SpineX: Entering New Frontiers in Neurological Treatments

It is a common misconception that the ultimate goal of a patient living with paralysis such as severe spinal cord injury (SCI) or neurological disorders, like stroke or cerebral palsy, is to regain physical mobility. However, their basic ability to perform activities of daily life (ADL), like control over the bladder and bowel, plays an instrumental role in the quality of life they lead.

Medication and physical therapy are the conventional treatments prescribed by doctors. However, they only manage symptoms secondary to paralysis and also result in side effects. Neuromodulation is an effective new frontier of treatment, but its invasive nature prevents many patients from accepting it.

With over 249,000 people living with SCI and over 6,000,000 people living with a stroke in the U.S. alone, there is an urgent requirement for an alternative treatment that is non-invasive with no side effects. This is precisely what SpineX specializes in.

SpineX is a clinical-stage bioelectric MedTech company developing spinal neuromodulation devices as a platform technology. Its primary goal is to develop novel non-invasive neuromodulation therapies for unmet clinical needs, like restoring breathing in quadriplegia patients and improving cardiovascular, bowel, and sexual functions in individuals with neurological conditions.
It has developed two FDA-recognized breakthrough devices, Spinal Cord Neuromodulator (SCONETM) and Spinal Cord Innovation in Pediatrics (SCiPTM), to treat urinary incontinence and Cerebral Palsy-related neurological dysfunctions.

“We continue to explore areas where we can utilize our technologies to treat patients with the basic scientific principle that the spinal cord is smart,” says Parag Gad, Co-Founder and CEO of SpineX.

SCONE aims to treat urge urinary incontinence due to stroke, SCI, or multiple sclerosis. It painlessly delivers modulated waveforms of varying currents to designated areas of the spine in a specific sequence via hydrogel electrodes placed directly over the skin. Neuromodulation waves from SCONE help patients with a lack of control of the urinary bladder in four ways, restore the ability to sense when the bladder is full, improve its capacity to store sufficient urine, reduce urgency and frequency of urination, and reduce urinary incontinence episodes. This is backed by patient research that showed an average of 70 percent reduction in urinary incontinence after three to 24 sessions of treatment.

Most patients are extremely satisfied with SCONE therapy. A common benefit reported after using SCONE therapy was its contribution toward improving their quality of life and enabling them to confidently continue performing daily activities including being able to drive 3 to 4 hours continuously vs having to stop every 30 mins or being able to sleep for 4 to 5 hrs at night instead of waking up 6 to 8 times throughout the night.
SCiP is also a non-invasive neuromodulation platform technology device developed to treat underlying neurological dysfunctions associated with cerebral palsy. Extended clinical trials for FDA clearance are expected to begin in 2023, but ongoing pilot clincial studies have recorded groundbreaking improvements in functions in children with cerebral palsy using SCiP.

We continue to explore areas where we can utilize our technologies to treat patients with the basic scientific principle that the spinal cord is smart

SpineX is determined to improve the quality of life of patients impacted by their neurological condition or post-partum or agerelated health disorders by creating a pain free and easy to use therapy in areas with no existing treatment. For instance, an elderly woman, who loved gardening in her backyard, had to cease her hobby due to urinary incontinence. She felt self-conscious due to her lack of control as it was a fair distance between her backyard and the restroom. However, after undergoing SCONE therapy and regaining better control of her bladder, she could resume her hobbies. She could also socialize with family and friends without worrying about finding the nearest restroom, enhancing her quality of life.

SCONE and SCiP are investigational devices and their safety and effectiveness have not been reviewed by the US FDA. Since they are non-invasive, patients can easily discontinue the treatment if needed. These factors make SpineX stand out in the medical industry despite being an early-stage bioelectric MedTech company.