|Nevro has raised $48 million to complete a pivotal trial for Senza.--Courtesy of Nevro|
Nevro, a 2012 Fierce 15 company, has pulled down $48 million more in venture financing, money it will use to buoy its pain-management implant toward FDA approval.
The latest haul follows a $58 million round in 2011, and Nevro will put the cash toward its ongoing pivotal trial for Senza, an implant that stimulates the spinal cord to relieve chronic back pain. New investor Novo Ventures led the latest round, joined by New Enterprise Associates and Covidien ($COV) Ventures, plus existing investors like Johnson & Johnson ($JNJ) Development Corporation and the Mayo Clinic.
That makes $106 million in about 20 months, and Nevro CEO Michael DeMane said the company's popularity with VCs has allowed it to blaze a quick trail with Senza.
"Since our last round of financing, we have initiated a substantial U.S. pivotal study, built a growing intellectual property portfolio, and demonstrated commercial traction at leading pain centers in key international markets," DeMane said in a statement. "With this investment, we are well positioned to complete our pivotal study, seek U.S. regulatory approval and extend access to this innovative therapy to patients in the U.S."
Nevro is in the midst of a 300-patient trial, planning to file for FDA approval next year, and Senza's early results have been heartening. In clinical trials, Senza patients reported that their back pain fell from an 8.4 to a 2.7 on the Visual Analog Scale after 6 months, Nevro says.
Spinal cord stimulation is a tried-and-true treatment for chronic pain, but devices currently on the market use low frequencies with limited reaches and high rates of paresthesia, a pervasive pins-and-needles sensation. Senza, however, uses a different waveform, making it powerful enough to treat back pain without the uncomfortable side effect, according to the company.
As DeMane told FierceMedicalDevices in October, the global market for spinal stimulation is about $1.5 billion, but Nevro believes it can push beyond that, touting Senza as safe and effective enough to challenge pharmaceutical and surgical therapies for chronic pain and grow the market.
- read Nevro's statement
Special Report: Nevro – 2012 Fierce 15