Neuronetics, Inc. is the world’s leader in advancing therapeutic applications of MRI strength pulsed magnetic field for disorders of the central nervous system. With our FDA-cleared NeuroStar TMS Therapy System, we have set a new benchmark in the promising field of neuromodulation.
Neuronetics is a privately held medical device company, founded by The Innovation Factory, an Atlanta-based medical technology incubator. Neuronetics has raised significant venture capital on the strength of its unique intellectual property portfolio and experienced management team. The investors supporting Neuronetics are some of the most successful venture capital firms in the life science industry, including:
- Investor Growth Capital (www.investorab.com)
- New Leaf Venture Partners (www.nlvpartners.com)
- Interwest Partners (www.interwest.com)
- Three Arch Partners (www.threearchpartners.com)
- Onset Ventures (www.onset.com)
- Polaris Venture Partners (www.polarisventures.com)
- Quaker BioVentures (www.quakerbio.com)
- Pfizer (www.pfizer.com)
- Accuitive Medical Ventures (www.amvpartners.com)
- KBL Healthcare Ventures (www.KBLVC.com)
Unmet need in Depression Treatment
Despite advances in pharmacotherapy, depression remains one of the most common and disabling medical illnesses. The World Health Organization has estimated that, by the year 2020, major depression will be exceeded only by ischemic heart disease in global disease burden. A recent survey estimated that 16.2% of the US population (>30 million people) suffer from major depression in their lifetimes. Twelve month prevalence included more than 13 million US adults. More than 50% of these patients were rated as severe or very severe.
Many patients with major depression obtain no or inadequate relief from drug therapy in spite of multiple courses of antidepressants. Even with symptomatic improvement, tolerability remains a considerable clinical problem. More than half of patients on antidepressant drug therapy report side effects that lead to noncompliance with medication (e.g. sexual dysfunction, weight gain, sleep disorders). Thus, there is a large, unmet need for an effective therapy free from undesirable systemic effects.
NeuroStar FDA-Cleared to Treat Depression*
The NeuroStar TMS Therapy system is the first non-systemic and non-invasive treatment for depression. It was cleared by the U.S. Food and Drug Administration (FDA) for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication. NeuroStar TMS Therapy is a 37-minute outpatient procedure that does not require anesthesia or sedation, and patients remain awake and alert during the procedure. The treatment is administered daily for 4-6 weeks.
During NeuroStar TMS Therapy, magnetic field pulses are generated and aimed at the left, prefrontal cortex, an area of the brain that has been demonstrated to function abnormally in patients with depression. These magnetic fields are the same type and strength as those used in magnetic resonance imaging (MRI) machines. The magnetic field pulses pass unimpeded through the hair, skin, and skull and into the brain.
Once inside the brain, the magnetic field pulses induce an electrical current to flow. The amount of electricity created is very small, and cannot be felt by the patient, but the electric charges cause the neurons to become active and are thought to lead to the release of neurotransmitters such as serotonin, norepinephrine and dopamine.
* NeuroStar TMS Therapy® is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. Click here for full prescribing and safety information
In the U. S., the Food and Drug Administration (FDA) must clear a device before it can be marketed (offered for sale to physicians for a specific clinical use). The clearance process involves several steps that may include pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of an application by the manufacturer of the device, FDA review of the application, and FDA clearance/rejection of the application.
Food and Drug Administration (FDA):
The U.S. Department of Health and Human Services agency responsible for evaluating the safety and effectiveness of all drugs, vaccines, and medical devices. Internet address: http://www.fda.gov.