Nalu Medical Releases “Haleakalā” Update, Extending Pulse Width Range and Unlocking the System’s Patient Activity Monitor


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With the introduction of a pulse width expanded to 2,000 microseconds, I now have one more tool to help address the short- and long-term pain relief needs of individual patients suffering from chronic intractable pain.

Nalu Medical (“NALU”) announces the “Haleakalā” update, substantially upgrading both the software and firmware of their award-winning Nalu Neurostimulation System. This update adds significant new capabilities for both spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS).

The update broadens the stimulation pulse width parameter to the widest range currently available in implantable SCS and PNS systems—up to 2,000 microseconds. The Nalu Neurostimulation System is optimized to utilize this energy-hungry parameter due to its external, wearable battery. This means that healthcare teams can program Nalu patients for their exact therapy needs without concern for depleting an implantable battery or accelerating the need for battery replacement surgery.

“Every patient’s pain is unique and having the ability to prescribe a wide range of stimulation options is significant,” said Robert M. Levy, MD, PhD of the Institute for Neuromodulation in Boca Raton, Florida. “Modulating stimulation pulse width has the potential to selectively recruit particular nerve fibers that could benefit patients with difficult to address pain patterns. With the introduction of a pulse width expanded to 2,000 microseconds, I now have one more tool to help address the short- and long-term pain relief needs of individual patients suffering from chronic intractable pain.”

The update also unlocks Activity Monitor 1.0, a patient activity monitoring capability that utilizes sensors built into the system’s Therapy Disc and stores a 30-day activity history viewable by both healthcare teams and patients.*

Dr. Aaron Calodney of Precision Spine Care in Tyler, TX and Past President of the American Society of Interventional Pain Physicians explains why this is important. “Activity monitoring reveals objective, measurable activity changes associated with patients’ daily lives away from the clinic, augmenting pain scores and self-reported changes in activity. It may help pain teams understand the impact of therapies beyond the pain score.”

Like a smartphone operating system, the Nalu Neurostimulation System can be updated with a simple download, enabling existing patients as well as new patients to benefit from current and future improvements to Nalu technology.

According to Earl Fender, CEO of Nalu, “We recognize that chronic pain is an ever-evolving condition for patients—and therefore healthcare teams need an ever-evolving toolset of treatment options and insights. This update is consistent with our commitment to continually empower patients with the latest technology and innovation. It is another significant upgrade of our award-winning Nalu Neurostimulation System that not only benefits new patients, but retroactively gives existing patients access to our newest engineering developments.”

*Any interpretations made from this information are not intended to replace traditional methods of diagnosis or treatment. The health care provider is not intended to interpret or take clinical action based on this output. It is for informational purposes only.

About Nalu Medical

Nalu is a Carlsbad, California-based medical technology company focused on developing and commercializing innovative and minimally invasive solutions for patients with chronic neuropathic pain. The Nalu Neurostimulation System delivers gentle electrical pulses to the nervous system to modulate pain signals to the brain. The Nalu system was designed to address major unmet needs in the treatment of chronic neuropathic pain and provide a differentiated value proposition for patients and physicians.

About the Nalu Neurostimulation System

The Nalu system consists of a fully-featured, battery-free, miniaturized implantable pulse generator (IPG) that is powered wirelessly by an externally worn Therapy Disc and controlled through a smartphone-based remote control app. Despite its small size, Nalu’s micro-IPG delivers treatment capabilities similar to larger IPGs as well as unique advantages associated with advanced waveforms, extensive programming options, exceptional upgradability, and an expected service life of 18 years. The Nalu Neurostimulation System is currently FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications. To learn more, visit http://nalumed.com.

Indications for Use

Spinal Cord Stimulation – The Nalu SCS system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (≤ 30 days) to determine efficacy before recommendation for a permanent (long term) device.

Peripheral Nerve Stimulation – The Nalu PNS system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Nalu Neurostimulation System for PNS is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (≤ 30 days) to determine efficacy before recommendation for a permanent (long term) device.

Nalu, the Nalu logo, nPower, and the ‘engineered to be more’ tagline are trademarks of Nalu Medical, Inc.

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