Bluesail Medical Successfully Completes Acquisition of Swiss TAVR Company NVT AG, Entering the High-Growth Structural Heart Disease Market

After nine months, Bluesail Medical’s overseas acquisition has finally reached a successful conclusion. On the evening of June 9, Bluesail Medical released the “Announcement on the Completion of Closing for the Acquisition of 100% Equity Interest in Swiss Transcatheter Aortic Valve Replacement (TAVR) Company NVT AG.” In the announcement, Bluesail Medical stated that the acquisition of 100% equity interest in interventional aortic valve company NVT AG (“NVT”) for RMB 1.39 billion has been smoothly closed. Effective immediately, NVT, a heart valve research and development enterprise headquartered in Switzerland, will be formally integrated into Bluesail Medical.

NVT’s flagship product is Allegra, an implantable device for transcatheter aortic valve replacement (TAVR), primarily used to treat aortic stenosis. The global TAVR market was valued at $4 billion in 2019. According to predictions by TCT (Transcatheter Cardiovascular Therapeutics), the economic value of TAVR will surpass that of coronary stents by 2025.

With the addition of NVT, Bluesail Medical has officially entered the high-growth, multi-billion-dollar TAVR sector. The company’s cardiovascular and cerebrovascular business landscape is further strengthened, while its premium consumables product line gains a flagship product, accelerating profitable growth.

Liu Wenjing, Chairman of Bluesail Medical, stated: “The acquisition of NVT represents a milestone in Bluesail Medical’s strategic development. With the integration of NVT, Bluesail Medical’s cardiovascular and cerebrovascular business portfolio has officially entered the promising field of minimally invasive interventional therapies for structural heart disease. This move adds an emerging new track, introduces a groundbreaking product that benefits patients, and ushers in a new future benchmarked against global standards while improving patient outcomes.”

According to the announcement by Bluesail Medical, NVT’s main product is Allegra, an implantable device for TAVR (Transcatheter Aortic Valve Replacement), primarily used to treat aortic stenosis.

In recent years, transcatheter aortic valve replacement (TAVR) has remained a hot topic in cardiovascular academia and investment. Compared with traditional treatment methods, TAVR, as a minimally invasive valve replacement procedure, allows interventional devices to be delivered to the heart via blood vessels—similar to percutaneous coronary intervention (PCI)—thereby completing valve replacement and restoring valve function. Clinical studies in recent years have expanded the indications for TAVR from high-risk patients with severe aortic stenosis to include those at moderate and even low risk. Data from the TVT CHICAGO conference showed that approximately 125,000 TAVR procedures were performed globally in 2018. With an annual growth rate exceeding 20%, the number of global TAVR procedures is projected to approach 290,000 by 2025. The global market size for TAVR products reached USD 3.5 billion in 2018, is expected to exceed USD 5 billion by 2021, and may double to USD 7 billion by 2024. The compound annual growth rate (CAGR) from 2018 to 2024E is estimated at 12%, surpassing most other medical device subsectors worldwide and indicating a phase of rapid growth.

Due to the high technological complexity and significant R&D challenges associated with TAVR products, implantable TAVR devices remain scarce globally. NVT possesses strong R&D capabilities in this field. Its core product, Allegra, obtained CE (Conformité Européenne) certification from the European Union in March 2017, making NVT one of only five TAVR manufacturers to enter the European market. The other four are Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott—all multinational giants in the comprehensive medical device industry. As one of only five TAVR manufacturers with access to the European market, NVT’s prominent position in the field of structural heart disease is self-evident.

▲ Estimated Number of Potential TAVR Candidates and Market Size in China Data Source: Infinity Capital

▲ Forecast of China's TAVR Market Size Data Source: Huatai Securities Research Report

China’s TAVR market is still in its nascent stage, with a penetration rate of only around 0.1%. The technology remains in the market introduction phase. To date, approximately 2,000 TAVR procedures have been performed in China, compared to roughly 350,000 cases completed internationally. This contrast highlights substantial growth potential for TAVR procedures in China, indicating a vast addressable market. According to data from Star Infinity Capital and Huatai Securities research reports (see figure above), the number of patients with severe aortic stenosis (sAS) in China is projected to reach 3.587 million by 2029, and the TAVR market size is expected to exceed RMB 10 billion, reaching RMB 13.12 billion. The future market opportunity is therefore immense.

TAVR is hailed as an innovative technology spearheading the “Fourth Interventional Cardiology Revolution.” Leading global medical device giants have successively made strategic moves in this field, strongly affirming the substantial market potential of TAVR products. In the global cardiovascular intervention market, TAVR business growth has emerged as a primary driver. A review of the annual reports of several major international players in the cardiovascular intervention sector reveals that TAVR is currently at the forefront of industry attention.

Source: The above data are derived from corporate financial reports and other materials (unit: USD 100 million).

Among the industry giants, Edwards Lifesciences has written a legend of tenfold market capitalization growth over a decade, driven by its TAVR products. In 2007, the company’s disruptive innovation, the transcatheter heart valve Edwards SAPIEN, was launched in Europe, propelling Edwards Lifesciences onto a fast track of development. With the introduction of the second- and third-generation transcatheter heart valves, SAPIEN XT and SAPIEN 3, and the gradual expansion of TAVR indications to include patients with severe aortic stenosis at intermediate surgical risk, the company’s transcatheter aortic valve revenue experienced explosive growth, accompanied by a steady rise in its stock price. In 2018, its TAVR business contributed nearly $2.3 billion in revenue, accounting for 61.4% of the company’s total revenue, while its market capitalization surged to nearly $40 billion.

In China, the TAVR sector is also highly sought after by the market. Currently, Hangzhou Venus Medtech’s transcatheter heart valve system (Venus-A), a domestically produced device, received approval for market launch in 2017 through the special review channel for innovative medical devices. Shanghai MicroPort’s aortic valve system (VitaFlow) was approved for market launch in 2019, while Peijia Medical’s transcatheter aortic valve system, TaurusOne, is currently in clinical trials. Among these three companies, Venus Medtech, Peijia Medical, and MicroPort CardioFlow have all secured investments from Hillhouse Capital. Venus Medtech listed on the Hong Kong Stock Exchange in December 2019, achieving a market capitalization of HK$16.9 billion on its first day of trading. Peijia Medical listed in Hong Kong in May 2020, with a first-day market capitalization of HK$15.7 billion. Although MicroPort CardioFlow has not yet generated revenue, its current valuation is reported to have reached US$1.3 billion (approximately RMB 9 billion).

The TAVR product Allegra™, from NVT which was recently acquired by Bluesail Medical, received CE registration in 2017 and is currently being sold in Europe. According to the announcement, the total consideration for this transaction amounts to RMB 1.39 billion, making it a highly cost-effective deal for Bluesail Medical.

Bluesail Medical stated that, following the completion of the acquisition, the company would immediately initiate clinical registration for TAVR in the Chinese market, leveraging NVT’s long-accumulated patents and core technologies alongside Biosensors International’s R&D capabilities in cardiovascular devices. As China is on the verge of a TAVR market boom, Bluesail Medical is well-positioned to capitalize on the substantial growth opportunities in the Chinese TAVR sector by introducing internationally leading product technologies, with clinical registration expected to be completed within approximately three years.

According to reports, NVT’s first-generation TAVR has received high acclaim in Europe and was approved in May 2020 for the region’s first “valve-in-valve” indication. Currently, NVT’s products marketed in Europe feature repositionability and recapturability after up to 70% sheath withdrawal, while its second-generation TAVR product will offer full 100% recapture and redeployment capabilities. In 2021, NVT will simultaneously launch clinical trials for its second-generation device in both Europe and China. Meanwhile, the company has already initiated R&D efforts focused on mitral and tricuspid valve repair and replacement, positioning its overall portfolio at the forefront of global innovation.

Since entering the high-value consumables sector, Bluesail Medical has adhered to a dual-drive development strategy of “organic growth + inorganic expansion,” formulating its corporate development strategy with a “global perspective, international standards, and local advantages.” By planning and laying out its operations with a global vision, the company has deeply cultivated the medical device market. The successful completion of this overseas acquisition once again validates the strategic success of Bluesail Medical’s globalization approach. It will further broaden the company’s international product portfolio, unlock new growth opportunities, and propel Bluesail Medical toward becoming a multinational, platform-based medical device enterprise centered in China with a global reach.