Auxilium Biotechnologies has enrolled the first patient in a study evaluating the efficacy of its NeuroSpan Bridge device for improving nerve regeneration.
The US-based biotech’s scaffold mimics the fascicular architecture of the nerve using microchannels as a means to organise regeneration so regenerating axons remain on the same path as they bridge an injury site.
According to the company, the investigational device is intended to accelerate nerve regeneration and nerve targeting, and to restore motor and sensory function while reducing complications and side effects observed in existing nerve stimulation treatments.
Auxilium’s pivotal trial aims to enrol 80 patients at sites across the US to assess the device’s performance, safety profile, and potential benefits over existing treatment options.
The prospective, randomised, subject and evaluator-blinded NeuroSpan-1 trial (NCT06529835) will assess the device’s performance, safety profile, and potential benefits over existing treatment options.
Due to complete by August 2028, the trial will involve two control arms. Enrolled patients with upper or lower extremity nerve injuries requiring repair of 0.5cm-1cm will be implanted with NeuroSpan Bridge or Integra LifeSciences’ NeuraGen Nerve Guide, a resorbable implant.
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By GlobalDataPatients requiring repairs between 1.1cm and 3.0cm will be implanted with NeuroSpan or receive nerve autograft, a surgical procedure wherein a segment of a patient’s nerve tissue is implanted at the site of a nerve injury.
The trial’s primary endpoints are efficacy measured based on the change on the static two-point discrimination (s2PD) scale after 12 months, and the analysis of complications and adverse events (AEs) such as infections, inflammation, tissue rejections at the 12-month follow-up point.
Secondary endpoints include motor and sensory function changes after 12 months, as assessed by the British Medical Research Council grading system.
Auxilium CEO Jacob Koffler commented: “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.”
Auxilium has been a close collaborator with Nasa. Having received approval from the space agency on a proposal centred on the creation of medical devices on the International Space Station (ISS) earlier this year, Auxilium revealed that its Auxilium Microfabrication Platform (AMP-1) bioprinter simultaneously built eight implantable medical devices for peripheral nerve repair on the ISS within two hours.
According to GlobalData’s Pipeline Products database, there are currently 38 peripheral nerve injury products in development, with 23 at advanced stages of development.
