Nevro Announces SENZA-PDN Clinical Data Presentations at the American Diabetes Association 82nd Scientific Sessions

Rhea-AI Summary

Nevro Corp. (NYSE: NVRO) announced that the SENZA Painful Diabetic Neuropathy (PDN) Randomized Controlled Trial data will be presented at the ADA's 82nd Scientific Sessions from June 3-7, 2022. The presentation will include 24-month follow-up results from the trial, which compares Nevro's 10 kHz spinal cord stimulation (SCS) therapy plus medical management to standard care. Previous results showed significant pain relief and improved quality of life. Nevro anticipates complete 24-month data availability in Q4 2022 for further presentation.

Positive

• SENZA-PDN trial is the largest RCT for spinal cord stimulation in treating PDN.
• 24-month results indicate sustained pain relief and quality of life improvements.
• Expected complete data to bolster market presence and therapeutic validation.

Negative

• None.

Poster Presentation to Include 24-Month Follow-Up Results from Original 10 kHz Arm of SENZA-PDN Randomized Controlled Trial

SENZA-PDN Study Results Selected to be Featured in ADA's Official Press Program

Company to Participate in ADA's Product Theater Presentation

REDWOOD CITY, Calif., May 31, 2022 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that data from the SENZA Painful Diabetic Neuropathy (PDN) Randomized Controlled Trial (RCT), the largest RCT to evaluate spinal cord stimulation (SCS) to treat PDN, will be presented at the American Diabetes Association (ADA) 82^nd Scientific Sessions to be held June 3-7, 2022 in New Orleans, LA.  Nevro will also showcase the company's HFX™ platform of SCS solutions in Exhibit Booth #1119 and in an ADA product theater presentation by Dr. Erika Petersen and Dr. George Grunberger. 

During the  poster presentation, Dr. Erika Petersen will present the 24-month follow-up results from the original 10 kHz arm of 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 complete 12-month results in Diabetes Care demonstrated significantly improved and sustained outcomes with high-frequency 10 kHz Therapy, including substantial, sustained pain relief and improved health-related quality of life in patients suffering from PDN.¹     

Details for the poster and product theater presentation are included below: 

Poster #22-LB, 24-Month Results for 10 kHz Spinal Cord Stimulation (SCS) in Treating Painful Diabetic Neuropathy (PDN)  

Presenting Author: Dr. Erika Petersen
Date & Time:  Sunday, June 5, 2022 at 12:00 PM to 1:00 PM CT (Poster will be available from June 4-6, 2022 in the Poster Hall)

These SENZA-PDN study results were selected to be featured in the Official Press Program for the ADA's 82^nd Scientific Sessions.  This study was selected based on overall excellence in furthering the research and treatment for people with diabetes. 

ADA Product Theater Presentation, Revolutionizing the Treatment of Painful Diabetic Neuropathy with High Frequency (10 kHz) Spinal Cord Stimulation

Presenters:  Dr. George Grunberger; Dr. Erika Petersen
Date & Time:  Sunday June 5, 2022 at 10:15 AM CT
Location: ADA Product Theater #2, Main Exhibit Hall

Note that only registered attendees of the ADA Scientific Sessions will be able to access the poster presentation and the exhibit hall.  If you are registered, embargoed text of abstracts will be made available on May 31, 2022. 

The company expects the complete 24-month data from the SENZA-PDN RCT to be available in the fourth quarter of 2022 and plans to submit this data set for presentation at NANS in January 2023 and publish as soon possible thereafter.

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.² 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.³  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.^4,5

About the ADA Scientific Sessions

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 delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 80,000 patients globally. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy. 

Senza®, Senza II®, and Senza Omnia™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Nevro's unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management.

Senza, Senza II, Senza Omnia, HFX, HXF Coach, HFX Cloud, HFX Connect, Nevro and the Nevro logo are trademarks of Nevro Corp.

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

1	Petersen et al.  Durability of High-Frequency 10-kHz Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy Refractory to Conventional Treatments: 12-Month Results From a Randomized Controlled Trial. Diabetes Care. 2022;45:e1–e4; https://doi.org/10.2337/dc21-1813.
2	World Health Organization. (‎2016)‎. Global report on diabetes. World Health Organization. https://apps.who.int/iris/handle/10665/204871
3	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	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.
5	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 expectation that the complete 24-month SENZA-PDN clinical trial results will be available later in the fourth quarter of 2022.  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 Annual Report on Form 10-K filed on February 23, 2022, 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.
Chief Corp Communications and Investor Relations Officer
650-433-3247  |  julie.dewey@nevro.com

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/nevro-announces-senza-pdn-clinical-data-presentations-at-the-american-diabetes-association-82nd-scientific-sessions-301558212.html

SOURCE Nevro Corp.

FAQ

What are the SENZA-PDN study results presented by Nevro?

The SENZA-PDN study results showcased 24-month follow-up demonstrating significant pain relief and improved quality of life for diabetic neuropathy patients.

When will the complete 24-month data from the SENZA-PDN trial be available?

The complete 24-month data from the SENZA-PDN trial is expected to be available in the fourth quarter of 2022.

What was the objective of the SENZA-PDN trial?

The objective was to evaluate the efficacy of Nevro's 10 kHz spinal cord stimulation in combination with conventional medical management versus conventional medical management alone.

Where is Nevro presenting its findings?

Nevro is presenting its findings at the American Diabetes Association's 82nd Scientific Sessions in New Orleans, from June 3-7, 2022.

What is the market opportunity for Nevro's treatment?

The annual total addressable market opportunity for treating painful diabetic neuropathy is estimated between $3.5 billion and $5.0 billion.