ESPOUSE Study Central to FDA Clearance of sTMS for Migraine Prevention
Baltimore, MD – April 3, 2018 – eNeura, Inc., a privately held medical technology company, announced today the publication of a study in the peer-reviewed journal, Cephalalgia, demonstrating the company’s portable, Transcranial Magnetic Stimulation (sTMS) technology, significantly reduces the frequency of migraine headache following daily administration. sTMS is the only treatment in the United States indicated both for the acute and prophylactic treatment of all types of migraine headache.
The paper, “A Multicenter, Prospective, Single Arm, Open Label, Observational Study of sTMS for Migraine Prevention, by Amaal Starling, M.D., et al., reported findings from eNeura’s clinical migraine prevention study, the ESPOUSE Study, which was conducted at eight leading U.S. headache centers. Data from the study indicated that 46% of patients following a protocol of daily use reported at least a 50% reduction in headache attacks. The non-drug treatment was shown to be as effective as currently prescribed medications but better tolerated without the debilitating side effects often associated with migraine medications. There were no serious adverse events reported during the study.
David K. Rosen, President and CEO of eNeura, commented, “The ESPOUSE study was instrumental in the FDA’s recent decision to approve sTMS for both acute treatment and prevention of migraine. The publication of these findings in Cephalalgia provides further validation of the tremendous value that sTMS offers to patients as an effective, well-tolerated migraine treatment.” The sTMS mini is a convenient, cost-effective treatment option and is usually reimbursed under commercial insurance plans.
sTMS is a non-invasive, prescription-only device that utilizes single-pulse TMS to induce a mild electric current in the brain that modulates nerve cells and interrupts the nerve hyperactivity associated with migraine. Treating with the portable device is painless, easy and takes just a few seconds. Patients place sTMS at the back of the head, and with the simple push of a button, deliver a focused magnetic pulse to treat a migraine attack and/or to prevent the onset of future migraine attacks. sTMS is also approved in Europe and Australia for the acute treatment and prevention of migraine.
To access the full publication in Cephalagia, please proceed to the following website: http://journals.sagepub.com/home/cep
To access the press release from the Mayo Clinic reporting on the publication, please proceed to the following website: https://mayocl.in/2GljskB
A video featuring lead investigator, Amaal Starling, M.D., may be accessed here: https://youtu.be/STelA_Kt7Po