• B Capital invests incremental $20M; previously raised $65M led by Novo Holdings with participation from existing investors

• Equity investment to advance treatment for chronic neuropathic pain, accelerate commercial growth, and expand clinical and health-economic evidence for the innovative Nalu Neurostimulation System

CARLSBAD, Calif (BUSINESS WIRE) March 5, 2024

Nalu Medical, Inc. (Nalu), a private company focused on innovative, minimally invasive, and non-pharmacologic solutions for chronic neuropathic pain, announced today the closing of an incremental $20M in equity financing from new investor B Capital, bringing the total Series E round of equity investment to $85M. Series E was led by Novo Holdings (Novo) with $65M of the total closing in late-December 2023. Also participating in the round were all existing significant investors: Gilde Healthcare, MVM Partners, Endeavour Vision, Decheng Capital, Longitude Capital, Advent Life Sciences, Pura Vida, and Aperture Venture Partners.

“The Nalu Team is committed to addressing the unmet needs of patients suffering from chronic intractable neuropathic pain. We believe that our highly capable technology and uniquely small implant will elevate the standard of care in peripheral nerve stimulation (PNS) while being disruptive to the established spinal cord stimulation (SCS) market,” said Tom West, President and CEO of Nalu. “We are proud that our efforts serve the greater well-being of patients who suffer from chronic pain, and we are grateful for B Capital’s support in fulfilling and accelerating our mission.”

“The unique, clinically proven Nalu Neurostimulation System has the potential to address the unmet needs of millions who suffer from chronic neuropathic pain,” said Dr. Robert Mittendorff, Head of Healthcare and General Partner at B Capital. “We look forward to partnering with Nalu’s talented management team and strong syndicate of investors at a time of high revenue growth and potential for the company.”

The proceeds from this financing will be used to accelerate commercial growth, expand clinical and health-economic evidence, continue product development, and scale operations. Nalu will continue to invest in building clinical data that provide physicians with clear evidence of its benefits while also serving as the basis for expanded access and payor coverage.

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, the Nalu logo, and micro-IPG are trademarks of Nalu Medical, Inc.

About B Capital

B Capital is a multi-stage global investment firm that partners with extraordinary entrepreneurs to shape the future through technology. With $6+ billion in assets under management across multiple funds, the firm focuses on seed to late-stage venture growth investments, primarily in the enterprise, financial technology, and healthcare sectors. Founded in 2015, B Capital leverages an integrated team across nine locations in the US and Asia, as well as a strategic partnership with BCG, to provide the value-added support entrepreneurs need to scale fast and efficiently, expand into new markets, and build exceptional companies. For more information, visit www.b.capital.

Media Contact

Nalu Medical, Inc.
Jon Ruais
jon@nalumed.com

CARLSBAD, Calif (BUSINESS WIRE) January 23, 2024

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, presented interim data from the landmark COMFORT randomized controlled trial (RCT) at the 2024 North American Neuromodulation Society (NANS) Annual Meeting in Las Vegas, Nevada.

The ongoing COMFORT RCT is a randomized, controlled, post-market, open-label, minimal risk, multi-center clinical study focused on evaluating the effectiveness of peripheral nerve stimulation (PNS) therapy with the Nalu Neurostimulation System to treat chronic pain in the shoulder, low back, knee, or ankle/foot. The study is designed to develop 3-year data to demonstrate the sustained pain relief and quality of life improvements achievable with the Nalu PNS system.

Interim 12-month pain relief data¹

• 87% of subjects were responders (≥50% pain relief)
• 73% average pain reduction

Holistic outcomes at 3 months²

According to Dr. John Hatheway, first author and presenter of the oral report, “Clinicians recognize the value of combining pain relief with functional outcomes to provide a more comprehensive assessment of device effectiveness in treating chronic, intractable pain. In the COMFORT RCT, we are measuring variables that present this broader picture. Results show that the Nalu PNS System is truly unique. For the first time, clinicians have access to advanced technology that enables us to offer effective long-term therapy to a broader range of patients.”

Highlights of the presentation include the following:

• 98% of subjects using Nalu PNS experienced ≥ 50% pain relief and/or reported improvement compared to 21% of the subjects who did not use Nalu PNS (p<0.001).
• 93% of subjects using Nalu PNS experienced ≥50% pain relief and/or reduced disability compared to 35% who did not use Nalu PNS (p<0.001).

“We are thrilled to see such promising results from our advanced micro-IPG in a rigorous RCT setting,” said Tom West, Nalu CEO. “The COMFORT RCT is intended to provide reliable evidence of the sustained effectiveness and impact on quality of life provided by Nalu PNS therapy and to expand the use of Nalu PNS to patients for whom physicians have limited options. Our approach to this research underscores our commitment to take a leadership role in generating evidence for continued and extended application of effective PNS therapy for chronic pain sufferers.”

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, the Nalu logo, and micro-IPG are trademarks of Nalu Medical, Inc.

Media Contact

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

1. Engel M, Song J, Guttierez G, et al. A report on interim long-term pain outcomes from the COMFORT PNS RCT. Presented at: North American Neuromodulation Society (NANS); January 18-21, 2024; Las Vegas, NV.
2. Hatheway J, Hersel A, Song J, et al. Composite (combined) outcomes from the COMFORT PNS RCT. Presented at: North American Neuromodulation Society (NANS); January 18-21, 2024; Las Vegas, NV.

• Proceeds will accelerate commercial growth and expand clinical and health-economic evidence for the innovative Nalu neurostimulation system featuring the revolutionary micro-IPG.™

• Series E round led by Novo Holdings and joined by all existing significant investors.

CARLSBAD, Calif (BUSINESS WIRE) January 3, 2024

Nalu Medical Inc. (Nalu), a private company focused on innovative, minimally invasive, and non-opioid solutions for chronic neuropathic pain, announced today the closing of a $65 million equity financing. The round was led by a new investor, Novo Holdings (Novo). Also participating in the round were all of the Nalu existing significant investors: Gilde Healthcare, MVM Partners, Endeavor Vision, Decheng Capital, Longitude Capital, Advent Life Sciences, Pura Vida, and Aperture Venture Partners. The proceeds from this financing will be used to accelerate commercial growth, expand clinical and health-economic evidence, continue product development, and scale operations.

“The Nalu Team is excited about meaningfully expanding and improving the treatment options in the peripheral nerve pain space by setting a new standard of care while also offering a disruptive, minimally invasive, solution in the established spinal cord stimulation market,” said Tom West, President, and CEO of Nalu. “We continue to invest in building clinical data to expand access for patients who often don’t have other therapeutic options. We are proud that our efforts serve the greater well-being of patients who suffer from chronic pain and benefit those that care for them.”

“The differentiated Nalu neurostimulation product has the potential to benefit millions of patients suffering from chronic neuropathic pain,” said Eric Snyder, partner in the Venture Investments team at Novo Holdings. “We are impressed with their growing body of clinical evidence demonstrating meaningful clinical results in both the emerging market for peripheral nerve stimulation (PNS) and in the established market of spinal cord stimulation (SCS). We are delighted to support the strong management team at Nalu in this period of rapid commercial growth.”

“Nalu has made tremendous strides commercially and clinically in the past two years. Novo’s investment in Nalu reflects that progress and the confidence they share in the strong commercial potential for Nalu,” observed Geoff Pardo of Gilde Healthcare and Chairman of the Nalu Board.

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, the Nalu logo, and micro-IPG are trademarks of Nalu Medical, Inc.

About Novo Holdings

Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.

Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novozymes A/S and manages an investment portfolio, with a long-term return perspective. Novo Holdings is a world-leading life sciences investor. In the U.S. Novo Holdings operates through its wholly owned subsidiary Novo Holdings US, Inc. Through its Seeds, Venture, Growth, and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development.

www.novoholdings.dk

Media Contact

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

CARLSBAD, Calif (BUSINESS WIRE) November 29, 2023

Nalu Medical, Inc (“Nalu”) is a Carlsbad, California-based company that has successfully miniaturized neurostimulation implants for the management of chronic intractable pain across a variety of targets with both spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) indications. Today the company announces publication of the SCS nPower™ US clinical study in the Pain Physician Journal that reports on clinical outcomes related to the use of the Nalu SCS System to treat patients suffering from chronic intractable pain of the of trunk and/or limbs, including unilateral or bilateral pain.

The SCS nPower US clinical study was a prospective, post-market observational study conducted at 15 comprehensive pain centers in the US. The Nalu Neurostimulation System was evaluated in 35 subjects with chronic low back and leg pain from baseline to 3 months. Highlights of the results include:

• 86% of subjects were “responders” (≥50% pain relief) in the low back and leg(s).
• 54% of subjects in the low back and 49% in the leg(s) were “high responders” (≥80% pain relief).
• 75% average pain reduction in the low back and 76% in the leg(s).
• The wearable Therapy Disc was reported by all patients to be comfortable and easy to use.
• Secondary endpoints regarding sleep, mood, functional disability, and quality of life all demonstrated statistically significant outcomes at 3 months compared with baseline.

According to lead author, Dr. Mehul Desai, “This study demonstrates best-in-class pain outcomes with the added benefit of a battery-free implant and minimally invasive procedure substantiated by a small, 1.5 cm incision. In addition to pain reduction, patients reported holistic improvements that may be attributed to the unique multi-dimensional waveform that potentially addresses up to 6 mechanisms of action simultaneously.”

“Tom West, Nalu CEO, said, “In addition to strong clinical outcomes, the Nalu SCS System offers interventional pain specialists a treatment option that traditional SCS systems do not provide: a micro-IPG™ paired with a wearable battery. The implanted, battery-free micro-IPG is cleared by the FDA to last at least 18 years. Therefore, the risks and costs associated with repeated IPG replacement procedures are significantly reduced, while battery replacement surgeries are entirely eliminated. The strong nPower study results in SCS reflect Nalu’s commitment to providing differentiated clinical and health-economic evidence to support the adoption and use of our unique neurostimulation system for chronic intractable pain in both spinal cord stimulation and peripheral nerve stimulation.”

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, the Nalu logo, and micro-IPG 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

Attributes 9,623% Revenue Growth to the exceptional clinical performance and unique technology of the Nalu Neurostimulation System in treating unmet needs in chronic intractable neuropathic pain.

CARLSBAD, Calif (BUSINESS WIRE) November 9, 2023

Nalu Medical today announced that it ranked number 19 in the 2023 Deloitte Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in North America, now in its 29^th year. Within the life sciences category, the company ranked number 7. Nalu Medical revenue grew 9,623% during the period from 2019 to 2022.

Nalu chief executive officer, Tom West, credits the exceptional clinical performance and unique technology of the Nalu Neurostimulation System for the company’s 9,623% revenue growth rate. He said, “We are proud to be in the company of so many life sciences leaders. We are also deeply gratified that our unique technology has been able to relieve the chronic pain of patients for whom traditional medical management and more conventional interventions would not be appropriate. Our use of advanced microelectronics has allowed us to develop an advanced and small implantable pulse generator (micro-IPG™) with an external battery that allows Nalu to uniquely and effectively treat neuropathic pain peripherally at the site of pain (PNS) and centrally in the spinal column (SCS). In addition, with Nalu, unlike conventional neurostimulators for pain, patients do not need to have a lithium battery implanted beneath the skin. A growing body of clinical data has clearly demonstrated the efficacy and lifestyle benefits for chronic pain patients of the Nalu System.”

Overall, 2023 Technology Fast 500 companies achieved revenue growth ranging from 201% to 222,189% over the three-year time frame from 2019 to 2022, with an average growth rate of 1,934% and median growth rate of 497%.

About the 2023 Deloitte Technology Fast 500

Now in its 29^th year, the Deloitte Technology Fast 500 provides a ranking of the fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies — both public and private — in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2019 to 2022.

In order to be eligible for Technology Fast 500 recognition, companies must own proprietary intellectual property or technology that is sold to customers in products that contribute to a majority of the company’s operating revenues. Companies must have base-year operating revenues of at least US$50,000, and current-year operating revenues of at least US$5 million. Additionally, companies must be in business for a minimum of four years and be headquartered within North America.

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.

About Deloitte

Deloitte provides industry-leading audit, consulting, tax, and advisory services to many of the world’s most admired brands, including nearly 90% of the Fortune 500^® and more than 8,500 U.S.-based private companies. At Deloitte, we strive to live our purpose of making an impact that matters by creating trust and confidence in a more equitable society. We leverage our unique blend of business acumen, command of technology, and strategic technology alliances to advise our clients across industries as they build their future. Deloitte is proud to be part of the largest global professional services network serving our clients in the markets that are most important to them. Bringing more than 175 years of service, our network of member firms spans more than 150 countries and territories. Learn how Deloitte’s approximately 457,000 people worldwide connect for impact at www.deloitte.com.

Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms.

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, the Nalu logo, and micro-IPG are trademarks of Nalu Medical, Inc.

Media Contact

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

CARLSBAD, Calif. (BUSINESS WIRE) July 20, 2023

Nalu Medical, Inc. (“Nalu”), a Carlsbad, California-based neurostimulation company that has miniaturized neurostimulation implants for the management of chronic intractable pain for both Peripheral Nerve Stimulation (PNS) and Spinal Cord Stimulation (SCS) indications, presented significant new data from several studies at the 2023 American Society of Pain and Neuroscience (ASPN) Conference in Miami Beach, Florida.

Interim analysis of 6-month outcomes from the COMFORT PNS RCT¹

The COMFORT RCT interim 6-month data show a 100% responder rate (≥50% reduction in pain) for subjects suffering from chronic peripheral neuralgia treated with the Nalu Peripheral Nerve Stimulation System (n=15). Additional highlights from the presentation include the following:

• 78% mean pain relief from baseline.
• 65% mean Oswestry Disability Index (ODI) score improvement.
• 100% improvement measured by Patient Global Impression of Change (PGIC) reported by patients.

The lead author, Dr. Mitchell Engle, noted, “Interim results show that the Nalu PNS System can provide sustained pain relief and functional improvement for patients with peripheral neuralgia. These results are best-in-class for this type of treatment. I am anticipating the final analysis of this study, which will provide pain management physicians with the clinical evidence they need to recommend the Nalu PNS System to their patients.”

Exploring composite endpoints from the SCS nPower™ US study²

This study explored how multiple endpoints may be an indication of valid clinical benefit. In addition to 86% of subjects implanted with the Nalu SCS System reporting significant pain relief in back and leg(s), the vast majority (97%) of patients achieved a minimal clinically important difference (MCID) in one functional metric or more. Additional highlights from the presentation include the following:

• 88% reported improved Patient Global Impression of Change (PGIC).
• 94% reported improved Activities of Daily Living (ADL).
• 77% reported improved Quality of Life (QoL).

According to the lead author, Dr. Mehul Desai, “These data show that 86% of patients experienced ≥50% pain relief and MCID was achieved across a variety of functional endpoints. This indicates that treatment with the Nalu SCS System provides a robust, holistic treatment response.” Nalu attributes results of this study to advanced engineering and the patented pulse stimulation pattern (PSP) waveform, which leverages multiple mechanisms of action in a single waveform³.

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, the Nalu logo, and nPower 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.

^1. Engle M, Sayal P, Liu E, et al. A report on the interim analysis of 6-month outcomes for the COMFORT PNS RCT. Presented at: Fifth Annual American Society of Pain & Neuroscience (ASPN) Conference; July 13-16, 2023; Miami, FL.
^2. Desai MJ, Raju T, Ung C, et al. Exploring composite endpoints from the US nPower study. Presented at: Fifth Annual American Society of Pain & Neuroscience (ASPN) Conference; July 13-16, 2023; Miami, FL.
^3. Desai, Mehul J et al. “A Novel Pulsed Stimulation Pattern in Spinal Cord Stimulation: Clinical Results and Postulated Mechanisms of Action in the Treatment of Chronic Low Back and Leg Pain.” Neuromodulation : journal of the International Neuromodulation Society vol. 26,1 (2023): 182-191. doi:10.1016/j.neurom.2022.10.053

Media Contact

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

CARLSBAD, Calif. (BUSINESS WIRE) May 31, 2023

Nalu Medical, Inc. (“Nalu”) a Carlsbad, California-based company that markets a minimally invasive neurostimulation implant for the management of chronic intractable pain for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications, announces the first patient enrollment in the Clinical Study Of A Micro-Implantable Pulse Generator For the Treatment of Peripheral Neuropathic Pain (COMFORT-2) Peripheral Nerve Stimulation Randomized Controlled Trial.

Together with COMFORT-1, COMFORT-2 is designed to enroll the largest cohort of randomized controlled trial subjects comparing the responder rate of PNS combined with conventional medical management versus the responder rate of conventional medical management alone.

In the United States, up to 8 million people suffer from peripheral neuropathic pain.¹ The Nalu Neurostimulation System for PNS (Nalu PNS system) is FDA-cleared 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. It offers long-term pain relief with an FDA-cleared serviceable life of 18 years.

The Nalu PNS system incorporates a battery-free, micro implantable pulse generator (micro-IPG™), powered by an externally worn device (Therapy Disc) housing the battery and controller. The system utilizes mild electrical pulses to create an energy field that acts to modulate the transmission of pain signals to the brain.

Dr. John Hatheway, interventional pain physician at Northwest Pain Care in Spokane, Washington, enrolled the first patient in the COMFORT-2 randomized controlled trial.

“I am thrilled to have enrolled the first patient in this important clinical trial. This is a significant milestone for our team and many clinicians who eagerly await empirical data to guide PNS treatment decisions,” said Dr. Hatheway. “I am confident that this trial will provide valuable insights into the safety and efficacy of this innovative therapy, and I look forward to continuing to work with Nalu Medical to advance this program and build Level 1 clinical evidence in the field of PNS.”

The COMFORT-2 randomized controlled trial will enroll up to 200 patients in up to 20 study centers in the U.S. Subjects who have been diagnosed with peripheral neuralgia, mononeuropathy, neuropathic pain, or osteoarthritis pain in the low back, shoulder, knee, or foot (including ankle) will be randomized to PNS combined with conventional treatments or conventional treatments alone.

The primary endpoints are responder rate at 3 months and the rate of serious and non-serious adverse events. Secondary endpoints include responder rates and the rate of serious and non-serious adverse events at 6 and 12 months, as well as patient-reported functional outcomes.

“This milestone marks an important step in clinically validating the efficacy of the Nalu PNS system for the long-term treatment of chronic intractable peripheral neuralgia of post-traumatic or post-surgical origin,” says Tom West, Nalu Medical CEO and President. “We are proud to lead the charge in building scientific evidence for PNS while growing our portfolio of Nalu PNS clinical outcomes. We are committed to being the leader in PNS clinical data development.”

This is the second PNS randomized controlled trial sponsored by Nalu Medical. An interim analysis of the COMFORT-1 study was presented at the American Society of Interventional Pain Physicians in March 2023. Preliminary data demonstrated 81% of patients in the treatment arm experienced ≥ 50% pain relief vs. 0% in the control arm.² Additional COMFORT-1 interim analysis will be presented at the 5^th Annual American Society of Pain and Neuroscience conference to be held in Miami, FL, from July 13-16, 2023.

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.

Disclaimers

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

© 2023. All rights reserved. Nalu, micro-IPG, and the Nalu logo are trademarks of Nalu Medical, Inc.

1. van Hecke O, Austin SK, Khan RA, Smith BH, Torrance N. Neuropathic pain in the general population: a systematic review of epidemiological studies. Pain. Apr 2014;155(4):654-662. doi: 10.1016/j.pain.2013.11.013.
2. Huynh, J., Martin, P., Kottalgi, S., Desai, M.J., et al. Early outcomes from a randomized control trial for the treatment of peripheral neuralgia. Presented at: American Society of Interventional Pain Physicians (ASIPP) Annual Meeting, March 16-18, 2023, National Harbor, MD.

Media Contact

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

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.

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 https://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.