Recently, Edward Life Sciences announced that its tricuspid valve product Evoque has been approved by the FDA for marketing. This is the first FDA-approved tricuspid valve replacement product.
The Zhitong Finance App learned that Zhongtai Securities released a research report saying that recently, Edward Life Sciences announced that its tricuspid valve product Evoque has been approved by the FDA for listing. This is the first FDA approved tricuspid valve replacement product. As the world's first approved tricuspid valve reflux intervention product, Edward's Evoque is expected to quickly seize the Blue Ocean market and achieve high performance growth. The bank believes that the number of patients with tricuspid valve interventional treatment is huge, there are many potential patients, and that the first product of Jianshi Technology (09877) is expected to become the first in China and the second in the world. The bank expects that the penetration rate of tricuspid valve interventional treatment will continue to increase, the market size will continue to expand, and many outstanding companies are expected to share the blue ocean market to achieve healthy development.
Incident: Recently, Edward Life Sciences announced that its tricuspid valve product Evoque has been approved by the FDA for marketing. This is the first FDA-approved tricuspid valve replacement product. It is suitable for treating tricuspid valve reflux (TR) patients treated with transcatheter treatment and improving the health status of patients with severe symptoms.
The views of Zhongtai Securities are as follows:
Demand for tricuspid valve intervention is strong and the market is broad. Edward Evoque's performance is expected to exceed the full-year guideline after approval.
According to estimates, the number of overseas tricuspid valve replacement surgeries is expected to reach 453,500 by 2030, and the market size is expected to reach 13.606 billion US dollars. As the world's first approved tricuspid valve reflux intervention product, Edward's Evoque is expected to quickly seize the Blue Ocean market and achieve high performance growth. According to Edward's announcement, thanks to the accelerated promotion of its differentiated PASCAL Precision platform, the launch of more clinical centers in the US and Europe, and the growth of transcatheter edge rift repair business, the company achieved high performance growth in transcatheter mitral valve and tricuspid valve therapy (TMTT). In 2023, the relevant sector revenue was about US$198 million, with a year-on-year growth rate of 67%, of which sales in the fourth quarter were US$56 million, an increase of 71%; and along with Evoque products in Europe (October 2023) and the US market (2024/2) With the successive listings (Monday), the company expects TMTT business sales in 2024 to exceed the previous guideline of US$28—320 million.
Domestic Jianshi Technology is expected to be the first to be approved, and leading domestic production such as Qiming and Peijia is progressing smoothly.
Up to now, no tricuspid valve interventional products have been approved in China, but many leading companies have registered R&D for tricuspid valve intervention. Among them, LUX-Valve and LUX-VALVE Plus products independently developed by Jianshi Technology have gained significant competitive advantages through unique designs in stress structure, valve clamping, ventricular spacing anchoring, delivery systems, etc., and are currently in the NMPA approval stage. It is expected that it will be approved as the first domestic model in 2024, enjoying a 3-year exclusive period; Qiming Medical's second and tricuspid valve replacement product Cardiovalve has entered critical clinical trials As of mid-2023, 40+ patients have been enrolled in Canada, Europe, etc.; Peijia Medical's tricuspid valve replacement product MonarQ has completed its first human implantation in the US and is expected to begin clinical enrollment; Niumai Medical's tricuspid valve replacement product Prizvalve-T has entered the design stage; Hanyu Medical's tricuspid valve replacement system ValveneO-T is undergoing prototype iteration; in addition, Bairen Medical's valve surgery and Huihe Medical's TTVR have also begun early human clinical trials.
Investment suggestions: The number of patients with tricuspid valve interventional treatment is huge, and there are many potential patients. No domestic product has been approved. Jianshi Technology's first product is expected to become the first in China and the second in the world. At the same time, many leading domestic intervention companies have begun to enter the tricuspid valve circuit one after another. With the launch of more domestic brands, the bank expects the penetration rate of tricuspid valve intervention to continue to increase and the market size to continue to expand. Many outstanding companies are expected to share the Blue Ocean market and continue to focus on recommending Jianshi Technology. At the same time, it is recommended to focus on intervention leaders such as Peijia Healthcare (09996), Qiming Healthcare (02500), and Bairen Healthcare (688198.SH).
Risk warning: Risk of product development progress falling short of expectations, risk of potential competitors, risk of product commercialization being blocked, risk that public data used in research reports may be delayed or not updated in a timely manner.