MAINSTAY-MEDICAL
19.3.2024 13:01:29 CET | Business Wire | Press release
Mainstay Medical Holdings plc today announced the publication of the 5-year follow up from the ReActiv8-B randomized, sham-controlled, double-blinded trial. There were 126 patients who completed the 5-year follow up, and the published data clearly indicated that ReActiv8® Restorative Neurostimulation is a long-term, effective, durable, and safe therapy. ReActiv8 is the only restorative therapy for patients suffering from non-surgical, mechanical CLBP evidenced by multifidus dysfunction.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240319164677/en/
The long-term responses across pain, disability, and health-related quality of life measures are shown in the following graphs. (Graphic: Business Wire)
The publication is available here:
https://www.sciencedirect.com/science/article/pii/S1094715924000552
The ReActiv8-B study saw multiple patients have their implants removed for resolution of back pain. These removals for success suggest a restorative mechanism, and the therapy shows no evidence of the loss of efficacy commonly observed with palliative treatments.
Dr. Chris Gilligan, Chief Medical Officer and Chief Quality Officer at Robert Wood Johnson University Hospital, stated: “The long-term, durable patient outcomes from this study are unprecedented in the field of neuromodulation. This is truly a unique therapy that is restorative in nature and does not show any of the loss of efficacy seen with other treatments in our field. With 5 year published outcomes, we are no longer limited to providing temporary or palliative treatments to our patients. ReActiv8 is changing the way we treat properly selected patients.”
Jason Hannon, CEO of Mainstay Medical, stated: "We are proud to have the only commercially available device with a strong safety profile and long-term, peer-reviewed evidence supporting the rehabilitation of this severely affected patient population. We look forward to sharing this data with our physician customers and their patients, as well as using it to further engage managed care organizations in the United States to expand commercial insurance access to this incredible therapy.”
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/20240319164677/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
Riskified Named to the CNBC World's Top Fintech Companies 2026 List23.7.2026 14:00:00 CEST | Press release
Payment category recognition marks Riskified's continued presence among the world's leading fintech innovators Riskified (NYSE: RSKD), a global leader in ecommerce fraud detection and risk intelligence, has been named to CNBC's World's Top Fintech Companies 2026 list, in the Payments category. The list, now in its fourth edition, is produced by CNBC in partnership with Statista Inc., the global statistics and industry ranking firm. It was announced on July 22, 2026, and is available on CNBC's website. This is Riskified's second time making the list. The company previously earned this recognition in 2024, reinforcing its position in the ecommerce fraud and risk intelligence sector and underscoring its ongoing success in empowering businesses to grow revenue and profitability by mitigating risk through its AI-powered platform. CNBC and Statista's ranking covers the top 500 companies across eight fintech segments — Payments, Neobanking, Alternative Financing, Wealth Technology, Digital As
Azafaros Completes Enrollment of Phase 3 (NAVIGATE) Study Evaluating Nizubaglustat for the Treatment of Patients with GM1/GM2 Gangliosidoses23.7.2026 13:00:00 CEST | Press release
NAVIGATE comprises two pivotal Phase 3 studies investigating nizubaglustatRecruitment completed in Phase 3 registrational study in patients with late-infantile and juvenile GM1/GM2 gangliosidosesEnrollment in Niemann-Pick type C disease (NPC) Phase 3 study is ongoingTopline data from GM1/GM2 gangliosidoses Phase 3 study is anticipated in early 2028 Azafaros, a private company building a portfolio of disease-modifying therapeuticsto become a leader in lysosomal storage disorders (LSDs) focused on addressing neurological symptoms, today announced the completion of patient recruitment in its Phase 3 study evaluating nizubaglustat for the treatment of GM1/GM2 gangliosidoses. “Completing enrollment in our Phase 3 GM1/GM2 study is a significant step toward potentially bringing nizubaglustat to patients and families living with these devastating neurodegenerative diseases," said Stefano Portolano, Chief Executive Officer at Azafaros. "We are deeply grateful to the patients, caregivers, invest
Francisco Partners Closes $21 Billion Across Flagship and Agility Funds23.7.2026 13:00:00 CEST | Press release
Largest fundraise in the firm’s history brings total capital raised to more than $75 billion Francisco Partners (“FP”), a leading global investment firm that specializes in partnering with technology companies, today announced the closing of $21 billion in capital commitments across its Francisco Partners VIII, L.P. flagship fund and Francisco Partners Agility IV, L.P., its middle-market fund. FP exceeded its initial targets of $14.0 billion and $3.5 billion, respectively. This milestone builds on Francisco Partners' longstanding track record of performance, underscored by its distinction as the only firm to rank among the top three performers in each of the past six HEC-Dow Jones Large Buyout Performance Rankings.* “In our business, long-term success is created through a series of relationships built on years of trust and collaboration," said Dipanjan (“DJ”) Deb, Co-Founder and CEO of Francisco Partners. "We want to thank our investors for their support, our management teams for their
Taiwanese ensembles showcase erhu and ocarina at Prague Folklore Days23.7.2026 10:21:00 CEST | Press release
The Prague Folklore Days 2026 was held on July 17 and 18 in the heart of Prague, bringing together 56 international arts groups from Germany, Austria, Slovakia, Spain, the Netherlands, and Poland. Four Taiwanese groups took part: Hildebrand Yu’s ocarina band, the Shi-xian Huqin Orchestra, the Taipei Folk Orchestra, and the Four Strings Ensemble. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722841530/en/ Taiwanese ensembles showcase erhu and ocarina at Prague Folklore Days Led by Huang Chun-sin, the official Taiwan representative band featured a diverse lineup of ocarina, erhu, and dance performers. Their program stood out among the European groups with its distinctive character and vivid stage presence. Hildebrand Yu’s ocarina band captivated audiences with warm, uplifting melodies accompanied by the ocarina and ukulele. Yu also performed “Twilight Waltz,” delivering a heartfelt piece of poetic expression, like sunlight
Taiwan Children’s Choirs Garner Major Awards at Hungarian Choral Competition23.7.2026 09:33:00 CEST | Press release
Competing against 36 leading contenders from 20 countries, four Taiwanese children’s choirs have garnered several major awards and top honors at the 5th Budapest International Choral Celebration, showcasing Taiwan’s cultural diversity and music excellence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722613876/en/ Puzangalan Children’s Choir and Yo Wu Wei Children’s Chorus join forces with international choral ensembles and orchestras to perform Mozart’s Requiem Mass in D minor, K. 626 at the Béla Bartók National Concert Hall of Müpa Budapest. With its pure, angelic voices and exceptional vocal techniques, Puzangalan Children’s Choir from Pingtung County won the top prize, Laurea Summa Cum Laude, in the Grand Prix Competition’s Youth Choir of Equal Voices, Folklore, and Sacred Music categories. In the Open Competition, Yo Wu Wei Children’s Chorus claimed three gold prizes in the categories of Youth Choir of Equal Voices
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