NXTMS Nexstim Ltd

Nexstim Plc Business Update Q3 2023

Nexstim Plc Business Update Q3 2023

Press release, Helsinki, 27 October 2023 at 9 AM (EEST)

Nexstim Plc Business Update Q3 2023

Nexstim Plc (NXTMH:HEX) (”Nexstim” or ”Company”) announces the key highlights of the Company’s business operations during Q3 2023.

CEO Mikko Karvinen’s Business Update

During the third quarter of 2023, we have continued our focus on projects that are crucial for the company's strategic competitive advantage, such as improving the company's cost efficiency through our new global team structures and marketing our new NBS 6 system in both the EU and US markets. In line with our main strategic objective, we have continued to focus on profitable net sales growth, targeting a positive EBITDA for the full financial year 2023, while minimizing future capital needs. We are also continuing discussions on new strategic partnerships to further scale the use of our technology.

We have continued to grow our Diagnostics (NBS) and Therapy (NBT®) Businesses with new system sales in our key markets in the United States and Europe. Between January and September 2023, we delivered a total of 9 new NBS systems and 2 new NBT® systems. In addition to these already delivered systems we had an open backlog of undelivered systems total of two NBS systems at the end of Q3 2023.

In the Diagnostics Business, about 220 NBS systems have been sold to research universities and leading hospitals across the world to date. Q3 2023 was an especially busy time in our sales and marketing activities, as we have continued investing in the most significant international events in our field. In September, we participated in the Congress of Neurological Surgeons (CNS) Annual Meeting held in Washington, DC, and took part in Multimodal EEG workshop: Integrating EEG and neuronavigated TMS techniques in Milan, Italy. We also took part in the Finnish clinical neurophysiology association’s annual event held in Kuopio, Finland this year. It has been a great pleasure to meet both current and new potential customers and engage into a lot of fruitful discussions about future needs in this area. We are very happy about the continuously growing interest towards using the Nexstim system in both diagnostic and therapeutic applications.

In the Therapy Business, at the end of Q3 2023 there were a total of 70 Nexstim systems with therapy capabilities installed worldwide (25 in the U.S. and 45 in Europe and the rest of the world) for the treatment of depression and chronic neuropathic pain. This number includes both NBT® systems as well as NBS systems with additional NBT® software option installed. Nexstim’s System with SmartFocus® nTMS is highly differentiated from other currently available TMS products due to its unique and highly sophisticated 3D navigation that uses its proprietary E-field algorithm to visualize the exact location, orientation, and magnitude of the stimulation.

Our second key strategic goal for 2023 is launching the new NBS 6 product, enabling easy-to-use systems and the use of future additional modules in the same system. The launch and development of the new product generation is an essential part of Nexstim’s operations during the 2020-2024 strategy period. The NBS 6 is a combined system that has been built on Nexstim’s unique, clinically established technology. The modular product design allows for an expansion of system capabilities over time. The new solution creates long-term value for Nexstim’s customers and investors. The first release in April-May concerned therapy applications. Nexstim's Therapy business markets and sells the NBS System 6 system, which has FDA marketing and distribution approval for the treatment of major depression in the United States. NBS System 6 is also CE-approved in Europe for use in the treatment of major depression and chronic neuropathic pain. Nexstim unveiled the NBS 6 system at the Clinical TMS Society 11th Annual Meeting, held in Colorado Springs, Unites States on May 4 – 6th and our sales opportunities for the product have developed favorably since then. We are prepared for the first customer orders and deliveries to happen during the second half of 2023. More information on the NBS 6 system is available on Nexstim’s website: .

Our third key strategic goal for 2023 is expanding the network of Nexstim exclusive collaboration clinics primarily in the USA and Europe. This would mean installing Nexstim systems in neuroscience clinics, in line with our revised strategy, mainly in cooperation with our partners. Our new partnerships focus on strategic investments in service organisations, especially on the vast US market, but partnerships are also possible to make targeted investments in the European market.

We are very pleased with the beginning of our cooperation with Dr Kuluva and his clinic, and we believe that our cooperation creates excellent conditions for future growth. Our joint venture, PNC Management Services LLC, is our first agreement on a strategic partnership and the acquisition of a minority interest in the joint venture is our first step on this important strategic development path. This partnership allows us to work close to the patients and collect accurate information at the patient interface. In addition, the purpose of our private equity company is to further expand the network of Nexstim’s neuroscience centers in the United States. We are looking forward to continuing our cooperation with Dr Kuluva’s team of experts. Through our cooperation, Nexstim’s TMS technology can be used to treat a growing number of patients in the United States. We are currently involved in negotiations with several potential partner clinics in both the United States and Europe, and we are working hard to grow our network.

Despite the tightened global political and weakened general economic outlook, our expectations continue to be positive for the last quarter of 2023. At Nexstim, we purposefully continue our work to enable personalized and effective therapies and diagnostics for challenging brain diseases and disorders. We strongly 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. In the short term, this can be seen especially as an investment in new system sales and in building strategic partnerships. While remaining optimistic about the future, we will continue to monitor closely the situation in Ukraine as we grow our business.

Further information is available on the website , or by contacting:

Mikko Karvinen, CEO

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About Nexstim Plc

Nexstim is a Finnish, globally operating 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 highly sophisticated 3D navigation providing accurate and personalized targeting of the TMS to the specific area of the brain.

Nexstim’s Diagnostics Business focuses on commercialization of the Navigated Brain Stimulation (NBS) system. The NBS System 5 is the only FDA cleared and CE marked navigated TMS system for pre-surgical mapping of the speech and motor cortices of the brain.

Nexstim’s Therapy Business markets and sells the NBS System 6 which is FDA cleared for marketing and commercial distribution for the treatment of major depressive disorder (MDD) in the United States. In Europe, the NBS 6 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.

For more information, please visit

 

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