s total.The settlement of this project will further improve the top talent chain in the field of cardiovascular and cerebrovascular diseases in Optics Valley, enhance the international influence and competitiveness of high-end medical device products for cardiovascular diseases in Optics Valley, and boost the high-quality development of the medical device industry in Wuhan New City.
丨Source: Medical Device Innovation NetworkDisclaimer: This article is intended solely for the purpose of information transmission and is for reference only. It does not constitute any advice on investment or treatment; please evaluate carefully. If it involves the content, copyright, or other issues of the work, to protect the rights and interests of both parties, please contact us and we will handle it immediately. If any platform reprints this article, it must take responsibility for the article itself; the Medical Device Innovation Network is not responsible for any secondary dissemination caused by the reprint.P R E V I E W
