Nexstim Reaches 208 Completed Treatment Sessions – Continues to Report a Remission Rate Greater than 50% of MDD Patients in the Patient Registry

Press release, Helsinki, 20 August 2021 at 9 AM (EEST)

Nexstim Reaches 208 Completed Treatment Sessions – Continues to Report a Remission Rate Greater than 50% of MDD Patients in the Patient Registry

Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company") reports clinical outcomes of the 208 patients who have 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: 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 average patient reported Patient Health Questionnaire (PHQ-9) depression symptom severity score in the Nexstim registry was 20.6 before treatment and decreased to 6.9 by end of treatment. In the >3800 patient series the average PHQ-9 score before treatment was reported to be 19.8 and to have decreased to 11.1 by end of treatment². The range of PHQ-9 is from 0 to 27 with higher scores indicating more severe symptoms. The scores correspond to disease severity as follows: 0-4 = none to minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, 20-27 = severe depression.

The clinical outcomes of majority of the patients treated with SmartFocus® rTMS in the United States are being collected in a registry — the anonymous information is provided by participating clinical sites using Nexstim’s SmartFocus® technology.

According to the registry, the average general impression of receiving SmartFocus® rTMS treatment reported by the patients having completed the treatment was very positive with a mean score of 9.27 on a scale from 0 to 10 (10 = best possible).

Mikko Karvinen, CEO of Nexstim, said: “We are very happy to have reached one of our year 2021 key strategic objectives of over 200 completed treatment sessions of depression patients in our patient data registry. This registry continues to provide us with more promising data on the outcomes of Nexstim SmartFocus® rTMS treatments with our Nexstim NBT® System. We are especially proud of the fast progress considering the challenging circumstances caused by the COVID-19 pandemic. These treatment results support our continued work in bringing Nexstim technology available for as many patients as possible.”

^{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

• Nexstim Plc Press release_Patient Registry_20082021_EN_FINAL

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