Nevro (NYSE:NVRO) announced today that it received FDA approval for its Senza system for treating chronic pain associated with PDN.
The Redwood City, Calif.-based company’s stock was up nearly 6%, to 152.54 per share, by afternoon trading today.
Nevro’s Senza system’s approval is specific to Nevro’s 10 kHz stimulation. The company is touting that it now has the only spinal cord stimulation system approved by the FDA with a specific indication for treating PDN (painful diabetic neuropathy).
FDA approval follows the published results of the SENZA-PDN trial in JAMA Neurology, which demonstrated the safety and efficacy of the spinal cord stimulation (SCS) system.
In April, Nevro touted results from the randomized SENZA-PDN trial, which met its prespecified primary endpoint by demonstrating that PDN patients with symptoms refractory to best available treatments can be safely and effectively treated with high-frequency (10 kHz) SCS, Nevro said. The trial pitted Senza, plus conventional medical management (CMM), against CMM alone in 216 patients across 18 centers in the U.S.
In addition to meeting the primary endpoint, the system delivered statistically significant, clear differences from the best available medical treatments in seven of eight secondary endpoints.
The company said it plans to immediately initiate the commercial launch activities for Senza in the U.S. under its recently launched HF branding as “HFX for PDN.” Nevro anticipates mid-to-single-digit million revenue contributions from PDN in 2021, with the majority generated in the fourth quarter.
A broader penetration and larger revenue contribution from Senza for PDN should come in 2022 and beyond, Nevro said, with international phased launch plans in the United Kingdom, Germany and Australia planned for next year.
“This FDA approval marks a capstone achievement that demonstrates the strength of our clinical data and provides a proven, new breakthrough SCS treatment option for PDN patients who are struggling with debilitating pain and who are unable to find relief with currently available pharmacologic options,” Nevro chairman, CEO & president D. Keith Grossman said in the release. “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.”
Analysts from Truist said revenue estimates for Nevro could move higher, based on early physician enthusiasm regarding Senza as a new solution for patients.
Investors have been expecting a second-quarter miss with lowered numbers for the full year, the analysts noted, and while uncertainty remains on guidance, positive updates on trends or early anecdotal comments related to Senza and PDN “should be well-received with the stock at current levels.” As a result, the analysts maintain their position that Nevro stock stands in the “buy” category.
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