Zhongda Medical Devices Files IPO Prospectus: Leveraging Sun Yat-sen University to Build a Global Leader in Nerve Repair with 'ShenQiao,' One of Only Two Such Products Worldwide

Amidst the grapevine, it seems that the capital market is often plagued by the inability to find high-quality “under-the-radar” projects. In reality, however, it is frequently trapped by the retinal effect, unable to shift its gaze away from hot, crowded sectors toward more common indications.

Peripheral nerve defect is a common yet often overlooked clinical symptom.

Accidental injuries, tumor resection surgeries, and other conditions can all lead to peripheral nerve injury. Improper treatment may result in disability, imposing a substantial economic burden on families and society. With rapid social development, advanced transportation networks, and a multiplied rate of population mobility, the number of individuals suffering from nerve damage due to accidental injuries, war, earthquakes, tumor surgeries, and other causes has been increasing year by year. In China, there are 600,000 to 900,000 new cases of peripheral nerve injury annually, among which approximately 300,000 to 450,000 cases require nerve transplantation for repair.

Autologous nerve grafting is currently the “gold standard” for repairing peripheral nerve defects, typically harvested from the patient’s own sural nerve. However, this approach is subject to numerous limitations, such as insufficient donor nerve availability, secondary loss of function at the donor site, and mismatches in the structure and dimensions of the donor nerve. Consequently, the lack of effective alternatives to autologous nerve grafts has long been a significant clinical challenge.

Sun Yat-sen University appears to be the most suitable entity to address this challenge.

The Pearl River Delta region, with its well-developed light industrial clusters and widespread motorcycle use, has become a high-incidence area for hand and upper extremity injuries. The accumulation of extensive clinical experience has facilitated the development of outstanding hand surgery and microsurgery programs at Sun Yat-sen University and its affiliated hospitals. A group of microsurgery experts, represented by Professor Liu Xiaolin, have gained prominent recognition on both domestic and international stages.

On the path to translational medicine, clinical practice and scientific research are both indispensable. Sun Yat-sen University not only boasts a top-tier medical school in China, but its School of Chemical Engineering and School of Biomedical Engineering also play key roles in developing numerous first-class disciplines. These schools provide a solid foundation in terms of experimental facilities, research data, and talent reserves, while also achieving a closed loop of industry-academia-research collaboration by undertaking major scientific research projects in partnership with enterprises.

With clear clinical demand, sufficient surgical volume, and an interdisciplinary research foundation, the translation of achievements into practical applications becomes a natural progression.

The “Shenqiao” project was included in multiple research initiatives in 2001, such as the National 863 Program, the National Natural Science Foundation of China, and the Guangdong Provincial Science and Technology Plan. The project represents the scientific achievements of Professor Liu Xiaolin’s research team at the First Affiliated Hospital of Sun Yat-sen University after years of dedicated study. These achievements were successfully commercialized into medical device products by Guangzhou Zhongda Yiliaoqixie Youxiangongsi, which obtained product registration certification in 2012.

According to Professor Yang Yuexiong, General Manager of Guangzhou Zhongda Yiliaoqixie Youxiangongsi, “Shenqiao” features a natural scaffold structure for peripheral nerves and, following decellularization treatment, minimizes the risk of rejection reactions. Compared with autologous nerve grafts, it effectively avoids injuries associated with secondary surgeries and functional deficits at the donor site caused by nerve harvesting. In contrast to other polymer-based nerve conduits, it holds a distinct advantage in length, with virtually no domestic competitors offering products within the 1–5 cm range.

Since its market launch in August 2012, “Shenqiao” has accumulated sales of over 10,000 units, with annual sales revenue exceeding RMB 50 million. As a product incorporating multiple technologies at the world’s leading level, “Shenqiao” is one of only two decellularized allogeneic nerve repair materials available globally, the other being AxoGen’s Avance Nerve Graft.

As a leading manufacturer and R&D enterprise in tissue engineering and biomedical materials, the DNA of scientific research has always been integral to Guangzhou Zhongda Yiliaoqixie Youxiangongsi.

As a National High-Tech Enterprise and one of the first batch of specialized, refined, distinctive, and innovative SMEs in Guangdong Province, the company has established long-term and stable collaborative relationships with top-tier research platforms and experts affiliated with Sun Yat-sen University, and has continuously undertaken major scientific research projects at the national, provincial, and municipal levels. Over the past nine years, the company has repeatedly undertaken provincial and municipal special projects, including: functional reconstruction and new product development of decellularized nerve repair materials; R&D of series products of tissue-engineered corneal scaffold materials; construction of an industrialization base for biomaterials and tissue engineering products; and R&D and industrialization of drug-loaded embolic microspheres. Additionally, the company has undertaken key projects under the National Key R&D Program, such as the R&D of key technologies and products for 3D bioprinting of bionic nerve grafts.

The core technical team of Guangzhou Zhongda Medical Devices also boasts profound technical backgrounds and extensive experience in industrialization. General Manager Yang Yuexiong is a professor-level senior engineer in the field of medical devices, an adjunct professor at the School of Biomedical Engineering of Sun Yat-sen University, and a graduate supervisor. Deputy General Manager Dr. Zhang Yang is also an adjunct professor and graduate supervisor at the School of Biomedical Engineering of Sun Yat-sen University, and previously served as a Chinese editorial board member for The Lancet. The company’s advisory team consists entirely of frontline clinical experts and discipline leaders from Sun Yat-sen University and its First Affiliated Hospital.

In terms of hardware, the team has been able to rely on the company’s 3,000-square-meter GMP-compliant workshop and its Class III medical device production license to complete numerous assigned projects, thereby bridging the “last mile” from academia to the market and fulfilling the need for genuine commercialization of scientific research achievements.

After accumulating over a decade of clinical experience and more than 10,000 cases with “Shenqiao,” Professor Yang Yuexiong has shifted his focus from traditional trauma applications to broader and newer indications.

Central HemiplegiaCentral hemiplegia results from unilateral brain damage caused by conditions such as stroke, traumatic brain injury, and cerebral palsy, leading to paralysis of the contralateral limbs. It is the most common and widely impactful sequela. In China, there are over 3 million new stroke cases annually, and among survivors, hundreds of thousands experience varying degrees of motor impairment in their limbs.

As an original Chinese technique, “C7 Nerve Transfer Surgery” has opened a new pathway for treating upper limb paralysis. Under the application of Professor Xu Wendong at Huashan Hospital in Shanghai, this procedure is based on research demonstrating that harvesting the healthy-side C7 nerve root does not result in loss of limb function. The affected-side C7 nerve root is severed at the intervertebral foramen, while the healthy-side C7 nerve root is transected distally. A pathway is established anterior to the vertebral body to route the stump of the healthy-side C7 nerve root to the affected side. Microsurgical epineurial suturing is then employed to directly coapt the two nerve stumps. In cases where the length of the healthy-side C7 nerve is insufficient during surgery, a “Nerve Bridge” graft is required. The length advantage of the “Nerve Bridge,” as mentioned earlier, is fully demonstrated in this context.

As of July 2023, “Shenqiao” has been applied in C7 nerve transfer procedures at 21 hospitals across China, with cumulative product usage nearing 40 cases. Multiple hospitals have begun to repeatedly perform surgeries using “Shenqiao.” Given the substantial existing patient pool and the large annual incidence of new central hemiplegia cases, “Shenqiao” is undoubtedly a high-potential hidden gem.

Regarding plans for the second half of 2023 and beyond, Professor Yang Yuexiong stated that he would leverage the successful development of “Shenqiao” in microsurgery to expand the distributor network and penetrate channels across more clinical departments.

During the interview, Professor Yang Yuexiong frequently brought out the books *Biomaterials Manufacturing and Clinical Evaluation for Peripheral Nerve Defect Repair* and *One Cerebral Hemisphere Controls Both Hands*, turning to specific passages and citing the latest clinical data with great familiarity. His passion for and rigor in academic research were evident as he spoke at length about the remarkable efficacy of “Shenqiao” in treating central hemiplegia.