The FDA granted pre-market approval a few months ahead of schedule to the Senza chronic pain device made by Nevro Corp. (NYSE:NVRO), allowing the company to label the device as superior to conventional spinal cord stimulators.
The safety watchdog said it approved Senza "as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain." The Senza device is designed to deliver up to 10,000Hz to the spinal cord, allowing it to avoid the tingling sensation known as paresthesia that bothers some patients.
"The FDA has approved several other totally implanted spinal cord stimulators for pain reduction, but this system is unique because it delivers a high frequency output of 10 kHz that does not cause a tingling sensation – called ‘paresthesia’ – in patients," Dr. William Maisel, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in prepared remarks. "Since some patients don’t like the paresthesia associated with traditional SCS, this device offers another treatment option."
Founded in 2006, Nevro has been led since 2011 by ex-Medtronic (NYSE:MDT) COO DeMane. The company has raised more than $153 million so far from backers including Johnson & Johnson (NYSE:JNJ), Covidien, Novo Nordisk and New Enterprise Assoc. A Series C round brought in $48 million last year.
Nevro shares surged in January when the FDA sent Nevro, which took itself public last November in a $145 million IPO, an approvable letter for the Senza device. Shares are set to boom again today after the company reported 1st-quarter results that topped expectations on Wall Street.
Nevro’s losses doubled for the 3 months ended March 31, to -$14.3 million, or -57¢ per share, but sales surged 45.0% to $9.7 million compared with Q1 2014. Analysts on The Street were looking for losses of -63¢ on sales of $8.5 million.
"I am pleased that adoption of HF10 therapy has continued at a strong pace in the first quarter in European Union and Australian markets," DeMane said in a press release. "As a result, more patients in need are afforded the benefits of Nevro’s best-in-class spinal cord stimulation technology. Now, with PMA approval and the first FDA SCS superiority label, these meaningful patient benefits will for the first time be made available to U.S. chronic pain patients."
Nevro said it still expects to post international sales of $36 million to $38 million this year.
