SpineX begins enrolling participants in SCONE Device clinical trial

Clinical stage bioelectric medtech company SpineX has: announced the enrollment of the first participant in a critical trial of the SCONE device.

The SCONE trial is designed to assess the effectiveness and safety of the device for the treatment of neurogenic bladder.

It is said to be the first large-scale pivotal study to test a non-invasive spinal neuromodulation technology developed to treat neurogenic bladder.

SpineX stated that the first participant was enrolled in the Rancho Research Institute, the research arm of the Rancho Los Amigos National Neurorehabilitation Center.

Neurogenic bladder is the most common comorbidity in humans after paralysis.

The effect goes beyond the inability to urinate when needed or the need for repeated daily catheterizations to empty the bladder for life.

People with neurogenic bladder will have symptoms such as low bladder capacity, a lost sense of bladder fullness, a constant fear of uncontrolled urine leakage, and frequent urination cycles during the day and night.

SpineX co-founder Dr. Evgeniy Kreydin said: “For a person in a wheelchair, the inability to walk is the most obvious functional loss, but the impact on quality of life due to neurogenic bladder is unparalleled.”

The company said the SCONE therapy is designed to treat each of these symptoms.

The device delivers patented modulated waveforms of changing currents to designated areas of the spine in a specific sequence via hydrogel electrodes directly above the skin.

As a result, the user has no pain or discomfort.

SCONE is designed for the treatment of neurogenic bladder caused by spinal cord injury, stroke or multiple sclerosis.

SpineX CEO Dr. Parag Gad said: “The initiation of the SCONE trial is an important milestone in the commercialization of the world’s first non-invasive treatment modality for neurogenic bladder.

“We are committed to transforming bladder management into a catheter-free and leak-free world.”

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