Domestic bio-heart valve introduces innovative products: Can it break the monopoly of foreign companies?
In the author's favorite novel "Muslim's Funeral" in the high school era, the young hero Han Xinyue unfortunately suffered from heart valve atresia caused by rheumatic heart disease, requiring surgery to replace the heart valve, but a series of stories make new The operation of the month had to be postponed repeatedly, which eventually led to her fate.
For people in the 1960s and 1970s, suffering from this disease, even if there is money to cure, I am afraid it is lifeless. Time is up, today, although surgery to replace artificial valves is not difficult, but there are not many valve products available on the market. In China, the artificial mechanical valves used by most patients have strong wear resistance and resistance. Fatigue, but can not stand its poor biocompatibility, patients must also take anticoagulants for life after surgery, even then, the patient's long-term survival rate still shows a rapid decline curve.
Development dilemma
According to statistics, artificial bio-heart valves have a market share of more than 75% in the United States, and this figure is less than 5% in China. That is to say, most valvular patients in the United States will choose artificial bio-heart valves, while China It is the opposite.
When the occupational rate of mechanical valves in developed countries is declining, the development of the biological valve market in China is in an embarrassing situation. It is precisely because the mechanical valve must cooperate with strict anticoagulant therapy, so in China, where the medical facilities and insurance system are not perfect, the biological valve is more suitable, but in turn, the domestic company has limited economic strength, the average age of the patient is low, and the valve is replaced. Surgical techniques require higher factors, which at the same time restrict their development and promotion.
Advantages and opportunities
From the characteristics of the biological valve itself, it has a natural advantage in the biocompatibility problem, and does not require anticoagulant therapy because of damage to the blood cells by the central blood flow. In recent years, with the development of biotechnology, the shortcomings of low bio-valve durability have been gradually overcome. The research data prove that the 20-year survival rate of bovine pericardial bioprosthesis has reached more than 90%, much higher than about 45% of mechanical valves. .
Secondly, under the premise of the above advantages, with the positive influence of doctors in the process of information transmission, people's acceptance rate of heart valves will gradually increase, bringing about a gradual increase in market demand, coupled with the high import of biological valves. The price, the good foundation of domestic raw material supply and the large profit margin of biological valves are a potential opportunity for enterprises.
In terms of market share, the gap in the domestic market is large. Even the mechanical valves are mainly imported. There are only a handful of domestic companies in the field of biological valves. The market is far from saturated, and the enterprises have bigger. Opportunities seize the opportunity. For teams with key technologies, they face the market for millions of valvular disease patients in China (4 million over 60 years old) and can only attract capital. Concerned, their commercialization is a huge potential. The same is true for investment institutions.
Domestic representative project
Last week, the CFDA issued a notice announcing the approval of the registration of the first “interventional artificial heart valve product†in China.
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