Medical Device Daily

People with upper motor neuron injuries or diseases often experience gait movement disorders, such as foot drop which is a result of partial leg paralysis. Gait movement disorders not only result in difficulty walking, but also may lead to fatigue, falls or abnormal walking patterns. An application developed by Bioness (Valencia, California) seeks to address these patients and quite possibly offer treatment for them.

The firm recently reported the commercial release of its NESS L300 Plus System an application that combines the NESS L300 Foot Drop System with a thigh cuff to activate even more of the nerves and muscles in the leg for greater control while walking.

The NESS L300 Plus was cleared for use by the FDA on April 29, 2011 and received CE mark approval on July 27, 2011 for sale in Europe,“ Todd Cushman, Senior VP of Global Sales, Business Development and Marketing for Bioness told Medical Device Daily via email. “The technology was developed by Bioness, the L300 Plus works in conjunction with Bioness' flag ship product the NESS L300 Foot Drop System. Both the foot drop stimulator and the thigh cuff stimulator work together in helping to correct gait problems including foot drop and thigh muscle weakness.“

The L300 Plus is intended for people living with neurological conditions resulting from stroke, multiple sclerosis, traumatic brain injury and spinal cord injury. The device is also said to facilitate muscle re-education, prevent muscle atrophy, increase range of motion and increase local blood flow.

“The product benefits include; wireless set-up and communication; option to stimulate hamstrings or quadriceps muscle groups; wireless sensor adapts to changes in walking speed and changes in terrain (including elevation),“ Cushman said.

Sheltering Arms Physical Rehabilitation Centers (Richmond, Virginia) is the first rehabilitation center in the country to offer the L300 Plus.

According to James Sok, president/CEO of Sheltering Arms Physical Rehabilitation Centers, “The L300 Plus is a welcomed addition to our iWalk program which empowers our patients by offering a wide-range of technology-based therapy solutions. We are excited to offer leading rehab technologies in combination with our highly trained therapists to help restore function in our patients as they reintegrate back into the community.“

The device was evaluated in a six week prospective, non inferiority study was conducted on 45 subjects suffering from foot drop and thigh muscles weakness due to upper motor neuron injury or disease.

“There was no occurrence of adverse events reported and all of the study subjects found the L300 Plus safe for use,“ Cushman said of the results. “All patients were able to walk immediately after being fit with the L300 Plus System and none of the study subjects reported a fall or a “near fall“ while walking with the system. All subjects showed improvements in gait performance with the NESS L300 Plus when compared with the NESS L300.“

The device has the potential to reach a large market according to the company.

“An estimated 12.5 million Americans live with the effects of central nervous system injuries and disorders, and many of these individuals have gait disorders that make it difficult if not impossible for them to walk with freedom,“ said Thomas Fogarty, president/CEO of Bioness. “The NESS L300 Plus will provide physical therapists an additional modality to optimize the patient's course of therapy and allow home users better control over their knee and foot making it easier to walk. Bioness continues to be committed to bringing innovative solutions to patients and in setting the standard of care with our advanced technology. The L300 Plus represents yet another product in our pursuit of this mission.“

The company most recently said that it would greatly reduce its activity, according to a financial report from Teuza Venture Capital Fund, which owns 4.5% of the company (Medical Device Daily, Aug. 29, 2011). The firm did not specifically spell out what this reduction in activity would entail, but added that action would happen by the end of this year.

Bioness has had $20 million in annual turnover for several years, but it has not been able to exceed this amount, and its annual expenses have been $30 million.

The company has 137 employees in the U.S. and 87 in Israel.

Omar Ford, 404-262-5546;