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releases

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

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.

February 24, 2022 0 comments
releases

Nalu Medical Inc. Announces $104 Million Equity Financing

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.

 

 

February 17, 2022 0 comments
releases

Nalu and Nevro Reach Settlement in Patent Infringement Lawsuit

CARLSBAD, Calif. (PRWEB) December 22, 2021

Nalu Medical, Inc. announced today that Nalu and Nevro Corporation have reached a settlement in the patent infringement lawsuit brought by Nevro in February 2020. 

“We are very pleased that we are able to put this litigation behind us, while maintaining our current menu of therapy options,” said Earl Fender, CEO.

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.

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

December 22, 2021 0 comments
releases

R&D 100 Award for IT/Electrical Technology is Fourth Prestigious Win for Nalu Medical

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 award1,2,3 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

December 1, 2021 0 comments
releases

Nalu Medical Named Best MedTech Company and Medical Device in Field of Neurology

CARLSBAD, Calif.  (PRWEB) November 2, 2021

Nalu Medical is pleased to announce its flagship micro-Implantable Pulse Generator (mIPG™) was selected as the 2021 winner of the MedTech Visionaries Award for Best MedTech Company and Best Medical Device in the field of neurology.  The MedTech Visionaries Awards honor organizations that apply science and technology to real-world problems to advance MedTech solutions for businesses and consumers alike.  Nalu Medical competed with innovative and creative entries from organizations and engineers from around the world.

The Nalu mIPG, was recognized by the judges for its creative and innovative application of technology to treat chronic intractable pain. Using advanced miniaturization and by eliminating the internal chemical battery in the implantable component, the Nalu mIPG is 27 times smaller than the largest commercially available implantable pulse generators (IPG).1 Its innovative design no longer requires patients receiving implantable neurostimulation treatment to have an implanted battery. The small size of the mIPG translates into a less invasive procedure with the potential to reduce certain post-implant complications associated with larger incisions to accommodate traditional sized IPGs or battery replacement surgeries associated with IPGs containing implantable batteries.

Cleared for the spinal cord stimulation and peripheral nerve stimulation indications, the Nalu mIPG is uniquely powered wirelessly by an external Therapy Disc containing a battery and controlled by the patient via a smartphone-based app.  Although micro-sized, the mIPG delivers stimulation outputs equal to larger IPGs but with additional capabilities around advanced waveforms, programming modes and upgradability.

“It’s an honor to be selected by the MedTech Visionaries as the medical device winner in the field of Neurology among many other innovative technologies,” said Earl Fender, President and CEO of Nalu Medical, Inc.  “We believe our advanced design stands apart from other spinal cord stimulation and peripheral nerve stimulation systems and provides meaningful advantages to clinicians, patients and the healthcare system.”

About MedTech Visionaries Awards

Now in its 2nd year, the MedTech Visionaries Awards highlights the advancements and accomplishments of those in this industry who are disrupting the status quo. It is our mission to humanize the people behind this new frontier that takes ideas and makes them into reality.

About Nalu Medical

We are a medical technology company focused on developing and commercializing innovative and minimally invasive solutions 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 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 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.


[1] Data on file, Nalu Medical, Inc. 2021.

November 2, 2021 0 comments
releases

Nalu Medical kicks-off ‘Engineered to be More™’ with new product releases and software upgrade to provide more therapy options and support for its patients and physicians

CARLSBAD, Calif.  (PRWEB) October 20, 2021

Nalu Medical, Inc. (“Nalu”), a Carlsbad, California-based company that has successfully miniaturized neurostimulation implants for the management of intractable chronic pain for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications, launches its ‘Engineered to be More’ branding campaign. The campaign highlights the award-winning engineering design of its Nalu micro-Implantable Pulse Generator (mIPG) and how the Nalu neurostimulation system is engineered to address major unmet needs in the management of intractable chronic pain and provide a differentiated value proposition for patients and physicians.

To kickoff this campaign, Nalu has released three products and a software upgrade to support patients across different stages of the Nalu neurostimulation experience:

  • Dual 4 mIPG & 4-contact trial lead – a new IPG and lead configuration for use in Peripheral Nerve Stimulation (PNS) applications
  • “Mauna Kea” software upgrade – the latest Nalu system software upgrade which expands programmable stimulation parameter ranges and introduces additional programming efficiencies
  • Nalu Patient Care Portal – an online, cloud-based software platform designed to engage Nalu patients with their multidisciplinary care teams from the time they are introduced to neurostimulation through post-surgery and beyond, living their lives with a Nalu implant

“As we build upon our foundational Nalu Neurostimulation System, we remain focused on a simple premise, enabling the management of chronic intractable pain while minimizing interference with the patient’s life,” said Earl Fender, President and CEO of Nalu Medical, Inc. “Each Nalu product is engineered to be more livable, durable and adaptable for our patients, so we are able to meet their needs at every stage and step of their pain management journey.”

The Nalu Neurostimulation System features a micro-Implantable Pulse Generator (mIPG) which is powered wirelessly by a wearable, external Nalu Therapy Disc. The external power source offers a distinct benefit over IPGs with implanted batteries, which require battery replacement surgeries over time. Additionally, the Nalu software controlling the mIPG can be non-invasively upgraded so patients can benefit from future FDA-authorized therapy options and advancements without additional surgical interventions.

The Dual 4 mIPG builds on the original Nalu mIPG technology and consists of dual connectors designed to accommodate two 4-contact stimulation leads. This new design further expands the adaptability of the Nalu Neurostimulation System for PNS patients. The Dual 4 mIPG allows physicians to address nerve targets with two individual leads, providing increased treatment flexibility with the positional stability of tined leads. To compliment the Dual 4 mIPG, two types of 4-contact PNS leads are available; a 4-contact tined lead for implants and a recently released 4-contact trial lead.

“The ability to have full, independent control of stimulation programs for multiple leads when addressing separate nerve targets is critical in many PNS applications,” said Dr. Amitabh Gulati, President of World Academy of Pain Medicine (WAPMU). “For example, neuropathic pain of the shoulder varies from patient to patient and may necessitate differing therapy applications to both the suprascapular and axillary nerves. The opportunity to address this for my patients in a single, powerful stimulator like the Dual 4 mIPG is significant.”

Like a smartphone operating system, the Nalu Neurostimulation System software can be upgraded allowing existing patients’ full access to future software innovation and additional capabilities as they are authorized by the FDA. This latest software upgrade, known as “Mauna Kea,” expands stimulation dosing parameter ranges and programming configurations for both PNS and SCS indications. The upgrade also introduces additional performance and display improvements to the clinical programmer intended for use by health care providers.

Nalu’s Patient Care Portal allows for monitoring and addressing the needs of patients at each stage of their Nalu Neurostimulation experience. The cloud-based Patient Care Portal experience begins during the patient’s Nalu Wear Experience & trial period as the patient completes a series of surveys to initiate a tailored post-implantation pain management treatment plan controlled and determined by the healthcare team. After the implantation procedure, pain management treatment plans are personalized further by the healthcare team based on regular engagements with the Patient through the Portal as they resume their routine daily activities post-surgery.

“Being able to track a patient’s progress and recovery is critical, especially with pain management patients,” said Dr. Sean Li of Premier Pain Centers in New Jersey. “The Nalu Patient Care Portal is designed to deliver valuable and usable data for my care team while also providing an effortless and engaging environment for my patients.”

About Nalu Medical 

We are a medical technology company focused on developing and commercializing innovative and minimally invasive solutions 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 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 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, nPower the ‘engineered to be more’ tagline are trademarks of Nalu Medical, Inc.

October 20, 2021 0 comments
releases

Nalu Medical Announces Scientific Presentations at 2021 North American Neuromodulation Society (NANS) Mid-Year Meeting

CARLSBAD, Calif.  (PRWEB) July 15, 2021

Nalu Medical, Inc. (“Nalu”), a California-based company that has successfully miniaturized neurostimulation implants for chronic intractable pain management indications, announced that the scientific presentation schedule during the 2021 North American Neuromodulation Society (NANS) Mid-Year Meeting in Orlando, Florida will include three abstract submissions all selected for oral presentations.

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 nPowerTM 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.

 

July 15, 2021 0 comments
releases

Nalu Micro-Implantable Pulse Generator Receives Award for Implanted Medical Device Innovation and Health Benefits

CARLSBAD, Calif. (PRWEB) May 24, 2021

Nalu Medical, Inc. (“Nalu”), a California-based company that has successfully miniaturized neurostimulation implants for chronic intractable pain management indications, announces its Nalu micro-Implantable Pulse Generator (mIPG) was named the Implant and Tissue-Replacement device Gold Winner at the 2021 Medical Design Excellence Awards (MDEA).  The MDEA is a prestigious award that recognizes medical device developers for innovative design, engineering and functionality enhancements that benefit the healthcare system and patients across multiple device categories – award levels include bronze, silver and, the top award, gold. An impartial panel of jurors made up of designers, clinicians, and engineers conducted the judging of all the entries.

“We believe our technology design provides a valuable neuromodulation option among the existing spinal cord and peripheral nerve stimulation systems,” said Earl Fender, President and CEO of Nalu Medical, Inc. “We greatly appreciate the MDEA for recognizing the unique and differentiating technology advancements of the Nalu System and the value it brings to patients, the healthcare system – and, society.”

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.

Media Contact

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

May 24, 2021 0 comments
releases

Nalu Medical Releases Latest Software Upgrade to Expand Nalu Neurostimulation System Capabilities

CARLSBAD, Calif. (PRWEB) May 13, 2021

Nalu Medical, Inc. (“Nalu”), a Carlsbad, California-based company that has successfully miniaturized neurostimulation implants for the treatment of intractable chronic pain via Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS), announced the release of their latest software upgrade that adds new capabilities to their micro neurostimulation system.

Like a smartphone operating system, the Nalu Neurostimulation System can be upgraded to enable existing patients full access to future innovation and additional capabilities that are authorized by the FDA. This software upgrade, known as “Mauna Loa”, adds real time current steering capabilities during programming and allows the simultaneous execution of Tonic and Advanced Programming Stimulation therapies.The upgrade also addresses the functionality of the programmer in order to simplify the programming process.

“Part of our lifetime commitment to patients and physicians includes providing access to the latest advancements in neurostimulation therapies through software upgrades,” said Earl Fender, Nalu’s President and CEO. “With this latest upgrade, we offer an expanded menu of therapy options to help people suffering with intractable chronic pain to better configure their therapies according to their preferences and within clinician-defined levels.”

“Neuromodulation innovation is constantly evolving and the ability to add new capabilities through upgrades to the software is important,” said Dr. Mark Malinowski, an Interventional and Surgical Pain Physician in Columbus, Ohio. “With this latest upgrade, Nalu has once again demonstrated its commitment to continuous and meaningful innovation to help deliver chronic pain relief therapy options to patients.”

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.

May 13, 2021 0 comments
releases

Nalu Micro-Implantable Pulse Generator Receives Expanded FDA Label for Service Life of 18 Years

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.

 

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.

March 25, 2021 0 comments
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