Andara™ Oscillating Field Stimulator (OFS) Device

The Andara™ Oscillating Field Stimulator (Andara™ OFS Device) is currently the subject of a Phase Ib clinical trial being conducted under an Investigational Device Exemption (IDE) from the FDA. The Andara OFS Device is designed to stimulate regrowth of the neural fibers surrounding the spinal cord across the area of injury to establish new neural connections that can restore function, including tactile sensation, sexual function and movement. The Andara OFS Device is designed to be used at the time of orthopedic stabilization of the injury, within 18 days of spinal cord injury. The device is removed after 14 weeks, however, improvement in function can continue for up to one year.

Published results from a ten-participant, Phase Ia trial completed in 2004 demonstrated 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 Device consists of a battery-powered device about the size of a lipstick tube with six leads. Three of the leads are attached to the bone at a distance of two disk segments above the area of injury, and three are attached 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 Device stimulates the neural fibers surrounding the spinal cord to grow across the injury in order to restore sensory and motor function. The Andara OFS Device technology is based upon well-documented principles of neurophysiology showing that neural tissues naturally grow in certain electrical field conditions.

Cyberkinetics is further developing the Andara OFS Device technology for use in combination with a wide range of neurotrophic factors (Andara OFS PLUS System). The goal of this program is to restore function in those with older, or chronic, injuries ­ even months or years after injury.

The Andara OFS Device 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, the Company expects to file a Humanitarian Device Exemption in 2006.

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