San Diego-based Auxilium Biotechnologies designed the investigational NeuroSpan Bridge device to accelerate nerve regeneration and nerve targeting after debilitating nerve injuries to extremities. About 3% of civilian trauma cases and 30% of military trauma cases involve nerve injury, said Auxilium Biotechnologies CEO Jacob Koffler.
“Nerves don’t regenerate where they need to go. They do that very randomly, sometimes even going backward towards the proximal end,” Auxilium Biotechnologies CEO Jacob Koffler said in an interview. “What we have is a technology that is able to organize this regeneration, keep them in the same pathway and bring them to the original target that was denervated due to the injury.”
The NeuroSpan-1 pivotal study is for an anticipated FDA 510(k) clearance submission. It will include 80 patients with upper or lower extremity nerve injuries to compare the Auxilium Biotechnologies NeuroSpan Bridge against the Integra LifeSciences NeuroGen Nerve Guide and nerve autograft repair.
In February, Auxilium Biotechnologies announced successful space experiments using its 3D bioprinter and proprietary biomaterial, simultaneously printing eight miniature implants in two hours.
The pivotal study won’t use devices printed in orbit, with Auxilium Biotechnologies planning to use that particular method later for a third-generation device that can “actively enhance regeneration using drug delivery,” Koffler said.
You can learn more about the investigational device and manufacturing method in an interview with Koffler at Medical Design & Outsourcing.
