The innovative development of the medical device industry has received another positive signal.

Recently, the Third Plenary Session of the Central Committee clearly put forward the "improvement of the mechanism to support the development of medical devices", which not only injects new impetus into the innovation and research and development of medical devices, but also points out the direction for the rapid development of the industry. The enhanced support from the top level design means that these manufacturers will receive more resources and policy support, injecting new impetus into the innovation and research and development of medical devices.

From an investment perspective, the market's focus on the medical device industry has shifted from simply replacing domestic products to a dual consideration of innovation capabilities and market competitiveness. Investors are increasingly concerned about companies that can provide disruptive products and continuously make breakthroughs to fill market gaps. These companies often have strong R&D capabilities and market insight, enabling them to seize opportunities in fierce market competition and achieve sustained growth and development.

On August 27, JianShi Technology released its 2024 semi-annual performance report. While the company's losses narrowed significantly, its cash reserves remained abundant, providing strong support for the company's stable operation and global expansion strategy.

According to the financial report, the company's net loss attributable to the parent in the first half of the year was 0.102 billion yuan, a significant narrowing of 41.8% compared to the same period last year. At the same time, as of June 30, the company's cash reserves remained at a high level of 0.922 billion yuan.

Through the financial report, it can be seen that JianShi Technology ensures effective use of funds through strict cash flow management, cost control, and cost saving strategies. By optimizing resource allocation, the company focuses on supporting the global market promotion and commercialization of its core products. This strategic resource allocation not only accelerates the internationalization of the company's products, but also further consolidates its competitive advantage in the global market.

Clinical trial successes are emerging in multiple regions, and the global layout strategy is steadily progressing.

From a strategic development perspective, as the global population ages, the demand for efficient and minimally invasive treatment methods is increasing not only in China, but also in various overseas regions.

Insight into market trends, Jianshi Technology focuses on the research and development of interventional medical devices for structural heart disease. It has successfully developed a series of treatment solutions for different types of structural heart diseases such as tricuspid valve disease, aortic valve disease, mitral valve disease, and cardioembolic stroke.

Among them, the company's biggest highlight is the LuX-Valve series of products for transcatheter tricuspid valve replacement.

Firstly, in terms of structural characteristics, the LuX-Valve series products, with the globally pioneering concept of 'intraventricular anchoring' and non-radial support force design, have set a benchmark for the treatment of tricuspid regurgitation. On this basis, the second generation LuX-Valve Plus, through the upgraded transvascular delivery system, has achieved a more advanced jugular vein access method, demonstrating extremely high clinical value.

Secondly, in terms of clinical progress, the global layout of LuX-Valve Plus has begun to take shape, showcasing the company's competitiveness and influence in the global field of structural heart disease treatment.

In China, LuX-Valve Plus has completed a one-year follow-up and is expected to be submitted for registration in the near future, entering the harvest period.

According to the six-month follow-up data from the TRAVEL II study released in July, LuX-Valve Plus demonstrates excellent efficacy and safety, with a device success rate of approximately 97% and an average device operation time of 35.56 minutes.

In terms of efficacy, all subjects showed improvement in tricuspid regurgitation, with 97.62% of patients demonstrating no moderate or severe regurgitation. In terms of improvement in New York Heart Association (NYHA) functional classification, 91.86% of patients improved from preoperative class III/IV to postoperative class I/II. In terms of improvement in quality of life, the average Kansas City Cardiomyopathy Questionnaire (KCCQ) score increased by 20 points. In terms of safety, the six-month composite event rate was only 8.33%.

The six-month clinical follow-up results of the TRAVEL II study have demonstrated the excellent mid-term clinical performance of LuX-Valve Plus. After entering a longer follow-up observation period, there has been no apparent increase in safety events, and efficacy continues to improve. Patients' cardiac function and quality of life have also been further improved, resulting in sustained clinical benefits.

LuX-Valve Plus has also made significant progress in overseas regions.

The follow-up results of the six-month TRAVEL II study, which was previously released by the company at the valve conference in New York, USA, have demonstrated that LuX-Valve Plus can achieve safe and effective shorter device operating times, lower composite event rates, significant reduction in regurgitation grade at the 6-month mark, as well as noticeable improvement in cardiac function and quality of life indicators. This has been widely recognized and highly regarded by experts and scholars in attendance.

In the United States, the early feasibility study of LuX-Valve Plus has obtained an investigational device exemption approval from the FDA. The study has now officially started, and the company will continue to promote the application of this product in the US market.

In Europe, the subject enrollment phase of the clinical trial for obtaining CE certification for LuX-Valve Plus is nearing completion. Multicenter clinical centers from seven countries around the world have all given unanimous praise.

A study on the compassionate use of LuX-Valve Plus globally, particularly for patients with advanced tricuspid regurgitation and a large right ventricle, as presented at the European Congress of Cardiology Interventions in 2024, shows that the product as a TTVR system is not only safe but also effectively reduces regurgitation grade. This validates its applicability and clinical value in a broader patient population.

It is evident that the performance of LuX-Valve Plus in terms of innovation and clinical value fully demonstrates Jenesis' strength in innovative research and development. Currently, LuX-Valve Plus has completed a series of commercialization preparations in multiple regions worldwide. In order to meet the large and urgent treatment needs of tricuspid regurgitation patients worldwide, the company will continue to promote the application of the product globally, further consolidating its important position in the field of structural heart disease interventional medical devices.

The pace of innovation continues to accelerate, adding certainty to growth.

However, the fierce market competition and rapid innovation in products nowadays also pose significant challenges to innovative medical device manufacturers like Jenesis.

In the face of this situation, Jianshi Technology not only needs to continue to increase research and development, accelerate product innovation, promote product commercialization, in order to maintain its leading position in the field of structural heart disease interventional medical devices. At the same time, it also needs to closely monitor global market dynamics, and flexibly adjust market strategies to respond to changes in market demand in different regions. Only in this way can the company establish itself in the global market and achieve sustainable development.

It is reported that Jianshi Technology continues to promote the clinical progress and global application of its innovative products to meet the huge and urgent clinical needs of the global market, and is expected to have multiple breakthroughs in the second half of the year.

Taking the core LuX-Valve series products as an example, according to the company's mid-term performance announcement, LuX-Valve Plus will complete the registration clinical trial enrollment in Europe in the third quarter of this year, submit the registration approval application to the National Medical Products Administration in mainland China, and is expected to complete the EFS clinical trial enrollment in the United States in the fourth quarter of this year.

Of course, in addition to the LuX-Valve series products, the commercialization of Jianshi Technology's other interventional medical device products is also steadily accelerating.

For example, the company expects that the transcatheter aortic valve replacement system Ken-Valve is currently in the process of applying for registration and evaluation; the transcatheter mitral valve repair system JensClip has completed all confirmatory clinical trial enrollments and one-month follow-up, with excellent clinical results.

It is expected that with the successive approval and listing of these products in the future, Jianshi Technology's commercial product portfolio will also become more abundant and complete, not only providing patients with better and more comprehensive treatment options, but also bringing more diversified sources of revenue to the company, enhancing its attractiveness and competitiveness in the capital market.

Conclusion

Looking at the capital market perspective, major brokerage institutions are generally optimistic about the future growth trend of the innovative medical device industry.

For example, Everbright Securities stated that in the domestic market, especially with the intensive introduction of policies to support innovation in medical devices, the value of the medical device sector is expected to be re-recognized by the market and the valuation level will be restored as products are gradually approved and put on sale.

Everbright Securities points out that domestic medical device companies have achieved success in exploring international markets, and the overseas market for medical devices is facing unprecedented opportunities. Currently, with the exploration of international markets, many high-quality companies with global layouts and strong research and development capabilities have emerged. It is recommended to focus on companies with global layouts and strong research and development capabilities.

In this environment, the advantages demonstrated by Innovative Medical Management in terms of innovative research and development and global strategic layout may indicate that the company's core competitiveness will be further enhanced. It is believed that as the company gradually explores and releases market potential, its performance is expected to significantly improve and achieve revaluation and enhancement in the capital markets.