BrainsWay Deep TMS System Receives FDA Clearance for OCD Treatment
Israel-based BrainsWay recently announced the de novo FDA clearance of its Deep Transcranial Magnetic Stimulation (TMS) system for treatment of obsessive compulsive disorder (OCD).
According to the press release, the BrainsWay Deep TMS system was previously cleared for treatment-resistant major depressive disorder in 2013, and this month’s de novo clearance is the second indication granted for the device, and marks the first clearance of a non-invasive device for treatment of OCD. The BrainsWay press release further notes that the Deep TMS system’s H7-coil targets the anterior cingulate cortex, which is known to play a role in the pathophysiology of OCD. BrainsWay stated that Deep TMS treatment, which uses changing magnetic fields to stimulate nerve cells in the brain, is non-invasive and has been shown to be safe and well-tolerated by patients.
BrainsWay plans to offer its OCD treatment both in new installations and as an upgrade to its existing systems. Addressing the broad future applicability of the Deep TMS system, BrainsWay president and CEO Yaacov Michlin said:
This clearance further establishes Deep TMS as a platform technology that will provide treatments for additional psychiatric indications, subject to successful completion of our currently ongoing multi center studies and regulatory approvals.
Orthofix secures option to acquire eNeura for $65 million
On March 31, 2015, Orthofix International N.V. announced it entered into an 18-month option agreement to acquire eNeura, Inc. Orthofix’s website states that the focus of the company is on “improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide.” In May 2014, eNeura received FDA 501(k) clearance for a portable, non-invasive Transcranial Magnetic Stimulation (TMS) device for the treatment of migraine headache. According to the press release, eNeura’s “SpringTMS™ is the first medical device available to patients in the United States for the acute treatment of pain associated with migraine headache with aura.” The eNeura website states that “The SpringTMS™ is the only non-drug therapy clinically proven to effectively stop or reduce migraine at the first sign of pain.”
According to the press release, “Spring TMS™ 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.” The press release states that to treat the pain of a migraine headache, the Spring TMS™ device is placed on the back of the head and generates a focused magnetic pulse.
The press release notes that Orthofix agreed to pay eNeura $15 million to assist in commercialization of Spring TMS in the US and Europe, and Orthofix has the option to pay $65 million to complete the purchase.
Brad Mason, President and CEO of Orthofix stated:
“This agreement underscores Orthofix’s commitment to pursue new growth opportunities in its BioStim strategic business unit that leverage our core competencies in pulsed electromagnetic field (“PEMF”) product design and manufacturing as well as our third party billing expertise.”
Share
