PARIS, May 26, 2026 /PRNewswire/ -- Venus Medtech convened its inaugural Global Partner Summit in Paris under the theme "Insights, Innovation, Impact," bringing together distributors and commercial partners to discuss the company's international growth strategy, structural heart portfolio expansion, and long-term commercialization priorities.

The event marked a milestone in Venus Medtech's efforts to strengthen alignment with its global partner network as the company continues to expand its presence across international markets.

Opening the summit, David Bréant, Vice President of Sales and Marketing at Venus Medtech, reflected on the company's evolution from an emerging innovator to a growing player in the global structural heart market, emphasizing the importance of clinical collaboration, product quality, and long-term execution.

Hou-Sen Lim, General Manager and CEO of Venus Medtech, outlined the company's strategic roadmap, highlighting progress across its transcatheter valve portfolio as well as upcoming regulatory and commercial milestones. He said the company is continuing to evolve from a product-focused organization into a multi-platform structural heart company spanning multiple valve therapies.

A featured session led by Prof. Francesco Maisano, Chief of Cardiac Surgery and Director of the Valve Clinic at IRCCS San Raffaele University Hospital, focused on the development of Cardiovalve and the growing demand for transcatheter treatment options for mitral regurgitation (MR) and tricuspid regurgitation (TR).

The presentation highlighted several design features of the Cardiovalve system, including single-step transfemoral access, a unified platform for both mitral and tricuspid procedures, a low-profile design intended to reduce left ventricular outflow tract (LVOT) obstruction risk, and an adaptive sealing mechanism designed to minimize paravalvular leak (PVL). According to the presentation, current device sizing is expected to address approximately 85% of the target patient population.

The session also underscored increasing clinical and commercial interest in therapies targeting the tricuspid valve, often referred to within the industry as the "forgotten valve" due to historically limited treatment options.

"International expansion remains a core strategic priority for Venus Medtech," said Hou-Sen Lim. "Following the international commercialization of Venus P-Valve, we are advancing the clinical, regulatory, and commercialization pathways for Venus-PowerX, Venus-Vitae, and Cardiovalve. We remain focused on building long-term clinical credibility and strengthening our presence in the global structural heart market through a broader and increasingly diversified product portfolio."

He added that the company continues to invest in local commercial capabilities, service infrastructure, and market-specific expertise to support growth across key international markets.

About Venus Medtech 

Venus Medtech (Hangzhou) Inc. (2500.HK) develops transcatheter heart valve technologies and treatment solutions for structural heart disease. The company's pipeline includes products and candidates across transcatheter aortic, pulmonary, mitral, and tricuspid valve therapies, along with related accessory products. Venus Medtech operates research and development centers in China, the United States, and Israel.

LONDON, Nov. 17, 2025 /PRNewswire/ -- Venus Medtech (Hangzhou) Inc. (2500.HK) today announced that Cardiovalve has submitted the CE technical file for its transcatheter tricuspid valve replacement (TTVR) system to DEKRA, the notified body responsible for CE mark approval in Europe. This milestone follows the successful completion of the TARGET study, which enrolled 150 patients and demonstrated the safety and performance of the Cardiovalve system.

The TARGET Study Interim Results: "Safety and Performance of the Cardiovalve Replacement System for Tricuspid Regurgitation" were presented yesterday by Prof. Georg Nickenig, on behalf of the TARGET study investigators, during the Top Late-Breaking Trials session at PCR London valves Main Arena.

The TARGET Study followed 150 patients across 30 sites in Europe, the UK, and Canada as part of a prospective, single-arm, open-label, multicenter clinical trial, designed to evaluate the safety and performance of the Cardiovalve TR System. 

The study interim results, published on Nov.16th,2025, showed that Transcatheter Tricuspid Valve Replacement (TTVR) with the Cardiovalve System effectively eliminated tricuspid regurgitation (TR) in the majority of patients, despite 73% presenting with massive or torrential TR at baseline, demonstrating the clinical effectiveness of the device in patients.

In addition to endpoints for efficacy, the procedure was observed to have an acceptable safety profile, with improvements in patients' symptoms by 30 days post-treatment.

Patients enrolled in the study will continue to be followed for up to five years. Comprehensive clinical and echocardiographic outcomes, including mortality and heart failure hospitalizations from the full 150-patient cohort, will be presented in the near future.

Prof George Nickenig said: "The results of the Cardiovalve study are highly encouraging, demonstrating strong efficacy in tricuspid regurgitation (TR) reduction and a favorable safety profile, particularly with the new device iteration. These findings represent an important step forward, offering hope that patients suffering from TR will soon have access to a novel and effective treatment option."

"The submission of the CE file marks a pivotal milestone and brings Cardiovalve closer to delivering transformative therapy for patients suffering from severe mitral and tricuspid regurgitation," said Amir Gross, CEO of Cardiovalve, "This achievement reflects the commitment of a focused team with a shared vision, a team that doesn't just aim; it hits the target. Deep appreciation goes to the investigators, coordinators, clinical partners, and most importantly, the patients and their families for their trust."

Lim Hou-Sen, CEO of Venus Medtech, stated: "These promising results mark a significant advancement for patients suffering from tricuspid regurgitation. With the CE submission under review, Cardiovalve is well-positioned to achieve certification and begin commercial rollout of the TR system by 2027."

About Cardiovalve

A subsidiary of Venus Medtech, Cardiovalve is a pioneer in transcatheter valve replacement technology, standing at the forefront of innovation in structural heart therapy. With more than 150 approved patents, a highly experienced team, and a state-of-the-art manufacturing facility, Cardiovalve is dedicated to providing physicians with next-generation solutions that improve patient outcomes and quality of life—without the need for open-heart surgery.

About Venus Medtech

Venus Medtech (Hangzhou) Inc. (2500.HK) is a leading innovator in transcatheter heart valve solutions for structural heart disease. The company has developed a comprehensive product pipeline covering all four heart valves — TAVR, TPVR, TMVR, and TTVR —and related accessory products. With global R&D centers in China, the United States, and Israel, the company is committed to providing effective treatment solutions for life-threatening diseases.

HANGZHOU, China, Oct. 25, 2025 /PRNewswire/ -- Venus Medtech (Hangzhou) Inc. (2500.HK, hereinafter referred to as the "Company") today announced the successful completion of patient enrollment in the Cardiovalve TARGET study for Transcatheter Tricuspid Valve Replacement (TTVR), with a total of 150 patients enrolled. The completion of enrollment marks a major milestone toward European regulatory approval for Cardiovalve's Transcatheter Tricuspid Valve Replacement (TTVR) system, the company's flagship solution for treating tricuspid regurgitation.

With enrollment now complete, the company is preparing to submit its CE Mark application to European regulators later this year. Pending approval, commercial launch of the Cardiovalve TR system in Europe is projected for 2027.

Building on this achievement, Cardiovalve is also preparing to initiate its AHEAD study, which will evaluate the safety and performance of Cardiovalve's mitral valve replacement system in patients suffering from significant mitral regurgitation (MR). The AHEAD study is designed to support a future CE Mark application for the mitral system.

Cardiovalve Participation at TCT 2025

Cardiovalve will present preliminary data for its mitral regurgitation (MR) system at TCT 2025.

The presentation, titled "Transcatheter Mitral Valve Replacement Using the New Generation Cardiovalve System," will be led by Dr. Christian Frerker.

Session Details:

• Session: Innovation Session 17 — New Generation Transcatheter Mitral Technologies: Case-in-a-Box Demonstrations
• Date: Tuesday, October 28, 2025
• Time: 12:25–12:30 PM
• Location: Moscone Center, North, Exhibition Level, Hall E- Innovation Theatre

About Cardiovalve

A subsidiary of Venus Medtech, Cardiovalve is a pioneer in transcatheter valve replacement technology, standing at the forefront of innovation in structural heart therapy. With more than 150 approved patents, a highly experienced team, and a state-of-the-art manufacturing facility, Cardiovalve is dedicated to providing physicians with next-generation solutions that improve patient outcomes and quality of life—without the need for open-heart surgery.

About Venus Medtech

Venus Medtech (Hangzhou) Inc. (2500.HK) is a leading innovator in transcatheter heart valve solutions for structural heart disease. The company has developed a comprehensive product pipeline covering all four heart valves — TAVR, TPVR, TMVR, and TTVR —and related accessory products. With global R&D centers in China, the United States, and Israel, The company is committed to providing effective treatment solutions for life-threatening diseases.

This outcome conclusively defends the validity of Cardiovalve's critical patent portfolio, strengthens Venus Medtech's global IP protections, and significantly advances its competitive position in structural heart disease—particularly its integrated "Quad-Valve" strategic platform.

Case Background

The dispute centered on Edwards' challenge to the validity of Cardiovalve's U.S. Patent No. 10,702,385 ("'385 Patent") covering an innovative transcatheter heart valve clamping and support structure for minimally invasive mitral and tricuspid valve therapies.

On June 2, 2021, Edwards petitioned for inter partes review of claims 1-10 of that patent.

PTAB issued Final Written Decision allowing Cardiovalve's motion to amend claims after Edwards failed to prove unpatentability by preponderant evidence on December 6, 2022.

On June 9, 2025, CAFC affirmed PTAB's ruling, validating Cardiovalve's patent claims.

About Cardiovalve

Venus Medtech completed the acquisition of Cardiovalve in January 2022, that marked a strategic milestone in building a comprehensive product portfolio and securing Cardiovalve's foundational technologies.

Cardiovalve, the next-generation transcatheter valve replacement system, is designed for treating regurgitation in both mitral and tricuspid valves, and features transformative technologies:

• Dual frame self-expanding nitinol stent reduces paravalvular leakage
• Low-profile stent design minimizes LVOT obstruction risk
• Transfemoral-transseptal access provides a less invasive alternative to the transapical approach
• Large annular sizing capacity (up to 55mm) accommodates approximately 95% of patient anatomies

The streamlined three-step implantation (Position-Anchor-Release) demonstrates exceptional reproducibility.

Mr. Lim Hou-Sen, CEO of Venus Medtech stated:

"This landmark victory validates Cardiovalve's original innovations and demonstrates the integrity of global IP systems. We remain committed to advancing structural heart therapies through clinically driven innovation."

Mr. Amir Gross, CEO of Cardiovalve emphasized:

"Our 'Innovation Never Stops' philosophy conquered technical barriers in mitral/tricuspid interventions. This four-year legal affirmation accelerates our global clinical strategy to deliver superior solutions for 40+ million regurgitation patients worldwide."

Key Financial Highlights

1. Revenue: RMB471 million, with overseas revenue growing 13.53% YoY to RMB82.5 million.
2. Adjusted non-IFRS EBITDA loss: Narrowed by 45.56% YoY to RMB254 million, reflecting stringent cost controls.
3. Commercial profit: Surged 112.60% YoY to RMB97.7 million, with the commercial profit margin rising from 9.35% (2023) to 20.74%.
4. Gross margin: Remained robust at 78.11%, underscoring pricing stability.

Facing a challenging landscape, Venus Medtech reinforced its leadership in China's valvular therapy sector while achieving significant progress in operational efficiency and commercial profitability, mainly reflected in：

Cost Optimization

• Sales expenses decreased by 18.44% YoY to RMB245 million, with the sales expense ratio decreasing from 61.15% (2023) to 52.05% through streamlined distributor management and accounts receivable reforms.
• R&D expenses declined 35% YoY to RMB341 million, as the Company prioritized high-value pipeline projects, reducing R&D expense ratio from 106.83% to 72.46%.

Profitability Focus

• The "Profitability-First" strategy drove a 112.60% increase in commercial profit (RMB97.7 million), while adjusted EBITDA losses halved (-45.56%), signaling sustainable financial traction.

Global Expansion and Maintain Domestic Leadership

In domestic markets, Venus MedTech focused on distributor channel development and penetrated tier-2 and tier-3 hospitals, securing its 1^st position as China's leading transcatheter aortic valve replacement (TAVR) provider.

• Products are now used in over 650 hospitals nationwide.
• The company participated in more than 90 third-party conferences and hosted over 100 proprietary events, engaging over 5,500 medical experts, and reaching more than 2 million online viewers.

Internationally, sales contributed 17.52% of total revenue (up from 14.79% in 2023). Growth was driven by Europe (+10.1%), Asia-Pacific (+16.6%), and Latin America (+38.6%). Venus Medtech expanded into 13 new countries, bringing its total global footprint to nearly 70 markets.

Key milestones included:

• VenusP-Valve, the Company's differentiated pulmonary valve product, entered 63 global markets, with new approvals in 12 countries/regions, including Canada, Australia, Singapore, Mexico.
• VenusA Series products expanded to 15 countries/regions, with new approvals in countries including Russia, Thailand, Mexico, and Kazakhstan.

Innovation-Driven Pipeline Optimization for Sustainable Growth

Venus Medtech remains committed to innovation, advancing its "Four-Valve Strategy" for structural heart disease solutions. Key 2024 developments included:

Aortic Valve

• Venus-PowerX completed its first patient enrollment in its global confirmatory trial (December 2024), with full China enrollment expected in 2025.
• VenusA-Deluxe received China market approval in November 2024.

Pulmonary Valve

• VenusP-Valve advanced its U.S. IDE (PROTEUS) pivotal study, with the first patient successfully implanted in June 2024.

Mitral/Tricuspid Valve

Cardiovalve's trial in the treatment of tricuspid regurgitation enrolled nearly 120 patients across 30+ renowned cardiovascular centers in Germany, Italy, Spain, the UK, and Canada.

The Company also strengthened its intellectual property portfolio, holding 886 patents and applications (473 granted), including 402 filings in China (275 granted) and 460 overseas (435 granted).

Robust Clinical Evidence Demonstrates Long-Term Efficacy

Adhering to the principles of evidence-based medicine, Venus Medtech has consistently conducted long-term follow-up studies for its registered clinical trials, generating outstanding data that validates the full spectrum of clinical benefits across its product lines. Key findings reported in the year include:

Cardiovalve TARGET CE Pivotal Study (Europe)

• Immediate outcomes in the first 105 patients demonstrated 93.7% achieved ≤mild tricuspid regurgitation.
• Early humanitarian use data in 20 patients with 100% severe or worse tricuspid regurgitation showed 90% reduced to ≤mild regurgitation at 30-day follow-up.

VenusP-Valve (5-year CE follow-up data)

• No mortality or reinterventions, with right ventricular reverse remodeling confirmed via MRI at 6 months and durable functional improvement.
• 94%+ of patients in NYHA Class I/II at 5 years, demonstrating sustained quality-of-life benefits.

"2024 was a transformative year for Venus Medtech," said Lim Hou-Sen, CEO of Venus Medtech. "By prioritizing profitability, operational excellence, and global expansion, we have positioned the Company for sustainable growth. Moving forward, we will continue to innovate, optimize our commercial strategy, and deliver long-term value to patients and shareholders."

About the company

Venus Medtech (2500.HK) was founded in 2009 and is headquartered in Hangzhou, China. It is an innovation-driven medical device company specializing in structural heart disease. The company's product portfolio covers aortic, pulmonary, mitral, and tricuspid valve diseases, as well as surgical support products, forming a comprehensive pipeline. With global R&D centers in China, the United States, and Israel, Venus Medtech has established a worldwide network for research, production, marketing, and service. The company is committed to providing effective treatment solutions for life-threatening diseases.

These successful implantations mark another leap forward for the company into the frontier of next-generation dry-tissue valves, representing a significant addition to our transcatheter heart valve solutions.

Following the first two successful implantations, Venus-Vitae SMART-ALIGN pivotal clinical trial will be progressively launched at around 20 centers in Europe, North America and China, enrolling a total of 150 patients. The trial data will be used to support registration applications in the EU, Canada, China and other territories.

The procedures were performed by Prof. So Chak Yu Kent and the team at Prince of Wales Hospital in collaboration with Prof. Scott Lim of University of Virginia Medical Center, supported by a multidisciplinary team from Ultrasound, Anesthesiology, and Imaging Departments. Both patients received 23mm Venus-Vitae implants. The procedures presented good immediate post-operative results with significant hemodynamic improvement.

Venus-Vitae Smart-ALIGN, abbreviated from Multicenter Pivotal Study to Evaluate the TreatMent of Severe AoRTic VALve StenosIs UsinG the VeNus-Vitae Transcatheter Heart Valve System, is a prospective, multicenter, non-randomized interventional study to evaluate the safety and efficacy of the Venus-Vitae TAVR system in patients with severe aortic stenosis.

"Recently, my colleague Dr. Michael Hainstock and I, at the University of Virginia Medical Center, completed the first patient implantation in the VenusP-Valve PROTEUS pivotal clinical trial in the United States, " said Prof. Scott Lim." Two months later, I am very pleased to have participated with Dr. Kent So in the implantation of the first two patients in the Venus-Vitae SMART-ALIGN international multicenter pivotal clinical trial at Prince of Wales Hospital in Hong Kong. These both represent important milestones in those studies. Additionally, both the VenusP Valve and the Vitae valve have been previously used in clinical applications, with excellent published results. Of note, the Venus-Vitae valve's stent frame is the shortest among current transcatheter aortic valves, and I am encouraged by its potential to treat aortic stenosis while maintaining coronary access. Furthermore, its dry valve leaflet technology facilitated rapid preoperative preparation time. We look forward to further international enrollment in the SMART-ALIGN clinical trial in the near future."

"It was an honor to collaborate with Dr. Scott Lim to complete the first two confirmatory clinical implantations of this innovative dry valve," said Prof. So Chak Yu Kent after the procedures. "Venus-Vitae's active anti-PVL technology and short frame design effectively prevent leakage and minimize the risk of coronary artery obstruction. I'm eager to see expedited enrollment of patients for Venus-Vitae, so that more patients can benefit soon."

"Venus-Vitae is our next generation balloon-expandable TAVR system, with global patent coverage," said Hou-Sen Lim, General Manager and CEO of Venus Medtech. "We have strong confidence in its international multi-center clinical trials and global strategy. The successful initial implantations provide a solid foundation for forthcoming trials in Europe, North America, and China. We are committed to advancing Vitae's global clinical application and regulatory registration, bringing our cutting-edge technology to physicians and patients worldwide."

About Venus-Vitae
Venus-Vitae utilizes the innovative Venus-Endura technology, which integrates multiple anti-calcification techniques, immunogenicity removal technology and 3D force-controlled dehydration technology, providing exceptional durability, biocompatibility, and excellent anti-calcification performance. In addition, this design allows for room temperature storage of the valve in a dry-tissue condition.

Additionally, the product features a unique patented technology, Lockwire Technology, ensuring the stability and accuracy of the valve during delivery and deployment. The short stent frame of Venus-Vitae's valve along with its steerable NAVIMASTER delivery system, significantly optimizes the performance across the aortic arch and positioning within the native valve. Venus-Vitae also features a unique Coronary Alignment technology, addressing the fundamental challenge that current TAVR products have been unable to address—aiding in protection of the coronary arteries. By utilizing three gold markers at the base of the valve leaflets in conjunction with the delivery system's steering, telescoping, and balloon rotation capabilities, Venus-Vitae can effortlessly and precisely achieve coronary alignment during the deployment process. This aids in accomplishing coronary protection throughout the implantation procedure.

Furthermore, Venus-Vitae features a self-adaptive anti-PVL technology, utilizing an adaptive polymer skirt. The proprietary polymer skirt material possesses a high compression ratio, excellent resilience, self-expanding properties, and adaptive sealing. It demonstrates adaptive deformation during valve crimping, without enlarging the profile of the delivery system. Upon deployment, it actively fills the gaps around the valve perimeter, achieving remarkable anti-PVL performance.

About Venus Medtech
Venus Medtech (Hangzhou) Inc. (02500.HK) is committed to structural heart innovation. We are developing and commercializing comprehensive solutions for structural heart disease. Our robust pipeline, encompassing all four heart valves from TAVR, TPVR, TMVR, and TTVR to hypertensive renal denervation (RDN) therapy, underscores our unwavering commitment.

For more information, please visit https://www.venusmedtech.com

*Provided for informational and academic purposes only, this content is not intended as professional medical or legal advice. Venus Medtech makes no representations, warranties or guarantees regarding the completeness, accuracy, or timeliness of this content.
*Venus Medtech makes no representations, warranties or guarantees regarding the property or clinical performance of any medical devices mentioned.
*VENUSMEDTECH, the stylized QI logo, Venus-Vitae, Venus-Endura etc. are trademarks of Venus Medtech (Hangzhou) Inc.
*Venus-Vitae is currently restricted to research only in the EU, North America, and China.

This marks a significant advancement in the international progress of VenusP-Valve and represents another milestone following its CE MDR approval in April 2022.

The VenusP-Valve PROTEUS STUDY, abbreviated from Evaluation of the PerfoRmance Of The VEnUsP-Valve System in Patients with Native Right Ventricular Outflow Tract (RVOT) Dysfunction, is a prospective multi-center non-randomized interventional study in patients with RVOT disorders comorbid with moderate or greater pulmonary regurgitation. With a target enrollment of 60 subjects, data from this trial will support VenusP-Valve's registration with the U.S. FDA and Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

In late 2023, the VenusP-Valve PROTEUS trial received coverage approval from the U.S. Centers for Medicare & Medicaid Services (CMS). With this endorsement, all eligible beneficiaries can be reimbursed for VenusP-Valve treatment in the study.

Following its first clinical implantation in 2013, VenusP-Valve has been applied in clinical practice for 11 years. To date, the device has been included in national health insurance programs in Germany, France, etc., and has been approved in more than fifty countries, including China, Germany, France, the United Kingdom, Italy, Spain, Canada, and Australia, with its implantation seeing continuous growth in new hospitals and centers.

"We're honored to be part of the VenusP-Valve PROTEUS trial," said Prof. Scott Lim after the procedure. "We've just completed the first patient enrollment in that trial using the VenusP-Valve. This worked quite well, and it really represents a possibility of better ways of treating patients with significant pulmonary valve disease." 

"That went really smoothly in this teenage patient with free pulmonary insufficiency", commented Prof. Michael Hainstock. "I'm very happy with the valve deployment and position. This (VenusP-Valve) is another option for our patients to treat pulmonary valve disease."

"The successful first implantation in the VenusP-Valve PROTEUS study in the U.S. represents an important milestone for Venus Medtech in this crucial market," said Lim Hou-Sen, General Manager and CEO of Venus Medtech. "The device has already received compassionate use approval from the FDA in a number of cases, underscoring its unique clinical advantages and high regulatory recognition. Moving forward, we will redouble efforts to advance VenusP-Valve's clinical progress, speeding up its approval process with both the FDA and Japan's PMDA."

About VenusP-Valve

As the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries remarkable clinical value. Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, VenusP-Valve is able to meet the needs of 85% of patients in the case of large RVOT.

The long-term safety and efficacy of VenusP-Valve has been backed by impressive clinical data. According to three-year follow-up results of the clinical trial in Europe, the product demonstrated 100% procedural success and 0% all-cause mortality and reoperation among 81 patients who underwent TPVR. Right ventricular function improved significantly. Only one patient had severe pulmonary regurgitation.

About Venus Medtech

Venus Medtech (Hangzhou) Inc. (02500.HK) is committed to structural heart innovation. We are developing and commercializing comprehensive solutions for structural heart disease. Our robust pipeline, encompassing all four heart valves from TAVR, TPVR, TMVR, and TTVR to hypertensive renal denervation (RDN) therapy, underscores our unwavering commitment.

For more information, please visit https://www.venusmedtech.com

Contacts:

Jill Liu  
Public Relations
liujie@venusmedtech.com

Ophelia Chen
Investor Relations
chenwenjuan@venusmedtech.com

As the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries remarkable clinical value. Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, VenusP-Valve is able to meet the needs of 85% of patients in the case of large RVOT.

"VenusP-Valve is able to eliminate pulmonary regurgitation in a wide range of anatomies," said Prof. Lee Benson, Director of Cardiac Diagnostic and Interventional Unit at the Hospital for Sick Children in Toronto, Canada. "Available in different sizes and specifications, the product offers extensive applicability to meet the clinical needs of a larger pulmonary regurgitation patient population."

Clinical data reveals that VenusP-Valve demonstrates safety and efficacy on par with similar products, and excels in aspects such as rates of reintervention and arrhythmia. According to three-year follow-up data of the European clinical trial, the success rate for TPVR with VenusP-Valve is 100%. All-cause mortality and reintervention rates were zero. In addition, no moderate or severe pulmonary regurgitation was observed. Paravalvular leakage and tricuspid regurgitation were mild or below in 96.87% of subjects. The data suggest excellent performance, robust safety and reliability, and drastic and steady improvements in patients' cardiac function.

As the company's international flagship product, VenusP-Valve received CE marking under the Medical Devices Regulation (MDR) on April 8th, 2022, becoming the first Class III implantable cardiovascular device approved under the new MDR. In 2023, after receiving Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA), VenusP-Valve gained its first ethical approval in the territory, setting the stage for the VenusP-Valve PROTEUS pivotal clinical trial. More recently, the U.S. Centers for Medicare & Medicaid Services (CMS) also granted coverage approval for the PROTEUS study.

"Seeking effective treatments for major diseases that pose a serious threat to human health is what we do at Venus Medtech, which makes us proud to have received this Health Canada approval,'' said Lim Hou-Sen, Chief Executive Officer of Venus Medtech. "The approval of VenusP-Valve represents a meaningful expansion of clinical options for patients in the country."

Following its first clinical implantation in 2013 by Academician Ge Junbo, Director of Cardiology at Zhongshan Hospital, Fudan University, VenusP-Valve has been applied in clinical practice for 11 years. To date, the device has been included in national health insurance programs in Germany, France, etc., and has been approved in more than fifty countries, including China, Germany, France, the United Kingdom, Italy, and Spain, with its implantation seeing continuous growth in new hospitals and centers.

About Venus Medtech
Venus Medtech (Hangzhou) Inc. (02500.HK) is committed to structural heart innovation. We are developing and commercializing comprehensive solutions for structural heart disease. Our robust pipeline, encompassing all four heart valves from TAVR, TPVR, TMVR, and TTVR to hypertrophic cardiomyopathy and hypertensive renal denervation (RDN) therapy, underscores our unwavering commitment.

For more information, please visit https://www.venusmedtech.com

Contacts:
Jill Liu                                              Ophelia Chen
Public Relations                           Investor Relations
liujie@venusmedtech.com       chenwenjuan@venusmedtech.com

Statements
*Provided for informational and academic purposes only, this content is not intended as professional medical or legal advice. Venus Medtech makes no representations, warranties or guarantees regarding the completeness, accuracy, or timeliness of this content.
*Venus Medtech makes no representations, warranties or guarantees regarding the property or clinical performance of any medical devices mentioned.
*VENUSMEDTECH, the stylized QI logo, VenusP-Valve, etc. are trademarks of Venus Medtech (Hangzhou) Inc.
Copyright 2024. Venus Medtech(Hangzhou) Inc. All Rights Reserved.

HANGZHOU, China, Nov. 20, 2023 /PRNewswire/ -- Venus Medtech is changing how the world treats structural heart disease. The company will present its products at its booth (#28), during two symposia, in multiple podium presentations and at a special cocktail reception where it will officially launch the SMART-ALIGN multicenter clinical study.

Structural heart symposia on November 20 and 21

The company will be hosting two symposia on November 20 and 21 that will allow interventional cardiologists to deepen their knowledge about structural heart interventions. The first, "Valve tricuspid Transcatheter: Cardiovalve keeps it in motion" will be dedicated to discussing the latest results and future plans for the Cardiovalve tricuspid valve replacement system. In the second, "Addressing remaining issues after TAVI: What to expect from the new generation," presenters will focus on the tools and techniques showcasing the Venus Vitae.

Launching the SMART-ALIGN Study with registration studies commencing annually

Additionally, Venus will be officially launching the SMART-ALIGN study to evaluate the performance of the Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis. The study will enroll 150 patients at 20 medical centers worldwide. This new study builds on the TARGET study launched at London Valves 2022, which is evaluating the Cardiovalve system for transcatheter tricuspid valve replacement. Cardiovalve is now on track for CE mark approval in late 2026, with about half of the patients already enrolled. Prior to this, Venus Medtech achieved significant success with its Pvalve system replacing the pulmonary valve, securing CE approval in 2022 and planning for an FDA registration study in 2024. These studies are a testament to Venus Medtech's mission, consistently improving the treatment of structural heart disease.

About Venus Medtech

Venus Medtech (Hangzhou) Inc. (2500.HK) is committed to structural heart innovation. We are developing and commercializing comprehensive solutions for structural heart disease. Our robust pipeline, encompassing all four heart valves from TAVR, TPVR, TMVR, and TTVR to hypertrophic cardiomyopathy and hypertensive renal denervation (RDN) therapy, underscores our unwavering commitment.

For more information, please visit https://venusmedtechconference.com/

IDE refers to the exemption of medical devices intended for marketing from regulatory requirements, allowing clinical trials to be conducted on such devices. The announced IDE approval will allow VenusP-Valve to initiate pivotal clinical trials in the U.S. to support the Pre-Market Approval (PMA). Through the Japan-US Harmonization By Doing program, jointly established by the FDA and Japan's PMDA, this clinical trial will be conducted concurrently at 10 centers in the U.S. and 5 centers in Japan, and 60 patients are expected to be enrolled. Last year, VenusP-Valve was applied in two cases for compassionate use in the U.S.

As the company's international flagship product, VenusP-Valve received CE marking under the Medical Devices Regulation (MDR) on April 8th, 2022, becoming the first Class III implantable cardiovascular device approved under the new MDR. To date, VenusP-Valve has been approved in more than thirty countries including China, the United Kingdom, Italy, Spain, Denmark, Greece, France, Germany, Poland, Switzerland, etc., and its implantations enjoy continuous growth in new hospitals and centers.

As the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries remarkable clinical value. Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, VenusP-Valve is able to meet the needs of 85% of patients in the case of large RVOT.

According to three-year follow-up data of the European clinical trial, the success rate for TPVR with VenusP-Valve is 100% in 64 patients (some patients have not been included due to the COVID-19 pandemic). All-cause mortality and surgical reintervention rate were zero. In addition, no moderate or severe pulmonary regurgitation was observed. Paravalvular leakage and tricuspid regurgitation were mild or below in 96.87% of subjects.

The device is set to enroll patients in the U.S. in the second half of this year and in Japan in early 2024, with approvals expected around 2026 in both markets.

In addition to VenusP-Valve, core products in the company's pipeline, such as the Cardiovalve mitral/tricuspid valve replacement system and Venus-Vitae and Venus -PowerX next-generation TAVR systems, are expected to receive successive domestic and international marketing approvals beginning in 2026.

Eric Zi, Co-Founder, Executive Director and General Manager of Venus Medtech said "The approval of VenusP-Valve's IDE marks a significant milestone in our global strategy and showcases the team's unwavering dedication to progress and innovation. As our innovative products enter the phase of fruition one after another, we anticipate 2026 as a year of substantial growth in global expansion. We excitedly look forward to VenusP-Valve's prompt patient enrollment and the collection of clinical follow-up results, leading to its marketing approval in the U.S."

Liwen RF ™ ablation system, an innovative device for the treatment of HCM, was developed in-house by Hangzhou Nuocheng Medical Technology Co., Ltd., a wholly-owned subsidiary of Venus Medtech. The clinical trial was led by Professor Liwen Liu of The First Affiliated Hospital of Air Force Medical University as the principal investigator (PI), with academicians Junbo Ge of Zhongshan Hospital, Fudan University and Yun Zhang of Qilu Hospital of Shandong University as co-PIs. Since the first clinical enrollment in January 2021, 128 patients have been enrolled in 20 hospitals, including The First Affiliated Hospital of Air Force Medical University, Zhongshan Hospital, Fudan University, Qilu Hospital of Shandong University, the Second Affiliated Hospital, Zhejiang University School of Medicine, West China Hospital Sichuan University, Guangdong Provincial People's Hospital, Xiamen Cardiovascular Hospital Xiamen University, University of Health and Rehabilitation Sciences Qingdao Hospital, Qingdao Municipal Hospital, the 7th People's Hospital of Zhengzhou, The First Affiliated Hospital of Dalian Medical University and Shanxi Cardiovascular Hospital.

Liwen RF ™ ablation system offers technical advantages such as less trauma, precise localization, no target vessel restriction, significant reduction of septal thickness, and reduced risks of conduction system damage and other complications. It provides an innovative therapy for HCM that is safe, efficient, precise, and less invasive. In August 2022, the product was qualified for the Special Approval Procedures of Innovative Medical Devices promulgated by the National Medical Products Administration (NMPA).

Exploratory clinical results showed that compared with the traditional gold standard surgical procedure, the Liwen RF ™ ablation system had an 88% success rate, no death case after operation one year, and significant improvements in patients' clinical performance, cardiac function and quality of life, and was significantly better than septal myectomy surgery and alcohol septal ablation, providing strong evidence of its safety and efficacy and superior performance. In January 2023, Liwen Procedure, as an innovative technique associated with the product, was selected as 2022 Level I Class A project in the category of new clinical techniques and therapies by Air Force Medical University.

In addition to 144 cases in earlier exploratory clinical trials, medium to long-term follow-up data of 200 HCM patients treated with the Liwen procedure showed an effective decrease in complications and mortality, as revealed in a recent study by Professor Liwen Liu and her team published in JAMA Cardiology in March 2022. Moreover, no permanent pacemaker was required from any patients. The results once again corroborated the long-term safety and efficacy of the product. Furthermore, Liwen Procedure received the Outstanding Innovation Award at CSI and First Prize of Scientific and Technological Progress Award of Shaanxi Province. It was also included in the 2023 Guideline for Diagnosis and Treatment of Patients with Hypertrophic Cardiomyopathy.

Professor Liwen Liu said, "It's such an exciting moment to witness the conclusion of patient enrollment for Liwen RF™. Venus Medtech has been a huge proponent throughout the journey to facilitate clinical trials and promotion. As an ultrasound specialist, I owe a debt of gratitude to cardiology and cardiac surgery departments for their valuable collaboration, support and recognition. The population of HCM patients has been greatly underestimated due to limited screening methods. As Liwen Procedure reaches broader communities, I'm confident it will benefit more patients."

Professor Mao Chen said "We appreciate Prof. Liu's personal presence. It is an important recognition of our technical capabilities that West China Hospital enrolled the last patient for the trial. We are also thankful to Venus Medtech. Although our hospital was a latecomer to the clinical trial, we will strive for a leading role in promoting the procedure, thus bringing hopes to more HCM patients."

Eric Zi, Founder, Executive Director and General Manager of Venus Medtech also felt a surge of emotions: "Liwen RF™ pioneers the use of ultrasound-guided percutaneous intramyocardial septal radiofrequency ablation. European experts have taken notice of the procedure and emphasized its importance as part of the larger family of structural heart solutions. Embedded in our mission is a commitment to addressing patient concerns. Therefore, we are actively exploring additional indications for the product to create greater synergy with our existing product line. We will also leverage our progress in China to advance clinical trials and registration overseas."

About HCM and its main therapies

Hypertrophic cardiomyopathy (HCM) is a common hereditary cardiovascular disease worldwide and the leading cause of sudden cardiac death (SCD) in adolescents and athletes, with epidemiological studies in the United States, Japan and Europe indicating a prevalence rate of 0.17%-0.23% and an estimated 20 million cases worldwide. The prevalence in China is approximately 0.18%, on which basis it is estimated that there are over 2 million cases in China. Approximately 40%-60% patients are caused by gene mutations in the myocardial sarcomere. In other words, it is difficult to significantly reduce morbidity in the future through treatment of the existing patient population. In addition, the cases of HCM are significantly underestimated with a clinical diagnosis rate of only 10% due to the lack of a standardized genetic screening system and limited application of imaging technology, which is an important reason for the high number of SCD in China.

There are no well-established therapies for HCM worldwide, while existing mainstream therapies focus on controlling complications and preventing disease progression by managing symptoms and improving cardiac function. Mavacamten has received the most attention in the HCM therapeutic area in recent years. In October 2020, Bristol-Myers Squibb (BMS) announced that it would acquire MyoKardia for US$13.1 billion in cash at a premium of 60%, in order to obtain its new drug candidate, mavacamten, an allosteric inhibitor of myocardial myosin, which can be used for the treatment of HOCM. The clinical results showed that although mavacamten can relieve obstruction, reached the primary and secondary clinical endpoints, it fails to reduce the ventricular septal thickness and has limited effect in patients with severe HOCM.

Septal myectomy surgery requires an open-chest procedure, which is traumatic, risky, prone to damage the conduction bundle, thus causing conduction block and eventually heart failure, thus having higher requirements on the operator. Alcohol septal ablation does not completely relieve left ventricular outflow tract obstruction in patients with a mismatch between the first septal branch and the site of obstruction; and implantable cardioverter-defibrillator (ICD) is currently the only effective treatment to prevent SCD in patients with HCM, but the ICD affects the quality of life of patients due to electric shock, has a high rate of complications and fails to reduce septal thickness. The advent of the Liwen procedure offers the possibility of safe and effective treatment of HOCM.

HANGZHOU, China, Nov. 25, 2022 /PRNewswire/ -- Venus Medtech is building an exciting pipeline of treatments for structural heart disease. The company will present its products at the conference taking place at the ExCeL London November 27-29, 2022 in its booth (#25), during a symposium, and at the official launch of the TARGET multicenter clinical study.

Structural heart symposium on November 27

The company will also be hosting a symposium on November 27 (Hall #4 at 17:30 pm) where top investigators will discuss the latest results and future plans for the Venus Medtech tricuspid and pulmonary valve replacement systems. During this symposium, "The Right Valves for The Right Ventricle: Venus MedTech tricuspid and pulmonary replacement systems," interventional cardiologists will have the opportunity to learn the latest about structural heart interventions.

Launch of TARGET CE Study for tricuspid valve replacement on November 28

Additionally, Venus Medtech will be officially launching the TARGET study at the conference. The TARGET study will evaluate the safety and performance of the Cardiovalve Tricuspid System—with its associated procedure—in reducing tricuspid regurgitation and the associated symptoms. The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter approach. The study will enroll one hundred patients in up to thirty medical centers. Patients will be followed for a period of up to five years.

The TARGET CE Study will be launched officially at the Sunborn London Yacht Hotel on Monday, November 28 at 18:30 pm.

Presentation of new data

The experiences with Cardiovalve and presentation of new data will be held in the following sessions:

• Dr. Estevez-Loureiro, Eliminate tricuspid regurgitation: transfemoral CardioValve tricuspid replacement system (Tricuspid interventions session, November 27, 13:30 - 15:00 at Interactive Case Corner 2).
• Dr. Sherif, Transcatheter transseptal mitral valve implantation: a new tool-in-the-box for patients with severe mitral regurgitation (TMVR challenges session, November 27, 15:05 - 16:05, at Interactive Case Corner 2).
• Dr. Schmidt, Transcatheter valve implantation in mitral and tricuspid valve position, (Rapid-fire clinical cases: Session 7, November 29, 14:50 - 15:35 at The Exchange).

About Venus Medtech: Increasing global presence

Venus Medtech (stock code: 2500.HK) is committed to structural heart innovation. As the leading transcatheter heart valve medical device player in China, Venus Medtech has established comprehensive solutions for structural heart disease. It now has a complete product pipeline covering all four heart valves, namely TAVR, TPVR, TMVR and TTVR, as well as hypertrophic cardiomyopathy, hypertensive renal denervation (RDN) therapy and relevant accessory products.

Venus is now intensifying its presence in overseas markets, making important breakthroughs in registration and commercialization. 

For more information

Visit our conference website: www.venusmedtechconference.com

According to interim financial statements, Venus Medtech recorded RMB 210 million in sales revenue in H1 2022, representing a 18.9% growth over H2 2021. Gross profit totaled RMB 164 million, a 20.5% growth over H2 2021. In specific, overseas sales recorded RMB 14 million, a year-on-year increase of 150.9%. It is worth noting that VenusP-ValveTM, the first Chinese-made transcatheter pulmonic valve replacement (TPVR) system approved for marketing in Europe, generated RMB 9 million in sales in only two months following its registration earlier this year, reflecting the huge potential of overseas markets.

2022 was a key year for Venus Medtech to deepen its global presence. VenusP-ValveTM, the Company's in-house developed novel TPVR system, became the first Chinese valve product to be approved in the EU. The product also set a precedent with its approval in China, as the National Medical Products Administration (NMPA) accepted overseas clinical trials data for the first time. It paved the road for our future devices and laid the foundation for global multi-center studies. The EU approval also facilitated the compassionate use of the product in the U.S., making it the first clinically applied Chinese TPVR system in the country. In addition, the Investigator Meeting for VenusP-ValveTM US Clinical Study was held, accelerating multi-center clinical trials in the U.S. and Japan.  

Acquisition of Cardiovalve Ltd. in January 2022 optimized our innovative products pipeline of mitral and tricuspid valve interventional treatments, the most promising area for innovation in structural heart therapies. Cardiovalve is also the first privately held company to receive FDA's early feasibility study (EFS) approval for both TR and MR indications. For the treatment of tricuspid regurgitation, its device received 'Breakthrough Device Designation' by the FDA. Following the completion of the acquisition, Cardiovalve enrolled 10+ patients over six months in Europe and the U.S. The procedures were successful, and patients recovered well. Clinical trial for Cardiovalve in China is expected to kick off within the year as part of its global multi-center study, targeting at global product launch and bringing innovative solutions to global patients.

In addition, Venus Medtech has a number of novel products undergoing clinical trials, such as the Liwen RFTM radiofrequency ablation system for the treatment of hypertrophic cardiomyopathy (HCM), new-generation TAVR products Venus-PowerXTM and Venus-VitaeTM for the treatment of aortic stenosis, and renal denervation (RDN) systems for the treatment of resistant hypertension. Venus Medtech looks to advance clinical trials for the above products in developed countries in Europe and America. In particular, the Liwen RFTM system recently entered the NMPA's Special Review and Approval Procedures for Innovative Medical Devices, which will fast-track its approval.

Domestically, repeated COVID-19 outbreaks had continued negative impact on the market performance of China's innovative medical devices. In response, Venus Medtech focused on profitability and quality growth, aiming to stabilize sales in middle to high-end centers and maintain its gross profit margin. In H1 2022, domestic sales recorded RMB 196 million, up 14.1% by H2 2021, primarily attributable to VenusA-ValveTM and VenusA-PlusTM, our first and second generation TAVR products approved in China. Specifically, VenusA-PlusTM accounted for approximately 60%.

In the first half of 2022, the VenusA series reported around 1,800 implantations, sustaining the Company's market dominance with a 63% share. As of the end of H1, the VenusA series accumulated more than 10,000 implantations through an extensive network of 370+ hospitals and clinical centers, making Venus Medtech the only TAVR device maker to hit five digits. As the first-mover in the market, the VenusA series has considerable clinical follow-up data backing up its long-term safety and efficacy. VenusA-ValveTM is the only TAVR system in China with seven-year data corroborating its long-term safety.

Looking ahead to the second half of the year, global growth and profitability will be the overriding goals of Venus Medtech. In overseas markets, the Company will strengthen its commercialization capabilities and continue to increase the percentage of foreign revenue, thereby building brand awareness. On the domestic side, the Company will aim at sales efficiency optimization and higher per hospital output at medium to high-grade hospitals. Profit margin is expected to grow by reducing production costs and expenses.

Eric Zi, Founder, Executive Director, and General Manager of Venus Medtech said "The global business community faces critical challenges in the post-pandemic era. Investors are getting more conservative. Trade tensions are mounting and the east and the west are playing a zero-sum game. In this context, the first thing for businesses is to survive. At Venus Medtech, global growth and profitability are our priorities. Gaining a solid foothold is key to better develop global markets. We need to improve quality and efficiency and be a powerhouse ourselves to avoid unproductive or even counterproductive work and make breakthroughs in global markets. We will survive hard times and garner strength for the future."

As the first self-expanding TPVR product approved for marketing in both China and Europe, VenusP-Valve^TM sets itself apart with remarkable clinical value. Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, VenusP-Valve^TM is able to meet the needs of 85% of patients in the case of large RVOT.

For the registration application, the NMPA has accepted the overseas clinical trials data of VenusP-Valve^TM as clinical evaluation data, that is, the CE clinical trial data was applied. In April 2022, VenusP-Valve^TM received CE marking under the MDR and has been applied to a number of commercial cases. The product was approved by the FDA for compassionate use in two cases in the U.S. in May 2022 and the first compassionate case was completed successfully in June 2022. In addition, the Investigator Meeting for VenusP-Valve^TM US Clinical Study was held, and the Japan-US Harmonization By Doing Program was agreed upon by the FDA and PMDA with a plan to conduct clinical trials in the U.S. and Japan simultaneously, which will accelerate its registration and marketing in both countries.

Following its first clinical implantation in 2013, VenusP-Valve^TM has been used in nearly 300 cases for humanitarian reasons, spanning more than 20 countries and regions in Asia, Europe, North America, and South America. With clinical data from Europe and China backing up its long-term safety and efficacy, VenusP-Valve^TM has received high recognition from the international medical community.

According to three-year follow-up data of the European clinical trial, the success rate for TPVR with VenusP-Valve^TM is 100% in 64 patients (some patients have not been included due to the ongoing pandemic). All-cause mortality and surgical re-intervention rates were zero. In addition, no moderate or severe pulmonary regurgitation was observed. Paravalvular leakage and tricuspid regurgitation were mild or below in 96.87% of subjects. Meanwhile, five-year follow-up data of the Chinese trial reported a 3.64% postoperative five-year all-cause mortality rate.

Noteworthily, Venus Medtech earned First Prize of the Technical Invention Award of the Excellent Achievements in Scientific Research (Science and Technology) of Higher Education in March 2021 for its key materials and technologies of self-expanding Interventional pulmonic valve system project, which was mainly applied to VenusP-Valve^TM. Jointly undertaken by the Company and Sichuan University, the project received strategic support from the National Key Research and Development Program under the 13th Five-Year Plan.

Academician Prof. Ge Junbo, Director of Cardiology Department at Zhongshan Hospital Affiliated to Fudan University and Principal Investigator (PI) of the Chinese clinical trial of VenusP-Valve^TM, congratulated Venus Medtech on the NMPA approval of the product. "The first clinical application of VenusP-Valve^TM dated to May 2013, and we were all impressed by its excellent immediate outcomes. The overall clinical results of the multi-center study testified to effective and steady improvements it brought to patients' cardiac function, making me extremely proud of this Chinese-developed valve product. Moreover, its recent launch in Europe and compassionate use in the U.S. demonstrated the recognition it received from the international medical community. That's how a truly meaningful innovative medical device is defined."

In recent years, the Center for Medical Device Evaluation (CMDE) of NMPA has continuously optimized its procedures by introducing new policies and boosting review quality and efficiency in accordance with the decision of the State Council to reform the review and approval system of drugs and medical device. By doing so, the CMDE has effectively expedited the review and approval of domestic innovative medical devices and contributed to the high-quality growth of the industry. New policy documents including the Special Review Approval Procedure for Innovative Medical Devices and Priority Review and Approval Procedure for Medical Devices have been issued to create a green channel for clinically urgent novel devices and accept overseas clinical trial data. The improvements underlined CMDE's science-based, pro-reform orientation.

 "The fast-tracked approval of VenusP-Valve^TM would not be possible without CMDE's generous support. Their patient-centric orientation is an important driver in promoting innovative medical devices", commented Eric Zi, Co-Founder, Executive Director, and General Manager of Venus Medtech. "As one of the first companies to work on transcatheter structural heart devices in China, we have always embraced a clinical value-oriented approach to innovation. Aspiring to lead technological advances in our country, we are committed to delivering unprecedented, groundbreaking products in China and beyond. The approval of VenusP-Valve^TM in China is another key milestone following its CE MDR approval. Filling a gap in China's TPVR market, the product is expected to benefit more patients across the country."

The procedure was performed at the Center by Professor Scott Lim's team under on-site guidance from Professor Yuan Feng and remote guidance from Professor Mao Chen, who are both from Cardiology Department, West China Hospital, Sichuan University in China. As the first-ever clinical application of a Chinese-developed heart valve product in the U.S., the case corroborates not only the unique clinical value of VenusP-Valve™ but also the significance of global-oriented innovation.

Although there are several transcatheter pulmonic valve replacement (TPVR) products available in the U.S. market, such as Melody™ TPV and Harmony™ TPV by Medtronic and the SAPIEN series by Edwards, they do not work for the considerable number of patients with dilated right ventricular outflow tract (RVOT). As a large-diameter product, VenusP-Valve™ can satisfy the clinical needs of 85% of patients in the case of large RVOT. In May 2022, VenusP-Valve™ was approved by the FDA for compassionate use in two patients.

This first patient was a 21-year-old man who suffered from severe pulmonary regurgitation, right ventricular dilation, pulmonary artery dilation, and left ventricular dysfunction after transannular patch (TAP) repair of Tetralogy of Fallot (TOF). The procedure was performed under local anesthesia where the patient remained conscious. Upon preoperative CT, intraoperative contrast-enhanced ultrasound, and balloon measurement, a P34-25 (valve diameter 34mm, straight length 25mm) VenusP-Valve™ that precisely fit the patient's anatomy was delivered through the right femoral vein. On the first postoperative day, ultrasound scan indicated a marked decrease in right ventricle volume with no pulmonary regurgitation. Left ventricular function also returned to normal. Making a sound recovery according to postoperative assessment, the patient was discharged on June 18 (within 24 hours of the procedure) local time.

 "It was a great honor to work with Professor Chen and Professor Feng on the first compassionate use of VenusP-Valve™ in the United States", commented Professor Scott Lim after the procedure. "The product was very easy to handle as it's designed to facilitate precise positioning and delivery. The patient demonstrated significant improvement after the procedure. For the benefit of more patients, I really look forward to formal clinical trials of VenusP-Valve™ here as soon as possible."

Professor Chen congratulated on the first compassionate use of VenusP-Valve™ in the U.S. As he noted, VenusP-Valve™ has gained broad recognition from the global cardiology community since its first implantation in 2013. In particular, the product is a lifesaver for patients with dilated RVOT. Its transcatheter approach reduces trauma and speeds recovery, enhancing quality of life for patients in various dimensions.

Professor Feng said "VenusP-Valve™ is an excellent TPVR product. Its unique double flared-end design enables one-time delivery of stent and valve and simplifies the procedural workflow, making it a powerful tool for transcatheter treatment of pulmonary regurgitation. It is a pride of China to launch such a self-developed innovation in the U.S."

In April 2022, VenusP-Valve™ became the first Chinese-developed self-expanding TPVR product to receive CE marking under the Medical Devices Regulation (MDR). Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, the product is able to meet the needs of 85% of patients. VenusP-Valve™ is also undergoing review and approval with the Chinese National Medical Products Administration (NMPA) and is expected to be marketed within 2022.

During its nine-year clinical use since 2013, VenusP-Valve™ has been applied to nearly 300 cases for humanitarian reasons, spanning more than 20 countries and regions in Asia, Europe, North America, and South America. In March 2021, VenusP-Valve™ received special use authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for use in designated medical institutions.

VenusP-Valve™ has impressive clinical data backing up its long-term safety and efficacy. According to two-year follow-up result of the clinical study in Europe, the product demonstrated 100% procedural success, with no reoperation or death observed in two years. In addition, moderate and severe pulmonary regurgitation plunged from 16.88% and 83.12% preoperatively to 0%. The data suggest excellent performance, robust safety and reliability, and drastic and steady improvements in patients' cardiac function.

"The first compassionate use of VenusP-Valve™ accentuates the urgent clinical need and high regulatory recognition of the product", said Eric Zi, Founder, Executive Director, and General Manager of Venus Medtech. "VenusP-Valve™ is undergoing clinical trials or marketing application in many mainstream countries. It is an exemplar for Chinese-developed innovative medical devices to reach global markets. We have full confidence in the rapid global launch of the product as well as the benefits it brings to patients worldwide."

As the first self-expanding TPVR product approved for marketing in Europe, VenusP-Valve^TM carries remarkable clinical value. Uniquely designed with both flared ends, the product provides stable anchoring and easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, the product is able to meet the needs of 85% of patients. Following its first clinical implantation in 2013 by Academician Ge Junbo, Director of Cardiology at Zhongshan Hospital, Fudan University, VenusP-Valve^TM has been used in nearly 300 cases for humanitarian reasons, spanning more than 20 countries and regions in Asia, Europe, North America, and South America. In March 2021, VenusP-Valve^TM received special use authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for use in designated medical institutions.

Moderate to severe pulmonary regurgitation is common after surgical correction of congenital heart disease. It leads to right ventricular volume overload and may cause arrhythmia and even sudden death in the long run. The traditional thoracotomy approach to pulmonic valve replacement is difficult and carries high mortality, while 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-Valve^TM, there was no TPVR product suitable for different anatomical structures and available in such a wide range of specifications.

VenusP-Valve^TM has impressive clinical data backing up its long-term safety and efficacy. According to two-year follow-up interim result of the clinical study in Europe, the product demonstrated 100% procedural success, with no reoperation or death observed in two years. In addition, moderate pulmonary regurgitation decreased from 16.88% preoperatively to 0%, and severe pulmonary regurgitation plunged from 83.12% to 1.54%. The data suggest excellent performance, robust safety and reliability, and drastic and steady improvements in patients' cardiac function.

As published on the EU MDR website, VenusP-Valve^TM is noteworthily the first Class III implantable cardiovascular device approved under the new MDR. Coming into effect in May 2021, the new regulations set out stricter and more specific standards in technical review and clinical evaluation and require the establishment of expert panels to support such evaluations. After the new rules were adopted, there was no CE MDR certificate issued to any Class III implantable cardiovascular device until VenusP-Valve^TM, which is stark evidence of Venus Medtech's world-class clinical trial and quality control systems.

Europe is the bridgehead of Venus Medtech's international strategy. To build a winning commercialization team for VenusP-Valve^TM, the Company engaged marketing veterans like Shakeel Osman and David Breant as senior managers. By now, VenusP-Valve^TM has received multi-million euro pre-orders.

Apart from the EU, VenusP-Valve^TM is undergoing review and approval of registration with the Chinese National Medical Products Administration (NMPA) and is expected to be marketed within 2022. 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. Apparently, the EU approval will give an important impetus to commercialization processes in China, the US, and other markets.

Professor Shakeel Qureshi at Evelina London Children's Hospital, Principal Investigator (PI) of the clinical trial for CE marking of VenusP-Valve^TM, congratulated Venus Medtech on the EU approval of the product. "I still remember the first procedure we performed in September 2016 in London and its excellent immediate outcomes", he said. "On that starting point, we continued to recruit additional patients for the trial. The overall clinical results underscored the sustained, effective, and steady improvements the product brings to patients' cardiac function. This is what a truly meaningful innovative medical device looks like."

"For Venus Medtech, the CE marking of VenusP-Valve^TM under MDR will open a new chapter of growth in the European market", said Eric Zi, Co-Founder, Executive Director, and General Manager of the Company. "We will leverage this product to scale up our overseas revenue, accelerating our progress to global prosperity. Also, we will continue our clinical trials and commercialization endeavors in global markets for other innovative technologies and products, bringing Chinese innovations to the world."

In 2021, Venus Medtech maintained rapid growth in the Chinese market with VenusA-Valve and VenusA-Plus, the earliest first-generation and second-generation TAVR products approved for marketing in China, which were applied in 3,600 procedures last year. The two products have covered 360 hospitals and medical centers nationwide, from which a wealth of clinical follow-up data was gathered, sufficiently testifying to their safety and effectiveness. In particular, VenusA-Valve is currently the only TAVR product with long-term safety verification for more than six years in China.

Venus Medtech boasts a best-in-class innovative cardiovascular device marketing team, which has by now expanded to 220 members. In 2021, the Company supported more than 60 free treatment events, engaging 300+ doctors and benefitting 2,000+ patients. These charitable endeavors made Venus Medtech the only high-value medical consumables company to win the Corporate Public Welfare Contribution Pioneer Award of Qingsongchou in 2021. In addition, Venus Medtech enjoys an efficient logistics team to ensure the safe and timely delivery of medical devices and subsequent procedures.

As one of the first domestic players to provide transcatheter structural heart valvular therapies, Venus Medtech has been expanding its global presence at a robust pace while keeping its leading position in commercialization in China. In 2021, Venus Medtech registered RMB10.51 million in overseas revenue, a marked year-on-year increase of 160.5%, with the sales of TriGUARD3™ cerebral embolic protection (CEP) device.

Europe is the bridgehead of Venus Medtech's international strategy. To build a winning commercialization team for the European market, the Company engaged marketing veterans like David Breant and Shakeel Osman as senior managers, laying a solid foundation for the upcoming launch of VenusP-Valve, its new transcatheter pulmonic valve replacement (TPVR) system. VenusP-Valve passed the CE MDR qualification audit in 2021 and is right now under certification management review. It is expected to become the first Chinese valve product approved in the EU and generate considerable overseas revenue in 2022. In March 2021, VenusP-Valve received special use authorization in the UK to enter the market in advance, which amply proved the urgent needs of patients for the product.

Continuous development and acquisition of innovative therapies have enabled Venus Medtech to establish a series of new product pipelines in developed markets as Europe and America. The Company announced the acquisition of Cardiovalve, an Israel-based high-tech company specializing in innovative therapies for mitral regurgitation and tricuspid regurgitation, in December 2021, and completed the acquisition in January 2022. Cardiovalve is the only FDA-approved device for treating both mitral regurgitation and tricuspid regurgitation, and has received the FDA Breakthrough Device Designation for its transcatheter tricuspid valve replacement system. The product is expected to commence clinical trials in China this year, bringing innovative solutions to domestic patients.

Furthermore, a number of globally cutting-edge products started their clinical trials in 2021, including the Liwen RF™ radiofrequency ablation system for treating hypertrophic cardiomyopathy (HCM), new-generation TAVR products Venus-PowerX and Venus Vitae for treating aortic valve stenosis, and a renal denervation system for treating resistant hypertension. In 2022, Venus Medtech aims to advance the clinical progress of the above products in China as well as developed countries in Europe and America.

 "2021 marked the beginning of our global journey", said Eric Zi, Co-Founder, Executive Director, and General Manager of Venus Medtech. "Our progress has been impressive. Looking ahead, we will make more determined efforts to create innovative products with global influence and develop unprecedented, ground-breaking technologies in China and beyond, thereby translating our strategic vision to build a comprehensive platform for structural heart disease into reality."

Prior to joining Venus Medtech, Shakeel Osman served as General Manager UK & Vice President Sales Middle East Asia and Africa at Occlutech Medical Devices, a Germany-based global leading provider of minimally invasive cardiac devices. As a 20-year veteran in the global marketing of medical devices, Shakeel Osman has been heavily engaged in the European and Middle East markets, boasting extensive experience in marketing and distributor management in the cardiovascular field.

Shakeel Osman said, "It is a great honor to join Venus Medtech's commercialization team in Europe. As a leading company in structural heart disease, Venus Medtech possesses internationally competitive innovative pipelines. I'm excited to leverage my experience and work closely with the team to lay a solid foundation for the commercialization of VenusP-Valve across Europe and contribute to the company's global presence."

VenusP-Valve is the only self-expanding TPVR system undergoing CE certification at the present time. It is expected to be Venus Medtech's second innovative medical device marketed in Europe following TriGUARD3™ cerebral embolic protection device. In March 2021, VenusP-Valve received a special use authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Eric Zi, Founder, Executive Director and General Manager of Venus Medtech, warmly welcomed Shakeel Osman to the company. "We are delighted to have another professional medical device marketing veteran joining Venus Medtech. The expertise and experience of Shakeel will be a tremendous addition to the commercialization of VenusP-Valve in Europe, which is expected to give important weight to the clinical progress of future innovative devices in the market."

Following the launch of TriGUARD3™ in Europe in 2020, Venus Medtech has been committed to enhancing its international commercialization endeavors to lay the foundations for global innovation and facilitate overseas clinical trials for more structural heart products. Furthermore, Venus Medtech appointed David Breant as Vice President of Sales Europe, responsible for the adult structural heart disease business, as well as direct sales in Germany, France and other markets; and Joyce Heo as Director of Sales, responsible for sales in emerging markets.

Cardiovalve Ltd. (previously Mitraltech Ltd.) was headquartered in Israel in 2010. Its independently-developed Cardiovalve System is a transcatheter interventional replacement product for patients suffering from mitral or tricuspid regurgitation. Compared with products of the same kind, its transfemoral approach significantly improves the safety of treatment and its 55mm annuli is suitable for about 95% of the patient population. Its unique short frame design lowers the risk of LVOT obstruction. In addition, Cardiovalve has applied for over 215 patents, of which 83 have been granted.

Patients suffering from mitral and tricuspid regurgitation are increasing with each passing day, due to the lack of effective and innovative treatments. Such patients are expected to exceed 22 million by 2025 in China, and 14 million and 9.2 million in Europe and the U.S., respectively in 2025. Huge patient group brings broad market space. According to Edwards Lifesciences, the global leader in medical innovations for structural heart disease, the total value of interventional therapy for mitral regurgitation and tricuspid regurgitation will reach US$5 billion by 2028, which increases by 5 times compared with that of year 2021.

Interventional treatments of mitral and tricuspid regurgitation have been regarded as technically difficult globally. FDA has not approved any products for mitral and tricuspid valve replacement at present. However, with unique characteristics and ahead-of-schedule progress among products of the same kind under clinical period, Cardiovalve stands as the first privately held company to receive FDA's early feasibility study (EFS) approval for both TR and MR indications.

As a pioneer in the field of heart valve disease treatment in China, Venus Medtech is committed to continuous innovation and building a complete product system to fully serve doctors and patients worldwide. After the acquisition of Cardiovalve, the company will continue to advance its clinical research in Europe and the U.S., while accelerating its clinical development and commercialization in the Chinese market. The acquisition of Cardiovalve will enable Venus Medtech to become one of the most complete platform companies in the field of mitral regurgitation and tricuspid regurgitation treatment in China, and it will also bring new opportunities for Venus Medtech's innovation and internationalization.

"The successful completion of this cross-border acquisition will have a significant impact on the company's further international development strategy," says Venus MedTech's CEO, Eric Zi, "and we will take this as an opportunity to further consolidate our long-term vision of making international innovation and global presence. Venus Medtech will continue to advance our overall product pipeline to provide innovative devices and services for global doctors and patients. "

"Partnering with Venus Medtech is crucial for Cardiovalve to accelerate its approach to key global markets," said Amir Gross, CEO of Cardiovalve. "We've built a strong relationship of mutual trust over the past few years and are committed to creating a new ecosystem of cooperation between China and Israel in the medical device innovation industry. Going forward, we will continue to develop innovative and superior R&D products."

Cardiovalve Ltd. (previously Mitraltech Ltd.) was headquartered in Israel in 2010. Amir Gross, CEO of Cardiovalve, is a serial entrepreneur. He founded and led Valtech Cardio until its acquisition in 2017 by Edwards Lifesciences, a global cardiovascular device giant, at a total deal size of $700 million.

Its independently-developed Cardiovalve System is a transcatheter interventional replacement product for patients suffering from mitral or tricuspid regurgitation. Compared with products of the same kind, its transfemoral approach significantly improves the safety of treatment and its 55mm annuli is suitable for about 95% of the patient population. Its unique short frame design lowers the risk of LVOT obstruction. Cardiovalve has applied for over 215 patents, of which 83 have been granted.

Its treatment of mitral regurgitation has entered clinical trials in Europe and is currently in an early feasibility study in the U.S.. Well-noted international cardiovascular centers such as the Piedmont Heart Institute (US), IRCCS Policlinico San Donato (Italy), Universitaet Mainz (Germany), Heart-Center University Clinic Bonn (UKB) (Germany), University Heart Center Lübeck Medical Clinic II (Germany), etc. were involved in its clinical trials. Furthermore, its device for the treatment of tricuspid regurgitation received 'Breakthrough Device Designation' by the FDA in January 2020 and entered an early feasibility study. It is worth mentioning that Cardiovalve is also the first privately held company to receive FDA's early feasibility study (EFS) approval for both TR and MR indications.

Interventional treatments of mitral and tricuspid regurgitation have been regarded as technically difficult globally. However, the patient population grows with each passing day. The number of people suffering from mitral regurgitation and tricuspid regurgitation is expected to exceed 22 million by 2025 in China alone, while the patient populations in Europe and the U.S. will reach 14 million and 9.2 million respectively in 2025. In this context, the total potential market value of mitral valve replacement and tricuspid valve replacement in China, Europe, and the U.S. is expected to exceed $4.7 billion in 2030.

As a pioneer in the field of heart valve disease treatment in China, Venus Medtech is committed to continuous innovation and building a complete product system to fully serve doctors and patients. After the acquisition of Cardiovalve, the company will continue to advance its clinical research in Europe and the U.S., while accelerating its clinical development and registration in the Chinese market. In May this year, Venus Medtech announced its investment in Valgen Holding Corporation in order to consolidate its mitral valve repair product and tricuspid valve repair product pipelines. The acquirement of Cardiovalve will make Venus Medtech one of the most complete platform companies in the field of mitral regurgitation and tricuspid regurgitation treatment in China, and it will also bring new opportunities for Venus Medtech's innovation and internationalization.

"First of all, Cardiovalve is a best in class device," said Prof. Francesco Maisano, Chief of Cardiac Surgery and Director of the Valve Clinic at the IRCCS San Raffaele University Hospital and fellow of the European Society of Cardiology (ESC). "Behind this device there is a great team, and the original concept goes back almost ten years. From the very beginning, we knew that the future of TMVR and TTVR would require a transfemoral implant, simple and repeatable, minimizing the many challenges of valve replacement. After ten years of intense work, the valve is ready to become the best solution for TMVR and TTVR." Prof. Maisano is known as one of the world's top experts in mitral and tricuspid valve treatment, as well as the principle investigator of Cardiovalve.

Prof. Scott Lim, Medical Director of the UVA Advanced Cardiac Valve Center， pointed out that "Increasingly, it has become evident that there will be a role for a transcatheter mitral valve, particularly for functional mitral regurgitation. Additionally, there has been a surge of excitement in the cardiovascular community about transcatheter tricuspid valve replacement, even over repair technologies. The Cardiovalve core technology, a transvenous transcatheter mitral and tricuspid valve, delivers the impressive potential of a less invasive valve replacement technology along with an evolved delivery system. We look forward to the continued clinical research trial investigations of this valve in the international cardiovascular community for both mitral and tricuspid valve disease."

"The acquisition of Cardiovalve will create synergy with the company's existing product layout," says Venus MedTech's CEO, Eric Zi, "and will further consolidate the company's leading position in the field of structural heart disease in China and globally. This is in line with the long-term vision of Venus Medtech to innovate and commercialize globally. We believe that the Cardiovalve system will promote innovation in Venus and provide more innovative treatments for doctors and patients worldwide."

"We are honored to be backed by Venus, the leading player in China. We believe that cooperation with Venus Medtech will accelerate our development in the global market, especially the Chinese market, and achieve more breakthrough innovations," said Amir Gross, CEO of Cardiovalve. "We believe that this agreement is only a first step to a fruitful, long-term relationship in which we will continue to bring multiple innovations to market jointly."

About Venus MedTech

Venus Medtech, is the leader in transcatheter structural heart valvular therapies in China. It was established in 2009, and listed on the Main Board of the Hong Kong Stock Exchange on Dec 10^th, 2019. A strong track record of innovative R&D has gained Venus Medtech significant first-mover advantages. VenusA-Valve and VenusA-Plus, self-developed 1st and 2nd generations of TAVR products, are the world's first products approved by the NMPA and commercialized in China. In terms of R & D layout, the company has built a number of technical platforms in order to move into the fields of hypertrophic cardiomyopathy, hypertension interventional therapy, and even heart failure treatment, besides heart valve disease, and is committed to providing a complete integrated solution for structural heart disease.

About Cardiovalve

Cardiovalve Ltd. was headquartered in Israel in 2010. With 40 employees, Cardiovalve operates from 1,700 sq. ft. facilities with inhouse manufacturing and clean rooms, and is the holder of over 200 patents and patent applications. The Cardiovalve System offers a self-developed mitral and tricuspid replacement valve delivered via a transcatheter approach, intended to reduce the mortality and morbidity associated with surgical treatment options for both mitral and tricuspid valve regurgitation indications. The Cardiovalve system is currently enrolling patients in several multi-center studies for both mitral valve replacement and tricuspid valve replacement in the US and in Europe. Initial clinical results are promising.