A minimally invasive device to relieve shoulder pain after stroke is heading to phase 3 trials by the end of this year.
SPR Therapeutics has been cleared by the FDA to begin a pivotal study of its Smartpatch Peripheral Nerve Stimulation System. According to CEO Maria Bennett, the randomized, placebo-controlled study will test for safety and efficacy of the device in about 60 patients and will begin by the end of the year.
The device addresses a gap in the treatment continuum for post-stroke pain, Bennett said, providing patients with moderate to severe pain another option besides drugs or surgically implanted devices. According to the Post-Stroke Rehabilitation Outcomes Project, shoulder pain affects up to one-third of stroke survivors.
SPR’s device is made up of an external stimulator that snaps on to an adhesive patch placed on the skin. The stimulator connects to a single lede that’s placed into the deltoid muscle by a physician in an office-based procedure.
Patients use the device, which Bennett said “electronically exercises the muscles” to create a deep massaging feeling, for a few hours a day for up to 30 days. Disposable batteries control the “dosing” of the device. Bennett said patients in past studies have reported pain relief even after the 30 days of use.
She anticipates that if all goes well, the company would be filing for regulatory approval in Europe in the fourth quarter of the year and receiving that approval next year. In the U.S., she hopes to see the device on the market by 2014.
“We like going into validated markets,” Bennett said, referring to competing neurostimulation devices from St. Jude Medical, Boston Scientific and Medtronic. “There’s still a lot of room here for innovation. We like the fact that ours is less costly and less invasive.”
Eventually SPR hopes to apply its technology to other kinds of peripheral pain. Bennett said the company has already done some feasibility work in amputation pain.
For now it will focus on closing its $2.2 million series A in the next few months and looking for a commercialization partner. If a partnership doesn’t form, Bennett said the company may need to raise a series B but will be ready to move forward anyway.
Cleveland-based SPR, which stands for “stimulation for pain relief,” was spun out of neurodevice company NDI Medical in 2010, but the technology dates back to the late 1990s, when Bennett worked on it during her graduate program at Case Western Reserve University.
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