Auxilium Biotechnologies has enrolled the first patient in its clinical trial evaluating the safety and efficacy of its NeuroSpan Bridge device designed to improve nerve regeneration.
The NeuroSpan-1 trial (NCT06529835) will assess the safety, efficacy, and overall benefits of the device in comparison to current treatments. A total of 80 patients will be enrolled across multiple US sites.
The San Diego-based company made headlines in February when it successfully deployed its 3D bioprinter, Auxilium Microfabrication Platform (AMP-1), aboard the International Space Station (ISS). The device made history by printing eight implantable medical devices simultaneously in two hours.
“This is a transformative moment for us,” said Dr. Jacob Koffler, CEO of Auxilium Biotechnologies. “We’ve spent years developing a technology with the potential to change lives, and today, we are one step closer to making that a reality.”
NeuroSpan Bridge is engineered to accelerate nerve regeneration and targeting, while reducing surgery time, complications, and long-term side effects such as chronic pain—a frequent issue in existing repair methods. The device is designed as a novel scaffold that mimics natural nerve structure with strictly linear microchannels to guide axonal regrowth.
Auxilium noted that, by creating a more effective method for reconnecting severed or damaged nerves, the NeuroSpan Bridge could address an unmet need for patients recovering from traumatic injuries, such as those caused by car accidents or workplace incidents.
Trial design and endpoints
The prospective, randomized NeuroSpan-1 trial is comparing the efficacy and safety of the NeuroSpan Bridge to both the NeuraGen Nerve Guide (resorbable collagen implant for nerve gaps of 0.5–1.0 cm) and traditional nerve autografts.
The study will enroll about 80 adult patients aged 18–80 with nerve gaps ranging from 0.5 to 3.0 cm in the arms or legs, including hands and feet. Repair must occur within three months of injury. It is projected to complete its primary evaluation phase by August 2027, as per clinicalstrials.gov.
The trial’s efficacy outcome is to assess the functional recovery of peripheral nerves by evaluating the change in Static two-point discrimination (s2PD) measured at 12 months. For its safety outcome, the study will track complications such as infections, inflammation, and chronic pain over a 12-month follow-up period.
Trial’s secondary outcomes include tracking motor and sensory function using the British Medical Research Council grading scale, patient-reported outcomes via the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Along with moving two-point discrimination (m2PD) and pain intensity scores. Surgery time and hospital readmission rates will also be evaluated to assess procedural efficiency and post-operative recovery.
