AI News, Ekso GT™ Robotic Exoskeleton Cleared by FDA for Use With Stroke and Spinal Cord Injury Patients

Ekso GT™ Robotic Exoskeleton Cleared by FDA for Use With Stroke and Spinal Cord Injury Patients

(OTCQB:EKSO), a robotic exoskeleton company, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Ekso GT robotic exoskeleton for use in the treatment of individuals with hemiplegia due to stroke, individuals with spinal cord injuries at levels T4 to L5, and individuals with spinal cord injuries at levels of T3 to C7 (ASIA D), in accordance with device’s labeling.

They are the only exoskeleton company to offer technologies that range from helping those with paralysis to stand up and walk, to enhancing human capabilities on job sites across the globe, to providing research for the advancement of RD projects intended to benefit U.S. defense capabilities.

Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of human exoskeletons, (ii) a projection of financial results, financial condition, capital expenditures, capital structure or other financial items, (iii) the Company's future financial performance and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above.

Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company's current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over.

Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company's inability to obtain adequate financing to fund the Company's operations and necessary to develop or enhance our technology, the significant length of time and resources associated with the development of the Company's products, the Company's failure to achieve broad market acceptance of the Company's products, the failure of our sales and marketing organization or partners to market our products effectively, adverse results in future clinical studies of the Company's medical device products, the failure to obtain or maintain patent protection for the Company's technology, failure to obtain or maintain regulatory approval to market the Company's medical devices, lack of product diversification, existing or increased competition, and the Company's failure to implement the Company's business plans or strategies.

ReWalk, Ekso Race to Sell Exoskeletons in Tough Rehab Market

Every day, Ashley Barnes straps a battery-powered device onto her waist, legs, and feet, which allows the paraplegic to stand up from her wheelchair and go for walks with the help of crutches.

The wearable brace has motors located at Barnes’s hip and knee joints that move the “exoskeleton,” along with her legs and feet, in a way that mimics walking.

The 38-year-old mother from east Texas is a passionate advocate for the exoskeleton technology, for spinal cord injury patients, and, as she puts it, for their right to get up and move around.

These powered, wearable robots have been designed not only for disabled people but also for able-bodied people in industrial and military settings, such as for factory workers to reduce fatigue and injury when doing difficult and repetitive tasks.

Many insurance companies have balked at covering the pricey exoskeletons, citing a lack of data on the devices’ medical benefits and concerns about whether patients would use the devices enough to really see those benefits.

Scheder-Bieschin says Ekso is focused on healthcare systems and providers, making its case to hospitals and rehabilitation centers that its device can speed up the rehab process and allow patients to go home in better shape.

Scheder-Bieschin says Ekso’s device comes with software that allows the exoskeleton to adapt in real-time to the changing needs of the patients as they gain strength and improve their walking, or as they get tired and need more assistance.

key part of the companies’ efforts is to generate more published clinical data showing the kinds of health benefits that Barnes reports, but across a larger number of patients.

Ekso Bionics’ CEO Provides Update on Magnitude of Stroke Rehabilitation Market on CNBC’s “On the Money”

Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of human exoskeletons, (ii) estimates or projection of financial results, financial condition, capital expenditures, capital structure or other financial items, (iii) the Company's future financial performance and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above.

Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company's current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over.

Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company's inability to obtain adequate financing to fund the Company's operations and necessary to develop or enhance our technology, the significant length of time and resources associated with the development of the Company's products, the Company's failure to achieve broad market acceptance of the Company's products, the failure of our sales and marketing organization or partners to market our products effectively, adverse results in future clinical studies of the Company's medical device products, the failure to obtain or maintain patent protection for the Company's technology, failure to obtain or maintain regulatory approval to market the Company's medical devices, lack of product diversification, existing or increased competition, and the Company's failure to implement the Company's business plans or strategies.

Ekso Bionics® Partners with HASOMED to Launch Functional Electrical Stimulation (FES) for the EksoGT™ Exoskeleton

The synergies between the two technologies mark an important step in our ability to offer an even more versatile device that enables clinicians to provide rehabilitation to a wider range of patients across different disease states, including spinal cord injuries and stroke.” FES is a technique that uses low energy electrical pulses to artificially generate body movements in individuals who have been paralyzed due to injury to the central nervous system.

Forward-looking statements may include, without limitation, statements regarding (i) the ability to manage successfully and complete the rights offering, (ii) the expected proceeds of the offering, (iii) the anticipated use of proceeds from the offering, if successful, and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above.

Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company's current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over.

Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company's inability to obtain adequate financing to fund the Company's operations and necessary to develop or enhance our technology, the significant length of time and resources associated with the development of the Company's products, the Company's failure to achieve broad market acceptance of the Company's products, the failure of our sales and marketing organization or partners to market our products effectively, adverse results in future clinical studies of the Company's medical device products, the failure to obtain or maintain patent protection for the Company's technology, failure to obtain or maintain regulatory approval to market the Company's medical devices, lack of product diversification, existing or increased competition, and the Company's failure to implement the Company's business plans or strategies.

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