Nevro Announces SENZA-PDN Clinical Data Presentation at the American Diabetes Association 81st Scientific Sessions

Rhea-AI Summary

Nevro Corp. (NYSE: NVRO) announced data from the SENZA Painful Diabetic Neuropathy (PDN) Randomized Controlled Trial will be presented at the American Diabetes Association (ADA) 81st Scientific Sessions from June 25-29, 2021. The study compares Nevro's 10 kHz spinal cord stimulation (SCS) to conventional medical management in 216 patients. Initial results showed significant pain relief and improved quality of life. CEO D. Keith Grossman emphasized the potential for FDA approval and market expansion, aiming to address a $3.5 to $5 billion market for PDN treatment.

Positive

• Presentation of 12-month follow-up results from SENZA-PDN trial at ADA Scientific Sessions.
• Initial results showed significant pain relief and improved quality of life.
• Market opportunity estimated between $3.5 billion to $5 billion for PDN treatment.

Negative

• None.

REDWOOD CITY, Calif., June 22, 2021 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced that data from the SENZA Painful Diabetic Neuropathy (PDN) Randomized Controlled Trial (RCT) will be presented at the American Diabetes Association (ADA) 81^st Scientific Sessions virtual meeting, June 25-29, 2021.  Nevro will also showcase the company's HFX™ platform of spinal cord stimulation (SCS) solutions in a virtual booth and will host an investor briefing. 

The late breaking poster presentation will describe the 12-month follow-up results and 6-month crossover patient data from the SENZA-PDN RCT. The objective of this study was to compare Nevro's proprietary high-frequency (10 kHz) SCS plus Conventional Medical Management (CMM) to CMM alone in 216 patients at 18 centers in the United States. Previously published 6-month results demonstrated significantly improved and sustained outcomes with 10 kHz SCS and substantial, sustained pain relief and improved health-related quality of life in patients suffering from painful diabetic neuropathy.  

"We are excited for Dr. Petersen to share for the first time the significant 12-month results and importantly, 6-month crossover patient data from our landmark SENZA-PDN trial at the ADA Scientific Sessions," stated D. Keith Grossman, Chairman, CEO and President of Nevro. "No traditional, low-frequency SCS treatments have demonstrated such positive results in treating PDN patients, and once FDA-approved, we believe there is a significant opportunity to expand this innovative treatment option to PDN patients who are unable to find relief with currently available pharmacologic options."    

Details of the presentation are included below: 

Poster #16-LB, Long-Term 10 kHz Spinal Cord Stimulation in Painful Diabetic Neuropathy: A Randomized Controlled Trial  
Presenting Author: Dr. Erika Petersen
Date & Time:  Friday, June 25, 2021 at 11:30 am ET (Posters will be available throughout the duration of the meeting)

Note that only registered attendees of the ADA Scientific Sessions will be able to access the poster presentation.  If you are registered, embargoed text of abstracts will be made available on June 22, 2021. You can access the 2021 ADA Scientific Sessions Online Planner on the web from your desktop/laptop computer. You can also visit ADAMeetingNews.org for instructions on downloading the mobile app.

The company plans to publish these 12-month results, including the 6-month crossover patient data, in a peer-reviewed journal. Study participants will continue to be followed out to 24 months. Nevro also plans to sponsor a Compendia and Podcast series with the ADA on Painful Diabetic Neuropathy, which will be published later this year. 

Nevro to Host Analyst & Investor Briefing on June 25, 2021

Nevro will host an analyst & investor briefing on Friday, June 25, beginning at 3:30 pm PT / 6:30 pm ET. Nevro Chairman, CEO and President D. Keith Grossman will host the event, which will include a clinical data update for the company's SENZA-PDN and SENZA-NSRBP clinical studies and a question & answer session. Nevro's Chief Medical Officer, David Caraway, MD, PhD, and Nevro's Chief Financial Officer, Rod MacLeod, will also participate in the event. 

Investors interested in listening to the briefing may participate via conference call or webcast.  The conference call can be accessed by dialing (833) 968-2321 in the U.S. or +1 7785602840 internationally, using Conference ID: 2819815. The live audio webcast can be accessed by clicking on the Investor Events link at https://nevro.com/English/us/investors/events-and-presentations/event-details/2021/Nevro-to-Host-Virtual-Investor-Briefing-from-ADA/default.aspx on June 25. This event is not part of the official ADA Scientific Sessions.

About Painful Diabetic Neuropathy (PDN)

The World Health Organization estimates 422 million adults with diabetes worldwide and prevalence (8.5%) that has nearly doubled over four decades.¹ Diabetes may cause systemic damage with profound impact on health-related quality of life and is potentially life-threatening.  Diabetic peripheral neuropathy is a common complication presenting as pain and other dysesthesias, including numbness, burning, or tingling. Approximately 20% of patients with diabetes will develop PDN, a progressive, potentially debilitating chronic neuropathic pain condition.²  In the U.S., it is estimated that there are approximately 140,000 to 200,000 PDN patients each year that become refractory to conventional medical management, representing an annual total addressable market opportunity of approximately $3.5 billion to $5.0 billion.^3,4

About the ADA Scientific Sessions – Virtual Experience

The American Diabetes Association's Scientific Sessions offer researchers and health care professionals from around the globe an exclusive opportunity to share ideas and gain knowledge about the recent advances in diabetes research, treatment, and care. Attendees will have access to more than 3,000 original research presentations, take part in thought-provoking speaking engagements with leading diabetes experts, and expand their professional networks.  For more information, please visit the ADA Website: https://professional.diabetes.org/scientific-sessions

Internet Posting of Information

Nevro routinely posts information that may be important to investors in the "Investor Relations" section of its website at www.nevro.com. The company encourages investors and potential investors to consult the Nevro website regularly for important information about Nevro.

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. Nevro's proprietary 10 kHz 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 10 kHz Therapy. 

SENZA, SENZA II, SENZA OMNIA, OMNIA, HF10, the HF10 logo, HFX, the HFX logo, HFX CONNECT, the HFX Connect logo, HFX ACCESS, the HFX Access logo, HFX COACH, the HFX Coach logo, HFX CLOUD, the HFX Cloud logo, RELIEF MULTIPLIED, the X logo, NEVRO, and the NEVRO logo are trademarks or registered trademarks of Nevro Corp.

To learn more about Nevro, connect with us on LinkedIn, Twitter, Facebook and Instagram.

¹ World Health Organization. (‎2016)‎. Global report on diabetes. World Health Organization. https://apps.who.int/iris/handle/10665/204871
² Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain. 2002;18(6):350-354.
³ CDC National Diabetes Statistics Report 2020; Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain. 2002;18(6):350-354.
⁴ Trinity Partners Market Research 2017.

Forward-Looking Statements    

In addition to historical information, this press release contains forward-looking statements reflecting the company's current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including: our belief that there is a significant opportunity to expand our innovative SCS therapy as an option to PDN patients who are unable to find relief with currently available pharmacologic options; our plan to publish the 12-month SENZA-PDN clinical trial results, including the 6-month crossover patient data, in a peer-reviewed journal; and our plan to sponsor a Compendia and Podcast series with the ADA on Painful Diabetic Neuropathy.  These forward-looking statements are based upon information that is currently available to us or our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including our ability to successfully commercialize our products; our ability to manufacture our products to meet demand; the level and availability of third-party payor reimbursement for our products; our ability to effectively manage our anticipated growth and the costs and expenses of operating our business; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; competition in our industry; additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims.  These factors, together with those that are described in greater detail in our Quarterly Report on Form 10-Q filed on May 5, 2021, as well as any reports that we may file with the Securities and Exchange Commission in the future, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements.  We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements. 

Investors and Media:
Julie Dewey, IRC
Nevro Corp.
Vice President, Investor Relations & Corp Communications
650-433-3247  |  julie.dewey@nevro.com 

 

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SOURCE Nevro Corp.

FAQ

What are the results of the SENZA-PDN trial presented by Nevro?

The SENZA-PDN trial results indicate significant pain relief and improved quality of life for patients treated with Nevro's 10 kHz spinal cord stimulation after 12 months.

When will the SENZA-PDN trial data be presented?

The SENZA-PDN trial data will be presented at the ADA Scientific Sessions from June 25-29, 2021.

What is the market potential for Nevro's PDN treatment?

The market potential for Nevro's treatment of painful diabetic neuropathy is estimated between $3.5 billion and $5 billion.

Who will present the SENZA-PDN trial results?

Dr. Erika Petersen will present the SENZA-PDN trial results at the ADA Scientific Sessions.

What is the significance of the SENZA-PDN trial results?

The results are significant as they suggest that Nevro's SCS therapy may offer a viable alternative for PDN patients who do not respond to conventional treatments.