eNeura, Inc. Reports Successful Completion of Post-Market ESPOUSE Study of SpringTMS® Migraine Device
Primary Endpoint of Reduction in Number of Monthly Headache Days Met
Topline Data Presented at European Headache and Migraine Trust International Congress
BALTIMORE, Sept. 19, 2016 /PRNewswire/ -- eNeura, Inc., a privately held medical technology company, announced today positive topline data from its ESPOUSE (eNeura SpringTMS Post-market Observational U.S. Study of Migraine) Study. The study achieved its primary endpoint showing reduction in monthly headache days. eNeura plans to submit the positive data to the U.S. Food and Drug Administration (FDA) to expand the SpringTMS® label to include migraine prevention.
Topline data was presented at the European Headache and Migraine Trust International Congress (EHMTIC) in Glasgow, Scotland on September 17, 2016 as part of a scientific symposium that also included additional scientific evidence on the mechanism of action of TMS in migraine, conducted by Anna Andreou, Ph.D., Primary Investigator of Headache Research at Wolfson CARD, King's College London & Director of Headache Research at The Pain Management & Neuromodulation Centre.
The ESPOUSE Study was conducted at eight leading U.S. Headache Centers on 132 migraine patients. Patients following a protocol of daily use of the SpringTMS device reported an average reduction from nine headache days per month at baseline to six days post treatment. There were no serious adverse events reported during the study.
The data is consistent with a post-market study published in the UK that supported the company's expansion of the CE Marking label for its SpringTMS device to include migraine prevention in addition to acute treatment of migraine. Of the 190 patients surveyed in the study (59 with episodic and 131 with chronic migraine), 62% reported pain relief, indicating that the device was effective at reducing or alleviating migraine pain. Patients with episodic migraine saw a reduction from a baseline of 12 days per month to nine days and patients with chronic migraine saw a reduction from 24 days baseline to 16 days. Patients also reported a reduction in headache duration, pain severity and medication use. There were no serious adverse events reported during this study as well.
"We are very pleased to announce that we have successfully met the primary endpoint of our post-market ESPOUSE Study, adding to the favorable data that has been generated in multiple studies examining the migraine prevention capabilities of the SpringTMS device," commented Dr. David K. Rosen, President and CEO of eNeura. "SpringTMS is now the only migraine therapeutic that has demonstrated clinical efficacy for both the acute treatment of a migraine attack and prevention of future attacks. This is particularly important for the many patients who suffer frequent migraines and have found current medications ineffective or poorly tolerated. We plan to submit this data to the FDA to request the expansion of our U.S. label to include migraine prevention."
SpringTMS is a prescription-only device that utilizes single-pulse Transcranial Magnetic Stimulation (sTMS) to induce very mild electrical currents that may depolarize neurons in the brain. This process is thought to interrupt the abnormal hyperactivity associated with migraine. The non-invasive, proprietary device is designed for patient use. To treat, the device is placed at the back of the head where the push of a button generates a focused magnetic pulse with the intent to eliminate or prevent the pain of a migraine headache.
About eNeura
eNeura, Inc. is a privately held medical technology company that is pioneering the use of portable, non-invasive Transcranial Magnetic Stimulation devices for treatment of migraine. SpringTMS is a prescription-only device that utilizes single-pulse Transcranial Magnetic Stimulation (sTMS) to induce very mild electrical currents that can depolarize neurons in the brain. This process is thought to interrupt the abnormal hyperactivity associated with migraine. Prescribed by physicians but designed for patient use, it is the first truly portable, convenient TMS product that will allow migraine patients to administer treatment as needed—at home, in the office or on the go. For more information about eNeura, please visit http://www.eneura.com.
Media Contact:
Claire LaCagnina
Tiberend Strategic Advisors, Inc.
+1-212-375-2686
clacagnina@tiberend.com
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