The product is an FDA-cleared Class II medical device.

If there is a category ripe for change, it is human mobility aids, which have seen very little true innovation during the centuries that they have been in use.

Devices such as crutches, walkers and wheelchairs provide important support, but fail to address the underlying neuromuscular system. Rather than helping to strengthen muscles and reinforce neuroplasticity, they can accelerate muscle weakness and a decline in community participation.

The founder knew that recent technological advances could power assistive technology that transcends simple data collection and analysis to potenital retrain the body over time, providing adaptive, real-time augmentation to improve mobility instantly.

In 2018, a company was founded in a garage by a father, someone who believed that there must be better options for his daughter's cerebral palsy diagnosis than crutches, walkers, and wheelchairs.

A technologist who has spent his career at the intersection of technology and the human body, he knew that the same technological advances powering innovation like self-driving cars and reusable rockets could be applied to people, in order to help the millions with mobility differences live more freely and independently.

The gap being filled by the product is one that allows users to not only regain mobility in the moment, but to potentially improve it by strengthening and retraining the body over time. The solution also enables individuals to wear the device as often as they like, to easily put it on and take it off themselves, and to control the device anytime and anywhere on their smartphone.

The Neural Sleeve is the first FDA-cleared product that combines the diagnostic power of a multi-million-dollar gait lab with the therapeutic power of Functional Electrical Stimulation, all delivered in a comfortable legging that combines function with form.

Packed inside the app-controlled sleeve is the breakthrough, proprietary Read+Write Neural Interface. The interface starts by measuring the neuromuscular system from the electrical signals being transmitted by the brain to the resulting kinematics of the body to predict movement in real time. Advanced algorithms precisely steer electrical current to activate individual muscles in perfect sequence.

The Neural Sleeve is the first assistive technology designed to look and feel like a regular garment, available in a range of colors and sizes to reflect individual preferences.

The product is the world’s first true bionic clothing; the first product to combine sensing, analysis, and augmentation into wearable technology. The lightweight leg-worn Neural Sleeve was created to improve mobility for people with foot drop and leg muscle weakness brought on by multiple sclerosis, stroke, cerebral palsy, and other conditions.

Movement is medicine, and that’s where the device excels.

The 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 signals from the brain, and, from there, leverages algorithms to analyze the data in real time to determine optimal muscle activation patterns.

Then, software delivers Functional Electrical Stimulation to the four major muscle groups of the leg to sequence proper muscle firing for natural movement. It is an adaptive system that provides real-time augmentation of the user’s movement, updating every single step.

The company conducted a multi-site study investigating the improvement in dorsiflexion and inversion during gait in people with foot drop due to neurological conditions.

Foot drop is a common symptom of multiple sclerosis (MS) and other conditions that limit an individual’s mobility. When subjects walked with stimulation provided by the product compared to walking without stimulation, ankle dorsiflexion at heel strike improved by an average of 5.2 degrees while ankle inversion during the swing phase of gait was reduced by an average of 3.6 degrees, bringing the ankle to a more neutral position for stabilization. During this study, 94 percent of users experienced improvements to foot clearance during walking.

In another survey, in addition to a reported improvement in mobility, the number of users experiencing moderate to severe pain was reduced by 60 percent, and those experiencing moderate to severe anxiety or depression was reduced by 75 percent.

Lack of mobility impacts nearly every aspect of daily life.

Most of us take for granted the ability to simply go for a walk, but for millions of people around the world, that activity is difficult, dangerous, and downright nerve-wracking.

With the support of its users, the company aims to bring bionic clothing to market so millions more people worldwide can move without limits.

If any category is ripe for change, it is human mobility aids, which have seen very little true innovation during the centuries that they have been in use.

Devices such as crutches, walkers and wheelchairs provide important support, but fail to address the underlying neuromuscular system. Rather than helping to strengthen muscles and reinforce neuroplasticity, they can accelerate muscle weakness and a decline in community participation.

The founder knew that recent technological advances could power assistive technology that transcends simple data collection and analysis to provide adaptive, real-time augmentation to improve mobility instantly, and potentially retrain the body over time.

The Neural Sleeve requires - and has received - authorization from the United State’s Food and Drug Administration. Now, because each state has different medical laws, the company is currently working with local licensure boards to secure state-level approval and has already received 60 percent state-level approval nationwide.

With more than 35 million Americans living with mobility impairment and more than 200 million more worldwide, the need for customizable, full-spectrum solutions is a growing necessity — particularly within our aging population. After all, as a gateway disease, when people lose the means to walk, other health problems emerge.