Enlight Medical Secures Hundreds of Millions RMB in Series B Funding to Advance NovoClasp® Transcatheter Mitral Valve Repair System

VCBeat (WeChat ID: vcbeat) recently learned that,Enlight Medical, a medical device platform company, announced the completion of its Series B financing round amounting to hundreds of millions of RMB. This round was co-led by SDIC Capital, Haisong Capital, and Qianhai Fund of Funds, with Yinglian Health Fund participating as a follow-on investor. Existing shareholders GL Ventures, WeMedical Capital, ZhenFund, and Chende Capital continued to increase their stakes. China Renaissance served as the exclusive financial advisor for this transaction.

The proceeds from this funding round will enable Enlight Medical to further advance the clinical development of its mitral valve repair product, NovoClasp®, while simultaneously accelerating the research and development of innovative products across its three major business segments: structural heart disease, peripheral vascular intervention, and neuromodulation and brain-computer interfaces.

Headquartered in Zhangjiang, Shanghai, Enlight Medical is a platform-based enterprise dedicated to the R&D and integration of cutting-edge global medical technologies, empowering the innovation pathway of China's medical device industry. The company’s business spans structural heart disease, peripheral vascular intervention, neural stimulation, and brain-computer interface platforms. To date, four Class III medical device products, including a thoracic aortic stent graft system, have obtained NMPA registration certificates, while multiple other products, including a mitral valve repair system, are currently in the R&D and clinical trial phases.

Enlight MedicalMaintains R&D centers in Shanghai, Beijing, and Boston, USA., the R&D team comprises senior engineers who graduated from top-tier domestic and international universities, with core members each possessing over 15 years of experience in medical device research and development.

Since its establishment, Enlight Medical has completed three rounds of funding, having previously received investments from institutions such as Hillhouse Ventures and ZhenFund.

Enlight Medical is positioned as aA Medical Device Platform Company Dedicated to the R&D and Integration of Global Cutting-Edge Medical Technologies, emphasizes "working smart" during development.

“The medical device market is experiencing explosive growth, with domestic and international enterprises gradually evolving from single-product companies into platform-based businesses. Industry leaders such as Medtronic, Abbott, and Boston Scientific have demonstrated that platform enterprises with diversified portfolios possess greater advantages in R&D, distribution channels, and branding, enabling them to deliver greater and more sustained value to physicians and patients.”

In the field of structural heart disease, Enlight Medical prioritizes market demand and unmet clinical needs, strategically targeting the mitral valve market—where cutting-edge technologies are advancing rapidly—from the highly competitive heart valve landscape.

Mitral regurgitation (MR) is the most common valvular heart disease, characterized by the regurgitant flow of blood from the left ventricle into the left atrium during systole due to incomplete closure of the mitral valve. Currently, China lacks accurate epidemiological data on MR. By extrapolating from U.S. epidemiological data, it is estimated that approximately 7.5 million MR patients require interventional treatment, with about 5.5 million having severe MR. However, the annual number of mitral valve surgical procedures in China is approximately 40,000, resulting in a treatment rate even lower than that in the United States, at only 0.5%.

Surgical repair and replacement of the mitral valve are associated with high risks, technical complexity, and the need for multidisciplinary collaboration. Consequently, their development has been limited both in China and globally, hindering treatment progress for patients with mitral regurgitation. In contrast, transcatheter mitral valve repair and replacement are minimally invasive and have emerged as a highly competitive and rapidly evolving field in recent years.

To date, only one imported product has been approved by China's National Medical Products Administration (NMPA) for transcatheter mitral valve repair, leaving substantial unmet clinical needs and immense market potential.

In the field of peripheral vascular intervention, Enlight Medical's focus is on resource integration.

In January 2021, the company acquired the interventional stent business of GRINM Medical.Enlight Medical intends to expand into the broad peripheral vascular market, coinciding with GRINM Medical's divestiture of its stent business. With over a decade of expertise in the interventional stent sector, GRINM Medical holds an NMPA-approved thoracic aortic stent graft product, which has laid a solid foundation for Enlight Medical's development in the peripheral vascular field.

“We need to maximize strategic leverage and optimize capital efficiency. In certain fields, there is no need to start from scratch, as developing a product can take seven to eight years. We can secure early market entry through acquisitions or partnerships, and continuously consolidate and refine our overall product portfolio by integrating resources.”

In the fields of neural stimulation and brain-computer interfaces, Enlight Medical has high aspirations.

Zhao Ruilin, CEO of the company, holds a Ph.D. in Neuroscience from Harvard Medical School and has cultivated years of expertise and a deep-seated passion for the field. He believes that the synergistic integration of interdisciplinary sciences will yield disruptive technologies that improve human health and even transcend humanity's understanding of its own development.

Led by an overseas-returned scientist with over 30 years of R&D experience in active medical devices, Enlight Medical is dedicated to developing world-class neurostimulation and brain-computer interface (BCI) products, harnessing cutting-edge technology to improve human health.

Focusing on global, cutting-edge innovative medical technologies is the guiding principle behind Enlight Medical's strategic business layout. While these three major business segments already feature numerous domestic and international players, Enlight Medical's focus lies in how to “empower China's medical device innovation” across technology, products, and business models.

Interventional therapy for mitral regurgitation is a major hotspot in the field of structural heart disease.Abbott, Edwards Lifesciences, and Medtronic have all placed their bets on this sector, while domestic players Hanyu Medical and NewPulse Medical have filed their prospectuses.

Among them, Transcatheter Edge-to-Edge Repair (TEER) has the most mature technology and market, and is recommended by numerous clinical guidelines. 《2021 ESC/EACTS Guidelines for the Management of Valvular Heart Disease》 provides a Class IIa recommendation for TEER therapy. Abbott's MitraClip system utilizes precisely this TEER technology, making it the only approved transcatheter mitral valve repair system in China.

Mitral valve clips are highly complex passive medical devices. Since the introduction of MitraClip, few products have reached the market, and most companies remain in the R&D or clinical trial phases.

Given the unmet clinical needs of millions of patients, there is a substantial market gap in China's transcatheter mitral valve repair sector.

The initial focus of Enlight Medical's venture was the mitral valve clip. At a gathering a few years ago, the company's CTO, Doug MacBride, discussed transcatheter mitral valve repair technology with a physician friend, and both highly recognized the clinical benefits it offered. At that time, investor Zhao Ruilin was equally optimistic about this sector. The two former MIT classmates quickly aligned on their vision, aiming to develop a mitral valve repair product better tailored to the Chinese market.

This September, Enlight Medical's NovoClasp® transcatheter mitral valve clip and steerable guide catheter system made its debut at China Structural Week.

The NovoClasp® Mitral Valve Clip is an exceptionally lightweight valve clip. Optimized through a unique structural design and advanced metal processing techniques, it exhibits enhanced fatigue resistance and resistance to slippage. While significantly increasing the clamping force, it reduces the risk of leaflet injury caused by localized stress concentration. Additionally, the clip’s optimized covering structure effectively promotes endothelialization and enhances its resistance to infection.

Via the transfemoral venous approach, the NovoClasp® Mitral Valve System features a delivery system with an enhanced deflection angle, enabling flexible navigation across a wide range of anatomical structures for efficient clip positioning, while ensuring precise 1:1 advancement.

"We want it to move 1 cm, and it will only move 1 cm."

Currently, the NovoClasp® system has completed long-term animal studies and has entered the human clinical trial phase.

Domestic independent R&D and the introduction of overseas technologies are the twin driving forces behind Enlight Medical's R&D and integration of cutting-edge global medical technologies.

Enlight Medical maintains a highly capable in-house R&D team, with its core members each possessing over 15 years of research and development experience in the medical device industry.

The company's CEO, Zhao Ruilin, has over 20 years of R&D and commercial experience in the healthcare industry,Previously served as Global Vice President and General Manager of Greater China at Illumina, and General Manager of the Peripheral Business Division at MicroPort, and also oversaw the research and development of neurovascular product lines at Johnson & Johnson in the United States.

Doug MacBride, the company’s CTO, has over 20 years of experience in medical device development and manufacturing. He previously served as CTO at Lexington Medical and as R&D Director at companies such as J&J, Allergan, and Hologic. He has led or participated in the development of multiple products that have received FDA or CE certification, spanning several fields including surgery, gynecology, and neurology, and generating over $1 billion in revenue.

While prioritizing independent research and development, Enlight Medical is also actively exploring strategic partnerships with leading domestic and international enterprises. In August 2021, the company entered into a collaboration with Seer, a leading U.S. proteomics firm, to help advance the commercialization of its potentially disruptive proteomics technology in the Chinese market.

"Enlight Medical views the market through the lens of technological innovation, and we are constantly seeking the next industry-leading technology."

The Life Sciences Team of SDIC Merchants stated：“The market for interventional therapies for structural heart disease is vast and growing rapidly. Mitral regurgitation is one of the most common valvular heart diseases, yet its clinical needs remain largely unmet. Enlight Medical boasts a world-class domestic and international R&D and management team, endowing the company with robust proprietary R&D capabilities and comprehensive resource integration. The company’s technological approach and R&D progress in mitral valve repair are at the forefront in China, positioning it to be among the first to launch innovative mitral valve repair medical devices in China. SDIC Capital highly recognizes Enlight Medical’s strategic deployment in the structural heart disease interventional therapy sector and will fully support the company in developing more innovative medical devices to benefit patients.”

Mr. Chen Liguang, CEO of Haisong Capital, stated：“The market demand for innovative medical devices is growing rapidly, with innovation and global expansion defining the next phase of development for China’s medical device industry. The markets for structural heart disease, pan-vascular medicine, neuromodulation, and brain-computer interfaces are broad and characterized by significant unmet clinical needs, offering substantial long-term investment value. We are firmly confident in the Enlight Medical team’s innovative R&D capabilities, rapid commercialization capabilities, and global vision. We look forward to working closely with Enlight Medical to effectively meet the medical needs in the cardiac and neurological fields, and to support Enlight Medical in becoming a leading global enterprise in innovative medical devices.”

Li Shengnan, Managing Director of Qianhai Fund of Funds, stated：“We recognize Enlight Medical’s strategic planning and are highly optimistic about its founding team. This team possesses exceptional R&D capabilities, strong execution strength, and a global perspective, with the capacity to build Enlight Medical into a world-class medical technology company. We will continue to support Enlight Medical’s pioneering innovations in structural heart, peripheral intervention, and neuromodulation, addressing more clinical challenges, meeting greater clinical needs, and delivering tangible benefits to a broader patient population.”

Mr. Yijing Xie, Managing Director and Head of the Healthcare and Life Sciences Group at China Renaissance, stated that: "We are honored to have accompanied Enlight Medical in successfully closing its latest round of financing. As a medical device platform enterprise with an international vision and global R&D capabilities, we believe that with the support of both existing and new shareholders, Enlight Medical will continuously launch groundbreaking products to benefit patients and society."

SDIC Merchants Investment specializes in advanced manufacturing investments, placing high value on technological innovation, exceptional entrepreneurs, and team capabilities. The firm prioritizes investments in smart manufacturing, smart new energy vehicles, life sciences, and information and communication technologies, and is committed to driving the green, digital, and service-oriented development of the manufacturing sector. The team’s cumulative assets under management exceed RMB 100 billion, with investors comprising financial institutions, social security funds, state-owned capital, and private capital.

Haisong Capital is a specialized investment management firm dedicated to long-term and value investing. As an investment institution focused on the hard-tech sector, Haisong Capital primarily invests in high-tech and medical enterprises driven by innovative technologies, with a particular emphasis on hard-tech companies possessing breakthrough and revolutionary technologies. Through long-term, sustained support for outstanding entrepreneurs, complemented by international operational management expertise and extensive industry resources, Haisong Capital empowers enterprises to achieve rapid growth.

Established in 2016 with a fund size of RMB 28.5 billion, the Qianhai Fund of Funds is currently the largest commercially raised fund of funds in China and a leading private equity investment fund. Placing equal emphasis on fund investments and direct equity investments, it is managed by Qianhai Ark Asset Management Co., Ltd., led by Jin Haitao, a pioneering figure in China's venture capital industry. Since its establishment, the Qianhai Fund of Funds has cumulatively invested in 1,651 direct/indirect equity projects, with over 67 of its directly/indirectly invested companies listed on domestic and international exchanges.

The anchor investors of the Yinglian Healthcare Fund are drawn from leading pharmaceutical companies in the industry. Research-driven, the fund deeply explores global investment opportunities in cutting-edge innovative drugs, medical technologies, and devices, and co-incubates companies alongside top scientists, Principal Investigators (PIs), and clinical translation teams to address the "zero-to-one" challenge of original innovation.