|Industry||Medical Devices and Medical Technology|
|Headquarters||Malvern, PA, United States|
|Key people||Bruce Shook, President & CEO
Mark Bausinger, Chief Financial Officer
Mark Demitrack MD, Chief Medical Officer
Mark Riehl, VP, Product Development & Operations
Judy Ways, Ph.D., VP, Regulatory Affairs & Quality Assurance
Stanford Miller, VP, New Business Development
Mary Hailey VP, Healthcare Policy and Government Relations
Mark Saxton, VP, Sales and Customer Service
|Products||NeuroStar Transcranial magnetic stimulation Therapy System|
Neuronetics is a privately held company developing non-invasive treatments for depression and other chronic psychiatric and neurological disorders based upon neuromodulation technology. The NeuroStar Transcranial magnetic stimulation (TMS) Therapy System was developed for treating major depression in patients who have not benefitted from prior antidepressant medications.
Neuronetics was founded within The Innovation Factory, an Atlanta, GA-based medical technology incubator. The Company has raised venture capital based on its intellectual property portfolio and management team. Neuronetics’ investors include life-sciences firms such as Quaker BioVentures, Three Arch Partners, Investor Growth Capital, Onset Ventures, Interwest Partners, KBL Healthcare Ventures, Accuitive Medical Ventures and New Leaf Venture Partners.
Neuronetics' first product, the NeuroStar TMS Therapy System is designed to non-invasively stimulate the brain using highly focused MRI-strength magnetic pulses, or transcranial magnetic stimulation (TMS). NeuroStar delivers therapy that is highly targeted, involving a brain region that is thought to be involved in depression. NeuroStar TMS Therapy is prescribed by a psychiatrist and is delivered in an outpatient setting. The patient sits in the chair and undergoes 40-minute sessions over the course of four to six weeks.
In January 2007 an advisory panel of the United States Food and Drug Administration (FDA) stated that a TMS device had a good safety profile but had failed to demonstrate that it was effective for the treatment of depression in patients with a range of 1-4 prior antidepressant treatment failures.
In October 2008, based on the safety and efficacy of rTMS in patients with major depression who failed to benefit from 1 prior antidepressant medication, the FDA cleared the TMS device for marketing. The rTMS device was cleared by the FDA De Novo process whereby the device was reclassified to Class II based on safety and efficacy in the indicated population and therefore not subject to premarket approval.
Safety and Tolerability
In clinical trials evaluating the safety of NeuroStar TMS Therapy, no seizures or systemic side effects (such as weight gain, sexual dysfunction, sedation, nausea or dry mouth) occurred. The most common adverse events reported were headache and scalp pain or discomfort, which were more prevalent in the active treatment group than in a TMS treated placebo control group. During trials, less than 5% of patients discontinued treatment due to adverse events.
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- Smith, Aaron (2007-01-26). www.Money.CNN.com "FDA to consider depression-fighting machine: NeuroStar machine could compete with antidepressant drug industry, if it wins FDA approval". CNNMoney.com (Cable News Network. A Time Warner Company). Retrieved 2010-09-23.
- Scudiero, JL (2007-01-26). "Brief Summary From the Neurological Devices Panel Meeting - January 26, 2007". FDA. Retrieved 2010-07-14.
- O’Reardon, JP; Solvason, HB; Janicak, PG; Sampson, S; Isenberg, KE; Nahas, Z; McDonald, WM; Avery, D et al. (2007). "Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial". Biological Psychiatry 62 (11): 1208–1216. doi:10.1016/j.biopsych.2007.01.018. PMID 17573044.
- Janicak, PG; O'Reardon, JP; Sampson, SM; Husain, MM; Lisanby, SH; Rado, JT; Heart, KL; Demitrack, MA (2008). "Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment". The Journal of clinical psychiatry 69 (2): 222–32. doi:10.4088/jcp.v69n0208. PMID 18232722.