MAINSTAY-MEDICAL
12.3.2024 13:01:34 CET | Business Wire | Press release
Mainstay Medical Holdings plc today announced the publication of a pooled analysis of three different clinical studies that evaluated the safety and efficacy of ReActiv8 therapy after two years in patients of various ages. The analysis, published in Regional Anesthesia & Pain Medicine, included 261 patients across the ReActiv8-B, ReActiv8-C, and PMCF studies, with the results demonstrating that age is not a factor when utilizing ReActiv8 to treat intractable mechanical chronic low back pain patients with multifidus dysfunction.
The publication can be found here: https://rapm.bmj.com/content/early/2024/03/08/rapm-2023-105032
There were no statistically significant or clinically meaningful differences between the groups in the magnitude or durability of response across pain, disability, or health-related quality of life measures. A summary of some of the data from the analysis for patients at two years of ReActiv8 therapy is as follows:
|
Percentage of
|
Mean Oswestry
|
Mean EQ-5D
|
Patients aged 56-82 (n=65) |
62% |
23.4 |
0.763 |
Patients aged 56 and below (n=196) |
66% |
20.8 |
0.770 |
Dr. Simon Thomson MBBS FFPMRCA, Consultant Lead at the Pain and Neuromodulation Centre, Mid and South Essex University Hospitals NHS, Essex, UK and the London Clinic, former President of International Neuromodulation Society (INS), stated: “Restorative Neurostimulation has proven to be a unique therapy that delivers consistent results in randomized, controlled and real-world studies. Until now it was unknown if age was a factor in predicting long-term outcomes. This pooled analysis demonstrates that properly selected patients can benefit from this therapy, irrespective of age.”
Jason Hannon, CEO of Mainstay Medical, stated: “High quality clinical evidence sets us apart in this industry. We study, learn, and demonstrate outcomes in patient populations before we suggest ReActiv8 is beneficial to a particular group of patients. This is how we partner with clinicians to deliver the best possible, and most durable, treatments for their patients. With these exciting results demonstrating the value of ReActiv8 across all studied age groups, we can now confidently support identification of older patients who are likely to benefit from the therapy. We look forward to continuing to partner with physicians to help chronic low back pain patients of all ages, and to growing the global body of peer-reviewed evidence supporting the ability of ReActiv8 to provide positive long-term outcomes.”
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.
Mainstay 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 clinical outcomes, commercial efforts and performance, research studies and results, financial position, financing strategies, product design and development, intellectual property portfolio and its scope, 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 2022, 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/20240312978913/en/
About Business Wire
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
Svante Acquires Carbon Dioxide Removal Project Developer, Carbon Alpha Corp.4.3.2026 16:00:00 CET | Press release
Svante acquires Carbon Alpha to accelerate commercial-scale carbon removal & expand its CCS/BECCS project development business in Western Canada. Acquisition adds the North Star BECCS Project, developed in partnership with the Meadow Lake Tribal Council, advancing the market for durable and verifiable CDR credits. The transaction strengthens Svante’s fully integrated carbon management platform, adding CO₂ storage expertise, a regional pipeline & a major geological storage hub. Svante Technologies Inc. (Svante), a leader in carbon management, and Calgary-based Carbon Alpha Corporation (Carbon Alpha) today announced that Svante has acquired Carbon Alpha and its related subsidiaries, including Carbon Alpha Development Corp. and its ownership interests in North Star Carbon Solutions Corp. and North Star Carbon Solutions Limited Partnership, a project developer for carbon capture and storage (CCS) in Western Canada. With this transaction, Carbon Alpha’s flagship North Star Bioenergy Carbon
Binarly Announces Leadership Transition as Enterprise Demand Accelerates for Supply-Chain Security4.3.2026 16:00:00 CET | Press release
Binarly, the industry leader in software and firmware supply‑chain security, today announced a leadership transition as the company enters its next phase of growth. Founder and current CEO Alex Matrosov has joined the company’s Board, and Gwenyth Castro has joined as Chief Executive Officer to scale global go-to-market and enterprise growth. Binarly developed its Transparency Platform on a unique, patented technology core designed to help the world’s largest enterprises identify and reduce third-party software risk across complex environments. The platform is trusted by organizations including Meta and Dell, among others. “We built Binarly to solve a problem the industry kept ignoring: you can’t secure what you can’t see,” said Alex Matrosov, Founder of Binarly. “Over the last five years, this team turned deep program analysis and vulnerability research into a platform trusted by some of the world’s most demanding enterprises. Now, as AI accelerates how software is built and shipped, t
Unleash Raises $35M Led by One Peak to Help Enterprises Ship AI-driven Software Faster, Safer, and Smarter4.3.2026 15:00:00 CET | Press release
Unleash, the open-source FeatureOps company, today announced a $35 million Series B financing led by One Peak, with participation from existing investors Spark Capital, Frontline Ventures, and Firstminute Capital. The new funding will be used to accelerate product innovation and global expansion as enterprises confront the opportunities and risks of AI-accelerated software delivery. AI has dramatically accelerated software development, creating a generational opportunity for anyone in an enterprise to turn ideas, prompts, and prototypes into applications. But AI has also outpaced the systems designed to control software delivery. DORA research shows that a 25% rise in AI adoption correlates with a 7% drop in software stability. Enterprises are shipping code 2-3x faster with AI, yet outages caused by uncontrolled feature rollouts and missing kill switches are costing businesses millions in lost revenue, prolonged customer downtime, and brand damage. FeatureOps is emerging as the missing
Capcom’s Resident Evil Requiem Surpasses 5 Million Units!4.3.2026 15:00:00 CET | Press release
– Worldwide acclaim contributed to strong sales – Capcom Co., Ltd. (TOKYO:9697) today announced that worldwide sales of Resident Evil Requiem, released on February 27, 2026, surpassed 5 million units. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260304446142/en/ Resident Evil Requiem Logo Resident Evil Requiem is the latest installment in the Resident Evil series, which celebrates its 30th anniversary this month. The title successfully elevated the essence of survival horror by heightening the interplay between intense fear and exhilarating action. Resident Evil Requiem was developed using RE ENGINE, Capcom’s proprietary game engine, which allowed the company to deliver visuals in photorealistic detail, including the characters’ skin, teary eyes, and flowing hair, as well as the translucency of light. In addition, the title offers a new game experience for a broad fanbase through multiple difficulty settings that accommoda
Siren Fusion 2026: The Convergence of People, Technology and Ideas4.3.2026 14:30:00 CET | Press release
An Invitation-Only Summit for Global Intelligence, National Security and Investigative Leaders Siren today announced Siren Fusion 2026, its inaugural global summit convening senior investigators, national security leaders and AI innovators for a high-trust forum on the future of investigative intelligence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260304240853/en/ Siren Fusion 2026 is the convergence of people, technology and ideas, in Galway, Ireland. An invitation-only summit for global intelligence, national security and investigative leaders. Taking place in Galway, Ireland, Fusion is the deliberate convergence of people, technology and ideas within a national security frame. Structured as an educational and strategic forum rather than a conventional conference, Fusion 2026 focuses on the issues that now define the intelligence and law enforcement agenda: Geopolitical instability AI-driven investigative transformati
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
