Recently, LuX-Valve Plus of Johnson & Johnson Medical Devices Companies' TRAVEL II multicenter clinical trial of Transcatheter Tricuspid Valve Replacement System was presented at the 2024 Transcatheter Cardiovascular Therapeutics (TCT 2024) in the USA.

LuX-Valve Plus is the second-generation Transcatheter Tricuspid Valve Replacement System independently developed by Johnson & Johnson Medical Devices Companies, designed for patients with severe tricuspid regurgitation and high surgical risk, eliminating the need for conventional open-heart surgery. It can be functionally implanted through minimally invasive intervention to replace the dysfunctional native tricuspid valve with an artificial valve.

As a core l product highly anticipated by the market, LuX-Valve Plus has many highlights in both market prospects and technical value.

Public information indicates that the heart valve market covers many valve device categories such as aortic, pulmonary, mitral, tricuspid valves, and tricuspid valve intervention belongs to a high R&D barrier, market scarce cutting-edge field, with broad blue ocean market space.

Tricuspid regurgitation is caused by the inability of the tricuspid valve to close completely, leading to blood flowing back from the right ventricle to the right atrium during the heart's contraction period, which can eventually lead to right-sided congestive heart failure, peripheral edema, ascites, and congestive hepatopathy. Traditional treatments only offer control through medication, while traditional surgical procedures as a final resort are highly invasive, posing considerable risks for elderly and high-risk patients.

Compared to traditional surgical procedures, transcatheter tricuspid valve intervention products have unparalleled safety advantages. Global companies like Edwards Lifesciences, Abbott Laboratories, and others are eyeing this promising niche market.

In comparison with global counterparts, LuX-Valve Plus is among the first-tier leaders in research and development progress. Public information reveals that currently, only Johnson & Johnson Medical Devices Companies' LuX-Valve series and Edwards Lifesciences' EVOQUE have entered the confirmatory clinical trial stage globally. LuX-Valve Plus is poised to become one of the world's first commercially available tricuspid valve intervention replacement products. With a rapid market penetration post-launch, this product is expected to significantly boost the company's performance.

The one-year follow-up results show excellent clinical performance.

Recently, the one-year follow-up results of LuX-Valve Plus were officially released at the Transcatheter Cardiovascular Therapeutics (TCT 2024) in the USA. The one-year follow-up data performed excellently, indicating further validation of product safety, efficacy, and moving closer to commercialization.

Specifically, effectiveness results show that in the one-year trial, all enrolled patients demonstrated improvement in tricuspid regurgitation level, with 95.30% of patients showing no moderate or severe regurgitation. Regarding heart function improvement according to the New York Heart Association classification, approximately 85% of patients improved from preoperative III/IV class to postoperative I/II class within one year. In terms of quality of life improvement, the Kansas City Cardiomyopathy Questionnaire score increased on average by 21 points at the one-year mark. Effectiveness indicators continued to show improvement.

(Illustration: Effectiveness Results)

Safety results indicate a composite event rate determined by the Clinical Events Committee (CEC) to be 12.50%. Among them, life-threatening major bleeding, cardiovascular injuries requiring surgical intervention (cardiac perforation, vascular injury), myocardial infarction, use of ECMO or IABP, acute liver function failure, and long-term mechanical ventilation (>72 hours) all had event rates of 0. The event rates for acute kidney failure, new implantation of pacemaker due to III-degree atrioventricular block, and severe paravalvular leak were 1.04%, 2.08%, and 2.08% respectively. The safety event rate remained at a low level.

(Illustration: Safety Results)

Overall, the one-year follow-up data demonstrated the excellent mid-to-long-term clinical performance of LuX-Valve Plus, with safety events remaining at a low level even after entering a longer clinical observation period. Effectiveness continued to improve, leading to further enhancement of patients' heart function and quality of life, providing sustained clinical benefits.

According to the WiseTech Financial News App, Lux-Valve Plus is a transcatheter tricuspid valve replacement product with complete independent intellectual property rights in China. It is the first globally to apply the design concepts of 'non-radial support force' and 'interventricular septum fixation.' The anchoring method of 'non-radial support force' can better adapt to the fragile nature of tricuspid valve tissue, without exerting radial force compression on the valve annulus, making it less likely to cause coronary artery injury or atrioventricular conduction blockage. The brand-new transvascular delivery system (via the jugular vein) minimizes physical trauma to patients, facilitates quick postoperative recovery, and further reduces surgical risks.

In addition, the LuX-Valve Plus offers a variety of optional models ranging from 40-70mm, making it flexible to deal with many challenging tricuspid valve anatomies and clinical treatment scenarios, greatly enhancing the versatility of the product. Up to now, there have been multiple successful applications of the LuX-Valve Plus around the world, with the product's safety and efficacy receiving unanimous acclaim from the industry.

At the Transcatheter Cardiovascular Therapeutics (TCT 2024) conference in the USA, a pathological report from Clinic Barcelona, a clinical center in Barcelona, showed that a 59-year-old male patient with a history of high blood pressure, obesity, type A hepatitis, permanent atrial fibrillation, as well as tricuspid endocarditis with tricuspid regurgitation, right heart failure, septic pulmonary embolism, pulmonary emphysema, and requiring long-term stay in the ICU. Due to the high-risk nature of this patient not suitable for traditional open-heart surgery, and severe valve annular dilatation with a large central opening, after CT evaluation, the center decided to select the LuX-Valve Plus system as the replacement product path. A 30-day follow-up post-surgery showed improvement in all functional and quality of life indicators, with heart function returning from NYHA class III to I/II, and a 37-point increase in KCCQ score; 6-month follow-up data showed an improvement in heart function to NYHA class I, and a 42-point increase in KCCQ score. Dr. Omar Abdul-Jawad Altisent from the hospital stated that this is the first successful case of a percutaneous tricuspid valve replacement product used for a patient with endocarditis, severe aseptic vegetations, and late-stage right heart failure.

At the EuroPCR 2024 conference, another retrospective cohort study was presented, with 76 patients included. The average age of the patients was 78 years, with 90.7% of patients classified as NYHA class III/IV, 97.4% had severe tricuspid regurgitation, 90.7% had atrial fibrillation/flutter, and an average eGFR level of 42.0 ml/min. The results showed that by assessing tricuspid regurgitation severity via echocardiography, 94.7% of preoperative populations in severe and above categories (regurgitation graded 3+, 4+, 5+) transitioned postoperatively to moderate or below (regurgitation grade ≤2+). The 30-day survival rate was 94.4%, with 95% postoperatively remaining stable at moderate or below tricuspid regurgitation for severe and above cases, and 85.4% transitioning to NYHA class II or even I postoperatively. Additionally, in terms of heart failure, the proportions of edema, ascites, and pleural effusion occurrence were lower at 30 days post-surgery.

The study concluded that using the Lux-Valve Plus system for TTVR via the jugular vein is safe, effectively reducing tricuspid regurgitation and converting to clinical improvement within 30 days. The prognosis for patients receiving smaller (≤55 mm) or larger (>55 mm) valves is comparable, indicating the feasibility of TTVR in patients with late-stage tricuspid diseases characterized by right ventricular enlargement. The study noted that the Lux-Valve Plus system provides a treatment option for patients who may not have other interventional treatment choices.

According to the latest announcement from Genesee Technology, as of the end of October, the company's self-developed transcatheter tricuspid valve replacement system products have been implanted globally in over 600 cases, with the longest follow-up record exceeding six years. In the current expanding domestic medical device market, as one of the representative innovative medical products, Lux-Valve Plus is expected to drive the accelerated release of the company's performance potential.

The global commercialization process is steadily advancing.

Clinical trial successes are boosting Genesee Technology's academic influence steadily. With rapid progress in global layout, Genesee Technology's leading position in the global structural heart disease interventional medical device market continues to consolidate.

According to the latest information, the LuX-Valve Plus registration clinical trial with the target of obtaining CE certification in Europe is nearing completion, and the early feasibility study in the US has been approved by the FDA and initiated; the product is expected to submit a registration application domestically soon and is likely to be approved in the second half of 2025. In addition, Ken-Valve and JensClip have also made positive progress in registration applications and clinical trials in mainland China.

At the same time, the company's first-half net loss narrowed significantly, with a net loss attributable to the parent company of 0.102 billion yuan, a year-on-year decrease of 41.82%; cash funds amounted to 0.922 billion yuan, providing solid support for the company's future research and development progress and market expansion.

As of now, Johnson & Johnson has six products in different stages of development, and its diversified product matrix lays a solid foundation for future performance growth. In the future, the company will focus on the global promotion of the LuX-Valve series of transcatheter tricuspid valve replacement products, bridging the entire industry chain from research and development to commercialization, and accelerating the transformation of research results.

Looking ahead, with the accelerated commercialization of blockbuster products, Johnson & Johnson is about to enter a period of explosive performance. As the medical device industry transitions to high-quality development, Johnson & Johnson's future growth prospects are worth investors' anticipation.