Venus Medtech Inc. Hangzhou - Global Leader in Transcatheter Therapy Products for Structural Heart Disease

Necessity is the mother of inventions!’ Today, this saying fits the healthcare industry more aptly than ever before, as the global healthcare industry continues to demand innovative products that improve treatment and save as many lives as possible.

The drastically changing lifestyle and the rapid pace of life have given rise to various structural heart diseases worldwide. It is known that matters related to heart diseases need to be dealt with delicately and with the best medical therapy available. Venus Medtech (Hangzhou) Inc. came into existence to empower the healthcare industry with superior technology-enabled products for the treatment of structural heart diseases.

Venus Medtech is a leader in transcatheter structural heart valvular therapies in China. Founded in 2009, the company is located in the Hangzhou National High-Tech Industrial Development Zone (Binjiang) and is committed to the development and industrialization of transcatheter therapy products for structural heart disease. Venus is the brainchild of the visionary and expert leader, Eric Zi. As the Executive Director and General Manager of the company, he ensures that the company always keeps innovating and expanding its presence worldwide with superior products.

Without further ado, let’s delve into the success story of Venus Medtech:

Comprehensive Solutions for Structural Heart Disease

As China’s dominant provider of transcatheter aortic valve replacement (TAVR) devices, Venus Medtech sustained its industry leadership in 2021, covering nearly 70% of implantations in the market.

Four industry-first achievements mark the impressive progress of Venus Medtech:

· The first company to start and complete NMPAregistered (The National Medical Products Administration) clinical studies.

· The first cardiovascular device approved by the NMPA Green Pathway for Innovative Medical Devices

· The first created-in-China heart valve device to conclude First-in-Man clinical use in Europe

· The first company approved to establish a heart valve research institute in China.

Venus Medtech has established comprehensive solutions for structural heart disease, with a complete product pipeline covering all four heart valves, namely TAVR (transcatheter aortic valve replacement), TPVR (transcatheter pulmonic valve replacement), TMVR (transcatheter mitral valve replacement), and TTVR (transcatheter tricuspid valve replacement), as well as hypertrophic cardiomyopathy, hypertensive renal denervation (RDN) therapy, and relevant accessory products.

On December 10, 2019, the company was listed on the main board of the Hong Kong Stock Exchange (SEHK)

with stock code 02500.

Leading Manufacturer of TAVR Devices

Venus Medtech owns the earliest first-generation, and second-generation TAVR products (VenusA-ValveTM and

VenusA-PlusTM) approved for marketing in China. They have been implanted into over 10,000 patients and have

covered 370 hospitals and medical centers nationwide so far. A wealth of clinical follow-up data was gathered from these establishments, sufficiently testifying to their safety and effectiveness. VenusA-ValveTM is currently the only TAVR product with long-term safety verification for more than seven years in China.

As China’s dominant provider of transcatheter aortic valve replacement devices, Venus Medtech sustained its industry leadership in 2021, covering nearly 70% (the largest) of the market share. Also, Venus Medtech boasts a best-in-class innovative cardiovascular device marketing team, which has by October, 2022 expanded to 260 members.

Systematic marketing training enabled Venus’s marketing team to better inform and assist doctors and patients on the clinical use of the products, ensuring strong support and considerate services.

Spreading Wings Worldwide

Venus Medtech has been expanding its global presence at a robust pace while keeping its leading position in commercialization in China. Europe is the bridgehead of Venus Medtech’s international strategy. The TriGUARD3TM cerebral embolic protection (CEP) device, the company’s first innovative medical device launched in Europe (March 2020), is widely recognized by clinical experts. Venus Medtech registered RMB10.51 million in overseas revenue in 2021, a marked year-on-year increase of 160.5%, with the sales of TriGUARD3™. And its in-house team developed an innovative TPVR system that obtained CE marking under the Medical Devices Regulation (MDR) on April 8, 2022.

VenusP-ValveTM is the first Chinese-made artificial heart valve approved in Europe; the first self-expanding TPVR product available in the Europe and the first Class III implantable cardiovascular device approved under the new MDR, marking a new milestone in the global presence of China’s innovative medical devices. By now, VenusPValveTM has completed the first commercial case in Europe and obtained approval from FDA (Food and Drug Administration) for Compassionate Use. With the approval by China’s National Medical Products Administration (NMPA) in July 2022, VenusP-Valve™ became the first self-expanding TPVR product approved in both China and Europe. Moreover, Venus Medtech has built a winning commercialization team for the European market. The company has also engaged quite an amount of marketing veterans as senior managers.

Last but not least, Venus Medtech has attached great importance to intellectual property protection. Leveraging

its strong R&D capability, as of October 2022, a total of over 800 patents and patents under applications, including over 300 authorized invention patents. Its global IP portfolio mainly covers China, the U.S., Europe, Japan, Canada, Russia, India, Brazil, and other countries.

Exclusive and Innovative Solutions Portfolio

Venus Medtech owns a complete product pipeline covering all four heart valves: TAVR, TPVR, TMVR, and TTVR.

TAVR: VenusA-ValveTM, developed by Venus Medtech, is the first NMPA-approved TAVR product and the first TAVR product commercialized in China.

VenusA-PlusTM is the earliest second-generation (retrievable) TAVR product approved for marketing in China.

TMVR & TTVR: Venus Medtech invested in Valgen Medtech in May 2021 to improve its strategic layout in the field of structural heart disease treatment and enhance the product layout in mitral valve repair and tricuspid valve repair. Its DragonFly is the first transfemoral mitral valve TEER product in China, and its DragonRing acts as the first catheter-based transfemoral direct annuloplasty ring system innovated in China that simulates the gold-standard atrioventricular annuloplasty technique from contemporary cardiac surgery.

Cardiovalve: Venus Medtech acquired Cardiovalve Ltd. (Cardiovalve), a pioneering transcatheter mitral and tricuspid valve treatment company, in January 2022. This acquisition enabled Venus Medtech to become one of the most complete platform companies in the field of mitral regurgitation and tricuspid regurgitation treatment in China. It’s noteworthy to mention that Cardiovalve stands as the first privately held company to receive FDA’s early feasibility study (EFS) approval for both TR and MR indications.

TPVR: VenusP-ValveTM, Venus Medtech’s in-house developed innovative TPVR system, obtains CE marking

under MDR and debuts in Europe as China’s first valve product. Following its CE MDR approval, the recent

approval of VenusP-Valve™ in China made it the first selfexpanding TPVR product approved in both China and Europe. It is also the first self-expanding TPVR product available in Europe.

Existing TPVR products in the European market, due to their balloon-expandable design, apply to patients with

particular anatomic structures only and require pre-stenting. Moreover, as these valves come in small diameters, they only work for 15% to 20% of patients. Prior to the certification of VenusP-ValveTM, there was no TPVR product suitable for different anatomical structures and available in such a wide range of specifications.

The Expert Leader

Eric Zi is the Executive Director and General Manager of Venus Medtech. He has over 20 years of R&D and operations experience in the implantable medical devices industry. He always insists on developing unprecedented, ground-breaking technologies in China and beyond. Eric’s experience as the main designer of China’s firstgeneration PTCA balloon, coronary stent, aortic aneurysm stent, and left atrial appendage occluder gave him a glimpse of the way forward for Chinese medical devices. Later, he developed the first generation of congenital heart disease interventional occluder and inferior vena cava thrombus filter products in China, and successfully introduced them to international markets.

Venus Medtech is Eric’s third entrepreneurial venture. “Given my past experience, I know at the very beginning

what kind of company is to be established and the vision ahead (becoming a global leader in structural heart

disease),” he says.

He elaborates further, “I can still recall that my 20 team members and I took every opportunity to study foreign

products. We would calculate the product parameters by merely looking at pictures of various international

exhibitions. I would like to mention that before VenusAValve, there was not even a single China-made TAVR valve. We were brave enough to enter ‘no man’s land’.“

However, the huge gap in technology at home and abroad was what his team had to face in the early stages of his entrepreneurship. Patient screening, BAV(bicuspid aortic valve), severe calcification of Chinese patients, and a small vascular approach posed a great challenge to the company during the initial days. The team took five years (2006–2011) to bring their concept to a real device, and another five years (2012–2017) to put the device into practice. It made continuous improvements and upgrades based on its clinical outcomes.

Eric and his team’s hard work finally paid off as the self-developed VenusA-ValveTM was approved by NMPA in 2017, becoming China’s first TAVR system. Afterwards, the first TAVR system with a retrievable function in China, VenusA-PlusTM, was approved by NMPA in 2020. VenusPValve™, Venus Medtech’s in-house developed innovative TPVR system obtained CE marking under MDR and was approved by NMPA in 2022, making it the first selfexpanding TPVR product approved in both China and Europe.

Eric asserts, “As one of the earliest med-tech moves into transcatheter structural heart valvular therapies in China, we keep creating innovative products with global influence and high clinical value.” He was keenly aware of the importance of promoting innovation through international cooperation. Leveraging Eric’s experience and interpersonal network, Venus Medtech established a Global Advisory Board to target the international market. The Board members include world-renowned experts specializing in interventional cardiology, namely, Ziyad M. Hijazi, Martin B. Leon, Horst Sievert, and Ron Waksman (in alphabetic order by last name). “With our Global Advisory Board, we are able to connect the world’s top doctors and high-tech talents more closely and efficiently. This is critical for our overseas development and commercialization,” Eric affirms.

Conquering Challenges

Challenges are unavoidable if a company must keep progressing and living up to market expectations. Eric talks about the present challenges at Venus, saying, “At present, expanding our global presence is a major challenge. Engaging in international business means facing different local laws and regulations as well as different commercial environments.”

Taking Europe as the bridgehead of Venus Medtech’s international strategy, the company has put two products in Europe: the cerebral embolic protection device TriGUARD3TM, also its first innovative device approved in Europe; and VenusP-ValveTM, the innovative TPVR system, which received CE marking in April 2022. “We’ve gained rich experience in carrying out clinical trials, registration, and commercialization,” Eric points out.

Referring to different quality standards, it would be difficult to establish an integrated system suitable for domestic and international standards. Fortunately, attempts have been made by Venus Medtech. The company has established a quality management system that meets the requirements of GMP of NMPA of the PRC, cGMP of FDA of the U.S., MDR of the EU, BGMP of ANVISA of Brazil, ISO13485, and other regulations and standards. And it carries out quality control in the whole life cycle of products, from R&D to post-marketing sales. This laid a solid foundation for Venus’s international strategy.

The Expert Guidance

When Eric was asked what advice he would like to give to healthcare manufacturing industry aspirants and entrepreneurs, he offered rich guidance. He asserts, “As an insider in the med-tech industry for over 20 years, I would say when venturing into the healthcare manufacturing industry, especially the innovative med-tech industry, entrepreneurs should have the mindset to make long-term efforts.”

“It may take eight to ten years or even longer for the result to come. Be prepared for this. Difficulties and challenges are all along the way. Giving up is quite easy, right after failure. However, always remember that perseverance does win out.”

Scaling Operations in the Near Future

Management affirms that Venus Medtech plans to expand its global presence while retaining its leading position in commercialization in China. In addition to the EU, Venus P-Valve™ was approved by NMPA and became the first self-expanding TPVR product approved in both China and Europe. With plans to launch clinical trials in the US in 2023, Venus Medtech is preparing for its investigational device exemption (IDE) application to the FDA. In May 2022, VenusP-ValveTM has also been approved by the FDA to carry out two cases of compassionate use in the United States.

In Europe, TriGUARD3™ (Venus’s cerebral embolic protection device) is expected to continue to gain market share from Sentinel (another cerebral embolic protection device from Boston Scientific) in the coming years.

On the clinical side:

Venus Medtech’s Liwen RF™ radiofrequency ablation system for treating hypertrophic cardiomyopathy (HCM) is going to obtain approval to start a clinical trial in Europe very soon.

The company’s Cardiovalve™ (TMVR and TTVR systems) will be speeding up its clinical trials in Europe, North America, and China. “Moving forward, Venus Medtech will focus on new materials, bionics, image fusion techniques, and digital sensing for continuous upgrades and innovation to meet the needs of doctors and patients worldwide,” Eric reveals.

Further, he says, “As a leading company in the field of the heart valve, we aim to motivate and inspire innovators in China’s healthcare sector with our path to development.

Innovation drives the future.”

“At Venus Medtech, we will continue our efforts to develop and commercialize novel structural heart devices,

supporting China’s rise as an innovation powerhouse and contributing to the well-being of global communities,” he concludes.

Awards and Recognition

Venus Medtech has received a wealth of awards at national, provincial and municipal levels as follows.

https://www.venusmedtech.com/index.php/about/ABOUTUS-Venus-Medtech.

Venus Medtech Inc. Hangzhou – Global Leader in Transcatheter Therapy Products for Structural Heart Disease