[WEB] Company Raises $12 Million to Fund Adoption of Neural Sleeve

Cionic, the neurotech company that created the FDA-cleared Cionic Neural Sleeve, announced an additional $12 million extension of its Series A financing, bringing the Series A total to $25 million. Part of the funds will be used to grow user and clinician adoption of the Cionic Neural Sleeve for people experiencing impaired mobility as a result of multiple sclerosis, strokes, cerebral palsy, and other neurological conditions.

The round was led by L Catterton, a leading consumer-focused investment firm, and joined by an additional new investor THVC, as well as all major investors. Additionally, Cionic has also partnered with Enable Ventures, the first impact venture fund dedicated to closing the disability wealth gap while achieving competitive, market-rate returns.

As part of L Catterton’s investment, Venture Partner and experienced entrepreneur Whitney Casey has joined Cionic’s board of directors.

“Transformative technologies are powering a new category of consumer medical devices that assist anywhere it is needed, and at any time,” says Whitney Casey, venture partner at L Catterton. “We have seen how Cionic’s unique bionic clothing has already transformed the lives of those living with mobility impairments, and with the growing consumer interest in wearable health technology, Cionic’s platform has the potential to change the trajectory of personalized healthcare, and clothing, as we know it.”

In addition to using funds from the Series A extension to grow user and clinician adoption of the Cionic Neural Sleeve, Cionic will also use the funds to accelerate the company’s product pipeline into new indications addressing the full spectrum of human mobility. Powering this roadmap is continued investment in Cionic’s wearable neuromodulation platform.

Cionic has doubled its headcount in the past six months and established a state-of-the-art manufacturing facility in Northern California. The company is now licensed to ship the Cionic Neural Sleeve to 45 states in the US, with over 400 prescribing institutions. Since the start of shipments in early 2023, Cionic customers have already clocked over 200,000 hours of use.

“There is a revolution underway in healthcare and with it a growing demand for brands that provide not only high-quality care where and when it is needed, but that are also capable of measuring progress and proving outcomes,” says Jeremiah Robison, founder & CEO of Cionic. “Our partners recognize that we are building something truly unique, and we are proud to work with organizations who share not only our vision for the future of healthcare, but whose deep expertise in brand building, healthcare transformation, and disability advocacy will help us accelerate the timeline for making this vision a reality.”

“The confluence of rising societal expectations of people with disabilities plus technological innovation that is driving systems change, and significant capital earmarked for DEI makes this moment the ideal time to pursue this profoundly underserved market,” says Regina “Gina” Kline, founder and managing partner at Enable Ventures. “Throughout history, disability has served as a catalyst for innovation and Cionic is a leading example. In helping his daughter, Jeremiah has addressed the mobility needs of more than 35 million people in the United States alone and has unlocked the potential of bionic clothing. Enable seeks to support enterprises like Cionic which truly represents the intersection of disability and epic technology.”

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[WEB] Cionic Neural Sleeve Receives FDA Clearance

Cionic’s first product offering, the lightweight leg-worn Cionic Neural Sleeve, has been granted FDA clearance for “functional electrical stimulation to assist in gait for people with foot drop and leg muscle weakness,” the company announces.

This FDA clearance allows Cionic to take its Neural Sleeve to market and begin actively helping people with mobility issues due to multiple sclerosis (MS), stroke, cerebral palsy (CP), and other neurological conditions. The Cionic Neural Sleeve combines movement analysis and augmentation into a wearable garment.

“We are incredibly excited for the Cionic Neural Sleeve to be an FDA cleared Class II medical device and are ready to start impacting the lives of individuals with movement challenges in meaningful ways,” says Jeremiah Robison, Founder and CEO of Cionic. “Our mission is to become the new standard of care by addressing the underlying brain body connections, enabling confident movement, and greater engagement in the community.”

The lightweight and durable Neural Sleeve is designed to help people walk, a fundamental activity key to independent living. However, Cionic has built its platform from the ground up to enable solutions across the mobility spectrum. Cionic completed human factors and efficacy testing and submitted the Neural Sleeve for FDA clearance in November 2021.

“This would not have been possible without the more than 70 individuals across multiple sclerosis, stroke, cerebral palsy, and spinal cord injury who participated in our trials. Together with our research partners at Cleveland State University we were able to demonstrate statistically significant improvement to foot clearance, leading to more stable and confident walking,” Robison continues.

Jim Vecchi, who has been participating in Cionic’s MS trials, describes his experience with the Neural Sleeve.

“Wearing the Neural Sleeve, I move in a way that is more flowing and natural. I am walking more quickly and smoothly, while using less energy in doing so. Already I feel that I am getting stronger and more endurant,” he says. “I should also mention that the Neural Sleeve is surprisingly comfortable and my body has become accustomed to wearing it surprisingly quickly. I do not have the words to properly explain the positive effects on my confidence and outlook. I very much look forward to seeing what progress I can make with the help of the Neural Sleeve.”

To pre-order the Neural Sleeve for delivery later this year visit Cionic to join the Founder’s Program.

[Source: Cionic]

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[WEB] Feasibility Study of Cionic’s Neural Sleeve Suggests Gait Improvement

by Debbie Overman

Participants in a gait study of the Neural Sleeve by Cionic demonstrated, on average, an improvement in their foot drop of 143%, Cionic reports.

The Neural Sleeve is an algorithm-powered bionic clothing designed to help those with cerebral palsy, multiple sclerosis, stroke, and other neurological disorders regain functional movement in their everyday activities, a media release from the company explains.

“It’s been incredible to see participants not just walk more confidently but also show quantitative improvements in their gait. Our participants are seeing 1.5x gain in dorsiflexion at heel strike, which means they’re clearing their foot through swing better, have a better chance to avoid falls, and have a more natural gait cycle. This is a tremendous step in building a scalable neuromodulation platform to help people with movement disorders leverage their own bodies and rebuild neural pathways for greater independence.”

— Jeremiah Robison, Founder and CEO of Cionic

“This month, we completed both our human factors and efficacy testing and we are now ready to submit our Neural Sleeve to the FDA,” Robison continues. “This is a huge milestone for the company. So much invention and hard work has gone into this first product, and we cannot wait to bring it to the many people living with a gait impairment.”

Trial participant Patricia Allen survived a stroke in 2019 that drastically affected her mobility, especially the ability to negotiate stairs. She has used a quad-cane and an ankle-foot orthotic with less than satisfactory results. During one of her trial sessions, Cionic recorded Patricia’s data while she walked outside in San Francisco.

“They’re just a great group of people. What Cionic is doing is a garment-type design so it’s not so obtrusive when you’re wearing it,” Allen shares. “My last visit I actually went out on the streets in North Beach in San Francisco, heavy population, all the flavors of San Francisco, and it was a feeling of inspiration for me that I haven’t felt for two and a half years. It was an impactful moment for me, and I am encouraged by what they’re doing, what the product is, and how it’s developing.”

How it Works

The Cionic Neural Sleeve analyzes, predicts, and augments a person’s movement. Using advanced algorithms, the system reads the signal sent from the brain to the muscles and can predict a person’s movement 1/10th of a second before their foot lifts off the ground.

The lower-leg Neural Sleeve uses a dense array of sensors to measure how the body is positioned and how individual muscles fire during movement, predicts intended movement by measuring the electrical signal from the brain, and then algorithms analyze this data in real time to determine optimal muscle activation patterns.

Cionic delivers Functional Electrical Stimulation to sequence proper muscle firing for natural movement. It is an adaptive system that provides real-time augmentation and adjustment of the participant’s movement, providing necessary assistance based on what can be measured of the participant’s neurological feedback that adjusts stimulation based on measured gait kinematics to optimize performance.

[Source(s): Cionic, Business Wire]

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