Clinically demonstrated safety, efficacy, response and remission with durable results in major depressive disorder

The safety and efficacy of NeuroStar has been demonstrated in two large prospective, multisite, randomized, sham-controlled trials. In addition, the efficacy of NeuroStar has been demonstrated in a multisite, real world, open-label, clinical trial in which patients who failed to achieve satisfactory improvement from antidepressant medication treatment in their current episode of major depressive disorder received an acute treatment course of TMS therapy. 6, 7, 8, 10, 11, 20 Overall, the results of this trial demonstrated that 58% of patients responded to treatment, and 37% achieved remission.6 In this trial, similar response and remission rates were observed across patients with a wide range of prior drug treatment attempts. The majority of patients in this trial also participated in a 12-month follow-up phase at the conclusion of which the clinician-assessed response rate in these patients was 68% and remission rate was 45%. 36.2% of patients received NeuroStar Advanced Therapy reintroduction (average of 16 treatments).20

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Demonstrated safety profile with high patient adherence and limited treatment-emergent side effects

NeuroStar has a demonstrated safety profile without the systemic side effects typically experienced with antidepressant medications.3, 11 The adverse events discontinuation rate in our sham-controlled clinical studies has been approximately 5%.7, 8 For single medication treatment in the STAR*D Study, the adverse events discontinuation rate was 9% to 41%.13 The most common side effect associated with NeuroStar is transient, localized pain or discomfort at or near the treatment location.

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Precise and reproducible office-based therapy.

Patients receive NeuroStar Advanced Therapy for five days a week for up to six weeks in a psychiatrist’s office without the need for general anesthesia or sedation. The NeuroStar Advanced Therapy System’s proprietary components and software are designed to deliver the recommended TMS treatment dose to the indicated location on the patient’s prefrontal cortex consistently. The treatment location is determined with a three-dimensional, laser-guided, six-point coordinate system. The SenStar Connect is a proprietary component of the device designed to ensure our NeuroStar Treatment Coil is functioning properly and positioned against a patient’s head. SenStar Connect provides continuous real-time feedback to the clinician throughout the course of treatment and it tracks lost pulses during each treatment session and provides the clinician with the opportunity to re-administer any lost pulses at the end of the treatment, all of which helps to ensure that a patient receives the prescribed dose of NeuroStar Advanced Therapy.

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Efficient and convenient treatment for the patient and the psychiatrist

We have developed and deployed the shortest duration treatment for MDD using TMS cleared by the FDA, with each treatment delivered in as short as 19 minutes.3 Our therapy is delivered while a patient is awake and alert, enabling the patient to drive a vehicle and resume normal activities immediately following each treatment session. NeuroStar was designed for patient and psychiatrist convenience by establishing a proprietary software system, which we refer to as MT Assist, that allows the psychiatrist to determine the proper dose and motor threshold unique to each patient. After the initial treatment session, the NeuroStar Advanced Therapy System records the treatment coordinates so they do not need to be re-identified in future treatments. Once a psychiatrist has established the patient’s coordinates during the initial treatment session, a trained member of the office staff under the supervision of the psychiatrist may administer subsequent treatment sessions.

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Unique cloud-based practice management system

Our TrakStar Cloud practice management system captures all treatment relevant information, and the encrypted information can be downloaded to any NeuroStar Advanced Therapy System in a psychiatrist’s network in order to make it convenient for a patient to receive care and increase scheduling flexibility. Patients do not need to be treated by the same NeuroStar Advanced Therapy System for each treatment session, and therefore psychiatrists who own multiple systems do not need to schedule patients to specific devices. A treating psychiatrist can download a patient’s encrypted information from TrakStar Cloud and analyze it real-time from their laptop, mobile phone, or tablet. TrakStar Cloud also manages the inventory of purchased treatment sessions, which can be replenished by an office administrator online at any time. We expect the next version of TrakStar Cloud will also enable remote software updates, diagnostics and troubleshooting and performance monitoring to maintain industry-leading up time. TrakStar Cloud also captures and records daily system utilization, office productivity and patient outcomes.

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Comprehensive customer support and practice development resources

We believe that we offer the most comprehensive practice support services among all TMS system providers to help our psychiatrist customers operationalize and grow their TMS service line.

Marketing

We provide our customers with a wide range of marketing support:

  • Tools to increase awareness with referring psychiatrists
  • Customizable advertising materials designed to educate patients within an existing practice and in the local community
  • A patient lead-generating digital marketing campaign comprised of paid search, display advertising, social media, and public relations

Implementation

Our clinical practice consultants focus their efforts on helping psychiatrist customers implement Practice Success Program:

  • Practice management planning
  • Outcomes data analysis
  • Patient identification
  • Practice marketing
  • Staff training on practice roles
  • Public relations strategies
  • Patient consult training
  • Other support services

Reimbursement

Our reimbursement managers help our psychiatrist customers to understand how they can navigate all issues regarding the insurance reimbursement process, including investigation of benefits, prior authorizations and claims documentation.

Technical Support

Our field service engineers are responsible for maintenance, repairs and installation of upgrades of our systems, and typically provide a response within 24 hours of a service call. This responsiveness has allowed us to realize over 99% uptime of our installed base. Finally, we also offer our customers a 24/7 support hotline to respond to medical information inquiries and technical questions that arise.

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