The neurostimulation company Nevro has secured a new FDA approval for its chronic pain treatment device, aimed at patients suffering from nerve damage associated with diabetes.
The agency’s green light for the Senza spinal cord stimulator (SCS) implant specifically covers its high-frequency, 10 kHz therapy for painful diabetic neuropathy—a first for the FDA in the indication. The device is designed to deliver 10,000 electric pulses every second to help disrupt pain signals as they travel through the central nervous system on their way to the brain.
Neurostimulators for chronic debilitating pain developed by Medtronic, Abbott and Boston Scientific use much lower frequencies, typically well under 200 pulses per second, to help extend their battery life for years. However, these rates can also produce a tingling or buzzing sensation during therapy, known as paresthesia.
Senza’s rechargeable battery is expected to last for 10 years without causing uncomfortable paresthesia, so the device can be used while the patient is sleeping or performing daily tasks.
"We are thrilled that we can now begin commercial launch activities in the U.S. and believe this new indication will be an important driver of the long-term growth of our business for years to come," said Nevro’s chairman, president and CEO, D. Keith Grossman.
The therapy will be immediately launched under the company’s new HFX branding, with Nevro expecting to bring in “mid-single-digit million revenue” from the device by the end of 2021, mostly concentrated within this year’s fourth quarter. As the rollout progresses, the company hopes to see sales ramp up next year, alongside phased international launch plans in the U.K., Germany and Australia.
Alongside the approval announcement, Nevro also provided a preliminary look at its second-quarter earnings, with worldwide revenue slated to top $102 million from its wider neurostimulation portfolio.
That’s up 81% compared to the $56.4 million brought in over the same period in 2020 and the early stages of the COVID-19 pandemic as well as a 9% increase over the $93.6 million Nevro saw in the second quarter of 2019.
"The recovery of procedural volumes in the pain market generally and the SCS market specifically has been slower than we anticipated, impacting not only second-quarter revenues, but in the case of lower trial procedures, revenue in future months as well," Grossman said.
“I believe we are well-positioned for attractive growth when the full impact and uncertainties of COVID on our market subsides,” he added. The company’s full second-quarter financial results are expected Aug. 4.