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On April 12, The Device Home learned that Venus-Neo, a new generation of expandable biological dry valve independently developed by Qiming Medical, recently completed the world's first clinical trial applied to humans at the Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology ("Wuhan Union"), which was jointly completed by Professor Dong Nianguo, Director of The Department of Cardiac and Macrovascular Surgery of Wuhan Union, professor Liu Junwei and Professor Wang Yin.
This is another new generation of dry valve products that has entered clinical research after Venus-Vitae and Venus-PowerX, marking the full layout of Aortic Valve Disease Solutions for Venus-Vitae and Venus-PowerX, which is a milestone for consolidating the company's position as a leader in the treatment of heart valve disease in China.
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A new generation of expandable biological dry valve Venus-Neo
As the first surgical biological valve of Qiming Medical, Venus-Neo adopts the upper ring valve design, with the bovine pericardial tissue as the leaflet, and through the optimization of the valve design and the unique anti-calcification drying treatment technology (Venus-Endura), it can be stored in a liquid-free environment and does not contain aldehyde residues, which improves safety and facilitates clinical use and storage and transportation.
In addition, Venus-Neo's valve stents are designed to be expandable, providing a better option for future patients who require "valve-in-valve" therapy. In September 2020, Qiming Medical and Changchun Haoyue Halal Meat Co., Ltd. established a joint venture company, Jilin Qiming Haoyue Biotechnology Co., Ltd., a strategic cooperation to ensure a stable and high standard raw material supply system.
Postoperative transesophageal ultrasound of the aortic valve and short axis section, and postoperative transesophageal ultrasound of the left ventricle and major axis section
The world's first patient in the new generation of expandable biological dry valve Venus-Neo in human clinical trials was a 67-year-old woman who was admitted to the hospital for long-term cough with dyspnea and recently worsened, and ultrasound suggested moderate to severe regurgitation of the aortic valve, mild to moderate regurgitation of the tricuspid valve, and mild mitral regurgitation. Surgical Aortic Valve Replacement (SAVR) was evaluated for Venus-Neo, with good postoperative valve opening and closing, no reflux and perivalle leakage, and the flow rate of the prosthetic valve was 1.4 m/s, the average cross-valve pressure difference was 7 mmHg, and the hemodynamic performance was excellent.
Valvular heart disease is one of the leading diseases in the elderly population worldwide, with more than 40 million patients worldwide. With the aging of the Chinese, aortic valve disease has become one of the main heart valve diseases, mainly aortic stenosis and aortic regurgitation. For the treatment of AS and AR, SAVR is still a relatively mature treatment method. However, the high risk of re-SAVR after the decay of the biological valve cannot be ignored. For such patients, transcatheter aortic valve replacement is a viable alternative to SAVR again, and intravalular TAVR has been progressively applied to the treatment of surgical biological valve decay.
Newly published follow-up data from the PARTNER2 ViV trial for 5 years showed that patients with high surgical risk of aortic valve biological valve failure underwent TAVR interventions, and clinical status and echocardiographic results continued to improve. At the same time, studies suggest that ViV-TAVR is effective in the treatment of aortic valve biological valve damage, based on two necessary factors: 1. Priority should be given to implanting valves of the largest possible size to lay a good foundation for future bio-valve decay ViV; 2. Improve the biological valves with fixed traditional valve structures, bring better therapeutic effects to ViV-TAVR after biological valve decay, and apply expandable valves.
Director Dong Nianguo said after the operation: "It is an honor to participate in Venus-Neo's world's first FIM study. Venus-Neo's dry flap material can be stored directly, effectively avoiding the aldehyde residue through glutaraldehyde preservation, thereby greatly improving valve durability, and the expandable structure of the flap frame also provides full convenience for future treatment of patients, which is a unique and innovative product. The patient's postoperative ultrasound showed a large effective opening area of Venus-Neo and excellent hemodynamic performance. ”
Mr. Zi Zhenjun, co-founder, executive director and general manager of Qiming Medical, said: "For a long time, Qiming Medical has been committed to the research and development and commercialization of structural heart disease medical devices, and adheres to the principle of solving the problem of biological valve durability from the source of biomaterials. The smooth FIT of Venus-Neo helps the company achieve a full layout of aortic valve disease solutions, which not only provides more flexibility for clinical use, benefits more patients, but also helps domestic innovative valves to a new level. ”
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Local leaders, international breakthroughs
Looking at the world, there are currently only 4 approved TPVR products. In April 2017, VenusA-Valve, a generation of product VenusA-Valve, was approved for listing by NMPA, becoming the first NMPA approved TAVR product and the first TAVR product commercialized in China. According to the information published on the official website of the European Union, VenusP-Valve is the first Class III cardiovascular implantable medical device approved under the new CE MDR regulation. According to statistics, there are currently only 28 NB institutions that can make MDR authorization announcements, while the number of notified institutions authorized by MDD in the past exceeded 50. It can be seen that the medical device products approved under the CE MDR regulation have "greatly increased their gold content".
In addition to the above-mentioned domestic valve VenusP-Valve, the other three models are Melody, Sapien XT and Harmony from overseas. However, due to the smaller available size of these three valves, clinical applications have been limited, and only about 15% to 20% of patient needs can be solved. VenusP-Valve valves are available in a wide range of sizes and can clinically meet the needs of more than 85% of patients. Before VenusP-Valve was approved, there was no treatment on the market with a wider coverage of different anatomical morphologies and sizes.
The second generation of VenusA-Plus was approved by NMPA in November 2020, is the only domestic approved second-generation TAVR, more advantageous than the first generation of other domestic enterprises, its important feature is recyclable, recyclable products are more conducive to beginners. In addition, it can make the implant more precise, reduce the use of pacemakers and the assistance of surgery, and bring better prognosis.
In 2021, the company maintained rapid growth in the domestic market with the first and second generation of TAVR products approved for listing in China, VenusA-Valve and VenusA-Plus, with a total of about 3,600 surgeries completed throughout the year. The two products have covered 360 hospitals or treatment centers across the country, and have accumulated rich clinical follow-up data, and the safety and efficacy of the devices have been fully verified. Among them, VenusA-Valve is also the only TAVR product in China with more than six years of long-term security data.
Qiming Medical has an outstanding sales team in the field of cardiovascular innovative devices, and the current team size has grown to 220 people. In 2021, the company co-organized more than 60 free heart valve clinic activities, attracting more than 300 free doctors and serving more than 2,000 patients. Through actively participating in public welfare free clinics and other activities, Qiming Medical, as the only high-value medical consumables enterprise, won the 2021 Pioneer Award for Corporate Public Welfare Contribution. In addition, the company is also equipped with an independent and efficient logistics team to ensure that clinical operations are carried out in a timely and safe manner.
As one of the earliest companies involved in the interventional treatment of structural heart disease in China, Qiming Medical not only maintains its leading position in commercialization in China, but also develops rapidly in the international market. With the sales contribution of TriGUARD3, an anti-embolic distal brain protection device (CEP), the company's international market revenue reached 10.51 million yuan, a year-on-year increase of 160.5%.
The European market is the "bridgehead" of Qiming Medical's internationalization strategy. Over the past year, the company has focused on the allocation of European business teams, and has successively appointed experts with rich marketing experience such as David Breant and Shakeel Osman as marketing executives, laying a solid foundation for the upcoming pulmonary valve replacement (TPVR) system VenusP-Valve. The product has passed the EU CE MDR certification audit in 2021, has entered the certification stage, will become the first EU approved valve product from China, and is expected to achieve considerable overseas revenue this year. In March last year, VenusP-Valve was granted a special use license in the UK to enter the market in advance, which also fully confirmed the urgent needs of clinical doctors and patients for this product.
Through the continuous development and merger and acquisition integration of innovative therapies, Qiming Medical has established a series of new product pipelines in the developed markets of Europe and the United States. In December 2021, the company announced the acquisition of Cardiovalve, an Israeli innovation company focused on innovative therapies for mitral and tricuspid recoil, and completed the acquisition in January 2022. Cardiovalve is the only FDA-approved therapeutic device that can be used for both mitral and tricuspid regurgitation, and has obtained breakthrough certification in the United States. The product is expected to be clinically studied in China this year, bringing innovative solutions to local patients.
In addition, the company has a number of international innovative products that entered the clinical stage last year, including the Liwen RF™ ablation system for the treatment of hypertrophic cardiomyopathy, venus-powerX and Venus-Vitae, a new generation of TAVR products for the treatment of aortic stenosis, and the renal artery sympathetic ablation system for the treatment of refractory hypertension. In 2022, the company will continue to promote the clinical research of the above products in China and developed countries in Europe and the United States.