Onward Medical using 2 grants to test spinal stimulation device

$2.5M awarded for studies of mobility, blood pressure effects in Parkinson’s

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by Andrea Lobo |

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Onward Medical has received two grants totaling about $2.5 million to support early feasibility studies assessing whether its implantable spinal stimulation system, called ARC-IM, can lessen mobility difficulties and blood pressure instability in people with Parkinson’s disease.

The ARC-IM system — in which targeted stimulation can be delivered to the spinal cord via the company’s implantable technology — has already received breakthrough device designations in the U.S. for restoring leg motor function and normalizing blood pressure, among other benefits, in individuals with spinal cord injury. Now, Onward is looking to investigate whether its spinal stimulation system could also benefit people with Parkinson’s, according to a company press release.

A $1 million grant was awarded by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to support a study testing whether the ARC-IM system can address mobility problems in six Parkinson’s patients. The first participant was implanted with the device late last year.

Another grant, this one of about $1.5 million, will now provide funding from the U.S. Department of Defense to support a new study expected to start by the end of June. That feasibility study will explore the system’s ability to treat blood pressure instability in five Parkinson’s patients.

“The versatility and promise of the Onward ARC-IM system has been validated by [these] grants,” said Dave Marver, Onward’s CEO. Marver said the funding will “[support] research to determine if our technology can be leveraged beyond spinal cord injury.”

In addition to benefits in leg motor function and blood pressure, the breakthrough device designations have noted the device’s potential to improve trunk stability and bladder control, and to reduce abnormal muscle tightness, in spinal cord injury patients. Those statuses, awarded by U.S. regulators, are meant to accelerate the clinical development of new treatments for serious medical conditions.

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Grants from MJFF, Department of Defense support Onward studies

A neurodegenerative disease, Parkinson’s is caused by the progressive loss of nerve cells called neurons that produce dopamine, a chemical involved in movement control. This results in impaired dopaminergic signaling in the brain, leading to motor symptoms, including slowness of movements, rigidity, and impaired balance and walking ability.

People with Parkinson’s can also experience blood pressure abnormalities like orthostatic hypotension, which is marked by a sudden drop in blood pressure upon standing up from a sitting or lying position.

“There are 10 million people worldwide living with Parkinson’s and we are hopeful the ARC-IM system may offer them new and powerful therapeutic options,” Marver said.

The ARC-IM system uses an implantable device that delivers electric stimulation through a thin wire, or electrode, that’s placed into areas in the spinal cord. Its placement is targeted to the areas responsible for triggering the desired movement or function. The system also includes a communications hub and a programmer.

The device can be controlled by the user via a smartphone or smartwatch, and the use of voice commands. According to the company, ARC-IM may eventually be used to control several functions at the same time, including hand and arm control, regulation of blood pressure, and mobility, by placing electrodes in different areas of the spinal cord.

There are 10 million people worldwide living with Parkinson’s and we are hopeful the ARC-IM system may offer them new and powerful therapeutic options.

The MJFF grant was specifically awarded to Jocelyne Bloch, MD, and Grégoire Courtine, PhD, at NeuroRestore, Onward’s research partner. The award was based on the duo’s previous findings that showed the ARC-IM therapy improved mobility and balance in a man with Parkinson’s. For that patient, the system also reduced freezing of gait, Onward noted.

One participant in the ongoing ARC-IM Parkinson’s study, named Marc, is featured on a company webpage detailing this new application of the device.

“I turn on the stimulation in the morning and turn it off in the evening. It allows me to walk better, to stabilize myself,” Marc stated. “Every Sunday I go to the lake, and I walk about six kilometers [about 3.7 miles]. It’s awesome.”

In addition to ARC-IM, Onward is developing a nonimplantable spinal stimulation system called ARC-EX. That system was approved in the U.S. late last year as a treatment for improving hand strength and sensation in people with chronic spinal cord injury.