United Kingdom National Institute for Health and Care Excellence (NICE) Publishes Interventional Procedure Guidance (IPG) for ReActiv8® Restorative Neurostimulation™
Mainstay Medical Holdings plc announced today that the National Institute for Health and Care Excellence (NICE), a public body of the Department of Health that carries out evidence-based health technology assessments by independent committees, has issued a recommendation that ReActiv8® Restorative Neurostimulation™ can be used in the National Health Service in the U.K., with special arrangements for clinical governance, consent, and audit or research. ReActiv8 is currently the only technology offering restorative neurostimulation to the NHS for refractory mechanical chronic low back pain (CLBP).
“U.K. physicians have some of the most extensive experience with ReActiv8 globally. We are thankful to NICE for recognizing this experience, as well as the substantial body of global evidence we have developed in support of the efficacy and safety of this ground-breaking therapy, “ said Jason Hannon, CEO of Mainstay Medical. “This new guidance will enable patients to have greater access to the therapy when previous treatment options have not proven successful. We look forward to supporting physicians across the U.K. going forward and to continued improvement in patient outcomes.”
“Historically, mechanical CLBP pain therapies were aimed at only managing the symptoms, which is the pain associated with this pathology,” said Dr. Ganesan Baranidharan, Consultant in Anaesthesia and Pain Medicine, Leeds Teaching Hospitals NHS Trust. “ReActiv8 is the only therapy available I am aware of where patients with many years of CLBP actually reverse and effectively rehabilitate their condition durably over a long period of time. ReActiv8 targets the cause of mechanical CLBP, not just the symptoms. The new NICE guidance is a major victory for patients and clinicians, which further confirms the positive patient outcomes we have seen to date. This new guidance will allow more patients to gain access to ReActiv8 within the U.K. and further afield.”
The NICE publication can be found here: Evidence | Neurostimulation of lumbar muscles for refractory non-specific chronic low back pain | Guidance | NICE
About ReActiv8®
ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.
About Mainstay Medical
Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation™ system, ReActiv8®, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands.
Further information can be found at www.mainstaymedical.com.
Forward-Looking Statements
All statements in this announcement other than statements of historical fact are, or may be deemed to be, forward-looking statements. These forward-looking statements may include, without limitation, statements regarding the company’s intentions, beliefs or current expectations concerning, among other things, the company’s commercial efforts and performance, including the use of the ReActiv8 therapy by physicians and patients in the U.K. and elsewhere, and the company’s financial position, financing strategies, product design and development, regulatory applications and approvals, and reimbursement arrangements.
Forward-looking statements involve risk and uncertainty and are not guarantees of future performance. Actual results may differ materially from those described in, or suggested by, the forward-looking statements. A number of factors could cause results and developments to differ materially from those expressed or implied by the forward-looking statements herein, including, without limitation, the risks and uncertainties included in the company’s Annual Report for the year ended 31 December 2021, which should be read in conjunction with the company’s public disclosures (available on the company’s website (www.mainstaymedical.com). The forward-looking statements herein speak only as of the date of this announcement.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220923005133/en/
Contact information
PR and IR Enquiries:
L
ifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com
FTI Consulting (for Ireland)
Jonathan Neilan or Patrick Berkery
Tel. : +353 1 765 0886
Email: mainstay@fticonsulting.com
Mainstay Medical
Corporate Communications
Email: Media@mainstaymedical.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
INNIO to Supply Technology for a Landmark Project in Texas, Reinforcing Grid Stability12.12.2025 10:59:00 EET | Press release
INNIO Group, a leading energy solution and service provider, is collaborating with the U.S. power utility Greenville Electric Utility System (GEUS) on a landmark 104-megawatt (MW) power plant. The new plant is designed to help reinforce grid stability, cover peak loads, and enable greater integration of renewable energy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251211712708/en/ Jenbacher J920 FleXtra “This project is a milestone for Texas and for INNIO. With fast-start capability, flexibility, and sustainability, we are creating the energy infrastructure that modern grids need: reliable, growth-promoting, and supporting the expansion of renewables,” said Dr. Olaf Berlien, President and CEO of INNIO Group. Groundbreaking for the plant’s construction took place in early December, with commissioning scheduled for summer 2027. The groundbreaking marks the beginning of the largest installation to date of Jenbacher J920 FleX
Kioxia Develops Core Technology that Will Allow the Practical Implementation of High-density, Low-power 3D DRAM12.12.2025 07:24:00 EET | Press release
Kioxia Corporation, a world leader in memory solutions, today announced the development of highly stackable oxide-semiconductor channel transistors that will enable the practical implementation of high-density, low-power 3D DRAM. This technology was presented at the IEEE International Electron Devices Meeting (IEDM) held in San Francisco, USA, on December 10, and has the potential to reduce power consumption across a wide range of applications, including AI servers and IoT components. In the era of AI, there is growing demand for DRAM with larger capacity and lower power consumption that can process large amounts of data. Traditional DRAM technology is reaching the physical limits of memory cell size scaling, prompting research into the 3D stacking of memory cells to provide additional capacity. The use of single-crystal silicon as the channel material for transistors in stacked memory cells, as is the case with conventional DRAM, drives up manufacturing costs, and the power required t
BEYOND Developments Reveals a New Vision for Purposeful Living on Dubai Islands with SIORA11.12.2025 19:02:00 EET | Press release
BEYOND Developments, the bold and design-led real estate developer shaping next-generation waterfront destinations in the UAE, today unveiled SIORA, its first beachfront masterplan on Dubai Islands and the company’s second large-scale community within a year. The launch underscores BEYOND’s accelerated growth and strong alignment with Dubai’s future urban vision. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251211014389/en/ BEYOND Developments - SIORA Masterplan at sunset - Dubai Islands (Photo: AETOSWire) Spanning over 2M square feet, SIORA is conceived as a coastal sanctuary inspired by Japanese garden philosophies, including the pursuit of Ikigai, the Japanese concept of finding purpose and fulfilment in everyday life. In this context, it reflects a philosophy of creating spaces that bring clarity, balance, and a sense of meaning, where architecture nurtures wellbeing and restores harmony between people, nature, and pla
3Degrees Welcomes David Dines to Board of Directors11.12.2025 18:00:00 EET | Press release
3Degrees, a global leader in renewable energy and climate solutions, is pleased to announce the appointment of David Dines to its Board of Directors, effective December 8, 2025. Dines brings more than four decades of leadership experience across global energy, commodities, financial services, transportation, and industrial markets. He served on the executive team as Chief Financial Officer and Corporate Senior Vice President at Cargill, Inc., the largest privately held company in the United States, where he oversaw enterprise-wide financial strategy, capital deployment, and financial performance. During his 29-year career at Cargill, Dines led multiple global businesses, played key roles in major technology and process transformations, and was a member of Cargill’s Commodity Risk, Financial Risk, and Process, Data, and Technology Committees. “We are thrilled to welcome David to the 3Degrees board,” said Philippe Vedrenne, CEO, 3Degrees. “He has an exceptional command of financial stewa
ITC Infotech wins PTC Partner Network Award for FY25 in the PLM Category11.12.2025 16:40:00 EET | Press release
ITC Infotech, a leading global technology services and solutions provider, has been awarded the PTC Partner Network Award for FY25 in the Product Lifecycle Management (PLM) category. This prestigious recognition, awarded to a single partner globally, celebrates excellence in deploying Enterprise PLM software, enabling global and cross-functional teams to effectively manage product data and providing a trusted system for product information. The award underscores ITC Infotech’s leadership in PLM-led digital transformation, as well as its strategic alignment with PTC’s Intelligent Product Lifecycle vision, which helps customers build a structured product data foundation that serves as the backbone for AI-driven transformation. Through its specialized DxP Services, ITC Infotech has helped enterprises transform and modernize their product development lifecycle processes, seamlessly transition to SaaS ecosystem and build digitally connected, intelligent and future-ready solutions to acceler
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom