Solving a Pressing Need for Structural Heart Disease Solutions
ABOUT VALVULAR HEART DISEASE
Structural heart disease refers to the defects or disorders of the heart structure, specifically, its valves. Also known as valvular heart disease (VHDs), VHDs can be an abnormality resulting in either blood flow obstruction (i.e., valve stenosis), backward leakage (i.e., valve regurgitation) or both.
In patients with valve stenosis, calcium built-up on their valves prevent the valves from fully opening, narrowing the valve opening, thereby reducing blood flow. Whereas in valve regurgitation patients, the abnormal structure of the valve results in it not being able to close fully, resulting in backflow across the valve. Both valve stenosis and regurgitation, if severe, can result in reduced heart function.
The prevalence of VHD increases along with age. More than one in eight individuals aged 75 and above suffer from moderate or severe valvular heart disease. VHD, when left untreated, can lead to many severe complications such as stroke, heart failure or even sudden death.
Globally, VHD is a major health problem affecting more than 2% of the general population. In the United States, more than 5 million patients are diagnosed annually with a prevalence of 2.5%. In China, 25 million patients are diagnosed with VHD. In 2020, the market size for China's structural valvular heart market is RMB 556 million and is expected to reach RMB 10.3 billion in 2025, with a CAGR of 79%. This is a terrifying growth trend that signifies an expected jump in the number of expected diagnosed cases.
Patient treatment is dependent on the symptoms and disease severity. In general, most patients with non-severe conditions will be prescribed medications to treat the symptoms. For patients with irregular heart rhythms, anti-coagulation drugs are prescribed to minimize blood clot risks. At the same time, they are advised to make healthy lifestyle changes including maintaining regular exercise and a healthy diet, managing stress and maintaining a healthy weight etc. At the moment, surgical approach is the gold standard treatment for patients with severe, symptomatic disease.
In the USA and China, 30% of severe symptomatic aortic stenosis patients are inoperable. This is due to other health risks or old age. For inoperable patients, minimally invasive valve repair or replacement via a transcatheter approach is recommended.
Unfortunately, there is a severe limitation on the options available to these patients. This is especially true for countries within Asia. In Asia, rheumatic aortic stenosis is most common. Similarly, in China, rheumatic disease is very common with the most common VHD being combined valvular disease, followed by isolated mitral regurgitation, isolated aortic regurgitation, then isolated aortic stenosis.
The limited accessibility of transcatheter solutions for many inoperable patients paints a grim picture. Except for aortic stenosis, patients suffering from mitral valvular diseases, aortic regurgitation diseases and pulmonary diseases have close to no available transcatheter solutions, with most of these innovations currently limited to use in Europe. Our latest product, J-Valve, the only TAVR indicated for aortic regurgitation, is only available in China.
Overall, the need to make transcatheter innovations available and accessible to more patients worldwide is critical. Diagnostic advances, increasing disease awareness coupled with the ageing population has led to a large patient population and a large unmet clinical need for more of these interventional devices. Through our acquisition of JC Medical, Genesis is actively placing such medical devices for VHDs in the hands of more healthcare practitioners, empowering them to save more lives and safeguard patient health.