NeuroMetrix gains on FDA clearance of over-the-counter wearable chronic pain device

NeuroMetrix's wearable Sensus Pain Management System--Courtesy of Neurometrix

NeuroMetrix ($NURO) CEO Dr. Shai Gozani told FierceMedicalDevices that the now-510(k)-cleared, over-the-counter version of its wearable therapeutic, the Sensus Pain Management System, will enable the company to pursue further innovations to the device that are not possible in the prescription market. 

The microcap's stock rose more than 20% on the Nasdaq to $2.30 on the company's July 8 announcement that the FDA gave it 510(k) clearance to market the device over-the-counter for the treatment of chronic pain. The new product will launch around the second half of 2015, according to the CEO.

Gozani said that the over-the-counter product will be Bluetooth-enabled and come with a smartphone that will help the consumer draw conclusions about how best to use the technology. These additions aren't possible with the prescribed version, he said, because "the prescription device really has to fit into a very narrow channel between what physicians want, what insurers are willing to pay for, and what works clinically."

In the over-the-counter market, "you have more opportunity to match the consumers' desires and needs," he said.

The new version of Sensus will have a different look and brand, the CEO said. New features will include different colors ("There's a fashion element to the device, if you will," he said) and the use of premium materials similar to those used in a high-end sports band.

Gozani described the over-the-counter market as a "parallel market." "If they [consumers] want to get the product paid for, which is entirely reasonable, then they would go through their physician and get it prescribed," he said. "If they want the unique aspects of the consumer device and the ready access and so forth they have the OTC market." 

The CEO said the new product will cost about $400, similar to the list price of the Sensus, but added that "there's not per se a ceiling on the price as there is with the [insurance] reimbursement prescription-based model." He stressed that the product's pricing is not yet determined and may vary based on several factors, saying "it has a lot to do with what the [retail] channels can handle."

Neurometrix is in the process of figuring out its distribution strategy; Gozani hopes the new product will be available in a variety of drugstores and big-box retailers. 

He was pleased that the FDA gave the over-the-counter version the clinical indication of treatment of chronic pain, saying, "That's a very strong label to have in an OTC product. Typically, OTC products have very watered-down claims like managing soreness and muscle ache." The strong indication will be useful for marketing purposes, he added.

But getting over-the-counter clearance is a bigger deal, regardless of the indication. "Really a lot of credit to the FDA for being open to understanding the dilemma of chronic pain and giving patients more access," he said. 

Sensus is a transcutaneous electrical nerve stimulator that is worn around the calf. When the device is turned on, it stimulates nerves that carry nonpainful sensations to the brain, according to the product's website. Now the company has permission to offer pain relief in the $4 billion over-the-counter chronic pain market as well, making it one of the few device companies in a market dominated by pills and other drugs.

But it is one of a handful of players in the market for wearable therapeutics. "There's a lot to be learned with how consumers react to that and what exactly they want in terms of form and function," Gozani said.

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