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May Edition 2023

Nalu Medical, Inc. – Giving patients more options for managing intractable chronic pain

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Nalu Medical, Inc. is a privately held commercial medical device company based in Carlsbad, California. The Nalu neurostimulation system is a battery-free, micro-implantable pulse generator (iPG) currently cleared by the FDA for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) for mitigating chronic pain. The system is highly capable and easily upgradeable, providing a menu of therapy options.

Peripheral Nerve Stimulation

Nalu peripheral nerve stimulation may finally offer a long-term solution for your chronic pain. Peripheral nerve stimulation (PNS) is a drug-free pain management approach that uses mild electrical impulses to block pain signals from various parts of your body before they get to your brain. With the Nalu system, most patients will not be aware of these electrical impulses. A small percentage of patients may feel a gentle tingling sensation called paresthesia. Thin wires, called leads, are placed under the skin near the nerves that are associated with the pain and an implantable pulse generator (IPG) is placed under the skin and connected to the leads to provide the electrical impulses.

You can think of each of your nerves as a single-line telephone that can only carry one conversation at a time.  Since the leads are already sending a signal to the brain through the nerves that normally carry the pain signal, the line is busy and the pain signal does not get to the brain. As long as the stimulation signal is on the line, the pain signal cannot get through. Peripheral nerve stimulation may relieve several types of pain throughout the body.

How you’ll “test drive” the system

Once your physician decides that Nalu peripheral nerve stimulation may be right for you, you can try the system on a temporary basis before you commit to it.

Step 1: Wear Experience

The purpose of the wear experience is to make sure you are comfortable with Nalu wearables and feel what it would be like to live with the peripheral nerve stimulator system on a daily basis. During this assessment period, you will wear an adhesive clip and non-functioning Therapy Disc in various positions for up to 14 days to determine the best location of the Therapy Disc and IPG for your anatomy and lifestyle.

Step 2: Therapy Trial

To begin the trial, you will undergo a small surgical procedure to place thin wires (leads) near the nerve(s) identified by your physician and connect them to an external stimulator. During the therapy trial period, you and your physician will evaluate the amount of your pain relief and improvements in sleep and daily activities. After the therapy trial, the wires will be removed and you and your physician will decide if Nalu peripheral nerve stimulation is appropriate for you.

Step 3: Permanent Implant

If Steps 1 and 2 are successful, your physician will perform a minimally invasive surgical procedure to place permanent leads (1 or 2) and the Nalu micro-IPG in the optimal location for your specific pain. Your physician’s prescribed therapy will be programmed into the Nalu system and you will be trained on how to control your peripheral nerve stimulator through the remote control app on your smartphone.

Step 4: Life Resumed

You will work with your physician and the Nalu support team to optimize your Nalu peripheral nerve stimulator and manage your chronic pain. With pain relief, you may be able to resume activities (work, family, travel, etc.) that were previously too painful to enjoy.

Neurostimulation

Chronic pain in the back or legs can be hard to treat. Even therapies that seem to work can stop working after a while. The Nalu Neurostimulation System for spinal cord stimulation may finally deliver the long-term relief you’ve been looking for. They identified the challenges and shortcomings of other stimulation systems and created a system that can offer patients a more livable alternative. To do that, they engineered a novel system based on proprietary advanced micro-electronics. Their system is considerably smaller than other neurostimulation systems and a lot easier to manage. You may find that it’s the pain solution you’ve been hoping for.

You can think of each of your nerves as a single-line telephone that can only carry one conversation at a time. Since the leads are already sending a signal to the brain through the nerves that normally carry the pain signal, the line is busy and the pain signal does not get to the brain. As long as the stimulation signal is on the line, the pain signal cannot get through. By stimulating the spinal cord, pain signals coming from several areas of the body can be blocked. Leads are placed above the spinal cord and the IPG is typically placed in the lower back or abdomen area. Spinal cord stimulation may relieve several types of pain, including pain in the legs, arm, and back.

Thomas A. West | President & Chief Executive Officer

Mr. West has served as the President and Chief Executive Officer and as a member of the board of directors since August 2022. Prior to joining Nalu, Mr. West served from 2019 to 2022 as President, Chief Executive Officer and Director at Intersect ENT, Inc., a publicly-traded medical device and drug delivery company. Intersect was acquired by Medtronic in May of 2022. Prior to Intersect, he served as Worldwide President, Diagnostic Solutions at Hologic from 2015 to 2019. He began his healthcare career at Johnson & Johnson where he assumed roles of increasing responsibility over a twenty-three year tenure including Worldwide President of Strategy and Business Development for the J&J Family of Diabetes Solutions Companies, Division President of LifeScan North America and Division President of LifeScan EMEA. He also currently serves as an independent member of the Board of Directors of Orthofix, a role he took on in 2021.

Mr. West received a B.A. in Politics and Economics from Princeton University and an M.B.A. from the University of Pennsylvania, Wharton School.

"Our team of seasoned entrepreneurs, engineers and scientists have developed the next generation of medical devices.  Our novel devices address a number of poorly treated clinical conditions."

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