Nevro Corp. announced receipt of FDA approval of its Senza® System for the treatment of chronic pain associated with Painful Diabetic Neuropathy (PDN). This approval is specific to Nevro's unique 10 kHz stimulation, and Nevro now has the only spinal cord stimulation system approved by the FDA with a specific indication to treat PDN. The company will immediately initiate commercial launch activities in the U.S. under its recently launched HFX™ branding, as HFX™ for PDN. The company continues to anticipate a mid-single digit million revenue contribution from PDN in 2021, the majority of which is expected to be generated in the fourth quarter, with broader penetration and a larger revenue contribution expected in 2022 and beyond. The revenue ramp is expected to build gradually during the initial months following the launch as awareness increases among referring physicians and patients, patients move through the referral to trial to permanent implant pathway, and access with insurance payers expands. Internationally, the company will be executing phased launch plans in the UK, Germany and Australia, with further expansion planned in 2022.