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Mainstay Medical Applies for CE Mark and FDA Approval for Their Neuromodulation Implant

Mainstay Medical Applies for CE Mark and FDA Approval for Their Neuromodulation Implant

By: Sarah Massey, M.Sc.

Posted on: in News | Medical Device News | Medical Device Safety and Regulation News

Mainstay Medical is seeking both European and North American approval for its neuromodulation device for chronic lower back pain. The company is submitting an application for a CE mark in Europe, and an application for Food and Drug Administration (FDA) approval for the medical device.

Dublin-based Mainstay Medical have developed ReActiv8, an implanted medical device that stimulates nerves in the back to provide relief to chronic lower back pain sufferers. Clinical trial data showing the device’s effectiveness at reducing back pain and improving patient quality of life, was included in the company’s application for a CE mark.

The clinical trial included 46 participants whose back pain was monitored over a 6 month study period. More than half of the participants found their condition improved after 3 months with the implant, and two-thirds of the patients had a significant reduction in lower back pain.

Two-thirds of participants also reported better quality of life with ReActiv8, and the device was able to continue to reduce symptoms 6 months after the device was implanted. This past May, Mainstay Medical received FDA go-ahead to start a clinical trial to assess ReActiv8’s effectiveness in the US. The company plans to apply for FDA approval through the agency’s Premarket Approval (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,” said Peter Crosby, CEO of Mainstay Medical. “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.”

As long as the device gains approval, the company plans to compile a direct sales team next year to launch the product on the European market. In support of its efforts, Mainstay Medical continues to secure funding for the project.

Last year they raised €18 million ($25 million) in European initial public offerings (IPO) to develop the ReActiv8 implant. Along with existing shareholders – including Medtronic and Fountain Healthcare Partners – the company secured $15 million in debt financing early this year, to back-up regulatory activities and commercialization of the device.

According to Crosby, the company doesn’t have any plans to sell in the near future, hoping that the funds will be sufficient for Mainstay Medical to remain independent. Though they have high hopes for the future, the company faces significant competition in the neurostimulation space with companies like St. Jude Medical and Boston Scientific battling for market share.

Crosby said, “You have to focus on the business and growing the business. 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.”


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