Haier Capital Portfolio Company Jinshi Bio's Pre-mounted Dry Valve Prostyle A® Receives NMPA Approval, Marking a Milestone in Medical Innovation

Recently, Haier Capital's medical portfolio co-creation achieved another milestone — Kingstron Bio's self-developed Prostyle A® Transcatheter Artificial Aortic Valve Replacement System - Dry Pre-mounted Retrievable Delivery System has been approved for marketing by the National Medical Products Administration (NMPA) (Approval No. 20253130729).

Prostyle A® valve is the world's first pre-mounted dry valve, utilizing the globally leading anti-calcification platform Micro-Ex to completely remove tissue debris while blocking calcification sources during valve preservation, significantly enhancing the durability of the valve.

As the world's first pre-mounted dry valve, the new-generation transcatheter aortic valve Prostyle A® launched by Kingstron Bio integrates numerous cutting-edge technologies in the field of valves. It features dry valve technology, a clever and convenient pre-loading system, excellent hemodynamic performance and durability of the valve, superior deliverability and trackability, smooth deployment, and reliable anchoring.

Kingstron Bio's Self-Innovated Dry Valve Technology: Patented Protection in China, Europe, the United States, Japan, and Other Countries. This unique technology not only makes pre-loading possible, eliminating the inconvenience of doctors assembling valves on-site in the operating room, but also endows the valve with greener performance. Compared with traditional wet valves preserved in aldehyde solution, it eliminates the risk of aldehyde residue, demonstrates better biocompatibility, effectively slows down the calcification process of biological valves, and extends the service life of the valve. The emergence of this product ushers in a new era for TAVR in China — the Dry Valve Era. It is believed that more dry valve products will emerge internationally in the near future, benefiting patients worldwide.

In terms of product configuration, Prostyle A® adopts a low stent waist-receiving design, offering balanced radial support force and a small taper angle, as well as an extended full-sealing zone. Its stable deployment and ability to expand in patients with severe calcification are the first impressions clinicians have of this product. Additionally, the delivery system features a compliant patented design, with a minimum outer diameter of only 18F and an optional inline sheath design, equivalent to a 14Fr/16Fr system. Its excellent arch-crossing performance has been well validated in clinical trials, demonstrating outstanding results in cases such as small-angle aortic arches and horizontally positioned hearts. The ultra-smooth coating on the distal end ensures smooth arch crossing and reduces the risk of dissection.

The safety and efficacy of the Prostyle A® system in treating aortic valve stenosis are supported by solid evidence-based medical proof. Under the leadership of Professor Mao Chen from West China Hospital of Sichuan University, trials conducted at top hospitals in China, including West China Hospital of Sichuan University, the Second Affiliated Hospital of Zhejiang University School of Medicine, the First Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army, the Second Xiangya Hospital of Central South University, Beijing Anzhen Hospital affiliated to Capital Medical University, Shanghai Chest Hospital, Cardiovascular Hospital affiliated to Xiamen University, Nanjing First Hospital, Peking University Third Hospital, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, and Yunnan Fuwai Cardiovascular Hospital, as well as many renowned cardiovascular experts, have confirmed its effectiveness.

As shown in the Prostyle A® trial results, the device performed excellently, and its unique valve design brought better clinical benefits. The follow-up rate was 100%, the mean aortic valve gradient at one year post-operation was 12 mmHg, the pacemaker implantation rate was only 10.4%, making the procedure safer and helping patients avoid multiple surgeries.

The excellent performance of this valve in the registered clinical trial left a deep impression on clinical experts. As is known, the prevalence of bicuspid valve patients among the Asian population is significantly higher than that in Western populations, and bicuspid valves are more challenging compared to tricuspid valves. Among the enrolled patients for this product, approximately 50% were patients with calcified bicuspid valves, yet under these circumstances, this valve still demonstrated outstanding performance. Notably, pacemaker implantation has always been a common complication post-TAVR, as the implantation of the valve can affect the conduction tissue beneath the valve. In the clinical trial of this product, the pacemaker implantation rate was reduced to a leading level within the industry, thanks to the ingenious stent design, stable and accurate deployment, and the multiple optimized options for retrieval and repositioning of the valve.

Since its establishment, Kingstron Bio has adhered to its original aspiration and remained committed to innovation, owning more than 80 patents domestically and internationally. In 2018, after the mitral annuloplasty ring was launched, the tricuspid annuloplasty ring, aortic valve bioprosthesis, mitral valve bioprosthesis, and bovine pericardial patch were successively introduced to the market. Relying on advanced material processing technology, Kingstron Bio has firmly rooted itself in the field of heart valve products, gaining deep market trust and user recognition. In particular, the annuloplasty ring has achieved leading sales among similar medical consumables produced in China.

The approval of Prostyle A® this time provides the market with a higher-quality product choice, serving a wide range of patients and doctors, marking another step forward for Kingstron Bio. Meanwhile, the transcatheter mitral and tricuspid valve replacement systems, as well as the pericardial tissue heart valve (dry valve), are currently in clinical trials.

In this era where life technology meets the digital revolution, Haier Capital will continue to cultivate a "tropical rainforest" of medical innovation through its industry-wide ecological investment and co-creation model, jointly writing a vivid footnote for "Healthy China" with pioneering companies like Kingstron Bio. When the warmth of technology meets the depth of life, we believe that the journey of深耕 (deep cultivation) in the healthcare field will leave more shining marks of Chinese innovation.