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 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, 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 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, 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 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.

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
[email protected]
(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

releases

Nalu Medical Presents 3-Month Data on the nPower-AUS Study at the 2021 North American Neuromodulation Society Meeting

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.

January 15, 2021 0 comments

releases

Nalu Receives FDA Clearance for 1.5T Full-Body MRI Scanning In Patients With Nalu Neurostimulation System Implants

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.

December 4, 2020 0 comments

releases

Nalu Announces Additional Industry Veterans to Join its Commercial Leadership Team

CARLSBAD, Calif. (PRWEB) September 28, 2020

Nalu Medical, Inc. (“Nalu”), a global medical device company that provides miniaturized Neuromodulation implants for the treatment of intractable chronic pain via Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS), today announced the addition of three senior leaders to the commercial organization, including the appointment of Allen Meacham as Chief Business Development Officer.

In this critical role, Mr. Meacham will be responsible for leading, developing and executing Nalu’s sales strategies to drive growth. Mr. Meacham brings with him over 25 years of senior sales leadership and sales training experience, most recently from Boston Scientific, where he spent the last 15 years building and leading their commercial business for the Spinal Cord Stimulator (SCS) and Deep Brain Stimulator (DBS) divisions.

Earl Fender, Nalu’s President and Chief Executive Officer is confident that, “Allen Meacham’s proven track record makes him uniquely positioned to lead Nalu’s commercial efforts to effectively scale our organization and achieve significant growth in the years ahead.”

Additionally, Alan Mock has joined Nalu as Director of Marketing. Mr. Mock is a seasoned leader with more than 30 years of experience in the medical device industry, the last 23 years in the neuromodulation business with Advanced Neuromodulation Systems, St. Jude Medical Neuromodulation and Nuvectra, in various senior sales and marketing leadership roles.

Nalu also welcomes Ron Kuykendall to lead sales training. Mr. Kuykendall is a neuromodulation veteran with over 20 years of sales training, employee coaching & development, sales management and marketing experience with Advanced Neuromodulation Systems, St. Jude Medical Neuromodulation and Nuvectra.

With these key hires, Nalu’s Chief Commercial Officer, Jon Ruais will continue to build the commercial organization while also developing rapid market growth strategies for SCS and PNS in his new role as Chief Commercial and Strategy Officer; his sales responsibilities will shift to Allen Meacham.

“We are excited to expand and strengthen our commercial leadership team with these outstanding individuals, whose deep knowledge of the neuromodulation business will help continue the momentum and propel us more rapidly toward a broader U.S. launch,” said Mr. Fender. “I would also like to recognize and thank Jon Ruais for his outstanding contribution in commercializing the Nalu system and leading our sales efforts these past 12 months.”

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.

September 28, 2020 0 comments

releases

Nalu Medical, Inc. Announces Additional Software Enhancements to the Nalu Neuromodulation System

CARLSBAD, Calif. (PRWEB) July 27, 2020

Nalu Medical, Inc. (“Nalu”), a global medical device company that provides miniaturized, battery-free implantable solutions for the treatment of intractable chronic pain via Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS), announced today that it has launched a software update that unlocks new capabilities for the Nalu Neurostimulation System.

The Nalu system is designed to be highly capable and easily upgradeable. At the heart of the system is the nPower™ Technology, a highly configurable microchip that allows for additional therapy options and features to be seamlessly added through external software updates. The current upgrade builds upon the existing significant capabilities, with Combination Therapies, Expanded Multi-Area, Program Scheduling, and Enhanced Patient Controls.

“There is no one therapy option that will work for every patient. Our philosophy is to continue to develop an ever-expanding menu of therapy options to give patients the best chance at responding, achieving high levels of success, and maintaining that success over the long run,” said Earl Fender, Nalu’s President/CEO.

“The pace of innovation in neuromodulation is accelerating,” said Dr. Sailesh Arulkumar, of SSM Pain Care in Oklahoma City, OK. “Nalu is uniquely positioned with a battery-free implant that is upgradable with new technology without the need for replacement surgeries, making Nalu attractive to patient centric physicians. When discussing the benefits of Nalu compared to other systems, the choice that has a battery-free implant, no charging pad, and an app that is integrated with smartphones, is almost always chosen by patients. The utilization of Nalu has expanded my ability to offer neuromodulation as a first line therapy 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.

July 27, 2020 0 comments