NewMed Medical Breaks Domestic Gap with Launch of Prizvalve TAVR System, Ushering in a New Era for China's Transcatheter Aortic Valve Replacement Market

Chinese companies have开创了新局面in the TAVR market, creating a new engine for market growth.

On August 14, 2024, the National Medical Products Administration officially approved the Prizvalve Transcatheter Aortic Valve System developed by NewMed.。

AsFirst Product Launch in ChinaThe self-developed balloon-expandable valve, the Prizvalve valve system, is expected to be the first to break the monopoly of imported products, effectively improve the quality of life, and quickly capture market share.

01

Dancing on the Apex

TAVRA Market Worth Over a Hundred Billion Sets Sail

Aortic valve disease mainly includes aortic stenosis and aortic regurgitation. With the deepening of aging, the prevalence of cardiovascular diseases (including aortic stenosis) continues to rise, and the number of patients with aortic valve disease in China and globally is increasing year by year. This trend not only severely impacts patients' quality of life but also poses a serious challenge to healthcare systems.

Traditional aortic valve treatment mainly includes medication, surgical procedures (SAVR), and the emerging TAVR procedure. Compared with SAVR, TAVR has the characteristics of no need for thoracotomy or cardiopulmonary bypass, minimal trauma, and quick recovery, offering a safer treatment option for high-risk surgical patients. With continuous advancements in device design and physician skills, the position of TAVR in the field of aortic valve treatment is increasingly solidified, with the potential to dominate aortic valve disease treatment and become the mainstream therapy for aortic stenosis.

According to Frost & Sullivan, the global TAVR market expanded from US$1.5 billion in 2014 to US$4.1 billion in 2018, and is estimated to reach US$10.4 billion by 2025, with a compound annual growth rate (CAGR) of 14.3%.

And its research on the Chinese market shows that, in 2021, China had 4.5 million patients with aortic stenosis, but the penetration rate of matching TAVR surgeries was only 0.8%. With the intensification of population aging and the increase in the penetration rate of TAVR surgeries, the size of China's TAVR market is expected to reach 11.36 billion yuan by 2030, which is expected to become an important growth point in the field of heart valve intervention.

Currently, the mainstream types of TAVR approved globally are mainly of two kinds: one is the short-stent balloon-expandable valve, and the other is the long-stent self-expanding valve.Among them, balloon-expandable TAVR has become one of the main treatment methods in the field of interventional treatment for heart valve diseases internationally, achieving a significant market share globally.

Balloon-expandable valves offer advantages such as a lower incidence of coronary obstruction, a reduced rate of permanent pacemaker implantation, and a decreased risk of paravalvular leakage, providing patients with a safer and more effective treatment option.

In the field of balloon-expandable valve implantation, imported brands occupy an absolute dominant position, accounting for more than 60% of the global market., with an annual implant volume exceeding 100,000 cases. As of November 30, 2023, China has performed 13,572 TAVR procedures (cumulatively 37,552 cases), with an estimated annual implant volume of approximately 15,000 cases,But it is roughly estimated that the proportion of balloon-expandable valve implants in the Chinese market is less than 10%.

In the face of huge market demand, a market revolution of balloon-expandable valves is quietly taking place in China.

02

Take the Lead

NewMed Breaks the Blank of China-Produced Market

In the selection of expansion modes, balloon-expandable valves and self-expanding valves each have their own advantages. Balloon-expandable valves offer more precise positioning, a valve-in-valve design, and a lower stent frame profile, which help preserve coronary access and facilitate subsequent coronary reintervention.Balloon-expandable valves, as one of the most commonly used types of TAVR procedures, currently have Chinese-produced balloon-expandable valve devices still in the initial and exploratory stages due to high technical barriers.

However, against the backdrop of a solid foundation and positive industry logic for aortic valves in China, the barriers in the Chinese balloon-expandable valve market have been broken by domestic companies.

As the first domestically developed balloon-expandable valve to be launched in China, NewMed's Prizvalve valve system truly fills the market gap for domestically produced balloon-expandable valves. The development of the Prizvalve valve system, which took eight years, has fully ushered in the era of balloon-expandable valve interventional treatment for valvular heart disease in China.

It is understood that,The Prizvalve valve system is suitable for patients with calcified, severe degenerative native aortic valve stenosis, assessed by the heart team as unsuitable candidates for conventional surgical valve replacement.The valve frame, made of cobalt-chromium alloy, provides sufficient radial support and can be compressed to a smaller size; a unique tissue treatment process enhances the durability of the valve; the design of the inner and outer sealing membrane skirts effectively reduces paravalvular leakage. The delivery system’s excellent bending adjustment capability helps avoid vascular complications and ensures coaxial alignment of the valve. The marker point design, along with the combination of inner and outer tubes, assists doctors in achieving precise positioning during the procedure.

The latest clinical trial data also proves this point: the Prizvalve valve system can extend and improve patient survival over 24 months, demonstrating reliable safety and effectiveness in clinical trials.

03

Focus on "Bottleneck" Problems

The Era of Balloon-Expandable Valves in the Interventional Treatment of Valvular Heart Disease Begins

The approval of the Prizvalve valve system has become the first "domino" to impact the balloon-expandable valve market in China, leading to a shift in technological innovation and competitive landscape across China’s entire arterial valve market. The era of domestically produced balloon-expandable valves has truly arrived.

Chinese-made balloon-expandable valves finally have the opportunity to compete with imported brands, although this is just the first step. With the accumulation of more clinical trial data and the iterative optimization of products, the market for Chinese-made balloon-expandable valves will also make significant progress, and the leap forward in China's heart valve field is within sight.

To continuously incubate cutting-edge technologies and integrate resources from the government, industry, academia, research, medical, and capital markets,Starting from September 22, NewMed will kick off a series of channel city salons in Chengdu as the first stop, followed by other cities across China., aiming to build an efficient and open communication platform, promote in-depth communication and cooperation among channel partners, and jointly explore new opportunities and challenges in the medical and health field.

The first stop of NewMed's Urban Salon will be officially held from 17:00 to 20:00 on Sunday, September 22, at the City Xingye - Greenway Campsite in Chengdu.，The event will feature various themed interactive sessions, including market status analysis, product advantage presentations, hands-on product workshops, marketing policy discussions, market planning discussions, special topic discussions, and a surprise carnival.

Note:The above timeline is a preliminary arrangement, and specific details may be adjusted according to the actual situation. Please refer to the final information we will release subsequently.

To ensure that you can obtain the latest conference updates and detailed agenda in a timely manner, we have specially set up an exclusive consultation channel. If you have any questions or need further information about the conference, please feel free to contact us.

Disclaimer: This article is intended solely for professional partners in the pharmaceutical, medical, and other health industries. It is for reading and reference by medical and pharmaceutical professionals only and is not aimed at the general consumer audience.