New Valve Medical Completes Tens of Millions USD Series B Financing, HAOYUE Capital Acts as Exclusive Financial Advisor

VCBeat has learned that Shanghai NewMed Medical Co., Ltd. (hereinafter referred to as “NewMed”), a leading domestic enterprise in interventional mitral valve therapy, recently announced the completion of its Series B financing round, amounting to tens of millions of US dollars. The round was led by OrbiMed, with Haoyue Capital serving as the exclusive financial advisor. According to the company, the funds raised will be used to advance the clinical development and regulatory approval for market launch of China’s first interventional mitral valve replacement device.

Previously, NewMed had secured early-stage investments from prominent venture capital firms in the industry, including Boyuan Capital, Lize Capital, and Zhangke Lingyi.

NewMed, established in 2015, is a high-tech medical innovation enterprise with independent intellectual property rights. Since its inception, NewMed has focused on the research, development, and industrialization of interventional artificial heart valve systems at an internationally advanced level, committed to providing more high-end medical devices that benefit the public for clinical use and patients.

On December 20, 2019, VCBeat released the "2019 Future Healthcare Top 100 List," with NewMed honored on the "2019 Future Healthcare Top 100 · China Innovative Medical Devices Top 100" list.

As the primary valves of the systemic circulation, the aortic and mitral valves in the left heart system are more susceptible to disease-related damage. According to 2018 statistics, there were approximately 270 million patients with valvular heart disease worldwide, of whom 190 million had left-sided valvular heart disease, accounting for about 70%. This condition causes approximately 2.6 million deaths annually, posing a significant threat to human health.

Valvular heart disease can be managed through pharmacological therapy, surgical intervention, and transcatheter procedures. Pharmacological therapy typically provides only temporary symptom relief and does not offer a definitive treatment solution. Surgical intervention is highly invasive, and some patients are ineligible for surgery due to factors such as advanced age and comorbidities.

Compared with traditional open-heart surgery, interventional therapy does not require cardiac arrest or cardiopulmonary bypass, significantly reducing surgical trauma and providing a better treatment option for high-risk patients who are unable to undergo open-heart surgery.

Since the world’s first transcatheter mitral valve replacement (TMVR) procedure was performed in 2012, it took eight years for Abbott to overcome the numerous challenges in the field of mitral valve therapy. Its Tendyne Mitral Valve Replacement System, the first-ever transcatheter mitral valve replacement product globally, finally received CE Mark approval from the European Union on January 30, 2020. The approval of the world’s first TMVR device has significantly boosted confidence among industry peers, with many believing that a golden era for TMVR is imminent.

According to publicly available research data, TMVR is associated with lower mortality and higher safety compared to traditional open-heart surgery, significantly improving mitral regurgitation in high-risk or very-high-risk patients.

Mitral Regurgitation (MR) is the most common valvular heart disease. In China, approximately 10 million patients with MR require treatment, and over 40,000 surgical mitral valve procedures are performed annually. Given the high risks associated with open-heart surgery, the widespread adoption of Transcatheter Mitral Valve Replacement (TMVR) technology would benefit a larger patient population.

Yang Zhenjun, Managing Director at Haoyue Capital, stated, “TAVR has attracted significant capital interest in recent years. It is expected that two more domestic TAVR medical device companies will go public this year, marking the entry of TAVR competition into a new era. Given that the incidence of mitral regurgitation is three to five times that of aortic stenosis, the market potential is enormous. We are very optimistic about the future development of the mitral valve market.”

According to statistical data, in 2018, the global number of patients suitable for left-heart valve interventional therapy was approximately 21 million, with about 2.5 million in China. It is projected that by 2025, these figures will rise to approximately 24 million globally and 3.3 million in China. Yu Qifeng, Chairman of NewMed, stated, “The global market for mitral valve interventional therapy is valued at approximately USD 30 billion, representing a substantial market size. Furthermore, with the accelerating aging of the population, the market is expected to continue growing.”

However, the current proportion of patients undergoing transcatheter valve interventions remains low. Globally, by 2018, only about 3.5% of eligible patients had received transcatheter aortic valve replacement (TAVR), whereas in China, this figure stood at approximately 0.1%, significantly below the global average.

The situation regarding transcatheter mitral valve interventions is even more urgent. Currently, only one transcatheter mitral valve replacement device and one transcatheter mitral valve repair product have been launched globally, with merely approximately 0.5% of patients with mitral regurgitation undergoing transcatheter surgical treatment. In China, the field of transcatheter mitral valve intervention remains blank, leaving many patients eligible for such procedures without access to treatment. With population aging, the demand for left-sided heart valve transcatheter interventions is becoming increasingly urgent.

In recent years, transcatheter mitral valve replacement (TMVR) devices have developed rapidly. Major international players in the cardiology field have launched large-scale clinical trials in Europe and the United States, driving new products to market to meet the substantial clinical demand in this area. While giants such as Abbott and Medtronic were developing their TMVR products, a domestic company, NewMed, was also making significant efforts in this field.

In May 2019, the Mi-thos transcatheter mitral valve developed by NewMed was successfully implanted for the first time at Zhongshan Hospital, Fudan University. Currently, exploratory clinical studies in humans have been initiated for Mi-thos at Zhongshan Hospital, Fudan University, and Xijing Hospital of the Air Force Medical University. Multiple patient implants have been successfully completed, with all procedures proceeding smoothly. Notably, NewMed’s Mi-thos is the first transcatheter mitral valve replacement (TMVR) product in Asia, with quality comparable to international standards.

Yu Qifeng stated, “According to clinical trials, patients are satisfied with postoperative valve function, with no significant regurgitation and no serious complications occurring; valve regurgitation has resolved. Currently, the patient has successfully entered the follow-up period. This demonstrates the superiority of TMVR technology and reflects that the R&D capabilities for high-end medical devices in China are catching up with international standards.”

Research data indicates that the Mi-thos transcatheter mitral valve system will simplify the heart valve replacement procedure, significantly reduce treatment risks, and markedly improve success rates. Furthermore, domestically produced transcatheter mitral valve products will shorten postoperative recovery time and substantially lower costs, thereby driving down the prices of imported counterparts. This will enable more patients to afford the treatment by mitigating both the financial burden and procedural risks.

As is well known, the research and development of high-end medical devices involves significant technical barriers and requires substantial capital investment. This is particularly true for the development of interventional devices in the field of mitral valve therapy, due to the unique anatomical structure of the mitral valve. Nevertheless, NewMed has risen to the challenge and rapidly deployed a portfolio of multiple products within a short period.

Yu Qifeng told reporters, “The original intention behind the founding of NewMed was to address the urgent clinical needs of patients with valvular heart disease worldwide by developing innovative mitral valve products. Through several years of accumulation, NewMed has established a comprehensive R&D platform and project resources, laying out a product line for minimally invasive mitral valve replacement and repair devices.”

NewMed’s focused strategy has also garnered strong support from top-tier investors in the biopharmaceutical industry. Dr. David Wang, Partner at OrbiMed, stated, “As an innovative medical device company established less than five years ago, NewMed has developed a portfolio of products in the field of transcatheter mitral valve replacement and repair, with its products and technologies leading the domestic market. We are highly confident in the NewMed team’s innovation and execution capabilities and are committed to supporting the company in advancing the commercialization of multiple products, thereby building a new platform centered on transcatheter mitral valve interventions.”

Yang Zhenjun, Managing Director at Hylink Capital, stated, “NewMed is a national leader in the field of mitral valve replacement, having pioneered multiple exploratory clinical trials. With a diversified portfolio of products for mitral valve therapy, it stands out as a rare and high-quality enterprise. Hylink Capital is honored to serve as the exclusive financial advisor for NewMed’s current financing round. We believe that, leveraging its technological leadership and with capital support, NewMed will accelerate the clinical development and market launch of its products, thereby benefiting patients in China.”

According to Yu Qifeng, there are three reasons why NewMed has attracted capital attention. First, NewMed’s strong protection of intellectual property. To date, NewMed holds more than 70 patents and is expected to have over 100 patents by 2020. Second, the transcatheter heart valve sector offers substantial market potential and addresses an urgent medical need. Third, NewMed is a leader in the transcatheter heart valve field, with products that rival international standards.

Yu Qifeng, Chairman of NewMed, concluded by stating, “Minimally invasive mitral valve replacement and repair devices, as a revolutionary therapeutic approach, are gaining increasing recognition among industry experts, with clinical demand poised for explosive growth. Following the completion of this financing round, NewMed will further strengthen product research and development, accelerate commercialization, and bring more innovative medical products to clinical application, thereby benefiting patients.”

Shanghai NewMed Medical Co., Ltd. is dedicated to innovative R&D, academic advancement, and the widespread adoption of therapies. The company has established a management team integrating industry, academia, research, and clinical practice, and forged strong collaborative partnerships with renowned hospitals and universities in China. It has developed a portfolio of innovative medical products for transcatheter heart valve interventions, filling domestic gaps in both products and technologies. Its projects have received support from multiple R&D funds, including the National Ministry of Science and Technology’s 13th Five-Year Plan programs and the Shanghai Municipal Science and Technology Commission’s Science and Technology Support Program.