Nexstim Plc Business and Clinical Update Q3 2022

press release, Helsinki, 20 October 2022 At 9 o’clock (EST)

Nexstim Plc Q business and clinical update3 2022

Nexstim Plc (NXTMH:HEX, NXTMS:STO) (“Nexstim” or the “Company”) announces key highlights of the Company’s business and clinical operations for the third quarter of 2022.

Business and clinical update from CEO Mikko Karvinen

After the first positive operating result in the company’s history in the first half of 2022, our business continued to develop positively in the third quarter of 2022. In line with our key strategic objective, we continue to grow profitably in net sales and lead to our first operationally profitable year while minimizing future equity requirements.

We continued to grow our Diagnostics (NBS) and Therapy (NBT®) businesses with new system sales in our key markets of the United States and Europe. Between July and September 2022 we delivered a total of 4 new NBS systems and one new NBT® system. In addition to the systems already delivered mentioned above, at the end of Q3 2022 we had an open backlog of undelivered systems of a total of 2 NBS systems.

In the diagnostics business, to date, the NBS system has been sold to more than 210 research universities and leading hospitals around the world. In our fall sales and marketing efforts, we have invested in the key international events in our area as key travel restrictions related to the COVID-19 pandemic have been lifted. I would consider our participation in the International Congress of Clinical Neurophysiology (ICCN), held in Geneva in September, and the Congress of Neurological Surgeons (CNS) Annual Meeting in San Francisco in October, to be the most influential of these events. In Finland, we participated in the Finnish Association for Clinical Neurophysiology’s annual event to celebrate the association’s 50th anniversaryth anniversary this year. It was great meeting both current and new potential clients. We are very pleased with the ever-growing interest in using the Nexstim system in both diagnostic and therapeutic applications.

In the therapy business, at the end of Q3 2022, a total of 62 Nexstim systems with therapy capabilities were installed worldwide (24 in the US and 38 in Europe and the rest of the world) for the treatment of depression and chronic neuropathic pain. This number includes both NBT® systems and NBS systems with the additional NBT® software option installed. Nexstim’s NBS system with SmartFocus® nTMS differs greatly from other TMS products currently available due to its unique and sophisticated 3D navigation that uses its proprietary E-Field algorithm to determine the exact location, orientation and extent of the visualize stimulation.

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In February, we announced the sale of our technology license for the NBT® System to Magnus Medical, Inc. The total value of the agreement is approximately EUR 17 million. The license agreement puts Nexstim in a unique position to realize financial benefits, expand the use of our technology in patient care and reallocate our resources to other business areas during the license term. In September, Magnus Medical announced that it had received 510(k) clearance from the US Food & Drug Administration (FDA) for its SAINT™ technology. According to its media release, Magnus Medical expects the commercial launch of the technology to begin in 2023. At Nexstim, we base our own estimates of the start of the royalty period of the License Agreement on this information that Magnus Medical has released regarding its expectations of the public commercialization plan.

Our key strategic goals for 2022 also include expanding Nexstim’s network of exclusive partner clinics, particularly in the United States. This includes the installation of Nexstim systems in neuroscience centers according to our revised strategy, mainly in collaboration with our partners. Our new partnerships focus on strategic investments in Management Services Organizations (MSO), particularly in the huge US market, but partnerships are also possible to make targeted investments in European and Asian markets.

Our first strategic partnership in the US with PNC Management Services, LLC and Dr. Kuluva got off to a good start. We believe that this cooperation offers excellent opportunities for us to continue to grow in the future. In order to enable further growth through the expansion of the network of exclusive partner clinics in the USA, we have founded a private equity company. As we near the end of 2022, we will continue to work hard to expand the network. We look forward to these future partnerships that will enable treatments for a growing number of patients in the United States with Nexstim’s TMS technology.

In early October, we reported the clinical results of the first 403 patients who completed Nexstim SmartFocus® rTMS treatment with the Nexstim NBT® System for major depressive disorder (MDD). The Nexstim NBT® System is indicated for the treatment of MDD in adult patients who have not achieved satisfactory improvement with prior antidepressant medication in the current episode. The treatment outcomes of these 403 patients were excellent: approximately 50% were in remission at the end of treatment and 76% had achieved a clinical response. These results are significantly higher than what is typically reported for MDD with TMS systems: in a well-conducted multisite study, remission rates were 26.5-28.7% and patient-reported response rates were 41.5-56, 4%1. Patient-reported remission and response rates are also higher than in a large sample of more than 3,800 patients who completed clinical rTMS treatment (remission 29.7-36.2%, response 62.7-70.4 %).2. We will continue to collect this invaluable data for the remainder of 2022.

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Our system differs significantly from the TMS systems currently on the market without navigation capability. In the future, the need for a navigation capability is likely to be even more emphasized in technologies that could treat patients in the hospital with severe, treatment-resistant depression (TRD) and possible suicidal thoughts. This could potentially open a new TMS treatment market for Nexstim that is separate from the current treatment of patients with MDD. Gathering more data on patient outcomes with the intensified accelerated treatment protocols is important to our company’s strategic development path.

The pilot study at Kuopio University Hospital continues. It examines the use of the accelerated iTBS protocol in the treatment of major depression with the Nexstim NBT® System. Accelerated iTBS means transcranial magnetic stimulation therapy (TMS), which involves stimulating several times a day for a week, while conventional TMS therapy involves stimulating once a day for several weeks.

In continuation of the previously reported pilot study, the effectiveness of the accelerated iTBS protocol will be tested on a further 20 patients. We currently anticipate that treatments will continue through the end of 2022. Nexstim is actively monitoring the continuation of treatment and results will be reported as soon as possible after completion.

As we invest in growth, we actively monitor the global political landscape, which has been transformed by the war in Ukraine. We unequivocally condemn Russia’s military action in Ukraine and hope that the conflict will be resolved quickly and peacefully. Despite international tensions, our outlook for 2022 remains positive.

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At Nexstim, we continue to work purposefully to enable personalized and effective therapies and diagnostics for challenging brain diseases and disorders. We firmly believe that our work supports the growth of shareholder value over the long term, in the form of stronger competitive advantages, rapid growth and better financial performance. While we look to the future with optimism, we will continue to closely monitor both the situation in Ukraine and the coronavirus pandemic as we advance our business.

1) Zimmerman L. et al. Transcranial magnetic stimulation (TMS) for major depression: a multi-site, naturalistic, observational study of acute treatment outcomes in clinical practice. suppress fear. 2012 Jul;29(7):587-96. Epub June 11, 2012.

2) Sackheim, H. et al. Clinical results in a large registry of patients with major depressive disorders treated with transcranial magnetic stimulation. Journal of Mood Disorders 277 (2020) 65–74

Visit the website for more information www.nexstim.comor contact:

Mikko Karvinen, chairman
+ 358 50 326 4101
[email protected]

About Nextstim Plc

Nexstim is a Finnish, global, growth-oriented medical technology company. Our mission is to enable personalized and effective diagnostics and therapies for challenging brain diseases and disorders.

Nexstim has developed a world-leading non-invasive brain stimulation technology for navigated transcranial magnetic stimulation (nTMS) with advanced 3D navigation that allows accurate and personalized targeting of the TMS to the specific area of ​​the brain.

Nexstim’s Diagnostics business is focused on commercializing the Navigated Brain Stimulation (NBS) system. The NBS System is the only FDA-cleared and CE-marked navigated TMS system for preoperative mapping of the speech and motor cortices of the brain.

Nexstim’s Therapy business markets and sells the Navigated Brain Therapy (NBT®) system, which is FDA cleared for marketing and commercial distribution for the treatment of major depressive disorder (MDD) in the United States. In Europe, the NBT® System is CE marked for the treatment of major depression and chronic neuropathic pain.

Nexstim shares are listed on Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden.

Visit www.nexstim.com for more information

  • Nexstim Business Clinical Update Q3 2022 Press Release_20102022_FINAL_EN

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