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 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 a noteable cause for traditional IPG failures1 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 73% (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 0.38 (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 the Nalu Medical 

Nalu Medical, Inc. is a privately-held, early-stage medical device company located in Carlsbad, California. Our team of seasoned entrepreneurs, engineers and scientists are developing the next generation of miniaturized medical devices. These novel devices are built upon a proprietary, versatile technology platform that will allow us to address several poorly treated clinical conditions. Our mission is to improve the therapeutic capabilities in miniaturized medical devices to improve the lives of people today and to meet the demands of medicine tomorrow.

About the Nalu micro-Implantable Pulse Generator

The Nalu implantable pulse generator (IPG) is the smallest and longest lasting neurostimulator for treating chronic pain. The device is powered wirelessly to eliminate the problems associated with implanted batteries. The IPG can deliver outputs equal to larger IPGs but with additional capabilities around advanced waveforms, programming modes and upgradability. The Nalu system is currently cleared by the FDA for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS). To learn more, visit http://nalumed.com.

 

Nalu, the Nalu logo 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 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, such as the type of MRI scanner, implant configuration and anatomical location. 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, early-stage medical device company located in Carlsbad, California. Our team of seasoned entrepreneurs, engineers and scientists are developing the next generation of miniaturized medical devices. Our novel devices are designed and developed upon a proprietary, versatile technology platform that will allow us to address several poorly treated clinical conditions. Our mission is to modernize, improve, and broaden the therapeutic capabilities in miniaturized medical devices, thus improving lives of people now and to meet the demands of medicine tomorrow.

About the Nalu Neurostimulation System

The Nalu Neurostimulation System is a micro-implantable pulse generator for treating individuals with chronic pain. The System, up to 26X smaller than other IPGs, utilizes the powerful nPower™ microchip to deliver treatment equal to larger implantable pulse generators but with additional waveforms, programming modes and upgradability. Uniquely battery-free and minimally invasive, the System offers a distinct advantage over bulky devices powered with implantable chemical batteries. The System is currently cleared by the FDA for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS). To learn more, visit http://nalumed.com.

Nalu, the Nalu logo 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 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 the Nalu Medical
Nalu Medical, Inc. is a privately held commercial medical device company based in Carlsbad, California. The Nalu neurostimulation system is a battery-free, micro-implantable pulse generator (iPG) currently cleared by the FDA for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) for mitigating chronic pain. The system is highly capable and easily upgradeable, providing a menu of therapy options. To learn more, please visit http://nalumed.com.  

Small size, without compromise.

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 chronic pain via Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS), announced today that it has launched a system 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 the Nalu Medical

Nalu Medical, Inc. is a privately held commercial medical device company based in Carlsbad, California. The Nalu neurostimulation system is a battery-free, micro-implantable pulse generator (iPG) currently cleared by the FDA for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) for mitigating chronic pain. The system is highly capable and easily upgradeable, providing a menu of therapy options. To learn more, please visit http://nalumed.com.

Small size, without compromise.

 

 

July 27, 2020 0 comments
releases

Nalu Medical, Inc. Appoints New Chief Executive Officer: Earl R. Fender Joins as President & CEO

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 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. He brings over 30 years of successful experience in building and leading medical technology companies. For the last 12-years, he worked in the chronic pain space as the CEO of Vertiflex, Inc., which was acquired by Boston Scientific in June 2019. He brings a wealth of experience in building industry-leading, high growth companies and I am excited to have him join the Nalu team.”

“I am very excited and proud to join Nalu’s illustrious team who has developed such differentiated technology to positively impact the lives of patients in the U.S. and abroad,” said Mr. Fender. “The uniquely miniaturized, battery-free and easily upgradable Nalu implantable pulse generator system will help expand patient acceptance in both spinal cord and peripheral nerve stimulation.”

“We are very excited to welcome Earl Fender to the Nalu team. I cannot think of a stronger person to lead Nalu as it enters its full commercialization and growth phase than Earl. He brings over 30 years of successful experience in building and leading medical technology companies.”

Mr. Fender added, “The Board thanks Keegan for his years of dedicated service to Nalu since founding the Company in 2014. As Nalu’s co-founder and CEO, Keegan built a strong team, developed a sophisticated product in record time, launched a successful first in human study in Australia, received FDA clearance in SCS and PNS, received CE mark approval, and completed a successful limited clinical launch in the U.S. We look forward to his continued leadership as Nalu’s Chairman.”

About the Nalu Neurostimulation System
The Nalu neurostimulation system is a battery-free, micro-implantable pulse generator (iPG) currently cleared by the FDA for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) for mitigating chronic pain. The system is highly capable and easily upgradeable, providing a menu of therapy options. To learn more, please visit http://nalumed.com.

About Nalu Medical
Nalu Medical, Inc. is a privately held early-stage medical device start-up company based in Carlsbad, California. The team of seasoned entrepreneurs, engineers and scientists are developing the next generation of medical devices to address a number of poorly treated clinical conditions. Nalu Medical’s vision is to modernize and enhance medical device technology to improve people’s lives.

April 23, 2020 0 comments