The firm owned by Parag Gad has created two devices that assist children with cerebral palsy and people who are unable to control their bladders owing to neurological, spinal cord, or brain disorders. Gad, who was born and raised in Los Angeles, is the CEO of SpineX, a clinical-stage MedTech bioelectric startup that specializes in creating non-invasive patient solutions.
“Imagine a pacemaker, but instead of targeting your heart, this pacemaker activates the spinal cord. And rather than being an implantable device requiring surgery, it’s non-invasive. We place it directly over the back at various levels,” Gad, Co-founder and CEO, SpineX, explains.
After earning his degree in 2008 from a university in Mumbai, biomedical engineer Gad moved to the US to pursue his master's and doctoral studies in neuroengineering and rehabilitation at the University of California, Los Angeles. Before founding SpineX, he worked as a full-time scientist for five years at UCLA, where he initially created the technology. Gad has over 15 years of expertise in product development and preclinical and clinical research.
SCONE and SCiP
Gad's SpineX is the creator of two products: the Spinal Cord Neuromodulator (SCONE), which is intended for adult patients and aids in the treatment of neurogenic bladder resulting from spinal cord injury, multiple sclerosis, and stroke; and the Spinal Cord Innovation in Pediatrics (SCiP), a device intended for children with cerebral palsy (CP) that affects a person's ability to move, maintain balance, and adopt proper posture.
The same technology, known as spinal cord stimulation or neuromodulation, underpins both devices. It entails attaching electrodes precisely to the part of the spinal cord that is causing the pain. The adult device transmits a stronger current than the pediatric device, which utilizes less current while keeping children in mind, as Gad points out. That is the only distinction between the two devices.
According to Gad, the spinal cord neuromodulation device, or SCONE, is battery-operated and around the size of an old-fashioned pager. It is wired up to the back, where it sends impulses that can activate particular spinal regions and produce a variety of inhibitory neurotransmitters, which block pain-producing brain impulses.
“Walking is an automatic process,” he explains. “When there is trauma that occurs, the communication or the neurons in the brain and spinal cord are now miscommunicating. With the electrical treatment, we rewire how the brain and spinal cord communicate with the rest of the body. That’s really the core of the therapy here: by delivering these impulses into the spine, you’re correcting the communication that’s occurring in the brain, spinal cord, and muscles.”
“Physical therapy has historically been advised to treat children's mobility issues related to cerebral palsy. Gad contends, however, that physical therapy just helps to control discomfort and does not promote functional development.”
“The magnitude of change that’s possible for a child who is unable to move his legs, to now be able to ride his bike at home, and the fact that you’re able to cause a physical change in the nervous system so that they can retain this improved function at home, even when the treatment is not actively being delivered—that is really the beauty of this treatment,” he said. “We are the first of its kind,” he continues.
A home-use device
When used in tandem with a companion app, SCONE enables caretakers, doctors, therapists, and users to track how well the therapy is working. Its AI interface suggests the best times to administer stimulation therapy and gives consumers access to more optimized stimulation parameters. “If the treatment is done one hour a day or twice a week for eight weeks, how do you know which two hours to stimulate and which two hours you should train? With that AI interface, it will accumulate a ton of data, and based on what we have seen over the last five days, we would have the best outcome for the next three days,” Gad explains.
Because it is noninvasive, it is safe and doesn't call for several procedures—and, maybe more crucially, a lot of clinic appointments. “It’s potentially a home-use device. You’re not expected to come to a clinic three or four times a week. Patients come in initially to get assessed, receive the device as per their requirements, and take it home with them to continue therapy at home,” says Gad.
Furthermore, according to Gad, a patient can save a lot of time by determining whether neuromodulation therapy is effective on their own without having to commit to six months of treatment. He advises patients to attend a one- or two-day session before signing up for extended sessions. “This is classified as what’s called a non-significant risk device. It has a very low-risk profile and has almost no adverse events on the patient population,” claims Gad.
Gad makes it clear that patients will only have access to the device if their doctor advises them to choose a non-pharmacological option rather than a prescription drug. “It’s a medical device and not an over-the-counter (OTC) medical device that may be offered for sale directly to the consumer, meaning it requires a prescription. It is not a one-size-fits-all; it has to be customized for the patient,” he says. “That’s where the physician comes into the picture. They will acquire the device from us, but then it will be set based on the patient’s needs by a qualified healthcare professional.”
