Mainstay Medical Announces Publication of Post-Market Clinical Trial Data from Ongoing ReActiv8®-C Study in Chronic Low Back Pain Patients
Mainstay Medical Holdings plc today announced the publication of data from a single center, real-world study with one-year clinical follow-up of patients selected from the ReActiv8®-C study. Patients implanted with ReActiv8 at Klinikum Itzehoe were consecutively included into this cohort if they presented with back pain ≥6 and no prior lumbar surgery. The one-year results, published in World Neurosurgery, showed that a majority of the 44 patients followed up with demonstrated statistically significant improvements in pain (NRS), disability (ODI) and quality of life (EQ-5D-5L).
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221122005230/en/
(Graphic: Business Wire)
This interim analysis indicates that the response to ReActiv8 for these patients is durable and the benefits improve over time, consistent with both a restorative mechanism of action and the ReActiv8-B randomized clinical trial results.
Dr. Med. Ardeshir Ardeshiri, Head physician of the Spine Surgery Section of the Clinic for Trauma Surgery and Orthopedics, Klinikum Itzehoe, said: “These favorable real-world data are consistent with the ReActiv8-B study, which is extremely important for me in adopting new technologies. I am excited to continue offering restorative neurostimulation with ReActiv8 for my patients with multifidus dysfunction resulting in chronic axial low back pain.”
Jason Hannon, CEO of Mainstay Medical, said: "These real-world results further validate ReActiv8’s restorative mechanism of action, which treats a primary underlying cause of mechanical chronic lower back pain, multifidus dysfunction. German physicians have been some of our foremost implanters of ReActiv8, and we look forward to continuing to make the therapy more broadly available to patients in this region.”
Link to publication of the study Real-World Evidence for Restorative Neurostimulation in Chronic Low Back Pain—a Consecutive Cohort Study - ScienceDirect
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 .
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, 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/20221122005230/en/
PR and IR Enquiries:
LifeSci Advisors, LLC
Tel: + 1 (212) 915-2578
FTI Consulting (for Ireland)
Jonathan Neilan or Patrick Berkery
Tel. : +353 1 765 0886
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
Tezos Foundation and Artist Misan Harriman Unveil First Works in Permanent Art Collection9.6.2023 18:42:00 EEST | Press release
Today, the Tezos Foundation, which promotes development on the Tezos blockchain, and Misan Harriman, the world-renowned photographer and activist, announced the first presentation of the Tezos Foundation Permanent Art Collection to celebrate artists and creators in the Tezos ecosystem. These works will be on display in a Digital Art Gallery, to be revealed on June 16 on the Collection’s website for public viewing. The initial presentation is just a fraction of the overall collection of over 2,000 works acquired between May 2022-2023 with a $1.2M USD endowment from the Tezos Foundation to Misan Harriman. Spearheaded by the Tezos Foundation and driven by Harriman, the initiative reflects the diversity of the digital art community in the Tezos ecosystem and showcases works by artists who span five continents and more than two dozen nationalities. The first online gallery is separated into three rooms - Who We Are, What We Become, and Tracks of Existence - which highlight important themes
Vertex Presents Data Demonstrating Significant Benefits of Long-Term Treatment With CFTR Modulators at the European Cystic Fibrosis Conference9.6.2023 18:00:00 EEST | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 12 scientific abstracts on the company’s portfolio of cystic fibrosis (CF) medicines were presented at this year’s European Cystic Fibrosis Society's (ECFS) 46th European Cystic Fibrosis Conference held June 7-10, 2023, in Vienna, Austria. Together, the data presented show the long-term benefits of treatment with CFTR modulators as well as the importance of treating the underlying cause of CF as early in life as possible. Key data presented at this year’s conference are highlighted below. Vertex presented an interim analysis (IA) of a registry-based study of real-world data collected from people with CF and treated with TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), also known in the European Union and in the U.K. as KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor, including over 16,000 people with CF from the Cystic Fibrosis Foundation Patient Registry (CFFPR) and nearly 3,00
Galtronics Improves Attendee Experience at NFL Stadiums and MLB Ballparks Nationwide9.6.2023 12:00:00 EEST | Press release
Galtronics, the company that combines collaboration with technology innovation to solve the world’s most complex wireless connectivity challenges, today announced distributed antenna system (DAS) upgrades across four major stadiums. Galtronics’ antennas will be deployed at Arrowhead Stadium, home of the defending Super Bowl Champion Kansas City Chiefs; Ford Field, home of the Detroit Lions; Bank of America Stadium, home of the Carolina Panthers; and T-Mobile Park, home of the Seattle Mariners. The recent upgrades will provide increased sectorization to drive higher levels of capacity and data speeds, allowing fans to stream other sporting events, keep up with fantasy team stats or share live event interaction over social platforms. In total, Galtronics is providing 705 antennas across the three stadiums and ballpark. The C-Band antenna upgrades range from HyperFlat (Ceiling mount Omni DAS Antenna), Small Panel antennas and a combination of 30x30 and 30x60 Stadium Panel Antennas. They w
Superior Graphite to Build 24.000 Ton Per Annum Active Anode Material Capacity at 1/3 the CapEx Cost9.6.2023 11:38:00 EEST | Press release
Superior Graphite, a leading producer of graphite, plans to construct a USD180 million anode materials facility to meet the accelerating demand for EV’s and energy storage in the North American and European markets. The company's state-of-the-art Anode Active Material (AAM) enables and accelerates the energy transition. The main facility will be in Hopkinsville, Kentucky, with additional capacity in Sundsvall, Sweden. Superior Graphite's innovative production technology and established operations at these locations result in a continuous production process, significantly reducing capital requirements and operational costs. "Our technology and product brands are trusted by high-volume customers worldwide. Our unique technology uses approximately 70% less electricity, labor, and space compared to traditional production processes. The carbon footprint is reduced by nearly 85%, and the cost savings for EV companies are substantial," says Ed Carney, CEO of Superior Graphite. Meeting the IRA
Mega Refining and Petrochemical Plant Selects Hytera as Provider of Professional Communications System9.6.2023 11:08:00 EEST | Press release
Hytera, a global leading provider of professional communication technologies and solutions, has been selected as the supplier of professional communications solution for the Yulong Island Refining and Petrochemical Integration Project in Shandong Province, China. Hytera won this public tender with its advanced professional digital trunking (PDT) infrastructure, control and dispatch system , network management system (NMS), digital voice recording system (DVRS), and intrinsically safe (IS) PDT two-way radios . This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230609005125/en/ PD790Ex Intrinsically Safe PDT Two-way Radio (Graphic: Business Wire) The Yulong project is the largest refining and petrochemical facility being constructed in China. With a projected overall production capacity of 40 million tons per year, this plant is a strategic venture aimed at driving economic growth, enhancing energy production capabilities, and pro
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