In an interview with PharmaShots, Jeremiah Robison, Founder, and CEO at Cionic shared his views on the US FDA’s clearance of Neural Sleeve for patients with cerebral palsy, MS, stroke, and other disorders

• Cionic’s Neural Sleeve has received the US FDA clearance for functional electrical stimulation to assist in gait for patients with foot drop and leg muscle weakness. The lightweight & durable Neural Sleeve is the 1st product to combine sensing & stimulation of the entire leg into a single wearable system
• Neural Sleeve is the 1st algorithm-powered bionic garment & was designed to help those with mobility issues due to MS, stroke, cerebral palsy, and other neurological conditions, regain functional movement in everyday activities. The product is expected to deliver in late 2022
• The studies showed that 94% of patients experienced increased dorsiflexion at heel strike & 88% experienced reduced ankle inversion during the swing

Tuba: Can you discuss the salient features of the Neural Sleeve?

Jeremiah Robison: Cionic’s Neural Sleeve is the first algorithm-powered bionic garment designed to assist people with mobility challenges, including individuals with cerebral palsy, MS, stroke, and spinal cord injury. Constructed with soft, flexible fabric, the sleeve’s design makes it easy for individuals to wear on their leg, looking more like a performance legging than a therapeutic aid. Inside it, we have packed our breakthrough read-write neural interface that can not only read the signals sent from the brain to the muscles, but also activate the muscles directly using functional electrical stimulation (FES).   Powered by advanced algorithms, the Neural Sleeve can properly sequence complex muscle firings to help people with motor impairments walk naturally and safely. It is available in a variety of colors to match an individual’s personal style.

Tuba: Please shed some light on the working of the Neural Sleeve.

Jeremiah Robison: With neurological injury and disease, the musculoskeletal system is intact, but there is difficulty sequencing the complex muscle firings needed for walking. The Neural Sleeve helps fill in those gaps by activating the individual’s muscles with functional electrical stimulation. First, the garment uses sensors to measure the body’s movement. Next, algorithms analyze the data in real-time to determine the needed pattern of stimulation. Then, our novel stimulation array steers current to the appropriate muscle groups to achieve a more stable, normative gait pattern. This updates every single step.

Tuba: Can you tell us how the clinical study supported the clearance of the Neural Sleeve?

Jeremiah Robison: The FDA clearance process was very challenging and extensive, involving over 1,500 pages of documentation. We conducted extensive research trials to ensure the efficacy of the product within our target populations.  These tests were held in multiple locations and our participants represented a wide variety of diagnoses, including stroke, multiple sclerosis, spinal cord injury, and cerebral palsy.

The most common mobility impairment across these groups is foot drop. This is characterized by the inability to lift the foot (otherwise known as dorsiflexion) during the swing phase of gait, which can lead to instability and falls. It is also often accompanied by an inward rotation of the ankle (inversion) which further increases fall risk. In our trials, 94% of participants experienced increased dorsiflexion at heel strike, and 88% of participants experienced reduced ankle inversion during swing. This contributed to an average combined improvement of 9° across all participants.

Tuba: What makes it unique from other wearable solutions for neurological conditions available in the market?

Jeremiah Robison: The Cionic Neural Sleeve is the only system to combine sensing and stimulation of the entire leg into a single, wearable system. We have an extensible software platform that enables new treatments to be developed at software speeds and software costs. Our breakthrough, read-write neural interface is the first to enable software-steered stimulation which allows us to easily reproduce nuanced muscle activations without fussing with electrode positioning.

Finally, the Cionic Neural Sleeve doesn’t look like a medical device - it is a sleek, stylish legging.

Tuba: How will this wearable change the lives of patients with mobility issues?

Jeremiah Robison: To best illustrate how the Cionic Neural Sleeve is changing the lives of people using it, we’d like to share this recent quote from one of our test pilots: “This afternoon [my husband] and I went for a walk with gait assist down our block to the Bluffs, toward the Coastal Trail. We then walked on very uneven grassy terrain for another city block and back home again. Neither of us can remember the last time I walked on the Bluffs. Coming home, we walked across our front lawn and again, I cannot remember the last time I did that.” For the Cionic team, our goal is to help our community reclaim the joy of mobility in their own lives.

Tuba: Are you planning for its approval in other geographies as well?

Jeremiah Robison: We are focused on a successful launch in the United States. That said, we have seen a lot of inbound interest from around the world and look forward to making the Cionic Neural Sleeve available as widely as possible in the future.

Tuba: What are your expectations with the Neural Sleeve regarding sales, revenue, and others?

Jeremiah Robison: We recently launched our Founder’s Program for our early adopters.  This group will have first access to the Cionic Neural Sleeve, including monthly assessments with our clinical care team to ensure a treatment plan optimized to their needs. We have been overwhelmed by the demand. This is a strong indication of the widespread unmet need for these populations, and we are pushing hard to make it available to the millions of people living with mobility impairments.

Tuba: Can you tell us about some of the patient experiences, or provide a video, to show our readers the comfort patients feel with the wearable device?

Jeremiah Robison: Overall, user feedback has been extremely positive. Many people describe their movement as more flowing and natural after using the Neural Sleeve. Some have spoken of a lightness and ease when walking - that they no longer have to think about every step and are no longer always afraid of falling. In terms of outlook, our users frequently share the optimism they feel from the progress they have made as they start to feel stronger, more stable, more confident, and more independent.

One of our early users, Jim, shares his experience: https://www.youtube.com/watch?v=Fwg6tfvwWp8

Tuba: What can we expect next from Cionic for other neurological conditions?

Jeremiah Robison: As a company we envision a world beyond disability, and we are developing treatments that can address other populations and other areas of the human body.

Tuba: How can one order this wearable for themselves and caregivers for their patients?

Jeremiah Robison: Individuals wanting to preorder the Neural Sleeve can still sign up for the Founder’s Program.  Visit cionic.com to determine eligibility and reserve your space.. We plan to start delivering later in 2022.

About Author: Jeremiah Robison is the Founder and CEO of Cionic. Robison is steadfastly working to develop the lower leg Neural Sleeve, via software development, product design, and individual trials. He is a proponent and an advocate for creating better solutions for people with mobility issues caused by neurological conditions and illnesses such as cerebral palsy, multiple sclerosis, stroke, and more. Jeremiah earned a master’s degree in computer science from Stanford University

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