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) 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 https://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.

CARLSBAD, Calif. (PRWEB) March 25, 2021

Nalu Medical, Inc. (“Nalu”), a California-based company that has successfully miniaturized neurostimulation implants for the treatment of chronic pain via Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS), in July 2020 received clearance from the U.S. Food and Drug Administration (FDA) of an expanded label for its micro-Implantable Pulse Generator (mIPG) to an expected service life of 18-years.  The expanded service life labeling is attributed to the mIPG construction and testing for hermeticity and accelerated aging¹, and is not limited to battery longevity.

The Nalu mIPG has no implanted battery and is powered wirelessly by an external Nalu Therapy Disc which contains control circuitry and a rechargeable battery.  The external power source offers a distinct benefit over other IPGs that have implanted batteries, which require battery replacement surgeries.¹  With the Nalu mIPG, battery replacement surgeries are eliminated, as are the risks and expenses associated with these types of surgeries.^2,3  Additionally, the Nalu mIPG can be non-invasively upgraded so patients can benefit from FDA-authorized therapy advancements without additional surgical interventions.

“The Nalu Neurostimulation System was designed with external power and non-invasive upgradability to deliver long-term chronic pain relief treatment with minimal disruption for patients,” said Earl Fender, President and CEO of Nalu Medical, Inc.  “With our expanded longevity labeling, physicians now have a compelling option for providing long-term relief for patients suffering from chronic, intractable pain of the trunk or limbs or severe intractable chronic pain of peripheral nerve origin.”

The Nalu mIPG service life extension follows other recent Nalu Neurostimulation System announcements including clearance for 1.5T Full-Body MRI scanning and preliminary clinical data presented at the 2021 North American Neuromodulation Society (NANS) Annual Meeting.

References:
1. Data on file
2. Falowski SM, Provenzano DA, Xia Y, Doth AH.  Spinal Cord Stimulation Infection Rate and Risk Factors: Results from a United States Payer Database. Neuromodulation. 2019;22(2):179-189.
3. Provenzano DA, Falowski SM, Xia Y, Doth AH.  Spinal Cord Stimulation Infection Rate and Incremental Annual Expenditures: Results from a United States Payer Database. Neuromodulation. 2019;22(3):302-310.

CARLSBAD, Calif. (PRWEB) January 15, 2021

Nalu Medical, Inc. (“Nalu”) announces 3-month clinical data from the ongoing Australia nPower-AUS Study were revealed today at the 2021 North American Neuromodulation Society (NANS) Annual Meeting.  The nPower-AUS study is a 12-month prospective, multi-center clinical trial scheduled to be completed later this year that evaluates the management of chronic intractable pain of the legs and/or back in 27 subjects implanted with the Nalu Neurostimulation System.  Per the study protocol, data is collected at 30, 90, 185 and 365 day intervals post activation.

The Nalu Neurostimulation System, a novel micro implantable pulse generator (mIPG) system enabled by nPower™ technology, is cleared for treating intractable chronic pain using spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS).  Key advantages of the Nalu Neurostimulation System are its miniaturized design and lack of implanted battery.  Power is supplied externally, which removes common issues associated with implantable batteries¹ and need for replacement surgeries².

Of these 27 subjects implanted, 24 completed 3 months follow-up and the data showed:

• Treatment with the Nalu Neurostimulation System reduced pain in the leg by 79% (n=24; p<0.0001) and the back by 77% (n=23; p<0.0001).
• Treatment response, defined as ≥ 50% pain relief, was noted in 83% (20/24) of subjects treated for leg pain and 78% (18/23) of subjects treated for back pain.
• Overall comfort score for continual wear of the external power source was 0.4 (n=24) with 0 being very comfortable and 10 being very uncomfortable.
• “The favorable patient response to treatment, quality of life improvements, comfort and ease of use are important outcomes for clinicians,” said Dr. Bruce Mitchell of Melbourne Australia and lead investigator in the nPower-AUS Study. “These initial data suggest the Nalu device, an exceptionally small IPG, provides a robust treatment for patients in support of clinical efficacy.”
• “Consistent with our early investigations, the data presented today provide early and additional confirmation of system effectiveness,” said Earl Fender, Nalu’s President and CEO. “We look forward to the 12-month results of this study and those from a multi-center trial (nPower-US) that is underway in the U.S. to study the Nalu Neurostimulation System’s effectiveness in a larger population.”

References:
1. www.fda.gov/medical-devices/letters-health-care-providers/conduct-trial-stimulation-period-implanting-spinal-cord-stimulator-scs-letter-health-care-providers?utm_campaign=2020-09-03%20Conduct%20a%20Trial%20Stimulation&utm_medium=email&utm_source=Eloqua
2. Costandi S, Mekhail N, Azer G, et al. Longevity and Utilization Cost of Rechargeable and Non-Rechargeable Spinal Cord Stimulation Implants: A Comparative Study Pain Pract. 2020;10.1111/papr.12926.

About Nalu Medical

Nalu Medical, Inc. is a privately-held, medical device company located in Carlsbad, California. Our team of seasoned medical device professionals have developed the next generation of miniaturized medical devices. The result is a novel, versatile and upgradeable technology platform that we believe will allow us to address several poorly met needs in the market. Our mission is to modernize, improve, and broaden the therapeutic capabilities of miniaturized medical devices, thus improving lives of people today and addressing the demands of medicine tomorrow.

About the Nalu Neurostimulation System

The Nalu Neurostimulation System, an implanted treatment for managing intractable chronic pain, consists of a fully-featured micro-Implantable Pulse Generator (mIPG™) free of an implantable battery and powered by an externally worn Therapy Disc and controlled by the patient via a smartphone app. The Nalu mIPG is built upon the nPower™ microchip platform that delivers outputs similar to larger IPGs but with additional capabilities around waveforms, programming modes and upgradability. The Nalu mIPG is currently cleared by the FDA for both Spinal Cord Stimulation and Peripheral Nerve Stimulation indications with an expected service life of 18 years. 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, the Nalu logo, mIPG and nPower are trademarks of Nalu Medical, Inc.

CARLSBAD, Calif. (PRWEB) December 4, 2020

Nalu Medical, Inc. (“Nalu”), a company that provides miniaturized neuromodulation implants for the treatment of intractable chronic pain, has received FDA 510(k) clearance for expanded labeling that allows for full-body 1.5 Tesla (T) magnetic resonance imaging (MRI) in individuals with select Nalu Spinal Cord Stimulation (SCS) implants. This clearance is retroactive to currently implanted SCS patients and considered MRI-Conditional. With a conditional classification, MRI scans can be safely administered under certain conditions, including specific requirements with respect to the type of MRI scanner, implant configuration and anatomical location, among other. The MRI safety labeling also includes 1.5T and 3T scans of the head and extremities for SCS and Peripheral Nerve Stimulation (PNS) Systems.

In today’s medical practice, MRI scans are necessary and routinely performed for diagnosis and clinical care. It is very likely that a patient with chronic pain will require a future full-body MRI scan.^1,2 The clearance for full-body MRI labeling removes a potential barrier for eligible patients to select the Nalu Neurostimulation System as a means to help manage their chronic pain.

“Expanding our MRI label from head and extremity only to full-body is a significant factor for extending our reach across the United States,” said Earl Fender, Nalu’s President and CEO. “With this clearance, clinicians can now recommend our life-changing therapy to eligible patients with fewer concerns about future imaging. It also underscores Nalu’s ongoing commitment to advance medical devices with miniaturized technology to provide meaningful differences in patients’ lives.”

“When evaluating neurostimulation systems best suited for my patients, I always consider their immediate and long term needs with regards to disease progression and imaging,” said Dr. Dawood Sayed, MD, Associate Professor University of Kansas School of Medicine and Division Chief of Pain Medicine. “The small size and broad capabilities of the Nalu implant is something that is especially important to many of my patients.  Adding full-body conditional MRI allows me to offer this effective therapy to an even greater number of patients with chronic pain, while maintaining more of my patients’ available imaging options”.

References:
1. Sayed D, et al. Neuromodulation. (2020) 23:893–911.
2. Desai MJ, et al. Spine. 2015;40(9):E531–E537.

About Nalu Medical

Nalu Medical, Inc. is a privately-held, medical device company located in Carlsbad, California. Our team of seasoned medical device professionals have developed the next generation of miniaturized medical devices. The result is a novel, versatile and upgradeable technology platform that we believe will allow us to address several poorly met needs in the market. Our mission is to modernize, improve, and broaden the therapeutic capabilities of miniaturized medical devices, thus improving lives of people today and addressing the demands of medicine tomorrow.

About the Nalu Neurostimulation System

The Nalu Neurostimulation System, an implanted treatment for managing intractable chronic pain, consists of a fully-featured micro-Implantable Pulse Generator (mIPG™) free of an implantable battery and powered by an externally worn Therapy Disc and controlled by the patient via a smartphone app. The Nalu mIPG is built upon the nPower™ microchip platform that delivers outputs similar to larger IPGs but with additional capabilities around waveforms, programming modes and upgradability. The Nalu mIPG is currently cleared by the FDA for both Spinal Cord Stimulation and Peripheral Nerve Stimulation indications with an expected service life of 18 years. 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, the Nalu logo, mIPG and nPower are trademarks of Nalu Medical, Inc.