releases - Nalu Medical
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.
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.
Media Contact
Nalu Medical, Inc.
Jon Ruais
(925) 667-6329
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.”
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 aging, 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. With the Nalu mIPG, battery replacement surgeries are eliminated, as are the risks and expenses associated with these types of surgeries. 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.
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 batteries and need for replacement surgeries.
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.”
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. 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.”
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.”
Nalu Medical, Inc. Appoints New Chief Executive Officer: Earl R. Fender Joins as President & CEO
CARLSBAD, Calif. (PRWEB) April 23, 2020
Nalu Medical, Inc. (“Nalu”), a global medical device company that provides miniaturized, battery-free implantable solutions for the treatment of intractable chronic pain in Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS), announced today that Earl R. Fender has been appointed President and Chief Executive Officer and member of the Board of Directors. Mr. Fender succeeds Keegan Harper, who has stepped down as CEO but will remain as Chairman of the Board.
“We are very excited to welcome Earl Fender to the Nalu team,” said Mr. Harper. “I cannot think of a stronger person to lead Nalu as it enters its full commercialization and growth phase than Earl.”