DUBLIN, Ireland – (BUSINESS WIRE) – January 6, 2022–
Mainstay Medical Holdings plc today announced the release of two-year patient outcome data from its pivotal clinical trial ReActiv8-B. The data, published in the journal of the International Neuromodulation Society, Neuromodulation, confirm the efficacy and safety of ReActiv8 restorative neurostimulation, and also demonstrate compelling long-term durability and improvement over time on key outcome measures in the treatment of chronic intractable low back pain.
On virtually all of the key efficacy measures, 2-year data showed improvements over 1-year patient visit data. To note :
|
Outcome measurement |
Result at 2 years (N = 156) |
Result at 1 year (N = 176) |
|
Patients reporting pain intensity (VAS score) reduced by 50% or more from baseline |
71% |
64% |
|
Patients reporting a reduction of more than 20 points in the Oswestry Disability Index |
61% |
57% |
|
Patients reporting a VAS score |
65% |
52% |
|
Patients taking opioids initially who have intentionally eliminated or reduced opioid use |
60% |
48% |
Dr Chris Gilligan, Director of the Brigham and Women’s Spine Center at Brigham and Women’s Hospital and Assistant Professor of Anesthesia at Harvard Medical School, said: ” Recently published data from the ReActiv8-B clinical trial showed clinically significant improvements in pain and function in patients with refractory chronic low back pain who received two years of neurostimulation. Pain scores in patients have significantly decreased from an average of 7.3 to 2.4 and are maintained for a period of 2 years and more with ongoing data collection. These long-term data are extremely important and encouraging given the chronic and refractory nature of this disease. “
“These impressive results represent an important milestone for Mainstay, as the profound improvements in patient outcomes that we have seen from baseline at 1 year to 2 years validate the restorative nature of therapy and represent a new paradigm among treatments. available for patients with chronic intractable lower back. pain,”notedJason Hannon, CEO of Mainstay Medical. “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 critically affected patient population, evidence that continues to grow. expand through multiple clinical trials. “
The full publication can be downloaded free of charge from https://www.sciencedirect.com/science/article/pii/S1094715921063868. The ReActiv8-B trial patient cohort continues to be evaluated to generate additional data on longer-term efficacy.
About ReActiv8®
ReActiv8 is an implantable medical device designed to treat adults with chronic intractable low back pain (LCBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be shown by imaging or physiological tests in adults who have failed treatment, including pain relievers and physiotherapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in multiple geographies and is commercially available in the European Economic Area, Australia, United Kingdom, and United States.
About the ReActiv8-B clinical trial
The ReActiv8-B clinical trial is an international, multicenter, prospective, randomized, active simulation-controlled, blinded, unidirectional crossover trial conducted under an Investigational Device Exemption (IDE) from the FDA. A total of 204 patients with chronic low back pain unresponsive to physiotherapy and medical management were implanted with ReActiv8 at major clinical sites in the United States, Europe and Australia and randomized 1: 1 for therapy or treatment. control. In the treatment group, the ReActiv8 pulse generator was programmed to deliver electrical stimulation believed to cause episodic contractions of the multifidus muscle. In the control group, the ReActiv8 device was programmed to provide a low level of electrical stimulation. Following the 120-day primary endpoint assessment, patients in the control group crossed over to receive levels of electrical stimulation similar to those in the treatment group.
Clinical trial funded by Mainstay Medical. Principal investigator of the trial, Dr. Chris Gilligan, is a consultant with Mainstay Medical. You can find information about the study at https://clinicaltrials.gov/ct2/show/study/NCT02577354.
About Mainstay Medical
Mainstay Medical is a medical device company focused on the commercialization of 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 contained in this announcement other than statements of historical fact are, or may be considered, forward-looking statements. These forward-looking statements may include, without limitation, statements regarding the intentions, beliefs or current expectations of the company regarding, among other things, the company’s business efforts and performance, financial condition, financing strategies. , product design and development, regulatory applications and approvals, and repayment terms.
Forward-looking statements involve risks and uncertainties and are not guarantees of future performance. Actual results may differ materially from those described or suggested by 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 possibility that future clinical results may not correspond. previous reported results; the potential for business results below expectations; and other risks and uncertainties included in the company’s annual report for the year ended December 31, 2020, which should be read in conjunction with the company’s public information (available on the company’s website, www.mainstaymedical.com ). The forward-looking statements herein speak only as of the date of this announcement.
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SOURCE: Mainstay Medical Holdings plc
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PUB: 06/01/2022 12:31 / DISC: 06/01/2022 12:32
