NERVALIGN® NERVE GRAFT
The NervAlign™ Nerve Graft – ReNerve is developing a size based range of ‘off-the-shelf’ nerve grafts for the repair of damaged nerves. These grafts will be of varying diameters and lengths that allow better tailoring of the graft to specific nerve surgical repairs. The NervAlign nerve grafts offers surgeons the ability to repair damaged nerves (neurotmesis) without the need to harvest the sural nerve from the patient, reducing the economic and physical impact of the harvesting procedure as well as creating an environment for a better outcome for the patient.
Current nerve replacement practice is to use nerves harvested from the patient or donor nerves which can have issues including:
- Secondary surgical site morbidity due to harvest (and increased time in theatre and recovery)
- Nerve mismatch in diameter, fascicle dimensions and axonal size
- Potential for local infection and neuroma formation
- Loss of function at one or both surgical sites
- Start of regrowth commences after a period of Wallerian degeneration Restricted regrowth due to Wallerian degeneration
- Mismatched tissue typing
The ReNerve NervAlign Grafts are being developed to come in various graft diameters enabling surgeons to match the graft to the size of the damaged nerve area making for better alignment and outcomes for patients. The grafts can be used across the main peripheral nerves including:
- Brachial plexus (radial nerve, median nerve, ulnar, digital nerves)
- Peroneal nerve (foot drop)
- Femoral nerve
- Lateral femoral cutaneous nerve
- Sciatic nerve
- Spinal accessory nerve
- Tibial nerve
The ReNerve nerve graft would be used with the ReNerve nerve cuff and can also be used in nerve transfers and nerve boosting and supercharging procedures.
Over the past four years ReNerve has developed an optimised processing method from an optimised animal nerve source to produce cleaned nerve scaffolds (grafts) that have been produced to enable rapid and directed nerve implant and regrowth. The nerve grafts are cleaner than autologous (harvested from the patient) nerves and are benign, preventing any post-implant rejection or complications.
ReNerve, working with Melbourne University Veterinary School, has also developed a nerve injury replacement animal model to simulate human nerve injury repairs. ReNerve has tested several generations of its nerve graft in this model, with the third-generation product allowing sheep to be able to walk within hours post-surgery and achieve full clinical recovery within three months.
The ReNerve nerve graft is unique in that it is the only specially developed, off-the-shelf nerve graft that doesn’t require either harvest (secondary surgical site) or the use of donor tissue, with the attendant cross-typing and possible cross-transfer risks. The ReNerve graft is produced to provide an ideal environment for nerves to re-establish a native functioning state and therefore better outcomes for patient’s post-surgery.
NervAlign™ Nerve Graft is superior to existing products because:
- It is ready to use and off the shelf
- NervAlign™ Replacement Nerve not frozen
- NervAlign™ Replacement Nerve doesn’t need cross-typing for patients
- No foreign DNA or cell contents remain, while the structure is preserved
- Removal of foreign cell contents prevents negative inflammatory and rejection responses
- Rapid recovery post-surgery
- Histology showed nerve regrowth through conduits as good as autologous (native) tissue
- Full nerve formation through entire length of nerve graft, including new axon and fascicular formation and functional nerves
- Recovery of walking within 3 months