logo
Nalu Announces Publication of the Largest Long-Term Report of Real-World Data (RWD) on a Permanent PNS Device

Nalu Announces Publication of the Largest Long-Term Report of Real-World Data (RWD) on a Permanent PNS Device

Business Wire08-05-2025
CARLSBAD, Calif.--(BUSINESS WIRE)--Publication of the Nalu Real-World Data (RWD) paper in the Chronic Pain and Management Journal is a significant milestone, establishing Nalu peripheral nerve stimulation (PNS) as a medically necessary treatment for chronic pain. 1
This analysis includes data from 2,273 patients implanted with the Nalu micro-IPG™ PNS System, making it the largest published real-world dataset on a permanent PNS device. The large sample size and a responder rate of 94% as measured by the highly respected Patient Global Impression of Change (PGIC) constitute solid evidence of reliable, exceptional effectiveness.
These RWD results confirm the outstanding 1-year published findings of the COMFORT Randomized Controlled Trial (RCT) 2 and the magnitude of the sample size supports generalizing those findings to the population at large. Combined with published data reporting a 50% reduction in total healthcare costs among patients receiving Nalu PNS therapy, 3 these findings provide strong real-world evidence that supports expanded coverage of PNS by private insurers.
According to John Hatheway, MD, lead author of the paper, 'The consistent improvements observed across a large, diverse sample of real-world clinic patients treated in multiple anatomic regions and nerve combinations emphasizes the broad applicability of PNS therapy delivered by the Nalu micro-IPG PNS system.'
Tom West, President and CEO of Nalu, notes that, 'These real-world results provide unmistakable evidence that the Nalu micro-IPG PNS System is dramatically reshaping pain management. No permanent PNS system has undergone greater scrutiny or shown comparable performance. We are thrilled to see that our groundbreaking technology is able to provide reliable long-term pain relief to such a broad spectrum of patients.'
About Nalu Medical
Nalu is a Carlsbad, California-based medical technology company focused on developing and commercializing innovative and minimally invasive solutions for patients with chronic neuropathic pain. The Nalu Neurostimulation System delivers gentle electrical pulses to the nervous system to modulate pain signals before they get to the brain. The Nalu System was designed to address major unmet needs in the treatment of chronic neuropathic pain and provide a differentiated value proposition for patients and physicians.
About the Nalu Neurostimulation System
The Nalu System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG) that is powered wirelessly by an externally worn Therapy Disc and controlled through a smartphone-based remote control app. Despite its small size, the Nalu 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 System has been repeatedly recognized for its revolutionary technology, including being named as one of the world's top 100 new products by R&D Magazine in 2021 and ranking number 19 in the 2023 Deloitte Technology Fast 500. It is FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications. To learn more, visit www.nalumed.com.
Indications for Use
Spinal Cord Stimulation — The Nalu SCS System is indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (≤ 30 days) to determine efficacy before recommendation for a permanent (long-term) device.
Peripheral Nerve Stimulation — The Nalu PNS System is indicated for pain management in adults who have severe chronic intractable 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, and micro-IPG are trademarks of Nalu Medical, Inc.
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause
Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause

Business Wire

time2 hours ago

  • Business Wire

Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elinzanetant. Elinzanetant is the first neurokinin 1 and neurokinin 3 receptor antagonist in late-stage clinical development for the hormone-free treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. The FDA has determined additional time is needed for a full review of the NDA submission, including information provided to support the application. The extension to the Prescription Drug User Fee Act (PDUFA) review period is up to 90 days. The FDA did not raise any concern regarding the general approvability of elinzanetant in its correspondence. 'We are confident in the potential of elinzanetant to provide meaningful clinical benefit to women pending regulatory approval,' said Yesmean Wahdan, M.D., Senior Vice President and Head of Medical Affairs, North America, Pharmaceuticals. 'We continue to work with the FDA to make this treatment available for women in menopause with moderate to severe hot flashes. Despite the universal experience of menopause, social stigma and misinformation persist, leaving many women to suffer without treatment and support. It's critical we advance innovation and education in menopause so women can work with their healthcare provider to determine the best option for them.' The NDA is based on the positive results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. Results from OASIS 1 and 2 were published in August 2024 in The Journal of the American Medical Association (JAMA). Detailed results of the Phase III study OASIS 3 providing supporting efficacy and additional long-term safety data were presented at The Menopause Society (TMS) annual meeting in September 2024. In the last 30 days, elinzanetant was approved under the brand name Lynkuet™ in the United Kingdom and Canada. Submissions for marketing authorizations for elinzanetant are also ongoing in the EU and other markets around the world. About Women's Healthcare at Bayer Women's Health is in Bayer's DNA. As a global leader in women's healthcare, Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low- and middle- income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 'Health for all, Hunger for none,' the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Agenus to Highlight Emerging Survival Plateaus with Botensilimab/Balstilimab in Oral Presentation of Study in Refractory Patients Across Five Tumor Types at ESMO 2025
Agenus to Highlight Emerging Survival Plateaus with Botensilimab/Balstilimab in Oral Presentation of Study in Refractory Patients Across Five Tumor Types at ESMO 2025

Business Wire

time2 hours ago

  • Business Wire

Agenus to Highlight Emerging Survival Plateaus with Botensilimab/Balstilimab in Oral Presentation of Study in Refractory Patients Across Five Tumor Types at ESMO 2025

LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today announced that four abstracts highlighting clinical progress across its botensilimab and balstilimab immunotherapy programs have been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2025, taking place in Berlin, Germany from October 17-21. The highlight is an oral presentation that will feature emerging survival plateaus from a study of botensilimab plus balstilimab in 343 evaluable patients with refractory metastatic solid tumors across five tumor types. Three additional poster presentations will feature data from investigator-sponsored studies in cervical cancer, MSS metastatic colorectal cancer (mCRC), and non-melanoma skin cancers, underscoring the broad potential of botensilimab and balstilimab based combinations in difficult-to-treat cancers. Presentation Details: 1. Oral Presentation Title: Emerging survival plateaus with botensilimab and balstilimab: Pan tumor data from a large phase 1b trial of advanced solid tumors Presenting Author: Dr. Michael Gordon; HonorHealth Research Institute-AZ, USA Mini Oral Session: Investigational Immunotherapy Session Date: Session Time: 2:00-3:00 PM CEST / 8:00-9:30 AM EDT Location: Hall 5.2 Abstract Number: 3220 2. Poster Presentation Title: Efficacy and safety of balstilimab with or without zalifrelimab in recurrent cervical cancer: Results from the global phase 2 RaPiDs trial Presenting Author: Dr. David O'Malley; The Ohio State University Comprehensive Cancer Center- OH, USA Session Date: Saturday, October 18, 2025 Session Time: 12:00-12:45 PM CEST / 6:00-6:45 AM EDT Location: Hall 25 Abstract Number: 2952 Poster Number: 1164P 3. Presentation Title: A Phase I trial of botensilimab, balstilimab and regorafenib (BBR) in chemotherapy-resistant patients with microsatellite stable (MSS) metastatic colorectal cancer Presenting Author: Dr. Marwan Fakih; City of Hope- CA, USA Session Date: Sunday, October 19, 2025 Session Time: 12:00-12:45 PM CEST / 6:00-6:45 AM EDT Location: Hall 25 Abstract Number: 6197 Poster Number: 851P 4. Presentation Title: A phase 2, open label study to evaluate the safety and clinical activity of balstilimab in patients with advanced/metastatic non-melanoma skin cancers (AGENONMELA) Presenting Author: Dr. Iwona Lugowska; Maria Sklodowska-Curie National Research Institute and Oncology Center - Poland Session Date: Monday, October 20, 2025 Session Time: 12:00-12:45 PM CEST / 6:00-6:45 AM EDT Location: Hall 25 Abstract Number: 7273 Poster Number: 1662P Expand About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. About Botensilimab (BOT) Botensilimab is a multifunctional, human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to 'cold' tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Botensilimab alone, or in combination with Agenus' investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. Approximately 1,200 patients have been treated across the botensilimab/balstilimab program in phase 1 and phase 2 clinical trials. For more information about botensilimab trials, visit About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," 'establish,' 'potential,' 'superiority,' 'best in class,' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Expand

Theraclion Growth Up in S1 2025
Theraclion Growth Up in S1 2025

Business Wire

time2 hours ago

  • Business Wire

Theraclion Growth Up in S1 2025

MALAKOFF, France--(BUSINESS WIRE)--Regulatory News: THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing Sonovein®, a robotic platform for non-invasive High-Intensity Focused Ultrasound (HIFU) varicose vein treatment, reviews its business for S1 2025. Sales of consumables (recurring revenue) up 30% compared to 2024 New treatment centers opened in Bulgaria and Spain Appointment of a new business manager and acceleration of commercial activities On-schedule completion of the follow-up period for the pivotal FDA clinical trial Martin Deterre, CEO of Theraclion, states: "In early 2025, Theraclion stepped up Sonovein's activity. In June, the final 12-month follow-ups for patients in the pivotal FDA-approved clinical trial were completed on-schedule. We are now awaiting the final results, which we expect to publish in September. Theraclion has also entered a business development phase: building a sales and marketing team, opening two new Sonovein treatment centers, and achieving significant growth in recurring revenue — all of which promise the achievement of our ambitious goals." Commercial activity acceleration As part of its business development, Theraclion is actively building its sales and marketing team. In May 2025, Thibault Le Normand joined the company as Chief Business Officer to boost sales in the Middle East and product placements (PPUs) of Sonovein in Europe. With over a decade of experience in international development of medical devices, Thibault Le Normand brings valuable expertise to this strategic growth phase. At the same time, the technological credibility and clinical maturity of Sonovein have been further demonstrated by the publication of new scientific articles as well as by over a dozen presentations at major international congresses by renowned physicians using the device. Sonovein's international profile has also increased through Theraclion's participation in congresses, such as Vein in Venice (April, Venice), Venous Symposium (May, New York), and the European Venous Forum (June, Krakow). This outreach effort was supported by the launch of a new product identity and a new website, giving Sonovein a new brand image that reflects innovation, clinical excellence, and ambition. In addition, two new product placement (PPU) contracts for Sonovein have been signed in Bulgaria and Spain, stepping up Theraclion's presence in Europe and expanding the installed base of the technology. Revenue for S1 2025 Theraclion's revenue for S1 2025 was €835K, up 89% compared to 2024 (€442K) (prior to the non-recurring adjustment of €680K related to the cancellation of Echopulse system sales in 2024). Consumables, which include recurring revenues from PPUs, was up 30% compared to S1 2024. Service revenues were up 232% over the same period. This strong momentum is a key indicator of increasing use of Sonovein by treatment centers and reflects the technology's sustained traction in the field. Combined, consumables and services — representing recurring revenue — was up 57% compared to 2024. Progress of the pivotal FDA clinical trial In the USA, the pivotal FDA-approved study for SONOVEIN® reached a major milestone in June 2025 with the on-schedule completion of the 12-month post-treatment patient follow-ups. Data analysis is currently underway, with results expected in September. Submission of the marketing authorization application to the FDA is planned for Fall 2025, with potential approval estimated for Q2 2026, subject to the FDA's processing time. This progress marks a critical strategic milestone in the work to access the world's largest market for venous disease treatment. Next financial publication: Theraclion will publish its interim financial results on October 29, 2025. About Theraclion Theraclion is a French MedTech company committed to developing a non-invasive alternative to surgery through the innovative use of focused ultrasound. High Intensity Focused Ultrasound (HIFU) does not require incisions or an operating room, leaves no scars, and patients can immediately resume their routines. HIFU treatment concentrates therapeutic ultrasounds on an internal focal point from outside the body. Theraclion is developing SONOVEIN®, a CE-marked, a robotic platform for HIFU varicose vein treatment, which could replace millions of surgical procedures every year. In the USA, SONOVEIN® is an investigational device limited to investigational use; it is not available for sale in the USA. Based in Malakoff (Paris), the Theraclion team comprises some 30 people, most of them involved in technological and clinical development. Theraclion is listed on Euronext Growth Paris Eligible for the PEA-PME scheme Mnemonic: ALTHE - ISIN code: FR0010120402 LEI: 9695007X7HA7A1GCYD29

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store