Mainstay: ReActiv8 data may be enough for CE Mark, announces earnings

Mainstay Medical (EPA:MSTY) said that data from a trial of its ReActiv8 neurostim may be enough to win it CE Mark approval in the European Union and released its 6-month earnings today.

The company’s multi-center, prospective ReActiv8-A clinical trial examined patients with chronic lower back pain treated with the company’s implantable ReActiv8 neurostimulation device. Of the patients in the trial, 70% were being treated with opioid painkillers.

Preliminary data from the 1st 47 patients implanted with the device showed an average 63% improvement in back pain as defined by a minimum 2-point gain on a 0-10 numerical rating scale after 90 days, and a 54% responder rate for pain, indicating an improved average numerical pain rating over 7 days without an increase in pain medications.

The company reported results from another cohort of 33 patients who reached the 180-day mark, with 58% reporting better back pain scores and 64% reporting a greater than 50% reduction in pain.

“The results from the ReActiv8-A trial show improvements which are better than any other therapy for this group of people as reported in the literature. We are excited that our unique approach to treating this type of chronic low back pain offers the potential to change the lives of millions of people worldwide who have no effective treatment alternative,” CEO Peter Crosby said in a press release.

Data from the trial will be used to support the company’s submission for CE Mark approval.

Mainstay also reported losses of $6.4 million, or $1.48 per share for the 6 months ended June 30.

That amounts to a 91.6% reduction in losses compared to the same period last year, with losses per share down 58.2% compared with the same period last year.

Operating expenses increased for the company by $1.5 million, mainly due to the increased activity of its clinical trial of ReActiv8, the company said in its earnings release.

Shares have been less than optimistic, dropping 7.9% as of mid-day trading.

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