NeuroMetrix seeks 510(k) nod for pain therapy device

NeuroMetrix ($NURO) reached a significant milestone this week. The Waltham, MA, company filed its 510(k) application with the FDA for its Sensus pain therapy device.

NeuroMetrix envisions using the non-invasive, transcutaneous electrical nerve stimulator to treat immediate pain symptoms, as well as chronic pain for conditions such as diabetic neuropathy.

Up to 20% of patients with diabetes suffer from neuropathy related to their condition, and they experience mixed results when using drug treatments, according to the company.

Spun out of the Massachusetts Institute of Technology and Harvard Medical School in 1996, the company has a presence in the neurodiagnostics market and has pursued new products, including Sensus, according to its website. However, NeuroMetrix is struggling, having generated $10.4 million in revenue in fiscal 2011 with a $10 million net loss, compared with nearly $14 million in revenue and almost $17 million in net losses for fiscal 2010. Earlier this year, the company held a public offering and raised more than $8.5 million, according to its fourth-quarter regulatory filing.

A number of players are focused on electronic stimulation to manage pain. Among them: Nervo, a pain management company focused on spinal cord stimulation therapy for back and leg pain. The company landed a $58 million financing round last summer, led by Johnson & Johnson Development Corp. St. Jude Medical ($STJ) is developing a device that delivers mild electric pulses to treat migraines and is implanted under the skin.

- here's the release

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