Subjects: TRI, FDA
Nurami Medical's ArtiFasciaŽ Dura Substitute Receives FDA Clearance
HAIFA, Israel, Aug. 21, 2023 /PRNewswire/ -- Medical device startup NURAMI MEDICAL has received 510(k) clearance from the US Food and Drug Administration (FDA) for its electrospun nanofiber-based product, ArtiFasciaŽ Dura Substitute, a resorbable Dural repair graft. Sales in the US will begin in the upcoming period.
Neurosurgeries require replacing the Dura Mater, which protects the brain and cerebrospinal fluid (CSF). ArtiFasciaŽ combines two layers of electrospun nanofibers that form biomimetic scaffolds and a non-porous barrier layer. This unique structure is dual functioning: the scaffolds are engineered to promote dural tissue regeneration and rapid healing, whereas the barrier layer is designed to address CSF leakage from suture holes and bacterial penetration.
Similar in thickness to native dura, ArtiFasciaŽ can be effortlessly sutured, accelerating surgeon workflow and lowering healthcare costs. The implant is strong, pliable, fully absorbable, synthetic, and easy to handle and cut.
This FDA clearance builds on Nurami's important randomized clinical trial. That 85-patient study showed excellent performance against primary endpoints of CSF leakage prevention as well as other safety and surgeon preference measures.
"This is an important milestone in Nurami's efforts to modernize soft tissue repair," said Hannoch Marksheid, Nurami's Co-CEO. "ArtiFasciaŽ is a novel alternative for Dura repair, addressing dangerous CSF leaks and infections at the surgical site, while promoting Dura regeneration."
Prof. Andrew Kaye, neurosurgeon at the Hadassah Hebrew University Hospital Jerusalem, and former Professor and Director of neurosurgery at The Royal Melbourne Hospital, adds, "There is a need for a thin, pliable Dural substitute that can be sutured in place, does not leak through the suture holes and that will integrate into the surrounding Dura." With regard to ArtiFasciaŽ, "Nurami's ArtiFasciaŽ Dura Substitute has exactly these features and showed impressive results in a clinical study. The presence of electropun nanofibers in the implant has the potential to be a game changer in optimizing Dural regeneration after neurosurgery."
Dr. Michael Schulder, Professor and Vice Chair in the Department of Neurosurgery, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell has stressed how ArtiFasciaŽ addresses the market need: "The necessity to cover the brain with a safe and reliable dural substitute remains a need even after 140 years of neurosurgery. ArtiFasciaŽ really looks like the solution we have been waiting for, going back to the days of Harvey Cushing and even earlier. Even for people having posterior fossa surgery, ArtiFasciaŽ has shown that it reliably seals Dural gaps and prevents the formation of pseudomeningoceles."
About Nurami Medical
Nurami Medical is a medical device company co-founded in 2014 by Dr. Amir Bahar and Nora Nseir Manassa, experts in nanofibers and biomaterials. The company develops innovative implants and sealants that are based on electrospun fibers and advanced materials to improve patient outcomes and enhance recovery in soft tissue related surgeries. Nora Nseir Manassa and Hannoch Marksheid are co-CEOs and Dr. Amir Bahar is COO, Clinical Director and a board member.
Contact details:
Hannoch Marksheid
[email protected]
SOURCE Nurami Medical
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