Business Wire

Mainstay Medical Announces Publication of Three-Year Patient Outcomes Data from ReActiv8-B Clinical Trial Demonstrating Long-Term Efficacy of ReActiv8® Restorative Neurostimulation ™

Share

Mainstay Medical Holdings plc today announced the publication of the three-year patient outcomes data from its pivotal ReActiv8-B clinical trial. The data, published in the journal of the International Neuromodulation Society, Neuromodulation,further establish the efficacy and safety of ReActiv8 Restorative Neurostimulation, including compelling long-term durability and improvement over time on key outcome measures in the treatment of intractable chronic low back pain.

The three-year data show improvements over results from the patients’ one-year and two-year visits on virtually all key efficacy measures. Of note:

Outcome measure

1-year result
(N = 176)

2-year result
(N = 156)

3-year result
(N = 133)

Patients reporting pain intensity (Visual Analog Scale (VAS) score) reduced by 50% or more from baseline

64%

71%

77%

Patients reporting a greater than 20-point reduction in Oswestry Disability Index

57%

61%

63%

Patients reporting VAS score < 2.5

52%

65%

67%

Patients taking opioids at baseline that voluntarily eliminated or reduced opioid use*

48%

60%

71%

*Percent of patients that were on opioids at baseline: (1-year=31/65), (2-Year= 34/57), (3-Year= 36/51).

Overall, 83% of patients experienced substantial and clinically meaningful improvements in pain or disability, or both, at three years.

Chris Gilligan, Director of the Brigham and Women’s Spine Center at Brigham and Women’s Hospital, assistant professor of Anesthesia at Harvard Medical School (Boston, USA), and Principal Investigator of the study, said: “The recently published data from the ReActiv8-B clinical trial continued to show clinically meaningful improvements in both pain and function for patients with refractory chronic low back pain who received three years of neurostimulation. The long-term trajectory and durability of clinical benefits are consistent with the restoration of neuromuscular control and muscle rehabilitation, which gives us confidence that we are able to treat the underlying cause of chronic low back pain in these patients.”

“Multifidus dysfunction in patients with chronic low back pain has historically been a challenging etiology for the spine surgeon community to properly treat,” saidFrank Schwab, Chair of Orthopedic Spine Surgery at Lenox Hill Hospital, and Chief of Orthopedic Spine Surgery for Northwell Health System.These patients are not indicated for surgery, with existing treatment options being temporary and palliative. ReActiv8 therapy has proven to maintain effectiveness long-term and provides this challenging patient population with a safe and restorative solution.”

Jason Hannon, CEO of Mainstay Medical, said: "These 3-year results further validate ReActiv8’s restorative mechanism of action, which treats a primary underlying cause of mechanical chronic lower back pain, multifidus dysfunction. 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, and we look forward to continuing to generate clinical and other research to compel physicians and their patients to further utilize the therapy.”

The full publication can be downloaded free of charge at Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction - ScienceDirect

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 future research studies, 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.

Contact information

PR and IR Enquiries:

LifeSci 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

Business Wire
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

Philip Morris International Announces New Regional Structure and Senior Management Changes to Accelerate Growth Toward a Smoke-Free Future25.11.2022 19:05:00 CET | Press release

Philip Morris International Inc. (PMI) (NYSE: PM) today announced a new regional structure and related senior management changes to enable continued growth as a multicategory leader internationally and advance its rapid transition toward a smoke-free future. “We are changing the company’s regional structure to further support the growth of our smoke-free business, reinforce consumer centricity, and increase the speed of innovation and deployment—all in alignment with our ambition of becoming a majority smoke-free business by net revenues by 2025,” said Jacek Olczak, PMI’s Chief Executive Officer. “The new structure will also create new opportunities to further grow our senior talent, deepening the bench of leaders who will spearhead PMI’s progress toward a smoke-free future for the years to come. I am confident of the exceptional caliber and determination of our people and wish them the best in their new roles.” By the end of January 2023, PMI will rearrange its operations in four regi

China’s Vanke Foundation presents fruitful green development achievements at COP2725.11.2022 15:44:00 CET | Press release

China’s Vanke Foundation invited dozens of Chinese charitable organizations, institutes and industry associations to present the fruitful achievements of China's green development at the recently concluded 2022 United Nations Climate Change Conference (COP27) in Sharm El-Sheikh. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221125005204/en/ Wang Shi(L4), Chairman of Vanke Foundation, and other Chinese delegates called for joint action on climate change at COP27 in Sharm El-Sheikh, Egypt on Nov. 11, 2022. (Photo: Business Wire) According to Wang Shi, Founder of Vanke Group, Chairman of Vanke Foundation, and Founder of C Team, only a few nongovernmental Chinese individuals, including himself, representing about 100 Chinese companies attended COP15 in Copenhagen back in 2009, while this year, together with numbers of partners from different sectors, approximately one million Chinese enterprises and institutions have been invol

Fruits Eco-Blockchain Project Completes its Security Audit of their Native Blockchain Conducted by Quantstamp25.11.2022 15:00:00 CET | Press release

Fruits Eco-Blockchain Project is pleased to announce their completion of a security audit of the Fruits Blockchain's contract system conducted by Quantstamp, a leader in web3 security. The focus of the audit was to verify that the smart contract system is secure, resilient and working according to its specifications. The audit activities can be grouped in the following three categories: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221120005089/en/ Fruits Eco-Blockchain Project completes its security audit of their native blockchain conducted by Quantstamp (Graphic: Business Wire) Security: Identifying security related issues within each contract and within the system of contracts. Sound Architecture: Evaluation of the architecture of this system through the lens of established smart contract best practices and general software best practices. Code Correctness and Quality: A full review of the contract source code. The prim

Abu Dhabi Hosts Annual Investment Meeting May 202325.11.2022 14:49:00 CET | Press release

Abu Dhabi will host the 12th edition of the Annual Investment Meeting from 8 to 10 May 2023, which will take place under the theme of “The Investment Paradigm Shift: Future Investment Opportunities to Foster Sustainable Economic Growth, Diversity, and Prosperity”. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221125005180/en/ Abu Dhabi Hosts Annual Investment Meeting May 2023 (Photo: AETOSWire) At a press conference held today in Abu Dhabi, the announcement of the launch of AIM Global 2023 which is supported by the Ministry of Industry & Advanced Technologies, with the Abu Dhabi Department of Economic Development (ADDED) as a lead partner was made in the presence of H.E. Dr. Thani bin Ahmed Al Zeyoudi, Minister of State for Foreign Trade, Vice Chairman of the UAE Industry Development Council and H.E. Mohamed Ali Al Shorafa, Chairman of ADDED. AIM Global 2023 pillars will discuss the global capital market transformation, way

Alberto Bona’s Exploit on the Class40 IBSA : Eighth at the Route Du Rhum25.11.2022 13:13:00 CET | Press release

Thursday, November, 24, at 3:34:50 pm local time (8:34:50 Paris-Rome time) in Pointe-à-Pitre, Alberto Bona on the Class40 IBSA crossed the finish line of the twelfth edition of the Route du Rhum in eighth place. His race time is 15 days, 6 hours, 19 minutes and 50 seconds. The skipper of the Class40 IBSA sailed the 3,542 miles between Saint-Malo and Pointe-à-Pitre at a speed of 9.67 knots on the great-circle course, actually covering 4005.51 miles at an average speed of 10.93 knots. He arrived in Pointe-à-Pitre 1 day, 3 hours, 11 minutes and 10 seconds after the Class40 winner, Yoann Richomme. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221125005116/en/ Alberto Bona on the Class40 IBSA crosses the finish line of the twelfth edition of the Route du Rhum (©IBSA | Beppe Raso) “A very nice but extremely hard regatta, especially in the upwind week”, stated Alberto upon arrival. “I am extremely happy: IBSA and I made it togethe

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