Linyan Medical Secures Tens of Millions Series A+ Financing and Partners with China Resources Pharmaceutical Commerce to Accelerate Commercialization of AR-Enabled Spinal Surgery Navigation System

April 13 News: LINYAN, an AR spinal surgery navigation company specializing in “human-machine integration,” announced the completion of its tens-of-millions-level Series A+ financing round. The funds will primarily be used for the market launch of its Holonavi S spinal surgical navigation and positioning system, as well as for the continued research and development of subsequent products.

LINYAN is a high-tech company specializing in human-machine collaborative surgical assistance devices, dedicated to addressing the needs of grassroots medical institutions and alleviating surgeons’ operational pain points. Through technological innovation, LINYAN aims to serve the surgical diagnosis and treatment market by ensuring consistent surgical quality and offering high cost-effectiveness. The core team brings over a decade of experience in translating academic research and industrial applications into practical outcomes. The company entered the market with spinal surgery navigation systems—representing the highest-risk procedures in orthopedics—and has been deeply engaged in this field for nearly seven years. It has accumulated more than 70 domestic and international invention and utility model patents, along with seven software copyrights, primarily in the areas of augmented reality, artificial intelligence, surgical navigation, and surgical robotics.

The product about to receive certification from LINYAN is the Holonavi S Surgical Navigation and Positioning System for Spine Surgery, whose notable features are:

1) Combined with enhanced mixed reality, intraoperative visual guidance is more convenient;

2) Next-generation registration technology, eliminating the need for intraoperative large-scale fluoroscopic imaging.

The product completed the enrollment of 150 subjects for its registration clinical trial in September 2022. Clinical results demonstrated that the use of the Holonavi S Spinal Surgery Navigation and Positioning System improved the accuracy and safety of pedicle screw placement. The quality and stability of spinal surgeries performed with this system were superior to those of conventional freehand techniques, indicating its suitability for assisting physicians in orthopedic spinal procedures.

The pivotal clinical trial for the registration of Holonavi S was led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, with joint participation from the Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital) and Shanghai Pudong New Area People’s Hospital. During this period, LINYAN jointly established China’s first “Joint Laboratory for AR Orthopedic Surgical Robots” with Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, aiming to achieve “precision” and “safety” in minimally invasive orthopedic surgeries, thereby maximizing the liberation of physicians’ productivity.

Figure: Human-Computer Interaction Effect of LINYAN's First-Generation Orthopedic Surgical Navigation and Positioning System

Chen Xiongsheng, Chief Physician, Professor, and Doctoral Supervisor, Department of Spinal Surgery, Shanghai Changzheng HospitalHe stated, “Previously, due to the high cost of spinal surgery navigation robots, the incremental cost per spinal procedure exceeded five figures. Holonavi S, leveraging innovative technology, has significantly reduced equipment costs and the learning curve for surgeons, thereby naturally lowering surgical fees for patients. This meets patients’ needs for accessible local care, addresses the issue of surgical accessibility in numerous secondary hospitals, and alleviates the challenge of enabling young physicians to rapidly acquire surgical proficiency.”

Hang Donghua, Deputy Director of the Second Department of Spine Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineIt is indicated that the LINYAN AR Orthopedic Surgical Navigation System seamlessly integrates with prior surgical experience, making it exceptionally easy to adopt. By employing a unique approach that eliminates the need for large-scale imaging equipment during procedures, the system effectively reduces the duration of spinal orthopedic surgeries while significantly minimizing intraoperative fluoroscopy requirements and radiation exposure.

Wang Jian, Director of the Department of Orthopedics, Chief Physician, and Professor at Pudong New Area People's Hospitalstated: “In spinal surgery, Holonavi S leverages artificial intelligence to provide an intuitive three-dimensional image, enabling surgeons to visualize and control the target area more effectively. This significantly enhances intraoperative precision, prevents iatrogenic injury, and reduces the risk of postoperative complications. With Holonavi S, even mid-level surgeons can independently perform spinal procedures efficiently within a short timeframe.”

LINYAN stated that it has submitted application materials to the National Medical Products Administration (NMPA), with the Holonavi S expected to be launched in 2024.

Over the past six years, LINYAN has actively responded to the national call for “domestic innovation” and “import substitution.” By leveraging creative technical pathways and a lightweight design philosophy, LINYAN has achieved innovation in domestically produced medical products through augmented mixed reality technology and registration techniques that eliminate reliance on large-scale intraoperative imaging. In the past two years, these advancements have gained recognition from authoritative industry institutions.

For example, in 2022, LINYAN made two prominent appearances at top-tier industry conferences. First, at the 2022 World Artificial Intelligence Conference, it signed an agreement to become a key artificial intelligence project in Pudong New Area. Second, as one of the organizers of the Zhangjiang Medical Device Industry International Forum, LINYAN’s Chairman and CEO, Liu Yang, delivered a keynote speech titled “Rebirth in the Virtual Realm: Prospects for the Future Medical Metaverse.” After the conference, he also participated in a symposium for key enterprises organized by the National Health Commission, the National Medical Products Administration, and the National Healthcare Security Administration.

In the first quarter of 2023 alone, LINYAN, a representative enterprise of Shanghai’s local intelligent medical device industry, participated twice in-depth in industrial development planning seminars organized by government agencies: in February, it was invited to attend the seminar on the Shanghai Municipal Science and Technology Commission’s AI Action Plan; in March, leaders from the Shanghai Municipal Commission of Economy and Informatization and relevant officials from the Biopharmaceutical Division conducted field research at LINYAN.

From the clinical stage to commercialization, LINYAN’s approach is to partner with industry leaders: in September 2022, LINYAN signed a comprehensive strategic cooperation agreement with Shanghai Regional Branch of China Resources Pharmaceutical Commercial Group, a subsidiary of China Resources Group—a key state-owned enterprise—in Shanghai. The two parties will jointly build a nationwide academic promotion and marketing channel.

China Resources Group is one of the state-owned key backbone enterprises. Its subsidiary, China Resources Pharmaceutical Commercial, ranks among the top three pharmaceutical commercial companies in China. In the Shanghai region, China Resources Pharmaceutical Commercial offers a diverse range of services, including pure sales and distribution of pharmaceuticals, medical devices, and reagents; DTP (Direct-to-Patient) retail pharmacy services; supply chain collaboration services; and “Internet+” services. Its sales network covers 96% of public medical institutions in Shanghai, serves over 350 non-public healthcare clients, and has more than 150 downstream distribution clients, achieving comprehensive coverage of the distribution network for public medical institutions in urban Shanghai.

Feng Shan, General Manager of the Shanghai Region at China Resources Pharmaceutical Commercial, stated, “We are optimistic about LINYAN’s representative products, which feature lightweight portability and ease of operation, facilitating their penetration into grassroots markets. China Resources Pharmaceutical Commercial’s strategic transformation focuses on supporting and promoting innovative domestic medical devices, with a layout aimed at replacing imported equipment with innovative domestic alternatives. Our two parties share consistency and complementarity in our judgments and strategic layouts regarding future trends in medical device technology and commercial development.”

Dr. Liu Yang, Chairman and CEO of LINYAN, stated, “Our collaboration with China Resources Pharmaceutical Commercial has strengthened LINYAN’s confidence in advancing from the clinical stage to product commercialization, and demonstrates our capability for rapid channel expansion during the early commercialization phase. With the support and partnership of China Resources Pharmaceutical Commercial, LINYAN is poised to fulfill its mission of ‘ensuring that Chinese people can access medical services with greater dignity’ and ‘making sure there are no difficult surgeries anywhere in the world.’”

In the upcoming early-stage commercialization layout, CR Pharmaceutical Commercial Shanghai Region will join hands with LINYAN to jointly explore key market areas. Leveraging the platform advantages of CR Pharmaceutical Commercial Shanghai Region and combining them with LINYAN’s product strengths of being lightweight, fast, precise, and cost-effective, the partnership will further promote academic consensus and expand coverage through a model that sets top-tier hospitals as benchmarks, empowers provincial-level hospitals, and promotes adoption in primary care hospitals.

According to incomplete statistics, China performs approximately 1.4 million spinal surgeries annually, while around 10 million spinal patients fail to receive timely surgical treatment each year. This is primarily due to the high technical difficulty and significant risks associated with spinal surgeries, as well as the excessive concentration of medical resources.

“Spinal surgeries, which cost an average of around RMB 100,000 per procedure, can lead to severe complications for patients if even minor deviations occur during the operation. Therefore, spinal surgeons typically require 5–10 years of clinical experience before they can perform surgeries independently, and they are primarily concentrated in Grade A tertiary hospitals in major cities.” Dr. Liu Yang shared that this is the current state of the spinal surgery market.

According to Dr. Liu Yang, LINYAN’s first-generation product can reduce costs to a fraction of those of imported equipment, making it affordable for most Tier II hospitals and enabling young doctors to perform spinal surgeries independently within months after training. “Tier II hospitals are widely distributed and extend into lower-tier regions; we can help nearly every county-level central hospital launch spinal surgery programs.”

LINYAN disclosed that the company completed its Series A+ financing round at the end of December 2022. The successful fundraising, achieved despite significant uncertainties in the domestic and international economic and policy environments, was primarily attributed to LINYAN’s focus on two key initiatives over the past year. First, the company optimized its corporate governance and management structure, further refining its product portfolio and business strategy. Second, at the operational level, LINYAN completed the registrational clinical trials for Holonavi S in September 2022, accomplishing this milestone within approximately one year.

LINYAN disclosed that investors in its Series A+ round hail from the specialized field of medical devices, bringing extensive experience in product registration, sales, channel promotion, and R&D incubation. These investors highly endorse LINYAN’s strategic direction of leveraging a low-cost strategy to expand coverage to primary care institutions and serve a broad base of young physicians.

Shanghai Equity Exchange Financial Services Co., Ltd. commented on LINYAN as follows: “Recent national medical policies and guidance opinions indicate that companies represented by LINYAN, which focus on artificial intelligence and human-machine collaboration in the healthcare sector, will face a broader market for developing more adaptable domestic alternatives and innovative products.”

Shanghai Shanggujiao Financial Services Co., Ltd. is a wholly-owned subsidiary of the Shanghai Equity Custody and Trading Center. It is a professional investment banking service institution that primarily provides capital market-related professional services to non-listed companies, especially micro, small, and medium-sized enterprises (MSMEs).

Liu Yunxing, Founding Partner of Yunding Capital, stated: “LINYAN is a leader in the research, development, and manufacturing of augmented reality (AR) surgical navigation systems for spinal surgery in China. Compared with traditional orthopedic robots, its AR surgical navigation devices offer superior services to physicians and patients through more convenient operation and greater cost-effectiveness. The company has completed the registration clinical trials for its first-generation spinal surgical navigation system and equipment, demonstrating excellent clinical outcomes, and the product is poised to receive certification from the National Medical Products Administration (NMPA). Furthermore, LINYAN is comprehensively expanding its product pipeline to cover joint surgery, sports medicine, neurosurgery, pulmonology, and hepatobiliary surgery. It is well-positioned to become the most comprehensive platform enterprise in China’s AR surgical navigation sector. Yunding Capital is honored to support LINYAN in securing subsequent rounds of financing. We are confident that, with capital support, LINYAN will achieve accelerated and robust growth.”

Yunding Capital is an emerging global industrial investment bank in the healthcare sector, dedicated to empowering leaders in the global medical and health industry. It helps high-quality enterprises both in China and overseas identify the most suitable investment and development solutions, driving their long-term growth.

Liu Yang revealed that LINYAN’s strategic goal is to become a provider of comprehensive surgical decision-support solutions tailored to operative scenarios. Following the completion of its Series A+ financing round, the company initiated planning for its Series B fundraising in Q2 2023. The proceeds are primarily intended to support the commercialization and academic channel development of its spinal surgery navigation and positioning system, as well as PCT patent registrations for related products. “Through the Series B financing, the company aims to further expand its distribution network in the domestic market and explore initial product promotion in countries along the Belt and Road Initiative, thereby laying a solid foundation for obtaining regulatory approval and commencing sales in 2024. During this new round of financing, the company has attracted significant interest and attention from numerous professional investment institutions both domestically and internationally.”