More than a decade after Maryland inventor Robert Fischell began exploring the use of magnets to relieve migraine pain, the idea could be on the verge of a $65 million sale.
A deal with a Texas medical device company announced last week gives Baltimore-based eNeura Inc. an immediate infusion of $15 million, a loan that company leaders said will pay for more testing and the commercial launch of a device that sends magnetic pulses into the brain to calm migraines.
Beyond that, at any time in the next 18 months, Orthofix International could exercise an option to buy eNeura and its device, SpringTMS.
David K. Rosen, eNeura's CEO, said the focus is on "business as usual" — pursuing the steps needed to get the device into the hands of migraine sufferers who have relatively few options for treatment.
"It doesn't change our plan and our focus over the next 18 months, which are to grow the business and make sure patients have access to a product we think is going to help them," Rosen said.
The foundation for the business is transcranial magnetic stimulation, in which a small coil placed on the scalp generates magnetic waves similar to those created by MRI machines.
The idea is that the pulses pass through the skull into the brain, where they interrupt abnormal electrical activity. The company's original device is among scores of inventions developed by Fischell, a former scientist at the Johns Hopkins Applied Physics Laboratory who donated $30 million to the University of Maryland, College Park to establish bioengineering and biomedical device programs in his name.
Migraines are headaches often associated with throbbing, sensitivity to light or sound, and nausea, and can often be debilitating or at least harm the quality of life for sufferers.
They can be triggered by hormonal changes, stress, and certain food or drinks, and typically last for hours. They can sometimes be treated with over-the-counter anti-inflammatories, but some sufferers might require prescriptions for more powerful anti-inflammatory medications, steroids or other drugs.
The magnetic therapy has been the subject of research for 40 years and has shown some success in treating migraines and depression. For eNeura, that has included approvals for use on migraine sufferers in Europe as well as the United States. The Food and Drug Administration approved SpringTMS last May for treatment of migraines.
The FDA first approved the technology for treating depression in 2008.
eNeura is working to get SpringTMS to migraine sufferers for whom medication doesn't work or isn't an option, such as for pregnant women, Rosen said.
About 10 percent of the U.S. population suffers from migraines, and for 14 million people, the headaches occur at least every other day on average, according to the Migraine Research Foundation in New York.
Most sufferers don't seek medical treatment and are never diagnosed, according to the foundation.
SpringTMS is designed to be used at home as soon as patients begin to feel a migraine coming on. They hold the device to the back of their heads and press a button; full treatment takes less than a minute.
The treatment costs $250 per month for patients, though it is largely available only through an ongoing clinical trial, Rosen said.
The trial is part of an effort to expand the product's reach and to prove the device's effectiveness not just at relieving migraine pain, Rosen said, but at preventing the headaches from starting in the first place.
As eNeura looks to pursue sales of the device more aggressively after that, its agreement with Orthofix could be a key. One of the Lewisville, Texas, company's four main business areas is dubbed BioStim, focused on using technology known as pulsed electromagnetic field design to promote bone growth.
While the technology is slightly different than eNeura's, Rosen said, the company has experience marketing similar products.
Orthofix officials declined to be interviewed for this article. In announcing the deal with eNeura, they said it should help the company boost its BioStim business. The company's stock price has surged 20 percent since the deal was unveiled.
"We believe eNeura's exciting application of electromagnetic field technology delivers a therapy that addresses a significant unmet need for patients and clinicians in the treatment of migraine headache," CEO Brad Mason said in a statement.
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The companies would not disclose terms of Orthofix's option to buy eNeura.
Local investors are hoping the deal will be a boon for the company. The Abell Foundation is one of the eNeura's largest investors, and foundation President Robert Embry said he was encouraged by the company's commitment to Baltimore. eNeura moved its headquarters from Silicon Valley to the University of Maryland BioPark two years ago, bringing with it the possibility of more jobs in manufacturing.
"We checked with a number of headache and migraine specialists around the country and they confirmed that it was effective and there was nothing that equaled it," Embry said. "It would have a dramatic effect on employment."
Whether or not the Orthofix deal ends with a sale, Rosen said he expects the partnership to help eNeura going forward.
"We just see a lot of opportunities to work with them and potential to grow with them in the future," he said.