Shandong Junxiu Biotechnology Co., Ltd. (“Junxiu Biotech”) has reached an important regulatory milestone with its independently developed Absorbable Dural Sealant, which has been included in China’s Special Review Procedure for Innovative Medical Devices, according to Public Notice No. 14 of 2026 released by the Center for Medical Device Evaluation (CMDE) of China’s National Medical Products Administration (NMPA).
Developed specifically for dural defects and cerebrospinal fluid (CSF) leakage associated with spinal surgery, the product is designed to provide rapid and reliable dural sealing through an absorbable biomaterial platform.
While dural sealants for adjunctive use following cranial dural repair are already available in China, products specifically developed for the sealing of spinal dural defects and associated CSF leakage remain under development and regulatory review, with no comparable product currently approved for marketing in China.
If approved, Junxiu Biotech’s Absorbable Dural Sealant has the potential to address an important unmet clinical need in spinal dural sealing.
Addressing CSF Leakage in Spinal Surgery
The dura mater is a tough, collagen-rich membrane that surrounds and protects the spinal cord, cerebrospinal fluid and spinal nerve roots, playing an important role in maintaining a stable environment for the central nervous system.
During spinal surgery, dural defects may occur as a result of surgical manipulation, tissue adhesion or underlying pathology, potentially leading to CSF leakage.
CSF leakage may contribute to complications including delayed wound healing, postural headache and pseudomeningocele, and in more severe cases may increase the risk of infection.
Current clinical management may include direct suturing, autologous tissue grafts, dural substitutes or other adjunctive sealing materials. However, achieving a reliable watertight closure can remain challenging in anatomically confined spinal surgical fields or in cases involving difficult-to-access dural defects.
Junxiu Biotech’s Absorbable Dural Sealant has been developed to provide an additional option for managing these clinical challenges.
Image source
Anat Cell Biol
A comprehensive review of the denticulate ligaments: application to surgery of the craniocervical junction and spine，PubMed/PMC
A Bioabsorbable Sealant Designed for Spinal Dural Repair
The Absorbable Dural Sealant is currently being developed as a Class III implantable medical device in China.
During surgery, the material can be sprayed or applied directly to the dural defect, where it rapidly forms a flexible, tissue-conforming hydrogel sealing layer.
Once formed, the seal combines tissue adhesion with mechanical compliance, allowing it to accommodate physiological pulsation, positional changes and local pressure fluctuations while maintaining close contact with the tissue surface.
As healing progresses, the material gradually degrades and is absorbed by the body, eliminating the need for secondary surgical removal.
The product builds on more than a decade of Junxiu Biotech’s experience in biomaterials and neural repair and has been specifically engineered around the anatomical environment and clinical requirements of spinal surgery.
Four Key Technology Features
This feature differentiates the product from many currently marketed dural sealants that are primarily indicated as an adjunct to sutured or standard dural repair, offering a different approach for the management of selected dural defects.
Stepwise-Triggered Crosslinking Technology
The stepwise-triggered crosslinking mechanism represents one of the key technological innovations incorporated into the product.
The technology was developed through collaborative research between Junxiu Biotech and the team of Professor Jianzhong Du at East China University of Science and Technology.
By combining expertise in polymeric biomaterials with Junxiu Biotech’s capabilities in product development and translational manufacturing, the collaboration has focused on material design, gelation mechanisms and sealing performance, providing a strong technical foundation for further clinical translation.
Expanding Junxiu Biotech’s Neural Repair and Regenerative Medicine Pipeline
Junxiu Biotech has focused on biomaterials and regenerative medicine for more than a decade and has established capabilities spanning original material development, performance evaluation, manufacturing and clinical translation.
The company is continuing to build its pipeline across the central nervous system, peripheral nerve repair and sports medicine, with the aim of developing an integrated regenerative medicine portfolio covering prevention, repair and rehabilitation.
Its independently developed decellularized extracellular matrix-based peripheral nerve repair membrane has already progressed to commercialization in China, further strengthening the company’s technological platform in neural repair biomaterials.
The inclusion of the Absorbable Dural Sealant in China’s Special Review Procedure for Innovative Medical Devices represents another important milestone in the development of this pipeline.
Under China’s innovative medical device regulatory framework, products included in the special review procedure may receive dedicated regulatory communication and technical guidance during subsequent registration activities.
The product remains subject to applicable regulatory review and approval requirements and may only be commercially marketed after receiving the relevant regulatory authorization.
Advancing Biomaterial Innovation in Regenerative Medicine
Looking ahead, Junxiu Biotech will continue to focus on unmet clinical needs and the development of advanced implantable medical devices and regenerative biomaterials.
By integrating materials science, regenerative medicine and clinical translation, the company aims to accelerate the translation of innovative technologies into clinical practice, provide safer and more reliable treatment options for physicians and patients, and bring more China-originated biomaterial innovations to the global market.