The acquired assets include all of Cyberkinetics’s rights and regulatory filings for the Andara Oscillating Field Stimulator (OFS) technology for treatment of acute spinal cord injury, an investigational device designed to stimulate spinal cord repair and restore sensation; and the rights to develop and commercialize a therapeutic product for peripheral nerve injury based on the Andara OFS neurostimulation technology.
NeuroMetrix also acquired development and commercialization rights to certain derivatives of the pharmacological agent 4-aminopyridine that may be useful in the treatment of central and peripheral nervous system injury and disease; and certain other intellectual property and technology.
The Andara OFS System is presently under review by the FDA under a humanitarian device exemption (HDE) application for the treatment of acute complete spinal cord injuries. While pursuing the FDA approval through the HDE process, NeuroMetrix plans to explore international regulatory pathways, including in Europe.
Shai Gozani, president and CEO of NeuroMetrix, said: NeuroMetrix’s core mission is to develop and market products in three clinical areas related to the nervous system. The first is diagnosis and monitoring of peripheral nerve and spinal cord dysfunction. The second is the delivery of anesthetic and therapeutic agents to peripheral nerves and the spine.
And the third, which we have significantly strengthened through this acquisition of the Andara OFS technology, is neurostimulation to promote repair and regeneration of peripheral nerves and the spinal cord. These three areas have a common scientific theme which is the measurement, modulation, and repair of neural conduction.