Mainstay Medical sails toward CE mark for neuromodulation implant

The ReActiv8 implantable neuromodulation device--Courtesy of Mainstay

Mainstay Medical is eyeing European approval for its implantable neuromodulation device, submitting an application for a CE mark in a bid to expand global commercialization for its product.

The Dublin-based company's ReActiv8 implant stimulates nerves in the back to contract muscles and offer a cure for chronic lower back pain. Mainstay's CE mark application includes data from a clinical trial of the device that shows the product significantly reduces low back pain while improving quality of life for patients.

In a study with 46 subjects, almost two-thirds of individuals had less lower-back pain after 3 months with the implant and more than half had their condition improve. A little more than two-thirds of patients reported a better quality of life after being outfitted with the implant. And ReActiv8 continued to deliver results in patients 6 months after implantation, the company said in a statement.

With positive data in tow, Mainstay is also shooting for FDA approval for its device. In May, the company got the agency's permission to launch a clinical trial of ReActiv8 in the U.S., aiming for approval of the device through the FDA's stringent PMA pathway.

"With FDA approval to start the ReActiv8-B clinical trial to gather data for an application for U.S. approval, we are moving towards our goal of commercialization of ReActiv8 in major world markets," Mainstay CEO Peter Crosby said in a statement. "We believe ReActiv8 has the potential to change the lives of millions of people who have no effective treatment for their chronic low back pain and we are now a step closer to selling ReActiv8 in Europe."

Mainstay Medical CEO Peter Crosby

If all goes according to plan, Mainstay will create a direct sales team in 2016 to commercialize the product in European markets, the company said in a statement.

Meanwhile, the Irish devicemaker continues to reel in funds to support its initiatives. In May 2014, Mainstay raised €18 million ($25 million) in a European IPO to develop its ReActiv8 implant, with existing shareholders such as device giant Medtronic ($MDT) and Fountain Healthcare Partners chipping in funds. In August, Mainstay brought in $15 million in debt financing to bolster commercialization and regulatory activities for its device.

The company hopes this progress will be enough to carry it forward as a solo act. Last year, Crosby said that Mainstay doesn't have plans to sell anytime soon, bucking the M&A trend to chart individual growth. And Mainstay will need all the help it can get as it battles rivals such as St. Jude Medical ($STJ) and Boston Scientific ($BSX) in the neurostimulation space.

"You have to focus on the business and growing the business," Crosby said. "Our strategy is to build a successful global company that's profitable and creates value for our shareholders. If someone else recognizes that value, then fine, let's have a conversation. But anyone who tells me they are building a company to sell is delusional."

- read Mainstay's statement

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