The proposed procedure would employ NTX-001 as a free functional muscle transfer to the upper extremity. This procedure is meant to restore the function of one or two joints in the upper extremity by bringing the gracilis muscle from the leg with its associated obturator nerve and its vascular pedicle. Most commonly, and in this case, as well, elbow flexion is the main function that is targeted for improvement. This is for a brachial plexus injury, and therefore we would be using an extraplexal nerve as a donor nerve to reinnervate the gracilis muscle. Most commonly, this is the spinal accessory nerve. The only proposed direct tension-free coaptation that would be subject to NTX-001 is the spinal accessory nerve to the obturator nerve. The benefit of this would be immediate reinnervation of the gracilis in the arm without a period of muscle atrophy that traditionally occurs with this operation. Usually, the first signs of any muscle contraction occur around 6 months when the patient tries to flex their elbow. With NTX-001, this may be significantly expedited with early return of function and result in greater muscle strength due to the prevention of muscle atrophy.
The proposed use of NTX-001 for transections of peripheral nerves in the upper extremity for subjects that don't qualify for study NTx20201.