HuaMu Medical: A Novel Self-Locking, Absorbable Cervical Interbody Fusion Device Eliminates Need for Metal Plates and Degrades Naturally

Spinal degenerative diseases are among the most common ailments in humans, including cervical spondylosis and lumbar disc herniation. With the aging population and the increasing number of "phubbers" (individuals constantly looking down at their mobile phones), the incidence of these conditions is rising, meaning that most modern individuals experience spinal issues to varying degrees.

Luo Yuxing, General Manager of Farmove Medical (Shanghai) Co., Ltd. (hereinafter referred to as “Farmove Medical”), stated, “Currently, approximately 3 million patients in China require spinal surgery. Spinal interbody fusion cages are the most commonly used implants for the surgical treatment of cervical spine disorders.”

However, traditional interbody fusion cages require the use of plates, which are prone to causing artifacts in postoperative imaging examinations, thereby affecting assessment. They also exhibit suboptimal biomechanical performance and excessive stiffness, leading to issues such as a foreign body sensation in the neck and dysphagia.

To address these pain points, Farmove Medical has developed a self-locking absorbable cervical fusion cage that does not require a plate.This product is made of polylactic acid-modified composite material, requiring no fixation with steel plates or screws. It can automatically degrade in the body, promote bone fusion, effectively alleviate patient discomfort, and avoid secondary surgery. This distinct innovation holds promise to become a mainstream spinal implant in the future.

Farmove Medical Novel Self-Locking Absorbable Cervical Interbody Fusion Cage

Luo Yuxing, General Manager of Farmove Medical, previously worked at Shanghai MicroPort Medical for five years, where he was responsible for the research and development as well as marketing promotion of trauma and spinal implants. As his understanding of the spinal field deepened, Luo realized that there were still many unmet needs in the area of spinal implants.

Human bone has a layered structure, composed of numerous small, adjacent, and alternating bone tissues. Current spinal implants primarily utilize titanium alloys and PEEK (polyether ether ketone) materials. Spinal implants made from titanium alloys produce artifacts during MRI and CT imaging, obscuring the visualization of bone fusion. This hinders physicians' ability to monitor bone growth and healing, and also interferes with MRI examinations of other body parts, posing significant challenges for both clinicians and patients.

Furthermore, due to the higher stiffness of titanium implants compared to native bone, issues such as stress shielding and accelerated degeneration of adjacent segments are prone to occur.

Although PEEK implants feature low density, lightweight construction, comfortable usage, and minimal CT and MRI artifacts, their hydrophobic surface hinders the formation of osseous integration at the bone-implant interface after implantation. This poor osseointegration can lead to complications such as implant displacement, collapse, and pseudarthrosis.

Notably, both titanium and PEEK are non-absorbable materials that do not degrade automatically after implantation and must be removed via a second surgery, causing secondary trauma to the patient.

Furthermore, traditional cervical fusion cages require the use of an anterior cervical plate. The plate is typically positioned posterior to the patient’s esophagus and trachea, necessitating a large surgical incision and increasing the risk of nerve injury as well as complications such as dysphagia and discomfort during swallowing.

Luo Yuxing stated, “In light of the above circumstances, industry professionals have been contemplating whether there exists an implantable product that does not require fixation with plates and screws, and can automatically degrade after bone healing.”

At this time, the founding team of Farmove Medical took notice of a research project at Zhongshan Hospital Affiliated to Fudan University—the self-locking absorbable cervical fusion cage.

Zhongshan Hospital, Fudan University, is a Grade A tertiary general hospital integrating medical care, scientific research, teaching, emergency services, healthcare, and rehabilitation, standing as one of China’s premier top-tier hospitals. For many years, Zhongshan Hospital has prioritized scientific and technological innovation as one of its core missions. With the imminent establishment of the Shanghai International Clinical Medicine Innovation Center, the hospital continues to lead the forefront of clinical research in China.

In 2006, the team led by Professor Dong Jian, Director of the Department of Orthopedics at Zhongshan Hospital Affiliated to Fudan University, began researching novel nanomaterials for implants. They explored the use of biodegradable materials as alternatives to traditional titanium alloys and PEEK (polyether ether ketone) for fabricating interbody fusion cages in spinal surgery. The subsequently developed self-locking absorbable cervical fusion cage completed in vitro testing and animal trials, confirming the product's efficacy and reliability.

In 2016, Farmove Medical began the industrialization of its research outcomes on self-locking absorbable cervical fusion cages, followed by clinical trials and regulatory approval for market launch.

“Self-locking” and “absorbable” are the two key features of Farmove Medical’s cervical fusion cage.

Farmove Medical's cervical fusion cages adopt advancedPolylactic Acid-Modified Composite Materials. Polylactic acid-modified composite materials are biomaterials with good biocompatibility, capable of forming osseous integration with natural bone tissue and promoting bone growth.

Additionally, this cervical interbody fusion cageThe plate-and-screw system of traditional fusion cages has been eliminated, with the locking mechanism integrated into the cage structure. After bone healing is complete, the cervical fusion cage naturally degrades in the body into non-toxic substances such as water and carbon dioxide.

After more than a decade of research and development, the study on absorbable modified polylactic acid composite materials and self-locking cervical fusion cages has successively received support from the National 863 Program, the National Natural Science Foundation of China, international cooperation and exchange projects, and key biomedical funds from the Shanghai Municipal Science and Technology Commission. The related research achievements were awarded the First Prize of Shanghai Science and Technology Progress Award in 2011, with 11 articles published in top-tier international journals. Six national invention patents have been filed, two of which have already been granted.

Luo Yuxing emphasized that Farmove Medical is not merely a medical device company in the spine field, but will increasingly become a company focused on the application of absorbable materials in the medical field. “The company entered the market by targeting degenerative spinal diseases and developed its first product, a self-locking absorbable cervical fusion cage. Over the past two years, the company’s focus has been on the research and development of absorbable material technologies.”

In accordance with the requirements of the ISO 13485 system, orthopedic implant products must be manufactured and packaged in a Class 100,000 cleanroom. In 2018,Farmove Medical has established a production facility spanning nearly 1,000 square meters, including a 500-square-meter Class 10,000 GMP-compliant cleanroom for medical devices, a supporting purified water system, and a standard laboratory.Equipped with a series of testing instruments for degradation and mechanical properties, we have established a comprehensive testing and inspection platform tailored for biodegradable materials and their products. We have also acquired production equipment for material pre-processing, toughness-enhancing composite preparation, and precision product molding, thereby constructing a processing production line suitable for the research, development, and manufacturing of biodegradable materials and products.

For startups, establishing manufacturing facilities and workshops entails significant expenditure. Consequently, most companies opt to focus on early-stage process research and development while outsourcing production and manufacturing to third-party enterprises. Luo Yuxing stated, “The manufacturing processes for titanium alloy and PEEK implants are already mature, whereas absorbable materials represent a new field both domestically and internationally. Currently, there are no manufacturing facilities or workshops in China equipped with production processes suitable for absorbable materials.”

Luo Yuxing also noted that ensuring the safety and stability of absorbable materials is a key challenge in the research and development process. The National Engineering Research Center for Biomaterials provided Farmove Medical with cutting-edge technological support for absorbable materials, the State Key Laboratory of Polymer Science and Technology at Fudan University offered theoretical research support, and the Shanghai Research and Testing Center for Biomaterials provided the conditions for biocompatibility validation. With the assistance of these partners, the technical challenges associated with the processing of absorbable materials were overcome one by one.

“Unlike traditional orthopedic implant materials, various parameters during the material forming process influence the degradation profile and physicochemical properties of the product. Therefore, strict control over all parameters of absorbable materials is required during production to ensure product stability.” As a result, all production and inspection processes have been independently developed and conducted by Farmove Medical.

Farmove Medical has established a comprehensive testing and inspection platform for bioabsorbable materials and products, capable of conducting relevant performance tests. Additionally, it has built a processing production line for the research and development of absorbable materials and products, which can perform processes such as preliminary material treatment, multi-material composite preparation, and precision material molding.

“Material R&D and technological accumulation is a lengthy process. After establishing manufacturing, design, and testing platforms, we were able to rapidly expand into the fields of trauma surgery, sports medicine, maxillofacial surgery, and neurosurgery,” said Luo Yuxing.

Currently, the preliminary development of the self-locking absorbable cervical fusion cage has been completed, and animal trials are underway.

Farmove Medical secured angel investment from the renowned fund Cowin Capital at its inception, and subsequently received funding from Hualing Capital, Nanjing Dynamic Balance Capital, Taiyu Capital, and Dingxin Capital. This capital support has accelerated the clinical translation of Farmove’s absorbable cervical fusion devices and the strategic layout of its subsequent product pipeline, positioning the company as a platform-based medical innovation enterprise.

Luo Yuxing stated, “Absorbable materials have broad application prospects across many fields. Moving forward, Farmove Medical will expand into more areas, replacing traditional implants with those made from absorbable materials.”