The Haifa, Israel-based company plans to begin U.S. sales of the resorbable dural repair graft soon.
ArtiFascia assists in the process of replacing the dura mater — which protects the brain and cerebrospinal fluid (CSF) — in neurosurgery. It combines two layers of electrospun nanofibers that form biomimetic scaffolds and a non-porous barrier layer.
The dual-function structure promotes dural tissue regeneration and rapid healing through the scaffold. Meanwhile, the barrier layer addresses CSF leakage from suture holes and bacterial penetration.
Nurami said it designed ArtiFascia with a thickness similar to the native dura for effortless suturing, accelerating surgeon workflow and lowering costs. The strong, pliable, fully absorbable, synthetic implant also offers ease in handling and cutting.
The company supported its bid for clearance with an 85-patient randomized clinical trial. This study demonstrated strong performance against the primary endpoints of CSF leakage prevention and other safety and surgeon preference measures.
“This is an important milestone in Nurami’s efforts to modernize soft tissue repair,” said Hannoch Marksheid, Nurami co-CEO. “ArtiFascia is a novel alternative for dura repair, addressing dangerous CSF leaks and infections at the surgical site while promoting dura regeneration.”
A burgeoning space
According to Peter Stebbins, executive chair at Nurami, current solutions, such as collagen patches, bovine pericardium or harvested autografts don’t always work well. These instances often require the addition of sealants,
Nurami’s ArtiFascia uses the innovative electrospinning technology to solve the issue and combine the barrier layer into the nanofiber scaffolds.
With methods like electrospinning, there has been a wave of advanced “biomimetic” materials, according to Stebbins. Companies can engineer products that look like native tissue and bring favorable absorption profiles. These provide strength and eventually foster healthy tissue.
The industry has seen interest shift this way, with different methods of producing materials. Last year, Conmed announced a deal to acquire Biorez and its BioBrace implant technology, a bioinductive scaffold. At the start of this year, Zimmer Biomet agreed to buy soft tissue healing developer Embody. Smith+Nephew has its Regeneten bioinductive implant for rotator cuff repair, too.
