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SEC Filing Details

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SEC Filing Details

Document Details

Form
CORRESP
Filing Date
08/13/19
Document Date
08/13/19
Form Description
CORRESP
Filing Group
Other
Company
Neuronetics Inc
Issuer
NEURONETICS, INC.

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*Free consultations are determined by providers and may not be guaranteed.

**Outcomes Registry data was published by Sackeim HA, et al. J Affective Disorders, 2020, 277(12):65-74. The outcomes reported represent the subset of study patients for which the CGI-S data was reported before and after an acute course of NeuroStar TMS. Patients were treated under real-world conditions where patients may have been prescribed concomitant depression treatments including medications. “Measurable relief” was defined as a CGI-S score <=3 and “complete remission” was defined as a CGI-S score <=2 at the end of treatment.

***Patients received more than one course of treatment and were treated with standard of care. Standard of care also included medications. CGI-S represents the scale used to define response and remission.

Indication

The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

NeuroStar Advanced Therapy is only available by prescription. A doctor can help decide if NeuroStar Advanced Therapy is right for you. Patients’ results may vary.

Important Safety Information

The most common side effect is pain or discomfort at or near the treatment site. These events are transient; they occur during the TMS treatment course and do not occur for most patients after the first week of treatment. There is a rare risk of seizure associated with the use of TMS therapy (<0.1% per patient).

NeuroStar Advanced Therapy should not be used with patients who have non-removable conductive metal in or near the head. NeuroStar Advanced Therapy has not been studied in patients who have not received prior antidepressant treatment.

Safety and Prescribing Information »

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Our Commitment

Neuronetics is committed to compliance with state and federal laws regarding interaction with healthcare providers.

Commitment to Compliance »

To find out more about NeuroStar® Advanced Therapy or where treatment is available near you, please provide your contact information and a Neuronetics customer service representative will contact you. The information you provide to us is subject to the Neuronetics Privacy Policy.

General Contact Information »

Customer Service Center: 877-600-7555

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