GlobeNewswire by notified

Nexstim Plc Business and Clinical Update Q3 2021

Share

Press release,Helsinki, 20 October 2021 at10:00 AM (EEST)

Nexstim Plc Business and Clinical Update Q3 2021

Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company") announces the key highlights of the Company’s business and clinical progress during Q3 2021.

CEO Mikko Karvinen’sBusiness and Clinical Update

I’m very happy to inform that following the strongest first half in the history of the company, our operational business has continued to show positive progress during the third quarter of the year. We have continued to focus on the growth of our Diagnostics Business (NBS) and Therapy Business (NBT®) new system sales in both of our key markets in the United States and Europe. At the same time, we have seen interest in our existing NBS and NBT® System customer base for system upgrades and continued to increase the utilisation rate of our installed base to a record level. This has led into steadily growing recurring revenue levels, which creates stability and a new kind of predictability for us. Our goal is financial success and minimizing future capital needs - we want to develop and evolve.

Parallel to focusing on growth efforts we will actively keep monitoring the COVID-19 pandemic environment. Despite the COVID-19 business environment still present, we have continued our work in increasing the numbers of both NBS Systems used for pre-surgical mapping of the brain and NBT® Systems installed mainly for use in the treatment of major depressive disorder (MDD). Between January-September 2021, we had delivered a total of 9 new NBS Systems and a total of 8 new NBT® Systems. In addition to the above mentioned already delivered systems we had an open backlog of undelivered systems total of 6 new NBS Systems at the end of Q3 2021.

In the Diagnostics Business, the NBS system has been sold to more than 190 research universities and leading hospitals across the world to date. We are happy to see that more and more of our customers seek to use the Nexstim system in both diagnostic and therapeutic applications. This has been made possible in the European markets where the new NBS deliveries to the hospitals enable neurosurgical diagnostics as well as MDD and pain therapy with the additional NBT software option. As an example of this progress, out of the 9 NBS systems delivered during January-September 2021, 5 had both diagnostics and therapy treatment applications in the system. We see this combined system as a clear competitive advantage and look forward to expanding with this platform approach to other key markets globally.

In the Therapy Business, at the end of Q3 2021 there were a total of 44 Nexstim systems with therapy capabilities installed worldwide (19 in the U.S. and 25 in Europe and the rest of the world) for the treatment of depression and chronic neuropathic pain. This number of systems includes both NBT® systems as well as NBS Systems with additional NBT software option. Nexstim’s NBS 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.

In August we reported clinical outcomes of the first 208 patients who had completed Nexstim SmartFocus® rTMS treatment with Nexstim NBT® system for major depressive disorder (MDD). Nexstim NBT® system is indicated for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. Treatment outcomes of these 208 patients were very good: 50.5% were in remission at end of treatment and 76.0% had obtained a clinical response. These outcomes are clearly higher than what is usually reported for MDD with TMS-systems: In a well-conducted multisite study, remission rates were 26.5-28.7% and the patient-reported response rates were 41.5-56.4%1. The patient-reported remission and response rates are also higher than those reported in a large >3800 patient series for patients completing clinical rTMS treatment (remission 29.7-36.2%, response 62.7-70.4%)2.

The clinical news flow continued in August with announces the continuation of the pilot study on the use of accelerated iTBS protocol in treatment of severe depression with Nexstim NBT® System at Kuopio University Hospital. Accelerated iTBS means transcranial magnetic stimulation (TMS) therapy where stimulation is given several times per day for one week whereas in conventional TMS therapy, stimulation is given once a day during several weeks.

In the continuation of the previously reported pilot study, the effectiveness of the accelerated iTBS protocol will be tested in an additional 20 patients. The treatment parameters have been modified based on the analysis of the initial, previously reported results announced on 3 March 2021. The patient treatments in the continued pilot are estimated to be completed in mid-2022. The results will be announced as soon as possible after their completion.

After already having received encouraging initial information from the Kuopio University Hospital in relation to the pilot study, we are now looking forward to continuing the collaboration. Our system clearly differentiates from the TMS systems currently on the market that do not have navigation capabilities. In the future, the need for a navigation function is likely to be further emphasised in technology that could treat patients in hospital for severe, treatment-resistant depression (TRD) and possible suicidal ideation. This could potentially open a new TMS treatment market for Nexstim that is separate from the current treatment of patients with MDD. Getting more data on the patient treatment outcomes with the intensified accelerated treatment protocols is important for the strategic development path of our business.

In addition to the above the Company provided an update in late September on the pilot study on the use of accelerated iTBS protocol in treatment of chronic neuropathic pain with Nexstim NBT® System at Helsinki University Hospital. The treatment of all except one patient had been completed in this total of five patient pilot study by end of Q3 2021. Nexstim is pleased with the progress of the pilot study in the present extraordinary circumstances effected by the COVID-19 pandemic.

In the Helsinki University Hospital pilot study, the effectiveness of the accelerated iTBS protocol will be tested in 5 patients. They are suffering from therapy resistant, chronic neuropathic pain and have not benefited from prior 10 Hz rTMS treatment targeted to the motor cortex. The results of the pilot study will be made public once available.

We are still living in the prolonged COVID-19 pandemic, but feel positive about Q4 and 2021, the first full year of implementing our new strategy. 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 will support long-term growth in shareholder value in the form of stronger competitive advantages, rapid growth, and better financial results. While again being optimistic about the future, we will closely continue to monitor the development of the COVID-19 pandemic as we operate our business.

1) Carpenter L. et al. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. Depress Anxiety. 2012 Jul;29(7):587-96. Epub 2012 Jun 11.

2) Sackheim, H. et al. Clinical outcomes in a large registry of patients with major depressive disorder treated with Transcranial Magnetic Stimulation. Journal of Affective Disorders 277 (2020) 65–74

Further information is available on the website www.nexstim.com, or by contacting:

Mikko Karvinen, CEO
+358 50 326 4101
mikko.karvinen@nexstim.com

About Nexstim Plc

Nexstim is a Finnish, globally operating medical technology company. Our mission is to enable personalized and effective therapies and diagnostics for challenging brain diseases and disorders.

Nexstim has developed a world-leading non-invasive brain stimulation technology called SmartFocus®. It is a navigated transcranial magnetic stimulation (nTMS) technology with highly sophisticated 3D navigation providing accurate and personalized targeting of the TMS to the specific area of the brain.

SmartFocus® technology is used in Nexstim’s proprietary 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.

In addition, Nexstim is commercializing its SmartFocus® based Navigated Brain Stimulation (NBS) system for diagnostic applications. The NBS system 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 shares are listed on the Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden.

For more information please visit www.nexstim.com

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

JLT Mobile Computers acquires French sales partner ID Work8.12.2021 23:30:00 CET | Press release

With an own sales office JLT strengthens its local presence in the French market, which has grown to become one of the largest and most important regionsin Europe for JLT Växjö, Sweden, 8Dec2021 * * * JLT Mobile Computers, a leading supplier of reliable computers for demanding environments, today announced that they have signed the agreement to acquire of ID Work, their French sales partner with effect from January 2022. Since its start in 2013 ID Work has successfully been driving sales in France through a country-wide network consisting of system integrators and resellers. Since then, the French market has grown to become one of JLT’s largest and most important markets in Europe. JLT will be taking over the business and establish a local sales office with own personnel. Through the acquisition JLT will get closer to its customers and sales partners in France. The founder of ID Work, who is running the company today will have a continued involvement in JLT over the next couple of year

JLT Mobile Computers förvärvar sin franska säljpartner ID Work8.12.2021 23:30:00 CET | Pressemelding

Frankrike är ett av de största och viktigaste länderna i Europa för JLT ochsyftet med förvärvet är att etablera ett säljkontori egen regi för att stärkaden lokala närvaron Växjö, Sverige, 8:e december2021 * * * JLT Mobile Computers, ledande leverantör av stryktåliga datorer för krävande miljöer, annonserar idag att man har tecknat ett avtal om förvärv av sin franska säljpartner ID Work med tillträde i januari 2022. Sedan starten 2013 har ID Work framgångsrikt drivit försäljningen av JLT:s produkter i Frankrike genom ett landstäckande nätverk bestående av systemintegratörer och återförsäljare. Den franska marknaden har sedan dess vuxit till att bli en av JLT:s största och viktigaste marknader i Europa. JLT kommer att ta över ID Works verksamhet och etablera ett säljkontor med egen personal. Förvärvet gör att JLT kommer närmare sina kunder och säljpartners. Grundaren av ID Work som idag driver företaget kommer att ha ett fortsatt engagemang i JLT under de kommande åren. För mer informati

Better Collective initiates share buyback program to cover future payments relating to completed acquisitions and incentive programs8.12.2021 18:00:00 CET | Press release

Regulatory Release no. 38/2021 December 8, 2021 Better Collective A/S (the “Company”) has today initiated a share buyback program for up to 10 mEUR, to be executed during the period from December 9, 2021 to February 24, 2022. The purpose of the buyback program is to cover future payments relating to completed acquisitions and to cover established Incentive Plans. The buyback program is being initiated pursuant to the authorization granted by the shareholders at the annual general meeting held on April 26, 2021 to repurchase up to nominal 4,694,532 shares of EUR 0,01 each of the Company’s share capital in the period until the annual general meeting in 2022. The Company has appointed Nordea as lead manager of the buyback program. Under the agreement with Nordea, Nordea will purchase shares on behalf of the Company and will make its trading decisions independently of, and without influence by the Company. The buyback program is subject to the following terms: The purpose of the program is

Nextensa Nv/sa: Shares Repurchase8.12.2021 17:40:00 CET | Press release

NEXTENSA NV/SA: SHARES REPURCHASE Nextensa NV announces that the board of directors has decided to initiate a share repurchase programme to acquire up to 65,000 shares for a total amount of no more than 4,800,000 euros within the limits set down in the (renewed) share repurchase authorization as granted by the extraordinary general meeting of shareholders of 19 July 2021. The goal of the share repurchase is to enable Nextensa to meet its obligations resulting from the purchase plans for the benefit of its executive management. Nextensa recognizes the need for active and committed managers that are able to guide the transformation into a mixed property investor and developer. Furthermore, based on previous experience and current market practices and trends, the nomination and remuneration committee and the board of directors are convinced that managers are more engaged and committed when they are able to participate in the capital of Extensa NV, as this aligns their interests with those

Millicom files standard form for notification of major holdings8.12.2021 17:13:53 CET | Press release

Millicom files standard form for notification of major holdings Luxembourg,December 8, 2021 – Millicom International Cellular S.A. announced today the CSSF regulatory filing of the form: ANNEX A: Standard form for notification of major holdings (attachment) -END- For further information, please contact Press: Vivian Kobeh, Director Corporate Communications +1-786-628-5300 press@millicom.com Yocasta Valdez, Group Manager Digital Media & Communications +1-305-929-5417 press@millicom.com Investors: Michel Morin, VP Investor Relations +1-786-628-5270 investors@millicom.com Sarah Inmon, Director Investor Relations +1-786-628-5303 investors@millicom.com About Millicom Millicom (NASDAQ U.S.: TIGO, Nasdaq Stockholm: TIGO_SDB) is a leading provider of fixed and mobile services dedicated to emerging markets in Latin America and Africa. Millicom sets the pace when it comes to providing high-speed broadband and innovation around The Digital Lifestyle® services through its principal brand, TIGO. As

Volta Finance Limited - Result of AGM8.12.2021 16:04:30 CET | Press release

8 December 2021 Volta Finance Limited (VTA / VTAS) RESULTS OF THE FIFTEENTH ANNUAL GENERAL MEETING Volta Finance Limited announces that at the Fifteenth Annual General Meeting held earlier today all resolutions proposed were duly passed. One of these resolutions was a special resolution. The full text of the resolutions can be found in the Notice of Meeting contained within the Annual Report and Accounts 2021, copies of which are available for viewing on the Company’s website http://www.voltafinance.com. Further information on the votes cast for each resolution will be available on the Company’s website shortly. CONTACTS For the Investment Manager AXA Investment Managers Paris Serge Demay serge.demay@axa-im.com +33 (0) 1 44 45 84 47 Company Secretary and Administrator BNP Paribas Securities Services S.C.A, Guernsey Branch guernsey.bp2s.volta.cosec@bnpparibas.com +44 (0) 1481 750 853 Corporate Broker Cenkos Securities plc Andrew Worne Daniel Balabanoff +44 (0) 20 7397 8900 ***** ABOUT V

New Kisqali® data shows consistent overall survival benefit across genomic and clinical subtypes of interest in HR+/HER2- metastatic breast cancer8.12.2021 15:30:00 CET | Press release

Data from the MONALEESA Phase III program provide further evidence of the unique profile of Kisqali, the CDK4/6 inhibitor with the longest reported median overall survival (OS) in HR+/HER2- metastatic breast cancer (over 5 years) and proven OS benefit across patient subgroups1-5 Kisqali pooled data at the San Antonio Breast Cancer Symposium confirms OS benefit across most common genomic intrinsic subtypes of HR+/HER2- metastatic breast cancer, including the aggressive, ET-resistant HER2-enriched subtype6 Data supports rationale for HARMONIA, the first prospective, head-to-head Phase III trial seeking to identify the best therapeutic option between Kisqali and Ibrance®* for patients with the HER2-enriched subtype Kisqali remains the only CDK4/6i with consistent OS benefit across the entire MONALEESA program, regardless of site and number of metastases, prior treatment, endocrine partner, line of therapy or menopausal status1-5,7-8 Basel, December 8, 2021 — Novartis today announced new K