Zhuoqia Medical's Magnesium Alloy Cannulated Screw Achieves First-in-China Clinical Enrollment, Demonstrating World-Leading Domestic Biomaterial Innovation
202210Month10th,ZHUOMED(abbreviated as“ZHUOMED”) independently developedMagnesium Alloy Cannulated ScrewsInBeijingJishuitan HospitalCompleted the First Clinical EnrollmentHand SurgeryDirector Tian Wen, Director Yang YongServing as the Principal Investigator for this clinical trial,Dr. Bin LiServing as the current clinicalTestThe main coordinator of the validation work.
ZHUOMED's First Clinical Enrollment of Magnesium Alloy Cannulated Screws
The first subject enrolled in this clinical trial was a 19-year-old male with a scaphoid fracture. The patient presented with left wrist swelling, pain, and limited mobility due to a traffic accident, and imaging confirmed a left scaphoid fracture. Following assessment by the investigator, the patient was selected to undergo fracture fixation using the magnesium alloy cannulated screw independently developed by ZHUOMED.
The scaphoid bone is located on the radial side of the proximal carpal row and serves as a pivotal link and bridge between the distal and proximal carpal rows, occupying a unique position in terms of morphology, kinematics, and biomechanics. Scaphoid fractures are the most common type of wrist fracture, accounting for 50%–60% of all wrist fractures. Unstable acute scaphoid fractures require surgical intervention. Currently, Kirschner wires (K-wires) and compression screws are the internal fixation devices commonly used in clinical practice. Among these, compression screws provide stable fixation and exert compressive force across the fracture fragments, facilitating early functional rehabilitation; therefore, they can be considered the preferred fixation method for unstable acute scaphoid fractures.
The ZhuoMED magnesium alloy cannulated screws used in this clinical trial offer significant advantages over traditional metal compression screws due to their unique biodegradable properties. On one hand, theirExcellent Mechanical Properties, can ensure a fixation effect similar to that of traditional metallic compression screws; on the other hand, after being implanted into the human bodyGradually degrades and transforms into bone, effectively avoiding various risks associated with long-term implantation, eliminating the need for a second surgical removal, reducing patient suffering, and significantly lowering surgical costs.
Magnesium Alloy Hollow Screw Implantation
Postoperatively, the researchers stated that there were no significant differences in the surgical procedure between the use of biodegradable magnesium alloy cannulated screws and conventional titanium alloy cannulated screws for closed reduction and internal fixation of scaphoid fractures, with a smooth implantation process. The magnesium alloy cannulated screws achieved stable fixation of the fracture and will gradually degrade thereafter. The surgery proceeded smoothly, and comprehensive assessments of fracture healing will be conducted at 6 weeks, 3 months, and 6 months postoperatively.
Researchers believe that biodegradable metals represent one of the key directions for the development of new materials in orthopedics. The excellent mechanical, biological, and degradation properties exhibited by biodegradable magnesium alloys will bring new solutions and momentum to their clinical application. Several magnesium alloy products have already been used clinically abroad, and there is great anticipation that they will provide patients with a wider range of therapeutic options in the future.
Hollow screws feature thin walls and precise thread structures, imposing stringent requirements on material degradation rates and mechanical properties. ZHUOMED’s magnesium alloy hollow screw is the first degradable magnesium alloy hollow screw product in China to enter the clinical stage, utilizing its proprietary intellectual property technology, ZHUOMAG.® Medical-grade magnesium alloy manufacturing. ZHUOMAG® Medical-grade magnesium alloys have overcome the challenges of excessive degradation rates and insufficient mechanical properties inherent in conventional magnesium alloys, providing a safe, convenient, reliably fixating, biocompatible, and fully degradable implant solution for reconstructive surgeries following fractures, dislocations, or other pathological bone changes.
Biodegradable magnesium alloys are innovative biomaterials that have garnered significant attention in the field of orthopedics. They have been the first to receive market approval in Europe, achieving initial market recognition. Currently, the most widely used magnesium alloy cannulated screw in clinical practice worldwide is MAGNEZIX, developed by Syntellix AG of Germany.® CS products have not yet been launched in China. In comparison, ZHUOMED’s magnesium alloy cannulated screwsFree of Rare Earth Elements, while ensuring mechanical strength and meeting the expected degradation rate, it also offers advantages in terms of biosafety.
Since 2016, ZHUOMED has been conducting research on medical-grade magnesium alloys, pioneering the material development concept of “low-alloying, high-strength” for medical magnesium alloys, and has completed ZHUOMAG®Medical Magnesium Alloys“Formulation–Smelting–Profiles–Products” Full-Process Technology Development,Possesses independent intellectual property rights and core technologies covering the entire process for biodegradable magnesium alloys and related implants, with the capability for stable mass production.
ZHUOMAG®Medical magnesium alloys exhibit excellent mechanical properties, can degrade uniformly and completely within the human body without requiring secondary surgical removal, and are free of rare earth elements with good biocompatibility. They provide a relatively ideal solution to the bottleneck issue of balancing biosafety, degradation performance, and mechanical properties in medical magnesium materials.
ZHUOMED®Medical Magnesium Alloys
The formal enrollment in this clinical trial marks ZHUOMAG®Medical-grade magnesium alloys are entering the clinical application phase. As a domestically developed innovative biomaterial with full independent intellectual property rights, their performance has reached a world-leading level.
About ZHUOMED
ZHUOMED, established in 2016, is dedicated to the innovative research and development of magnesium-based biomaterials and surgical solutions in the field of orthopedics. Headquartered in Suzhou, the company focuses on the R&D, manufacturing, and regulatory registration of orthopedic implant products, while its Material R&D Center in Xi’an specializes in the research, development, and production of medical-grade magnesium alloys and magnesium-based biomaterials.
ZHUOMED Suzhou Headquarters
The company has successively won the Third Prize in the 2019 Shaanxi Province Science and Technology Innovation and Entrepreneurship Competition, the Third Prize in the Beijing Division of the 2019 China Medical Device Innovation and Entrepreneurship Competition, the Excellence Award in the Finals of the 2019 China Medical Device Innovation and Entrepreneurship Competition, and the Third Place in the Medical Device Industry Group Finals of the 2021 Jinji Lake Entrepreneurship Competition. Patents have been applied for.27 items, Substantive Examination and Grant13 items。
2021 Jinji Lake Entrepreneurship Competition – Medical Device Industry Group Finals
Mr. Xiao Jie, FounderMr. Xiao Jie holds a Bachelor’s degree in Bioengineering and Economics, as well as a Master’s degree in Engineering Thermophysics, and previously engaged in investment banking at leading financial institutions. Driven by shared entrepreneurial ideals and passion, Mr. Xiao joined forces with his former university classmate from the United States, Dr. Gong Haibo, to co-found ZHUOMED. Dr. Gong has long been engaged in research and product development of biodegradable metals and advanced manufacturing technologies. He previously served as the principal investigator for key projects under the National Key R&D Program of the Ministry of Science and Technology, bringing over ten years of experience and foundational expertise in biomedical materials.