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Nevro Announces TGA Approval and July 1st Prostheses Listing of Senza® Omnia™ Spinal Cord Stimulation System

June 16, 2020
  • Next-generation system designed to provide physicians maximum versatility to manage chronic pain
  • Omnia offers Nevro's proprietary HF10® therapy in addition to all other available frequencies between 2-10,000 Hz

MELBOURNE, Victoria, June 16, 2020 – Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced it has received TGA approval and upcoming July 1, 2020 Prostheses Listing for the Senza® Omnia™ Spinal Cord Stimulation (SCS) system. The TGA approval and addition of Omnia to the upcoming Prostheses List allows for the launch of the system in July.

“Following a successful launch in the United States last fall, and a recent launch in Europe, we are now eager to provide physicians and patients access to the Senza Omnia SCS system in Australia,” said Niamh Pellegrini, Chief Commercial Officer of Nevro. “Omnia was developed as a result of extensive feedback from physicians to provide a versatile solution to help more patients with chronic pain. With Omnia, patients will have access to the widest range of SCS frequencies, and physicians can have the peace of mind knowing that they can provide their patients the broadest range of solutions for the best possible outcomes today, and in the future. With the upcoming launch in Australia, we are excited that Omnia will be available to all of our global customers.”

The Omnia system is a completely new SCS platform and consists of a number of new components. The first is the new Omnia programmer, which will allow physicians to easily offer the widest array of waveforms across the full SCS frequency spectrum, either separately or paired together with HF10. The second element of the system is a redesigned patient remote that is more intuitive for patients to use. The new remote supports greater programming capacity, allowing for the flexibility to expand on the HF10 algorithm by giving physicians the ability to provide additional waveforms. The third component is a redesigned, slimmer patient charger with an improved user interface. Lastly, the system comes with an updated and upgradeable implantable pulse generator. Unlike non-rechargeable systems, the Omnia battery is designed to last over ten years no matter what stimulation profile is used, has conditional full body MRI approval, and will be upgradeable to future waveforms and frequencies.

“The TGA approval of the Omnia spinal cord stimulation system to treat chronic refractory pain will be a welcome new platform from Nevro,” said Nick Christelis, Pain Specialist Physician, Director of Pain Specialists Australia and current president of NSANZ. “I’m looking forward to using Omnia’s updated programming suite which reflects a more versatile solution to treat the changing, dynamic, and sometimes even progressive, nature of chronic pain.”
Other SCS systems on the market are limited to frequencies below 1,200 Hz. In contrast, Omnia delivers the widest range of frequencies of any SCS system, between 2 and 10,000 Hz. In addition to Nevro’s proprietary HF10 waveform, Omnia offers the most waveforms on one device and can be programmed to provide waveforms independently or paired with HF10. The ability to pair frequencies allows Omnia to pair HF10 – the most studied SCS therapy with over 55,000 patients treated across the world – with other waveforms, including traditional, paraesthesia-based stimulation, subthreshold 1 kHz therapy or burst waveforms.

For more information about the Omnia system, please visit www.nevro.com/Omnia.

About Nevro

Headquartered in Redwood City, California, Nevro is a global medical device company focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain. Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of chronic pain. HF10 therapy has demonstrated the ability to reduce or eliminate opioids in ≥65% of patients across six peer-reviewed clinical studies. The Senza® System, Senza II™ System, and the Senza® Omnia™ System are the only SCS systems that deliver Nevro's proprietary HF10® therapy. Senza, Senza II, Senza Omnia, HF10, Nevro and the Nevro logo are trademarks of Nevro Corp.

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Investor Relations:

Juliet Cunningham

Vice President, Investor Relations

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ir@nevro.com

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Splice Marketing

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