Neurostep^®

“This section is specifically intended for consultation ONLY by experts qualified by scientific training and experience allowing them to investigate the safety and efficacy of neuromodulation medical devices under investigation. Furthermore, the SOLE purpose of this section is to recruit potential qualified investigators for Neurostream’s clinical trials.”

Neurostep^®, a Fully Implantable Closed-Loop System for Patients Who Suffer from Foot Drop

The Neurostep^® is a neurostimulation investigational medical device incorporating our proprietary sensing, stimulation and advanced signal processing technologies. The entire system is designed to be implanted into the patient’s leg via a surgical procedure, during which electrodes are attached to the peripheral nerves responsible for sensing and stimulating the proper muscles that lift the foot during normal walking.

The Neurostep^® includes the Control Unit, two (2) Neurocuff™ electrodes, Gaitway™ software, and implant accessories. The Control Unit and electrodes are surgically implanted into the patient’s leg to sense key physical events and stimulate the muscles of the ankle flexing the foot upward.

Neurostream is proud to announce the ongoing development of the Neurostep^®, an implantable closed-loop neurostimulation investigational device designed for patients suffering from foot drop. The Neurostep^® has been engineered to integrate with the body’s natural sensing and stimulation network and designed to closely mimic specific functions that have been interrupted or lost due to disease or injury. The Neurostep^® combines our patented Bionized™ CLS platform with Neurocuff™ electrodes to create a closed-loop neurostimulation system for the peripheral nervous system.

Closed-Loop System – the Neurostep^® is surgically connected directly to the targeted nerves, which should establish a “closed loop” that is intended to provide greater mobility and more natural movements.

Once implanted into the patients leg, the battery-operated Neurostep^® Control Unit is  always “on”, which should allow it to sense key physical events, interpret them and stimulate specific muscles of the ankle, flexing the foot at the right time so the toes no longer drag across the ground.

Neurosensing Module with Bionized™ CLS

About the size of a cell phone, the Control Unit is the “brain” of the Neurostep^® that houses our patented Bionized™ CLS technology integrating three digital modules that are designed to work in concert to perform all the necessary functions of the system. These include the:

• Neurosensing Module: Receives nerve impulses, amplifies and filters them for interpretation;
• Real-Time Adaptive Control Module: Interrogates the signals and identifies specific physical events like heel strike or when the toes lift off the ground;
• Neurostimulation Module: Generates and delivers the optimal stimulation energy to the target nerve to activate the muscular contraction.

Surgical Implant Procedure and Setup During the Clinical Study

The entire Neurostep^® is implanted via a surgical procedure using general anesthesia. The surgeon begins by making a small incision in the back of the thigh, just above the knee, to gain access to the peroneal and tibial nerves. After which, a Neurocuff™ electrode will be placed around each nerve. These two electrodes are connected to the Neurostep^® Control Unit. The surgeon will then place the Control Unit with the attached Neurocuff™ electrodes into a “pocket” in the upper thigh region, between the skin and muscle, where the Control Unit can be easily accessed for wireless programming, data acquisition, magnetically turned “on” or “off” and future battery replacement. The last step is to close the surgical site. Following the recovery period, the patient will be brought to the clinic where their gait characteristics will be observed by the physician or trained technician, who will wirelessly program the device to optimize the sensing and stimulation parameters so as to produce the most natural gait possible.

Neurostep^® – A Fully Implantable Design

Neurostep^® proposes an implantable design, which means there are no external parts to don or doff or remove during certain daily activities, so it should always be “on” and ready to provide event sensing and stimulation energy at the right time. Also, since the Neurocuff™ electrodes are connected directly to the targeted nerves and not placed on the surface of the skin there is no chance for skin irritation, burns and need to periodically replace surface electrodes. The following table highlights the potential benefits of the Neurostep^® proprietary technology and design features.

Neurostep® Feature	Potential Patient Benefit
Fully Implantable	Always “on” or 24/7 system availability No external parts or sensors to don or doff Nothing to remove for activities such as bathing, swimming or sleeping
Bionized™ CLS Platform	Mimics the normal nerve sensing and stimulation Delivers treatment only when needed Utilizes advanced power (battery) management Advanced signal noise reduction Wireless programmability Internal memory collects data for future analysis Optional exercise mode can assist in building muscle mass and tone
Neurocuff™ Technology	Multiple chambers provide greater selectivity of nerve sensing and stimulation Cuff design accommodates temporary post-surgical nerve swelling Minimizes signal noise contamination and leakage

Important Notice

Please note that the Neurostep^® is an investigational medical device currently in clinical study, which means that the safety and efficacy of this device are still under investigation. The commercialization and distribution of this investigational medical device has not yet been approved in any country.

CAUTION: INVESTIGATIONAL DEVICE, LIMITED BY THE UNITED STATES FEDERAL LAW TO INVESTIGATIONAL USE.