On August 22nd, the National Medical Products Administration announced that it has recently approved the registration applications for two innovative products, the "Transcatheter Aortic Valve System" of Beijing Balance Medical Technology Co., Ltd. (hereinafter referred to as "Balance Medical"). The transcatheter aortic valve system is mainly used to treat aortic valve stenosis, and there are two main treatment options: surgical thoracotomy for valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). TAVR can be roughly divided into ball expanding and self expanding instruments. Compared to SAVR, TAVR has the characteristics of no need for thoracotomy and extracorporeal circulation, minimal trauma, and fast recovery, providing a safer treatment option for high-risk surgical patients.

However, in the Chinese market, the penetration rate of TAVR is still relatively low, far below the global level, and a large amount of demand has not been met, with broad prospects. According to Frost&Sullivan data, there were 4.5 million patients with aortic valve stenosis in China in 2021, but the matching TAVR surgery penetration rate was only 0.8%. However, with the worsening of population aging and the increasing penetration rate of TAVR surgery (expected to reach 10.2% by 2030), the market size of TAVR in China is expected to reach 11.36 billion yuan by 2030, which is expected to become an important growth point in the field of heart valve intervention.

Balance Medical was founded in 2005 and is a leading domestic enterprise in the research and development of animal based implantable medical devices. Its products cover three major fields: heart valve replacement and repair, congenital heart disease implantable treatment, and surgical soft tissue repair. This time, Balance Medical's approved transcatheter aortic valve system may usher in a technological revolution in the new era of TAVR2.0. Unlike the previously approved transcatheter aortic valve system, Balance Medical's product adopts a balloon expansion valve structure design and uses its patented technology - "stent and leaflet junction connection" sewing process to achieve the same leaflet opening and closing mode as surgical biological valves, in order to overcome clinical concerns about the durability of traditional transcatheter valve products.

Moreover, as the world's first balloon dilation transcatheter aortic valve product with independent intellectual property rights that adopts the same opening and closing mode as surgical biological valves, it has a size model of 19-29 # every 2mm, which can more accurately match the needs of different types of lesions (including various types of bicuspid and tricuspid valves); The unique hexagonal cobalt chromium alloy valve stent structure improves expansion speed and precise positioning, and achieves stent expansion performance during future secondary interventional treatments, optimizing the management of the entire lifecycle of valve disease; The long and short delivery systems adopt the same principle of loading, delivery, and valve release, which can meet the clinical needs of various approaches suitable for patients except for the femoral approach; The conveyor system has dual adjustable bends, achieving simplified operation and precise release.

It is worth mentioning that Balance Medical relies on its original animal tissue engineering and chemical modification technology to produce an artificial biological heart valve - the bovine pericardial valve, which is the earliest registered and currently the only domestically produced product with long-term evidence-based medical data in China. Balance Medical is also the first to achieve profit in the TAVR track, with a revenue of 370.6383 million yuan in 2023, a year-on-year increase of 25.57%.

Source: https://news.yaozh.com/archive/44080.html