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Nevro's (NVRO) FDA Submission to Treat Patients With PDN

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Nevro Corp. NVRO recently announced that it has submitted a pre-market approval supplement to the FDA to get authorization for its Senza System. The approval is required for the treatment of chronic pain related to Painful Diabetic Neuropathy (PDN).

It is worth mentioning that about one in 10 adults in the United States suffer from diabetes, which can damage peripheral nerves leading to severe pain and numbness in the extremities. In fact, per published literature, around 4 million diabetic patients are suffering from PDN in the United States alone.

Following this announcement, Senza — Nevro’s flagship platform and key driver of growth — is likely to receive a boost. Notably, Senza has been developed and commercialized for the treatment of chronic pain. The system delivers paresthesia-free HF10 therapy, a superior one over traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain.

More on the News

Notably, Nevro’s SENZA-PDN study is the largest randomized clinical trial (RCT) of spinal cord stimulation treatment that has been conducted to date. The study draws comparison with the HF10 therapy plus Conventional Medical Management (CMM) to CMM alone in 216 patients across 18 centers in the United States.

The RCT has been developed to offer safety and effective data that can be utilized to lend support to customer adoption and efforts to enable required payor coverage of this procedure.

The submission marks a key milestone in the evaluation of HF10 high frequency spinal cord stimulation therapy that can provide relief with presently available pharmacologic options to many PDN patients.

Post review and regulatory approval of the submission, the company can commence U.S. launch activities for the Senza System and HF10 therapy for treating chronic pain in PDN patients in the second half of 2021.

Market Prospects

Per a report by Fortune Business Insights, the global diabetic neuropathy market size was worth $3.61 billion in 2018 and is expected to reach $7.12 billion by 2026, witnessing a CAGR of 8.9% during the forecast period (2019-2026). Hence, the announcement is a well-timed one for Nevro.

Notable Developments

In June 2020, Nevro announced that it has received TGA approval and Jul 1, 2020 Prostheses Listing for the Senza Omnia Spinal Cord Stimulation (SCS) system — a next generation system developed to help physicians manage chronic pain with maximum versatility.

In May, the company announced that it has received CE mark approval for the SCS system, which is likely to aid Nevro in strengthening its already solid international presence.

Price Performance

Shares of this Zacks Rank #3 (Hold) stock gained 52.4% in a year’s time, outperforming the industry’s growth of 18.8%.

Stocks to Consider

Some better-ranked stocks from the broader medical space are Merit Medical Systems, Inc. MMSI, Patterson Companies, Inc. PDCO and McKesson Corporation MCK, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Merit Medical has a projected long-term earnings growth rate of 12.6%.

Patterson Companies has an estimated long-term earnings growth rate of 9.6%.

McKesson has a projected long-term earnings growth rate of 6.6%.

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