Nevro Announces American Association of Clinical Endocrinology Clinical Practice Guideline Has Been Updated to Include High-Frequency 10 kHz Spinal Cord Stimulation to Treat Painful Diabetic Neuropathy

Rhea-AI Summary

Nevro Corp. (NYSE: NVRO) announced that its HFX 10 kHz Therapy is the only spinal cord stimulation (SCS) method referenced in the American Association of Clinical Endocrinology's 2022 Diabetes Clinical Practice Guideline for treating painful diabetic neuropathy (PDN). This therapy is a nonpharmacological option for patients who have not responded to traditional medications. The guideline underscores the significant need for effective treatments in managing PDN, which affects a substantial number of diabetic patients, representing a market opportunity of $3.5 to $5 billion annually.

Positive

• HFX 10 kHz Therapy recognized in AACE 2022 guidelines, boosting credibility.
• Strong clinical trial data showing double the patient responder rate and pain relief.

Negative

• None.

REDWOOD CITY, Calif., Oct. 3, 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 Nevro's HFX 10 kHz Therapy is the only form of spinal cord stimulation (SCS) therapy to be referenced by the American Association of Clinical Endocrinology (AACE) in its 2022 Diabetes Clinical Practice Guideline to treat painful diabetic neuropathy (PDN).

Based on results from Nevro's landmark SENZA-PDN randomized controlled study, the AACE guideline states that high frequency (e.g., 10 kHz) spinal cord stimulation is a nonpharmacological approach that may be effective in persons with painful diabetic peripheral neuropathy that failed at least one medication.¹^,²  The treatment algorithm in the guideline also includes a referral to a pain physician for assessment if medical therapy has failed.   

"For a clinician specializing in providing care for patients with diabetes, helping those with intractable pain of peripheral diabetic neuropathy is probably the most frustrating aspect of my practice," commented Dr. George Grunberger, Chairman of the Grunberger Diabetes Institute in Bloomfield Hills, Michigan and Past President of the American Association of Clinical Endocrinologists.  "There is a dearth of effective medications approved by the FDA for its management, and none of these are disease modifying.  Medications which are being used are in many cases ineffective and/or associated with side effects.  Of course, their use also necessitates life-long adherence.  It was thus welcome news when the FDA approved high-frequency spinal cord stimulation for the management of PDN and also encouraging to see that its use for these patients is listed in the latest update of the AACE guideline for comprehensive care planning for diabetes."

"This is a very positive endorsement of our proprietary, high-frequency 10 kHz Therapy by an important community of health care providers specializing in endocrinology, diabetes, and metabolic disorders," stated D. Keith Grossman, Chairman, CEO and President of Nevro.  "Based on our strong and growing body of published, peer-reviewed clinical trial data that demonstrated twice the patient responder rate, twice the pain relief and the only study to demonstrate neurologic improvements, we believe that our HFX solution is uniquely positioned to provide relief to the thousands of patients suffering from PDN."   

The 2022 guideline update synthesizes thousands of articles to provide health care professionals with the latest evidence-based information on the total care of diabetes. 

Read the full AACE guideline here.

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.³ 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.⁴  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.^5,6

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.

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, 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 EA, Stauss TG, Scowcroft JA, et al. Effect of high-frequency (10-kHz) spinal cord stimulation in patients with painful diabetic neuropathy: A randomized clinical trial. JAMA Neurol. 2021;78(6):687e698. 
https://doi.org/10.1001/jamaneurol.2021.0538.
² Petersen EA, Stauss TG, Scowcroft JA, 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(1):e3ee6. https://doi.org/10.2337/dc21- 1813. 
³ World Health Organization. (‎2016)‎. Global report on diabetes. World Health Organization. 
https://apps.who.int/iris/handle/10665/204871
⁴ 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 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.
⁶ 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 based on our strong and growing body of published, peer-reviewed clinical trial data that our HFX solution is uniquely positioned to provide relief to the thousands of patients suffering from PDN.  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.

 

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SOURCE Nevro Corp.

FAQ

What is Nevro Corp.'s HFX 10 kHz Therapy?

HFX 10 kHz Therapy is a spinal cord stimulation method for managing chronic pain, specifically painful diabetic neuropathy (PDN).

How does the AACE guideline recognize Nevro's therapy?

The AACE 2022 guidelines are the first to reference Nevro's HFX 10 kHz Therapy as a treatment for PDN.

What market opportunity does painful diabetic neuropathy represent for Nevro?

The total addressable market for treating PDN is estimated to be between $3.5 billion and $5 billion annually.

What are the key benefits of HFX 10 kHz Therapy according to the studies?

Clinical trials indicate that HFX 10 kHz Therapy provides twice the patient responder rate and pain relief compared to traditional methods.

When was the AACE guideline updated to include Nevro's therapy?

The American Association of Clinical Endocrinology updated its guidelines in October 2022.