Recently, the wind in the field of peripheral intervention has re-emerged: the intravenous radiofrequency ablation system independently developed by Synradaz has been approved for listing. This is the first domestic intravenous radiofrequency ablation system approved by NMPA in Mainland China with complete independent intellectual property rights. The listing of this product marks a breakthrough in the field of varicose veins by domestic innovative enterprises, which means that China's varicose vein treatment has ushered in a new era.
It is understood that this product is another blockbuster product after the first domestic peripheral drug balloon, the world's first peripheral drug balloon for sub-knee arterial disease, and the first domestic peripheral thrombosis suction system.
Prior to this, the mainland varicose vein market was occupied by multinational machinery companies such as Medtronic. Nowadays, with the approval of the intravenous radiofrequency ablation system of Synradia intravenous, the varicose vein market will break the monopoly and benefit more domestic patients; at the same time, Synrad, as a highly concerned innovative enterprise, will enter the varicose vein market with a first-mover advantage, which will lead many domestic innovative enterprises to enter the game, promote market cultivation, and benefit more domestic varicose vein patients.
Innovative solutions for more than 100 million patients
Varicose veins are those that are varied and dilated due to factors such as blood stasis and weak venous walls.
Varicose veins may be a relatively unfamiliar term for most people, but the disease is very common. The "2021 Varicose Vein Internet Health Insight Report" shows that there are 120 million patients with varicose vein disease in the lower extremities in China, of which more than 80 million are women, and the trend of rejuvenation is also showing a trend of rejuvenation.
From the perspective of market space, the cardiovascular intervention market associated with 11 million patients with coronary heart disease once had a market size of up to about 10 billion yuan; the neurointervenous market associated with 13 million stroke patients was about 19.3 billion yuan; from this point of view, the venous intervention market associated with 120 million varicose vein patients is indeed immeasurable. According to industry insiders: intravenous intervention is a neglected 10 billion blue ocean market.
Not only is the patient base and market space large, but the harm of varicose veins is also not small. For patients with varicose veins in the asymptomatic stage, lifestyle changes and prevention of disease exacerbation are mainly used. However, for patients with varicose veins in the acute stage, if not treated in time, the development may occur in the later stages of lower limb ulceration, infection, and even amputation.
Clinical expert introduction: The treatment methods of varicose veins are mainly divided into three categories: physical therapy, drug treatment and surgical treatment. Among them, physical therapy and drug therapy can only delay the development of the disease and alleviate symptoms.
Surgical treatment includes great saphenous vein extraction, foam sclerotherapy, and interventional energy ablation. The principle of such treatment is to close the venous lesion site, block the superficial vein reflux of the lesion, and restore normal venous blood circulation.
However, there are significant pain points in saphenous vein extraction and foam sclerotherapy, which may cause a variety of complications. Energy ablation interventional treatment is different, it is through radio frequency, microwave, laser and other energy heat energy to destroy and seal the vein, with the advantages of small surgical incision, few complications, short recovery period and so on. Based on this, both the U.S. Intravenous Forum and the National Institute of Clinical Excellence recommend venous energy ablation as the first-line treatment for varicose veins.
Among them, radiofrequency ablation has accounted for more than 70% of the interventional treatment of energy ablation in China in 2019 due to its low temperature, not easy to burn the skin, and mild postoperative pain.
Source: Eggshell Institute
At the same time, varicose veins, as a disease that occurs more in women, may appear commonly known as "green tendon bulge" after the onset of the disease, which seriously affects the appearance. As a minimally invasive operation, varicose vein radiofrequency ablation is an improved aesthetic surgery for many young and middle-aged female patients today compared with the previous open surgery.
It is worth noting that although radiofrequency ablation has many advantages in the treatment of varicose veins, due to the fact that there are only a few imported products in China, and the market time is short, the market is still in the cultivation stage, resulting in most medical institutions in mainland China still mainly using the traditional great saphenous vein trunk stripping and sclerosing agent injection.
On the other hand, as the advantages of radiofrequency ablation therapy are gradually revealed, its surgical procedures are rapidly being promoted. The data shows that in 2015, there were only 2,700 patients in mainland China who received radiofrequency ablation for varicose veins, while in 2019, it has reached 26,300 cases, with a compound annual growth rate of 76.9%.
It can be seen that with the listing of the first domestic radiofrequency ablation system, the rapid development of vascular surgery, and the improvement of doctors' and patients' awareness of varicose veins, the number of patients treated with varicose veins will grow rapidly, and the related market will also expand.
Rely on differentiated advantages to cut into the market
Previously, the domestic and foreign weekly ablation product market was mainly monopolized by multinational companies such as Medtronic. Today, with the approval and listing of Synradia intravenous radiofrequency ablation system, domestic innovative enterprises will also join the domestic market competition. However, Medtronic has strong capital and a century of history, how should Synrad break through the market?
According to reports, on the one hand, Xianruida will rely on the advantages of product differentiation to enter the market, on the other hand, it will rely on the advantages of localization to promote varicose vein radiofrequency ablation to benefit more domestic varicose vein patients.
From the perspective of product differentiation advantages, Xianruida is one of the few enterprises in China that independently grasps the RF ablation generator, and its intravenous radio frequency ablation system includes an RF ablation generator and an RF ablation catheter, and is equipped with intelligent algorithms such as adaptive PID temperature control algorithm, 2-fold system monitoring, and heating curve monitoring.
In one sentence: heating up faster, temperature control more refined, higher safety.
At the same time, Synrad has previously realized the commercialization of peripheral drug balloons, peripheral thrombosis suction systems and other products. Based on the mature commercialization experience and the brand image of high-quality products established by Xianruida, Xianruida will be able to quickly promote products into the hospital, break the monopoly situation of imported products, and walk in the forefront of domestic production.
Why Synrad?
For the varicose vein market, why are there so few corporate layouts? Why is It that Xianruida came out on top and took the lead in launching the first domestic intravenous radiofrequency ablation system?
The arterial network learned that there are mainly Xianruida, Guichuang Tongqiao, and Hengrui Medical Layout Venous Radiofrequency Ablation System in China. The reason why there are fewer layouts is that the R&D barriers in the field of intravenous intervention are high, which requires an interdisciplinary R&D team and strong innovation ability and execution ability; second, most enterprises mainly lay out deep vein thrombosis, pulmonary embolism and other diseases that affect the safety of patients' lives, while ignoring varicose vein diseases that seriously affect the quality of life of patients.
As a leading interventional medical device company, Synrad's original intention is to meet the unmet needs of the clinic. From the domestic first peripheral drug balloon to meet the treatment of peripheral superior knee artery disease, to the world's first drug balloon for peripheral sub-knee artery disease, and then to the launch of the first domestic peripheral thrombosis system for deep vein thrombosis and pulmonary embolism, Xianruida has been practicing the original intention of "meeting the unmet needs of the clinic". The intravenous radiofrequency ablation system is Synrad's response to varicose veins, a disease that lacks excellent treatment options in the clinic.
What cannot be ignored is that only the original intention is not to develop innovative devices, and the innovative strength of Xianruida provides a solid foundation for the launch of the first domestic intravenous radiofrequency ablation system.
It is understood that the R&D team members of Synrad are from all over the world, including the inventor of the world's first drug balloon, the former senior R&D head of Stryker, the former R&D head of OrbusNeich, the former head of GE Medical R&D, etc., all of whom have decades of rich R&D experience.
It is worth mentioning that the R&D team of Xianruida has strong execution. For example, the team completed the project and product design of the peripheral IVL system in seven months, and the speed of progress can not be underestimated.
In terms of R&D investment, From 2019 to 2021, Synreda invested 25.5 million yuan, 83.5 million yuan and 140 million yuan for product research and development.
With the blessing of senior R&D team, strong execution and sufficient R&D investment, It is reasonable for Xianruida to preemptively win the first domestic intravenous radiofrequency ablation system.
However, just like 6 years ago, after winning the first domestic peripheral drug balloon, it faced a lower limb artery market with extremely low penetration and urgent market education, Synreda is now facing a varicose vein market with extremely low penetration and untapped.
Today, after years of market cultivation and education, Synrad's peripheral drug balloons occupy almost all of the market share. Perhaps, the intravenous radiofrequency ablation system will also have the same fate, that is, after long-term and unremitting market cultivation, it will occupy the vast majority of the varicose vein market.