Medtech Startup Receives US Approval For Brain Graft Treatment

An Israeli startup has received approval from the US Food and Drug Administration for its graft that can replace the brain and spinal cord’s outermost protective membrane.  

Nurami Medical develops patches and sealants based on nanofibers – tiny strands of material – to help patients recover better after surgery.

Its first product is made for brain surgery intended to repair the spinal dura mater, the dense membrane that covers and protects the brain and spinal cord.

There are many ways the dura mater can become damaged, including severe head injury, tumors, or a surgeon’s need to open it up to gain access to the brain or spinal cord during invasive surgical procedures.

Nurami’s ArtiFascia product is made of two layers: one to promote tissue regeneration and rapid healing and the second to address cerebrospinal fluid (CSF) leakage from suture holes and bacterial penetration.

Today, neurosurgeons often use a graft and a liquid sealant to repair the dura mater and prevent post-surgery leakage of cerebrospinal fluid. 

The startup received FDA approval following positive results from its clinical trial, which found that patients who underwent the graft did not experience leakage. 

“This is an important milestone in Nurami’s efforts to modernize soft tissue repair,” said Hannoch Marksheid, Nurami’s co-CEO.

“ArtiFascia is a novel alternative for dura repair, addressing dangerous CSF leaks and infections at the surgical site, while promoting dura regeneration.”