Recently, the results of the 6-month follow-up study of the LUX-VALVE PLUS transcatheter tricuspid valve intervention system independently developed by Jianshi Technology-B (09877) were officially released at the 2024 New York Valves 2024 (New York Valves 2024) and the 18th Oriental Cardiology Conference and World Cardiology Conference (OCC-WCC 2024). The data performance was impressive and received great attention from participating experts and scholars.

The globalization of LUX-VALVE Plus has progressed rapidly in recent years. Currently, the registered clinical enrollment of LUX-Valve Plus in Europe is nearing completion, preparations for the US IDE application have begun, and a series of commercialization preparation activities have been carried out in Asia Pacific and North America. In February of this year, LUX-VALVE Plus successfully completed the first implantation procedure in Brazil. This is also the first application of transcatheter tricuspid valve intervention in Latin America. The clinical performance, cardiac function and quality of life of patients after surgery all showed significant improvements, indicating the broad scope of application, high reliability and ease of operation of LUX-Valve Plus.

In the short term, Lux-Valve Plus, which has the world's leading R&D progress, is expected to become the core single product commercialized by Jianshi Technology, and has strong profit expectations due to its high scarcity and innovation; on a longer scale, Jianshi Technology has widely laid out high-growth heart valve tracks, and is about to commercialize various products, and its future growth potential is already showing.

Major core products have made further progress, and the safety and efficacy of 6-month clinical data have been outstanding

According to the Zhitong Finance App, as the population ages and the prevalence of cardiovascular disease continues to rise, the burden of tricuspid valve reflux disease in China is increasing year by year. Transcatheter tricuspid valve edge repair (T-TEER) is currently the main research direction in the international exploration of transcatheter tricuspid valve interventional treatment. However, due to the unique anatomical characteristics and pathological mechanisms of the tricuspid valve, T-TEER's curative and technical benefits are limited, and it is often limited by special anatomical variations caused by tricuspid valve reflux, such as valve ring dilatation and excessive valve fissures.

Under these circumstances, the transcatheter tricuspid valve interventional replacement system represented by Jianshi Technology's LUX-VALVE Plus is becoming a new, effective, and safe clinical solution.

The TRAVEL II study is a prospective, multicenter, single-arm clinical trial to evaluate the long-term safety and efficacy of LUX-VALVE Plus in patients with severe tricuspid valve reflux. The TRAVELL II clinical trial included a total of 96 patients from 15 clinical centers in China. The average age of patients was 71.35 years old, with an average STS score of 9.09%. 37.50% of patients underwent left heart valve surgery before the study, and 15.63% of patients had a history of pacemaker implantation. At the same time, most of them had other underlying diseases. The baseline situation was poor, and there was a high risk of surgery and the difficulty of receiving other forms of interventional treatment.

According to the newly disclosed 6-month clinical trial data, LUX-VALVE Plus excels in both safety and efficacy. Among them, the security results showed that the compound incident rate was only 8.33%. Among them, the incidence of myocardial infarction, stroke, use of ECMO (extracorporeal membrane pulmonary oxygenation) or IABP (intraaortic balloon counterpulsion), acute liver failure, long-term mechanical ventilation (>72 hours), cardiovascular injury requiring surgical intervention (heart perforation, vascular injury), and life-threatening hemorrhage were all 0. The all-cause mortality rate was only 2.08%; the incidence of acute renal failure, severe perivalvular leakage, and tricuspid valve replacement or plasty was 1.04%, 2.08%, and 3.13%, respectively. The incidence of new grade III atrioventricular blockade requiring the implantation of a permanent pacemaker was only 1.04%.

Efficacy results showed significant improvements in the level of reflux, cardiac function, and quality of life of patients. Among them, 100% of patients and 97.62% of patients showed no moderate or above reflux at 30 days and 6 months, respectively, and the remodeling of the patient's right ventricular system also benefited.

In terms of improving cardiac function from the New York Heart Association (NYHA), the 30-day data showed that 80.43% of patients were upgraded from grade III/IV before surgery to grade I/II, and the 6-month data showed that 91.86% of patients were upgraded from grade III/IV before surgery to grade I/II; in terms of quality of life, patients' Kansas City Cardiomyopathy Questionnaire (KCCQ) scores increased by an average of 15 points over 30 days and an average increase of 20 points over a 6-month period.

Overall, the 6-month follow-up results of the multi-center clinical trial study TRAVEL II initially verified the safety and efficacy of LUX-VALVE Plus. In addition to achieving a shorter instrument operation time and a lower incidence of complex events, LUX-VALVE Plus also significantly reduces the level of tricuspid valve reflux over a period of 6 months, and brings about significant improvements in indicators such as cardiac function and quality of life.

The R&D progress is leading in the world, and major products are scarce

According to the Zhitong Finance App, the tricuspid valve has always been called the “forgotten valve” by the medical community in the past. Despite the large number of patients with tricuspid valve reflux, the risk of surgical intervention for tricuspid valve reflux is much higher than mitral valve, and patients often only receive conservative treatment.

However, when it comes to research in tricuspid valve-related fields, Chinese companies are already at the forefront of the world. According to the “Annual Report on Transcatheter Tricuspid Valve Reflux Interventional Treatment” jointly published by the Structural Cardiology Branch of the Chinese Medical Doctors Association (CCCP) and the Cardiovascular Health Alliance Heart Valve Disease Interventional Center, in the field of tricuspid valve interventional treatment, original Chinese tricuspid valve devices, including Lux-Valve series products (Jianshi Technology), have emerged one after another, and many domestic studies have been presented at international conferences.

Unlike most transcatheter aortic valve replacement (TAVR), which uses a transfemoral artery and transapical approach, LUX-VALVE Plus innovatively uses a transjugular vein as the main route of surgery, which can quickly deliver the artificial valve to the target surgical area. The overall delivery journey is short, effectively reducing anatomical tissue complications around the entrance and the risk of bleeding during surgery.

At the same time, LUX-VALVE Plus has a unique chamber spacing anchoring device and valve clamping design, which can form a multi-dimensional anchoring structure and reduce excessive radial pressure on surrounding tissues, thereby avoiding the occurrence of conduction blockages.

Finally, for clinically common tricuspid valve reflux combined with pacemaker implantation, LUX-Valve Plus's exclusive adaptive woven ring technology can effectively reduce the occurrence of perivalvular leakage, and has become an effective choice for patients at high risk of surgery to resolve tricuspid valve reflux.

Up to now, only Jianshi Technology's LUX-Valve series and Edward's EVOQUE have entered the confirmatory clinical trial stage globally, and are in the first tier of development progress. As LUX-VALVE Plus advances in commercialization on a global scale, it is expected to become one of the first commercialized tricuspid valve replacement products in the world.

In the empty market window period where Edward EVOQUE products have not yet entered the domestic market and the R&D progress of the rest of the domestic manufacturers is lagging behind, Jianshi Technology will use its first-mover advantage to reap considerable profits and continue to consolidate its leading competitive position in the market through the accumulation of clinical data.

Focusing on the global commercialization layout, a number of initiatives have opened up space for overseas growth

Driven by the trend of an aging population, demand for medical treatment with immediate needs continues to rise, and the field of structural heart disease treatment will undoubtedly have a broad market space. Zhongtai Securities also pointed out in the research report that the transcatheter tricuspid valve intervention (TTVI) market is expected to reach a market size of 10 billion dollars in the future.

As a leader in the structural heart disease segment, Jianshi Technology is also actively promoting overseas commercialization. With subsequent product launch, overseas markets are expected to become a new growth engine.

Take LUX-Valve Plus, the company's core product, as an example. In the US, where the medical device market is most mature, the pre-submission (EFS) pre-submission (pre-submission) of LUX-Valve Plus has been officially accepted by the US Food and Drug Administration (FDA), and preparations for the experimental device exemption (IDE) application have been officially initiated. It is expected that EFS clinical research will be completed in the fourth quarter of 2024 and entered the IDE clinical trial preparation stage; at the same time, LUX-Valve Plus was selected Joining the FDA Total Product Life Cycle Advisory Program (TAP) also shows that product innovation and social value have once again been recognized.

In the European market, Lux-Valve Plus was selected to join the European Clinical Expert Committee Scientific Advice Pilot Project (Expert Panel Advice Pilot) initiated by the European Medicines Agency (EMA), with active participation from clinical centers in countries including France, Germany, Spain, Denmark, etc. in 2023, and received unanimous praise from participating clinical centers. ), European commercialization progress will be further accelerated.

In North America and the Asia-Pacific region, LUX-Valve Plus also completed a series of commercialization preparation activities in 2023, and the commercialization capabilities of the product are already beginning to show. In order to meet the huge and urgent treatment needs of tricuspid valve reflux patients around the world, Jianshi Technology will continue to expand commercialization preparations this year.

At the same time, in order to accelerate the global application of products, the company is exploring business development cooperation and partnerships with overseas medical device manufacturers and companies in stages.

In terms of operator training, the 2023 LUX-Valve series products have trained more than 24 independent surgeons and trainers overseas, expanding nearly 50 hospitals to successfully complete implant surgery or therapy promotion, covering North America, Europe, Asia Pacific, Latin America, etc.; globally, the company has trained more than 74 independent surgeons and trainers, covering nearly 270 hospitals.

Since this year, Jianshi Technology and Lux-Valve Plus have also actively participated in academic conferences related to structural heart disease at home and abroad, sharing major clinical research data, classic cases, and live surgical broadcasts, etc., such as 2024 Hangzhou Valve (HANGZHOU) 2024, 2024 European Interventional Cardiology Conference (EuroPCR 2024), 2024 Taipei Valve Summit (Taipei Valve Summit 2024), and 2024 New York Valve Conference (New York) York Valves 2024), 18th Oriental Cardiology Conference and World Congress of Cardiology (OCC-WCC 2024), etc. This not only allows the company to actively follow global academic trends, but also advance the commercialization of subsequent products.

Simply put, in the huge “blue ocean” market of large tricuspid valve products, Jianshi Technology is expected to take the lead in gaining market share with the LUX-Valve series, a core product independently innovated and developed; the excellent performance of LUX-Valve Plus in overseas markets also shows that its ability to go overseas is gradually being verified, driving the gradual fulfillment of profit expectations.

As one of the few medical device companies that completely innovates independently in China, Jianshi Technology already has strong scarce value; with the continuous accumulation of LUX-Valve Plus clinical data and the rapid release of commercialization potential, Jianshi Technology's leading potential is also worthy of market attention and expectations.