Both studies report on clinical outcomes related to the use of the Nalu proprietary, multidimensional Pulsed Stimulation Pattern (PSP) waveform

CARLSBAD, Calif. (PRWEB) January 5, 2023

Nalu Medical, Inc. (“Nalu”), a Carlsbad, California-based company that has successfully miniaturized neurostimulation implants for the management of chronic intractable pain for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications, announces the publication of two key studies in Neuromodulation: Technology at the Neural Interface. One publication discusses the potential mechanisms of action (MOAs) leveraged by a novel, multidimensional waveform Pulsed Stimulation Pattern (PSP) and the results of a pilot clinical study. The other publication reports on interim results from a first-in-human SCS clinical study evaluating the safety and performance of the Nalu Neurostimulation System, composed of a micro-implantable pulse generator (micro-IPG™) and a wearable Therapy Disc (power source and stimulation control).

Following are some highlights of the PSP pilot study report on the theory behind and design of the multidimensional PSP waveform along with pilot study results from 31 patients with chronic intractable pain:

• The PSP waveform is composed of three independently configurable temporal dimensions designed to target different MOAs.
• PSP yielded a greater reduction in both back and leg pain than traditional SCS (Back: -60% vs. -46%; Legs: -63% vs. -43%
• PSP yielded higher responder rates for both back and leg pain compared with traditional SCS (61% vs. 48% and 78% vs. 50%, respectively).

“Up until now, neurostimulation waveforms for SCS have been a ‘one-note proposition’ for pain relief. One waveform leverages one unique MOA, much like playing a single musical note,” said Dr. Mehul J. Desai, President and Medical Director of the International Spine Pain & Performance Center and lead author of the PSP pilot study publication. “Pulsed Stimulation Pattern is more like playing a musical chord. Multiple MOAs are leveraged simultaneously for multimechanistic therapeutic relief. This represents an exciting new era for SCS, where we may provide patients with ‘broad-spectrum’ relief that may address their evolving pain patterns over the long term.”

Following are some highlights of the first-in-human Nalu SCS clinical study report on the 90-day (three-month) outcomes of 22 subjects who chose the PSP waveform using the Nalu Neurostimulation System for treatment of chronic intractable leg and lower back pain:

• At the 90-days follow-up visit, the average pain reduction was 79% in the leg and 76% in the lower back compared with baseline.
• Responder rates (≥50% pain relief) at 90 days were 86% in leg pain and 81% in lower back pain.
• Subjects rated the external wearable power source “very comfortable” throughout the study period. 

“Fully implanted SCS systems are intuitively appealing, but they entail ongoing burdens to manage and risks to continually replace,” said Dr. John Salmon, pain medicine specialist at PainCare Perth and lead author of the first-in-human Nalu SCS clinical study publication. “The Nalu System defines a new standard for minimally invasive, lower-risk, and markedly more cost-effective neuromodulation treatment for a patient’s lifetime of managing chronic pain. Our study, and continued experience over more than three years to date, have demonstrated that patients respond favorably to a system with a tiny implant and a battery that may only need to be worn at intervals.”

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 before they get 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, the Nalu 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 System has been repeatedly recognized for its revolutionary technology, including being named as one of the world’s top 100 new products by R&D Magazine in 2021. It is FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications. To learn more, visit www.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 chronic intractable 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, micro-IPG, and the Nalu logo are trademarks of Nalu Medical, Inc.

Disclaimers

The specific parameters used in the commercial use of the Nalu Neurostimulation System have evolved over time and are now different from the early set of programming parameters used in these clinical studies.

Any medical opinions expressed are those of the physician/medical providers. Individual experiences and outcomes may vary.

Media Contact

Nalu Medical, Inc.
Jon Ruais
jon@nalumed.com
925-667-6329

Nalu Medical, Inc. gave the following five scientific presentations during the 2022 American Society of Pain and Neuroscience (ASPN) Annual Conference in Miami Beach, Florida. For more information, please reach out to the Nalu Medical team. 

Comparison of Outcomes in Australian and US Subjects Implanted with A Micro-IPG SCS System

Authors: MJ. Desai, S. Arulkumar, J. Salmon, P. Verrills, G. Heit, S. Kottalgi.

Affiliations: International Spine, Pain and Performance Center, Washington, D.C, USA; SSM Health, Pain Management, Oklahoma City, OK, USA. Pain Care Perth, Pain Management, Perth, Australia. Metro Pain Group, Pain Management, Melbourne, Australia. Department of Neurosurgery, Kaiser Permanente-The Permanente Medical Group (TPMG), Redwood City, CA, USA. Nalu Medical, Inc., Carlsbad, CA, USA.

Introduction

A battery-free, spinal cord stimulation (SCS) system with a micro-implantable pulse generator (micro-IPG) (Nalu Medical, Inc., Carlsbad, CA) delivers various therapy options (traditional tonic, proprietary Pulsed Stimulation Patterns (PSP), current steering, burst waveforms, multi-area programs, scheduled therapy, and combinations and paired therapies).

Methods

Two contemporaneous, prospective, multi-center clinical studies were initiated in the US (US nPower) and Australia (AUS-FIH) to evaluate the micro-IPG SCS system in subjects with chronic pain of the leg(s) and/or low back. Both studies had similar eligibility criteria and included a Visual Analog Scale (VAS) to record pain as an endpoint. Per each protocol, following consent, data including VAS, was obtained at baseline and 3-month post-activation of the permanent implant. Both studies were conducted per applicable local guidelines with approval from Ethics Committees.

Results

To-date, 3-month data is available on a total of 46 subjects, 24 in Australia and 22 in US. Concordant outcomes were noted in responder rates (percentage of subjects with ≥ 50% pain relief from baseline to 3-months) (AUS=83% [20/24], US=86% [19/22]) and improvement in VAS scores (AUS=78%, US=77%), in the leg(s).  Similar agreement in improvement in VAS for lower back (AUS=73%, US=80%) was noted, while the US study showed a better responder rate (AUS=70% [16/23], US=87% [20/23]; 1 patient had no back pain at baseline in AUS). Both studies had no reports of pocket pain nor serious adverse device effects. A majority of patients in both studies used some form of PSP (PSP alone, scheduled, layered with tonic), even though they were each provided a choice of many therapy options.   Both studies showed improvements in patient reported functional outcomes. The Beck’s Depression Inventory showed a 48% improvement in the Australia cohort, while the US subjects showed a 78% improvement, at 3-months. The Oswestry Disability Index showed a similar trend, with subjects in Australia reporting a 38% improvement compared to the 55% improvement seen in the US study.   In addition, the reported average comfort scores were <1, on a 0-11 Likert scale with 0= Very Comfortable and 10=Very Uncomfortable, in both Australia and US subjects.

Conclusions

While this is not a formal meta-analysis, the similar outcomes of the two studies conducted in culturally and geographically diverse populations, may provide some indication of consistency of results.  Data from two studies indicate that use of the micro-IPG system, with its multiple therapy options, may produce significant reductions in pain. Both studies are ongoing and additional investigation is warranted to confirm these findings.

Two-Year Results of an Externally Powered, Micro-implantable Spinal Cord Stimulator For Treatment Of Chronic Pain

Authors: Bates, MBBS; Verrills, MBBS; Salmon MBBS; Yu, MD; Mitchell, MBBS; Du Toit, MBChB; Green, BMBS; Taverner, MBBS;  Mohabbati, MD; Peter Staats, MD; Gary Heit, PhD, MD; Levy MD, PhD; Kottalgi

Affiliations: Metro Pain Group, Pain Management, Melbourne, Australia. Pain Care Perth, Pain Management, Perth, Australia. Sydney Spine and Pain, Pain Management, Sydney, Australia. Pain Medicine of South Australia, Pain management, Adelaide, Australia. Frankston Pain Management, Pain Management, Frankston, Australia. Sydney Pain Management Centre, Pain Management, Sydney, Australia. Premier Pain Centers, Shrewsbury, NJ USA. Department of Neurosurgery, Kaiser Permanente-The Permanente Medical Group (TPMG), Redwood City, CA, USA. Institute for Neuromodulation, Neurosurgery, Boca Raton, FL USA. Nalu Medical, Carlsbad, CA, USA.

Introduction

A spinal cord stimulation (SCS) system with a battery-free micro-implantable pulse generator (micro-IPG; Nalu Medical, Inc. CA, USA) is available for the treatment of intractable chronic pain. The system utilizes an external power source that bi-directionally communicates with the micro-IPG (~1.5 cc volume).

Methods

A prospective, multi-center clinical study was initiated to confirm the safety and performance of this system, in the treatment of intractable pain of the trunk and/or limb(s). Specifically, subjects with leg(s) and/or back pain, meeting eligibility criteria were recruited and consented into the study. Subjects underwent a SCS trial utilizing a menu of therapy options, including tonic and the Pulsed Stimulation Pattern (PSP) therapy. Eligible subjects received the permanent implant and were followed at pre-determined timepoints. This abstract reports on the 2-year pain relief and functional outcomes (depression, activities of daily living, overall change in quality of life). The study was approved by an independent Ethics Committee and conducted in compliance with local regulations.

Results

Twenty-one (21) subjects have completed 2-years of device use in this ongoing study. Due to COVID restrictions and other comorbidities, NRS pain diary and/or questionnaire data was not reported by 5 of the 21 subjects. In the remaining 16 subjects, leg(s) pain decreased from an average of 6.7 ± 1.3 at baseline to 0.8 ± 0.9 at 2-years; similarly, low back pain decreased from an average of 6.9 ± 1.2, at baseline, to 1.8 ± 1.8 at 2-years. The average percent pain reduction was 86% in the leg and 70% in the back, from baseline to this time point.  The responder rate (≥50% pain relief from baseline) was 94% (15/16) in the leg and 73% (11/15) in the back. Of note, 81% (13/15) subjects with leg(s) pain were high-responders (≥ 80% pain-relief). The Beck’s Depression Inventory (BDI) and Oswestry Disability Index, both showed a 45% improvement from screening to 2-years. Ninety-four percent (94%; 17/18) of subjects indicated “very much improved” or “much improved” on the Patient Global Impression of Change.

Conclusions

These results continue to demonstrate the favorable long-term performance of this battery-free, externally powered micro-implantable SCS system.  Further investigation is warranted to confirm these preliminary findings.

Real-World Survey of Chronic Pain Patients with a micro-IPG System and External Wearable Battery Source

Authors: J. Lefkovitz; J. Ruais, S Kottalgi, P. Martin

Affiliations: Nalu Medical Inc., Carlsbad, CA, USA.

Introduction

Nerve stimulation to treat pain was first mentioned in the literature in the 1960s.  Technical advancements have allowed for the miniaturization of fully featured implantable pulse generators to less than 2cc in volume. A novel neuromodulation system with a micro-implantable pulse generator (micro-IPG) and external, wearable battery source (Nalu Medical, Inc., Carlsbad, CA) has FDA 510k clearances for spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS). This micro-IPG system has options for multiple electrodes, bi-directional communication, and advanced programming options.

This is the first report of a large-scale real-world survey to collect patient reported outcome data on system use compliance, pain response, and functional improvement in micro-IPG patients.

Methods

One hundred eighty-five (185) subjects with either SCS or PNS micro-IPG implants were consented.  Surveys were then administered via a secure and HIPAA compliant survey portal. Subjects answered standardized questions regarding the amount of pain relief achieved, changes in their level of activities, emotional status, overall quality of life, compliance in following wear instructions and general satisfaction with the therapy device.

Results

185 patients were consented and entered into the database.

• 85.3% (157/184*) reported an improvement to their overall function. (*one subject did not answer this question)
• 83.8% (155/185) reported moderate to great improvement in change in activity limitations, emotions, and overall quality of life.
• 88.6% (164/185) of respondents reported ≥50% pain relief and/or moderate to great deal improvement in overall quality of life.
• 80.5% (149/185) of respondents reported that they wear the Therapy Disc, external battery, for a majority of the day.

Conclusions

The real-world patient reported outcome data suggests that use of the micro-IPG can significantly reduce pain, improve activity levels, and improve quality of life scores in a majority of patients. The data indicates that wearing the external battery does not interfere with the reported improvements in pain reduction and function. These promising results warrant further investigation.

Novel implementation of a 3-axis microelectromechanical system (MEMS) accelerometer within a wearable device for objective functional improvement measurement

Authors: Valimahomed, MD, FAAPMR; L. Mishra; K. King; M. Graves; A. Ding; C. Linden

Affiliations: Gramercy Pain Center, Red Bank, NJ, USA;  Nalu Medical Inc., Carlsbad, CA, USA.

Introduction 

Functional improvement data presents an additional tool to understand and communicate progress for pain patients.  A neuromodulation system with an external wearable component (Nalu Medical, Inc. CA, USA) incorporates a 3-axis MEMS accelerometer which may be activated to monitor and record activity during use.

Activity is categorized into three discreet groups (sedentary, walking, running) via a custom algorithm and then presented within an activity report representing objective functional improvement information.

Methods

A validation effort was performed to qualify the hardware and refine the algorithm to accurately capture user activity.  The accelerometer was configured such that it collects data at 50 Hz, where a ‘sample’ is an X, Y, and Z reading.  The X, Y, and Z values are 10-bit resolution numbers which each map to a range of -4 g to +4 g.  These inputs are read in another pass of the data to find the number and type of impacts seen in the set.  This impact information is then used to update the current activity level of the patient.

Initially, six unique data sets were used to validate the model: Sample 1 – Stand, Medium Walk, Medium Jog, Medium Walk; Sample 2 – Fast Walk, Slow Jog, Stand, Sprint, Slow Walk; Sample 3 – Fast Walk, Slow Jog, Stand, Sprint, Slow Walk; Sample 4 – Medium Uphill Walk, Medium Downhill Run, Stand, Medium Uphill Run, Medium Downhill Walk; Sample 5 – Medium Treadmill Walk, Medium Treadmill Run, Stand, Medium Indoor Walk, Medium Indoor Stairs Walk; Sample 6 – Medium Treadmill Walk, Medium Treadmill Run, Stand, Medium Walk, Medium Run.

Subsequently, six adult participants wore a production version of the device for a multi-day comparison of reported activity versus device captured and categorized activity.

Results

The model correctly categorized all extended duration activities across all data sets.  The largest challenges involved accurately assigning the data logged during the delay between an activity being started and its classification as that activity and transitions between activity types. This is due to the activity level requiring a certain number of consecutive periodic impacts before updating.  However, occasional missed impacts are handled gracefully and do not commonly trigger false transitions to “sedentary”.  The participant evaluation yielded acceptable alignment between reported and captured activities.  Any perceived inaccuracies were not widespread or focused in scope, and were not enough to make the participants feel that their activity was being unreasonably represented.

Conclusions

Validation efforts demonstrated system capability and accuracy in activity characterization across time and type.  Activity measurement provides an additional metric for the evaluation of functional improvement for pain patients not susceptible to the subjective nature of commonly used self-reported data and may represent a useful assessment of progress.

First Results of a Real-World Survey of Patients Receiving Peripheral Nerve Stimulation to Treat Neuropathic Pain

Authors: J. Lefkovitz; J. Ruais, S Kottalgi, P. Martin

Affiliations: Nalu Medical Inc., Carlsbad, CA, USA.

Introduction

Peripheral nerve stimulation (PNS) is a well-established modality to treat severe intractable chronic pain of peripheral nerve origin. A novel neuromodulation system with a micro-implantable pulse generator (micro-IPG) and external, wearable battery source (Nalu Medical, Inc., Carlsbad, CA) has US market clearance for PNS and spinal cord stimulation (SCS) applications. This micro-IPG system has significant therapy options, with multiple electrodes, bi-directional communication, and advanced programming options. This is the first report of a large-scale survey of micro-IPG patients for PNS treatment of chronic pain.

Methods

One hundred ninety-eight (198) subjects with PNS implants provided consent to provide their clinical data to be housed in a company sponsored, secure, and controlled database; patients also agreed to be contacted by company representatives for telephonic follow up. Patient information was entered into the database through a secure web-based portal. Employees of the company contacted the patients for follow ups, and to collect data and resolve errors/omissions. Patients were asked a series of questions related to their pain profiles, quality of life, and overall satisfaction with therapy at various time points post implant of their micro-IPG system. The data collection is ongoing and will continue to house all commercial patients.

Results

• PNS therapy was used to treat thirty-eight (38) different nerve targets/nerve combinations. The top targets were legs (29%), trunk (26%), shoulder ( 20%), foot (8%), arm (3%), and hip (2%).
• 87% of all PNS patients had a successful treatment (defined as ≥50% pain relief), with an average pain relief across all patients of 70%.
• 36% of all PNS patients were high responders (defined as ≥80% pain relief).

Conclusions

This data is capturing real-world patient reported outcomes following permanent implant of a micro-IPG PNS system. Limitations of this survey include a small sample size and the use of non-validated instruments to capture patient reported outcomes; this will be addressed through an updated, recently implemented survey. This data indicates that PNS therapy delivered by a micro-IPG system can produce pain relief and improvement in general quality of life in most patients at a level usually associated with the SCS literature. A registry will be implemented to further the study of these positive results in a larger population.

Nalu Medical, Inc. (“Nalu”), a private company focused on innovative and minimally invasive solutions for chronic neuropathic pain, announced today that the Board of Directors has appointed Thomas “Tom” West as President and Chief Executive Officer.

This leadership appointment is effective on August 8^th and follows the decision by Earl Fender, Nalu’s current CEO, to retire. Mr. Fender will remain as a consultant to the company for the next 12 months.

Mr. West remarked, “I am very excited and honored to be leading Nalu. I believe Nalu’s unique system and technology, including the miniaturized, battery-free implantable pulse generator with its broad capabilities, upgradability and industry leading longevity are going to meaningfully expand the number of chronic pain patients who can benefit from both Spinal Cord and Peripheral Nerve Stimulation. Nalu is poised for rapid growth, and I am eager to join the company and to build upon the strong foundation it has established.”

Mr. Fender added, “I am proud of the Nalu team and what we have accomplished to date. The company is in a strong position and the timing is right for me to retire. We are very fortunate to have someone of Tom’s caliber joining the team. Tom has a proven track record of leading and building strong teams during high periods of growth. He has more than 30 years of medical device leadership experience, including as Division President, Diagnostic Solutions at Hologic, and most recently as the President and CEO of Intersect ENT (NASDAQ: XENT) prior to its recent sale to Medtronic. Tom began his healthcare career at Johnson & Johnson and serves as an independent member of the board of directors at Orthofix. He is very focused on customers and clinical outcomes, which are at the heart of Nalu’s success.”

Speaking on behalf of the Board, its Chairman, Geoff Pardo, said, “we are very grateful for Earl’s leadership, particularly in leading the recent $104M equity financing and establishing a strong foundation for the company’s continued growth. We wish him well in his retirement. The Board is very excited that Tom has joined the company. He is a visionary leader and we believe his commercial and operational skills and experience are what Nalu needs for its next phase of growth.”

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 before they get 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^TM 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 System has been repeatedly recognized for its revolutionary technology, including being named as one of the world’s top 100 new products by R&D Magazine in 2021. It is FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications. To learn more, visit www.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, micro-IPG and the Nalu logo are trademarks of Nalu Medical, Inc.

CARLSBAD, Calif. (PRWEB) February 24, 2022

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.

CARLSBAD, Calif. (PRWEB) February 17, 2022

Nalu Medical, Inc. (“Nalu”), a private company focused on innovative and minimally invasive solutions for chronic neuropathic pain, announced today the completion of a $104 million equity financing. The round was led by new investors, MVM Partners and Gilde Healthcare. Also participating in this round were new investors Pura Vida Investments and Aperture Venture Partners, as well as existing investors, Advent Life Sciences, Decheng Capital, Endeavour Vision, and Longitude Capital. The proceeds from this financing are intended to be used for scaling commercial operations to accelerate growth, continued expansion of clinical evidence, and continuing product development, in addition to other general corporate purposes.

“Chronic pain causes suffering to millions and can be addressed by targeted, non-addictive therapy. Nalu is uniquely positioned to meet this medical need by providing a patient friendly, neurostimulation technology and MVM is excited to support its continued growth,” said Hugo Harrod, a partner with MVM Partners, who joins Nalu’s Board of Directors. “We believe Nalu’s technology is one of the most advanced on the market, with huge potential to meet the needs of more patients,” said Geoff Pardo of Gilde Healthcare, who is also joining the Board of Directors.

“This additional funding underscores the potential of Nalu’s miniaturized technology and will allow us to accelerate the already strong adoption of our system,” said Earl Fender, President and CEO of Nalu. “We welcome the addition of new top-tier investors and appreciate the continued support of our current investors, who share our mission of commercializing innovative and minimally invasive solutions that make meaningful differences to people suffering from chronic pain.”

J.P. Morgan served as placement agent to Nalu for this transaction.

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 and the Nalu logo are trademarks of Nalu Medical, Inc.

CARLSBAD, Calif. (PRWEB) December 1, 2021

Nalu Medical, Inc. (“Nalu”) is named the R&D 100 Award winner for IT/Electrical technology. For nearly 60 years, the coveted R&D 100 Awards have recognized new products for their technological significance in industry sectors spanning telecommunications, high-energy physics, software, manufacturing, and biotechnology. This is the fourth major award^1,2,3 recognizing Nalu for its innovative micro-technology.

Nalu is a California-based company with miniaturized, commercially available neurostimulation implants for chronic intractable pain management. Nalu’s miniature implantable pulse generator (IPG) is 27 times smaller than the largest commercially available IPGs. Accordingly, Nalu describes it as a mIPG^™. Despite its small size, Nalu’s mIPG delivers treatment outputs similar to larger IPGs, but with additional capabilities around advanced waveforms, programming modes, upgradability and an expected service life of 18 years.

“We are grateful to be recognized by R&D World for the important value and innovative technology of the Nalu mIPG,” said Earl Fender, President and CEO of Nalu Medical, Inc. “The Nalu system is bringing novel technology enhancements to the field of neuromodulation. We are pleased this is not only evident to technology experts, but is also making an impact in the lives of many patients now receiving pain management treatment with our system.”

About the R&D 100 Awards

Continuing a tradition begun in 1963, R&D World magazine identifies the 100 most technologically significant products and advancements each year. The R&D 100 is the only science and technology awards competition that recognizes the technological significance of new commercial products, technologies, and materials that are available for sale or license. The R&D 100 Awards have long been a benchmark of excellence for industry sectors as diverse as telecommunications, high-energy physics, software, manufacturing, and biotechnology. Other 2021 winners include Sandia National Laboratories, Oak Ridge National Laboratory, Los Alamos National Laboratory, Argonne National Laboratory, MIT Lincoln Laboratory, E.I. DuPont de Nemours, Thermo Fisher Scientific, Lawrence Livermore National Laboratory, and UVL Robotics.

About Nalu Medical

Nalu is a 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 neurostimulation 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 proprietary Nalu neurostimulation system consists of a fully-featured, battery-free, miniaturized IPG (implantable pulse generator) that is powered by an externally worn Therapy Disc and controlled through a smartphone-based remote control app. The proprietary nPower^™microchip provides a broad menu of programmable therapy options. 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, mIPG and nPower are trademarks of Nalu Medical, Inc.

References:

1. 2021 Medical Design Excellence Awards (MDEA) Gold Winner – Implant and Tissue-Replacement Device Category
2. 2021 Medtech Visionaries Award for Best Medical Device in the Field of Neurology
3. 2021 Medtech Visionaries Award for Best MedTech Company in the Field of Neurology

CARLSBAD, Calif.  (PRWEB) November 2, 2021

CARLSBAD, Calif.  (PRWEB) October 20, 2021

CARLSBAD, Calif.  (PRWEB) July 15, 2021

Oral presentations include:

Novel SCS Waveform Produces Significant Improvements and High Responders (AUS nPower™ study)

• Session: Spinal Cord Stimulation Waveform and Energy Profile
• Presenter: Peter Staats, MD, MBA¹
• When: Friday, July 16, 7:30 am – 7:40 am (EDT)

Comfort and Compliance with an External Wearable Component of a Novel, Battery-Free, Micro-Implantable Spinal Cord Stimulator (AUS nPower™ study)

• Session: Novel Applications of Neuromodulation
• Presenter: Peter Staats, MD, MBA
• When: Saturday, July 17, 6:50 am – 7:00am

Long-term Results of a Prospective, Multi-Center Trial with a Novel, Battery-Free, Micro-implantable Neurostimulator for SCS (AUS nPower™ study)

• Session: Other Applications of Neuromodulation
• Presenter: Robert Levy, MD, PhD¹
• When: Saturday, July 17, 7:30 am – 7:40 am

“We are excited the 12-month results from our nPower Australia study will be presented at the 2021 NANS Mid-Year Meeting,” Commented Earl Fender, CEO of Nalu Medical.  “We look forward to Drs. Levy and Staats providing insight into the Nalu System’s longer-term data on pain relief, high responder rates and the comfort of the wearable Therapy Disc.”

About Nalu Medical 

We are a medical technology company focused on developing and commercializing innovative and minimally invasivesolutions for patients with chronic neuropathic pain. Our Nalu Neurostimulation System, or Nalu System, delivers gentle electrical pulses to the nervous system to modulate pain signals to the brain. We designed our Nalu System 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

Our proprietary Nalu system consists of a fully-featured, battery-free, miniaturized IPG (Implantable Pulse Generator), which is powered by an externally worn Therapy Disc and controlled through a smartphone-based remote control app. Our proprietary nPower^TM microchip provides a broad menu of programmable therapy options. The Nalu Neurostimulation System is 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 Neurostimulation System for SCS 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 (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

Peripheral Nerve Stimulation – The Nalu Neurostimulation System for PNS 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 (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

Nalu, the Nalu logo and nPower are trademarks of Nalu Medical, Inc.

1. Paid consultant of Nalu Medical, Inc.