The Electrospinning Company supported Nurami Medical to manufacture an electrospun Dura mater: ArtiFascia® for neurosurgery. Here are the challenges, solutions and results obtained during this process.
The Electrospinning Company has supported Nurami Medical with the manufacturing process development of their dura mater repair product (Artifascia®) and is supplying key Artifascia components for clinical trials.
Dura Mater Repair
Patients who have undergone neurosurgery have a 30% chance of cerebral-spinal fluid (CSF) leakage despite treatment with a graft and a liquid sealant. CSF leakage can result in longer periods of hospitalisation or repeated surgery, which have an adverse effect to the patient’s recovery. Currently available grafts are mainly derived from bovine collagen.
Nurami Medical Ltd., a clinical stage medical device company with expertise in brain physiology and biomaterials, has designed a synthetic dura mater graft product to reduce the risk of CSF leakage and enhance patient recovery after neurosurgery.
Artifascia is a porous nanofibre material made from electrospun medical grade polymers that degrade naturally over time and is replaced by native tissue. It has excellent mechanical strength and flexibility enabling convenient surgeon handling and it eliminates the need for an additional liquid sealant. The Artifascia dural graft was evaluated in the NEOART pivotal clinical study of 92 patients.
Nurami Medical did not have the facilities to manufacture the nanofibre component of Artifascia in house and required an ISO 13485-certified development and manufacturing partner.
The Electrospinning Company is an ISO 13485-certified contract design and manufacturing organisation specialised in nanofibre biomaterial design and manufacturing, built around its electrospinning technology platform.
The Electrospinning Company swiftly adopted the Nurami Medical protocol and conducted several developments and scale up studies to manufacture critical components of Artifascia. Artifascia entered clinical trials early 2020 and completed these in 2022.
In less than 2 years, the Electrospinning Company supported Nurami Medical in taking Artifascia from a product development stage to clinical stage and is now supporting them with process validation.
The Electrospinning Company worked with Nurami Medical, using its tried and tested development process to progress the project through key milestones. The Electrospinning Company collaborated closely with Nurami Medical’s development and quality staff, assuring production of the nanofibre component in compliance to ISO 13485 quality regulation.