Trisol Medical Announces Expansion of Trisol Transcatheter Tricuspid Valve Replacement System Production to 4,000 Units Annually Following Successful Clinical Outcomes

With the aging population, valvular heart disease has gradually become the third most common heart condition after hypertension and coronary heart disease. Academician Ge Junbo once stated: "Valvular heart disease is a hurdle that humanity needs to overcome on the journey towards longevity."

In order to cross this "hurdle," humanity embarked on a century-long exploration.

The History of Heart Valve Surgery Can Be Traced Back to the Early 20th CenturyTraditional heart valve surgery uses a standard median sternotomy incision, which allows for direct visualization during procedures such as valve separation and replacement. However, this approach involves significant trauma, slow recovery, and high risks, making it unsuitable for elderly patients and those with severe comorbidities.

Thus, driven by minimally invasive technology, heart valve treatment has entered the 2.0 era. With the assistance of video-assisted thoracoscopy and surgical robots, valve surgery can be performed through small incisions without a full sternotomy. However, due to limited visibility and operating space, the technical difficulty has greatly increased. Moreover, compared with traditional surgery, clinical efficacy does not show significant advantages. Although this method can reduce surgical trauma, it cannot decrease surgical risks.

At the beginning of the 21st century, transcatheter valve intervention technology ushered in the 3.0 era of heart valve treatment. Through catheter technology, procedures such as valve dilation, repair, or replacement can be performed without the need for extracorporeal circulation or cardiac arrest. It is suitable for patients at high risk or contraindicated for traditional surgery, and the safety of the procedure has also significantly improved.

There is no doubt that interventional treatment will be the most important development direction for the treatment of heart valve diseases in the future. This is undoubtedly good news for the tricuspid valve, which is referred to as "the forgotten valve" by the academic community.

The tricuspid valve is so named because it rarely suffers from isolated diseases and often appears alongside other heart conditions. The challenge lies in the fact that there are usually no obvious clinical symptoms in the early stages of the disease, and it is typically discovered in the later stages when patients often already have other complications. When both medication and traditional surgical treatments show minimal effectiveness, transcatheter therapies almost become the inevitable choice.

Trisol Medical is a company dedicated to the development of transcatheter tricuspid valve replacement devices, aiming to eliminate tricuspid regurgitation (TR) while preserving normal right ventricular function, to address the significant unmet need in the transcatheter treatment of severe tricuspid regurgitation.

Generally, tricuspid valve diseases are caused by changes in anatomical morphology, and "radical cure" cannot be achieved through medication. Only surgical repair or replacement of the tricuspid valve can potentially lead to complete treatment. In the past, open-heart surgery was the standard treatment for valvular diseases. However, due to the high risks involved, most patients with severe tricuspid regurgitation are unable to undergo surgical treatment.

Medical Director Charles Davidson introduced that if these patients were referred to surgical treatment, the mortality rate within 30 days would be approximately 10%. Therefore, before the advent of transcatheter treatment methods, medication therapy became their only treatment option.

To address this dilemma, TriSol Medical has developed its core product, the TriSol System.

The Trisol system is an artificial heart valve system used to treat tricuspid regurgitation. It can be implanted through transcatheter tricuspid valve replacement, with the entire procedure taking up to 30 minutes, compared to 2-4 hours for standard surgery. The system consists of a self-expanding conical nitinol stent and a single-piece bovine pericardial dome-shaped leaflet, suitable for all patients with severe tricuspid regurgitation.

During the surgical procedure, the doctor first inserts the Trisol catheter into the right atrium through the right jugular vein or right femoral vein and positions it at the tricuspid annulus. The position and orientation are then confirmed and adjusted using transesophageal echocardiography (TEE) or X-ray imaging. Next, by rotating the wrench on the Trisol catheter, the Trisol valve is released from the catheter and deployed onto the tricuspid annulus. During this process, the frame of the Trisol valve automatically adapts to the size and shape of the tricuspid annulus, forming a secure fit. Finally, the function of the Trisol valve is evaluated using TEE or X-ray imaging, checking for any residual tricuspid regurgitation or complications. If everything is normal, the Trisol catheter can be removed from the body, concluding the surgery.

The implantation method of the Trisol system is simple and intuitive. The entire process does not require open-heart surgery or extracorporeal circulation, nor does it involve the removal of the native tricuspid valve or manual suturing. This reduces the risk of death and stroke associated with direct open-heart surgery, shortens operation time and recovery period, allowing patients to be discharged generally within 2 to 3 days after the procedure.

The Trisol patented valve features a unique design. It consists of a single leaflet that is secured by two opposing central suture points, allowing it to function similarly to a bileaflet valve. Notably, this innovative design results in a slower closing speed of the leaflet compared to conventional tricuspid valves, reducing pressure on the right ventricular wall and thereby better preserving right ventricular function after valve replacement.

Dilation of the tricuspid annulus is one of the most common causes of tricuspid regurgitation.

Moreover, the morphology and motion of the tricuspid annulus are relatively complex and irregular, posing significant challenges for transcatheter tricuspid valve replacement surgery. If the stent cannot be securely fixed onto the tricuspid annulus, issues such as displacement, leakage, or detachment may occur, potentially causing damage to the heart and blood vessels.

The Trisol system, on the other hand, can be implanted into a tricuspid annulus of any size and achieve stable anchoring. Unlike other transcatheter tricuspid valve repair or replacement technologies, the Trisol system does not have strict requirements for the size and shape of the tricuspid annulus. It uses axial anchoring technology to adaptively secure the valve onto the tricuspid annulus, without being affected by the size or shape of the tricuspid annulus, and without causing excessive contraction or deformation.

The stent of the Trisol system has multiple anchor points that can closely adhere to the tricuspid annulus and adaptively adjust their position with changes in the cardiac cycle. Additionally, the stent is welded with six curved fixation arms that engage with the native valve leaflets and adjacent walls to anchor the valve onto the native annulus, avoiding compression or obstruction of the right coronary artery, thereby minimizing impact on normal blood flow through the right coronary artery. Furthermore, Trisol incorporates two axially extending anchor hooks at both ends of the stent to securely fix the stent onto the tricuspid annulus, preventing displacement or leakage.

The stent height of the Trisol system is lower than that of similar products. This reduces pressure and damage to surrounding structures (such as the right coronary artery, atrioventricular node, and His bundle), avoiding complications like coronary obstruction and atrioventricular block. Additionally, the low-profile design of the Trisol system means it will not occupy excessive space after implantation, ensuring no interference with the heart's electrical conduction system, thereby preventing complications such as arrhythmia, infection, or thrombosis.

On August 23, 2023, Trisol Medical announced the successful completion of the first and second transcatheter tricuspid valve replacement surgeries using the Trisol system in the United States. The trial, led by principal investigator Dr. Isaac George, is an early feasibility study (EFS) approved by the U.S. FDA.

The first procedure was performed on an 84-year-old female patient with severe tricuspid regurgitation (TR). After the surgery, her tricuspid regurgitation (TR) level decreased from severe to none, and she was discharged within two days post-operation. Dr. Pradeep Yadav and others from the Piedmont Heart Institute stated: "The patient was able to move within a few hours after the surgery, and her recovery process was simple and rapid, marking a significant milestone in the treatment of tricuspid regurgitation (TR)."

To date, the Trisol system has been implanted in ten subjects. Five of these cases were part of a pilot study in Israel, with the longest follow-up period now exceeding two years. Trisol Medical plans to complete its EFS and initiate pivotal studies in 2024.

During the feasibility assessment, TriSol Medical will develop a market entry strategy and further development plans, while establishing and expanding its supply chain. In the second phase of the company’s development, TriSol Medical will upgrade the valve and delivery system components of the TriSol system to address various valvular conditions, such as mitral regurgitation. It will also increase the production capacity of the TriSol system to 4,000 units per year and initiate multiple clinical trials to obtain CE certification.

According to VCBeat, from 2021 to 2030, the global transcatheter tricuspid valve intervention device market size will grow from USD 0.1 billion to
$11.28 billion, with a CAGR of 118.35%; in China, from 2023 to 2030, the overall market for tricuspid valve interventional devices will grow from 0.9 billion yuan to 203.1 billion yuan, with a CAGR of 118.44%. It is not difficult to see that the growth rate of China's tricuspid valve interventional device market is consistent with the global growth rate, both of which will be in a state of rapid growth. Among them, a group of domestic innovative medical device companies are making progress and achieving remarkable results in this field.

Peijia Medical was founded in 2012, with its headquarters located in Suzhou. It was listed on the Main Board of the Hong Kong Stock Exchange in May 2020, with the stock code 9996.HK. Its product, the MonarQ TTVR system, features a unique attachment system that conforms to biomechanics, which can fix the implant onto the native leaflets while utilizing and maintaining the heart's natural movement. This system can distribute the heart's contractile load, widely adapt to native annulus sizes, and minimize the occurrence of paravalvular leakage as much as possible. Currently, Peijia Medical has successfully completed the first patient implantation in the MonarQ TTVR clinical trial.

Ningbo Jianshi Technology Co., Ltd. is a medical device company that develops innovative solutions for structural heart disease. Its product, LuX-Valve, is specifically designed for patients with severe tricuspid regurgitation and high surgical risk, replacing the dysfunctional native tricuspid valve with an artificial valve stent through minimally invasive intervention. Currently, the product has received Breakthrough Device Designation from the U.S. FDA.

According to Frost & Sullivan data, the市场规模 of TTV interventions in China is expected to reach 850 million yuan by 2025, with a compound annual growth rate of 215.2% from 2023 to 2025. By 2030, the market size of TTV interventions will reach 20.31 billion yuan. With the continuous iteration of minimally invasive technology and the emergence of innovative equipment, it is believed that tricuspid valve interventions will continue to drive the paradigm shift in structural heart disease therapies, ensuring that the tricuspid valve is no longer "the forgotten valve."

References:

[1] Zhongshan Hospital Shanghai Heart Center. Interventional Treatment of Heart Valves: Technical Principles, Historical Evolution, and Current Understanding [EB/OL]. (2022-03-16) [2023-09-11]. https://m.thepaper.cn/newsDetail_forward_17067894.

[2] Frontiers of Medical Science in China (Electronic Version). Review: The 3.0 Era of Heart Valve Treatment [J/OL]. (2017-12-29) [2023-09-11]. https://m.medlive.cn/cms/research/137309.