NeuroMetrix's OTC Pain Management Device Gets FDA Nod, Shares Up

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Massachusetts-based medical device company NeuroMetrix, Inc. (NURO) received the U.S. Food and Drug Administration (:FDA) 510(k) clearance for the over-the-counter (OTC.TO) sale of its wearable therapeutic technology-based chronic pain treatment product.

Following the news, NeuroMetrix's share price surged 19% to eventually close at $2.25 yesterday.

The device is based on wearable technology, which is presently positioned in the company's SENSUS Pain Management System. The SENSUS system is the second generation of NeuroMetrix's wearable therapeutic technology, which uses comfortable, non-invasive electrical stimulation of sensory nerves to foster safe and effective pain relief.

As a transcutaneous electrical stimulator, it is the only chronic pain management device that can be worn during sleep as per FDA's sanction. It is lightweight and about 20% thinner than the first-generation device.

NeuroMetrix had originally designed SENSUS primarily targeting diabetic patients who suffer from chronic nerve pain. However, this device was also found to be beneficial to those suffering from fibromyalgia, post-herpetic neuropathy and restless leg syndrome.

At present, NeuroMetrix is engaged in late stage development of the OTC device. Until now, SENSUS was sold solely as a prescribed wearable device. The FDA clearance will now allow NeuroMetrix to market SENSUS through the retail distribution channel, without the need for a prescription.

Per management, since its launch in 2013, patient response to SENSUS has been rather positive. The company is now keen to avail the large untapped market potential of the product, with its OTC version. This should help the company augment its market share and customer base. The commercial launch of the OTC SENSUS device is expected in 2015.

Currently, NURO holds a Zacks Rank #3 (Hold). Some better-ranked medical product stocks that warrant a look include Hospira Inc. (HSP), OraSure Technologies, Inc. (OSUR) and Cardiovascular Systems, Inc. (CSII). While Hospira and OraSure sport a Zacks Rank #1 (Strong Buy) each, Cardiovascular Systems holds a Zacks Rank #2 (Buy).




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