Pain, Intractable

DUBLIN--( BUSINESS WIRE )--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.libproxy1.nus.edu.sg/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 patients with >50% pain reduction Mean Oswestry Disability Index (ODI) Score Mean EQ-5D Quality of Life Score 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.

CARLSBAD, Calif.--( BUSINESS WIRE )--Nalu Medical, Inc. (Nalu), a private company focused on innovative, minimally invasive, and non-pharmacologic solutions for chronic neuropathic pain, announced today the closing of an incremental $20M in equity financing from new investor B Capital, bringing the total Series E round of equity investment to $85M. Series E was led by Novo Holdings (Novo) with $65M of the total closing in late-December 2023. Also participating in the round were all existing significant investors: Gilde Healthcare, MVM Partners, Endeavour Vision, Decheng Capital, Longitude Capital, Advent Life Sciences, Pura Vida, and Aperture Venture Partners. “The Nalu Team is committed to addressing the unmet needs of patients suffering from chronic intractable neuropathic pain. We believe that our highly capable technology and uniquely small implant will elevate the standard of care in peripheral nerve stimulation (PNS) while being disruptive to the established spinal cord stimulation (SCS) market,” said Tom West, President and CEO of Nalu. “We are proud that our efforts serve the greater well-being of patients who suffer from chronic pain, and we are grateful for B Capital’s support in fulfilling and accelerating our mission.” “The unique, clinically proven Nalu Neurostimulation System has the potential to address the unmet needs of millions who suffer from chronic neuropathic pain,” said Dr. Robert Mittendorff, Head of Healthcare and General Partner at B Capital. “We look forward to partnering with Nalu’s talented management team and strong syndicate of investors at a time of high revenue growth and potential for the company.” The proceeds from this financing will be used to accelerate commercial growth, expand clinical and health-economic evidence, continue product development, and scale operations. Nalu will continue to invest in building clinical data that provide physicians with clear evidence of its benefits while also serving as the basis for expanded access and payor coverage. About Nalu Medical Nalu is a Carlsbad, California-based medical technology company focused on developing and commercializing innovative and minimally invasive solutions for patients with chronic neuropathic pain. The Nalu Neurostimulation System delivers gentle electrical pulses to the nervous system to modulate pain signals before they get to the brain. The Nalu System was designed to address major unmet needs in the treatment of chronic neuropathic pain and provide a differentiated value proposition for patients and physicians. About the Nalu Neurostimulation System The Nalu System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG) that is powered wirelessly by an externally worn Therapy Disc and controlled through a smartphone-based remote-control app. Despite its small size, the Nalu micro-IPG™ delivers treatment capabilities similar to larger IPGs as well as unique advantages associated with advanced waveforms, extensive programming options, exceptional upgradability, and an expected service life of 18 years. The Nalu System has been repeatedly recognized for its revolutionary technology. It is FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications. To learn more, visit www.nalumed.com . Indications for Use Spinal Cord Stimulation (SCS) — The Nalu SCS System is indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (≤30 days) to determine efficacy before recommendation for a permanent (long-term) device. Peripheral Nerve Stimulation (PNS) — The Nalu PNS System is indicated for pain management in adults who have severe chronic intractable pain of peripheral nerve origin as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Nalu Neurostimulation System for PNS is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (≤30 days) to determine efficacy before recommendation for a permanent (long-term) device. Nalu, the Nalu logo, and micro-IPG are trademarks of Nalu Medical, Inc. All rights reserved. About B Capital B Capital is a multi-stage global investment firm that partners with extraordinary entrepreneurs to shape the future through technology. With $6+ billion in assets under management across multiple funds, the firm focuses on seed to late-stage venture growth investments, primarily in the enterprise, financial technology, and healthcare sectors. Founded in 2015, B Capital leverages an integrated team across nine locations in the US and Asia, as well as a strategic partnership with BCG, to provide the value-added support entrepreneurs need to scale fast and efficiently, expand into new markets, and build exceptional companies. For more information, visit www.b.capital .

DUBLIN--( BUSINESS WIRE )--Mainstay Medical Holdings plc today announced an equity financing in which it will receive gross proceeds of US$125 million. Mainstay intends to use the funds to support the company’s continued commercial growth of ReActiv8 ® Restorative Neurostimulation in the U.S., Europe and Australia, additional post-market clinical studies and research, and general operations. The financing was co-led by new investors Gilde Healthcare and Viking Global Investors. Key existing investors who participated in the financing include Ally Bridge Group, Sofinnova Partners (Crossover Fund), Fountain Healthcare Partners, and Perceptive Advisors. “ A financing of this magnitude will allow us to accelerate our efforts to revolutionize the treatment of mechanical low back pain through ReActiv8 Restorative Neurostimulation, including by continuing our rapid commercial growth and building on our insurance coverage for ReActiv8,” said Jason Hannon, CEO of Mainstay Medical . “We are now strongly capitalized to execute on our corporate objectives. In addition to commercial expansion in our target markets, these objectives include the generation of additional clinical and health economic data to further demonstrate that ReActiv8’s purpose-built, restorative approach to the treatment of mechanical chronic low back pain is superior to competitive therapies originally designed for other indications, as well as the continued development and enforcement of our dominant intellectual property portfolio. ” “ We are excited to lead this financing and to work with Mainstay to continue to unlock the potential of ReActiv8 therapy,” said Geoff Pardo, Partner at Gilde Healthcare , who also joins the Mainstay Medical Board of Directors . “Patients with mechanical chronic low back pain have had very limited treatment options, and the restorative mechanism of action offered by ReActiv8 is both unique and very promising .” Two extraordinary general meetings of Mainstay shareholders were held on 23 February 2024 to approve the financing and related matters. At the EGMs, all resolutions were duly passed. The results of the voting on each of the resolutions is available on the Company’s website. 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 funding needs, strategies, alternatives and transactions, ability to fund its objectives moving forward, commercial efforts and performance, research studies and results, financial position, 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.