Andara™ OFS™ Therapy

The Andara™ OFS™ Therapy is based upon well-documented principles of neurophysiology showing that neural tissues naturally grow in certain electrical field conditions.

In September, 2006, the Food and Drug Administration (FDA) designated the Andara™ OFS™ System as a Humanitarian Use Device (HUD). In February 2007, Cyberkinetics submitted a Humanitarian Device Exemption to the FDA to make the Andara™ OFS™ System available to treat acute spinal cord injuries (within 18 days of injury). The Andara™ OFS&trade System is designed to stimulate nerve repair to restore sensory and motor function. The Andara™ OFStrade; System is designed to be removed after 14 weeks.

Results from a ten-participant, Phase Ia trial published in the January 2005 issue of the Journal of Neurosurgery: Spine, reported that all participants showed statistically significant improvement in sensation and some improvement in movement, including hand, arm and leg movement. For those with cervical spinal cord injuries, for example, there is evidence of a two-segment improvement, or the functional difference between non-movement of an arm or hand and the ability to grasp a utensil to feed oneself.

The return of sensation for those with spinal cord injuries is extremely valuable and can be life-saving in addition to significantly improving the quality of life. For example, the ability to sense pain could prevent the formation of pressure injuries of the skin. Although treatable in early stages, if such injuries to the skin remain undetected, they can cause death as with Christopher Reeve. Sensation is also important to vital functions such as bowel and bladder control, as well as to sexual function.

Cyberkinetics' Andara™ OFS™ System consists of a battery-powered device about the size of a cardiac pacemaker with six electrical leads. Three of the leads are attached to the vertebrae at a distance of two disk-segments above the area of injury, and three are attached to the vertebrae at a distance of two disk-segments below the injury. By applying an oscillating, low-voltage, direct current of electricity to the areas above and below a spinal cord injury, the Andara™ OFS™ System creates an electrical field that surrounds the injury and stimulates the nerves surrounding the spinal cord to grow and form new connections that can restore sensory and motor function. The Andara™ OFS™ System is an investigational device. It is not currently approved for sale and is available only through participation in a clinical study. Cyberkinetics has filed an application for Humanitarian Use Device status from the FDA. If the application is successful, Cyberkinetics could market the device commercially in late 2007.

Cyberkinetics is further developing the Andara™ OFS™ Therapy for use in combination with a wide range of growth factors The Andara™ OFS™ PLUS™ System is being designed to restore sensory and motor function in injuries that are months or years old. A preclinical study of the Andara™ OFS™ PLUS™ System is currently being conducted in naturally injured dogs.

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