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4 4  
5 5  = Overview =
6 6  
7 -Nevro is a global medical device company focused on providing innovative products that improve the quality of life of patients suffering from chronic pain. Nevro has developed and commercialized the Senza® spinal cord stimulation (SCS) system, an evidence-based neuromodulation platform for the treatment of chronic pain. The company's proprietary paresthesia-free HF10TM therapy, delivered by its Senza system, was demonstrated in its SENZA-RCT study to be superior to traditional SCS therapy with it being nearly twice as successful in treating back pain and 1.5 times as successful in treating leg pain when compared to traditional SCS therapy. Comparatively, traditional SCS therapy has limited efficacy in treating back pain and is used primarily for treating leg pain, limiting its market adoption. The company's SENZA-RCT study, along with its European studies, represents what the company believe is the most robust body of clinical evidence for any SCS therapy. The company believe the superiority of HF10 therapy over traditional SCS therapies will allow it to capitalize on and expand the approximately $2.0 billion existing global SCS market by treating both back and leg pain without paresthesia.
7 +Nevro (NVRO) is a global medical device company focused on providing innovative products that improve the quality of life of patients suffering from chronic pain. Nevro has developed and commercialized the Senza® spinal cord stimulation (SCS) system, an evidence-based neuromodulation platform for the treatment of chronic pain. The company's proprietary paresthesia-free HF10TM therapy, delivered by its Senza system, was demonstrated in its SENZA-RCT study to be superior to traditional SCS therapy with it being nearly twice as successful in treating back pain and 1.5 times as successful in treating leg pain when compared to traditional SCS therapy. Comparatively, traditional SCS therapy has limited efficacy in treating back pain and is used primarily for treating leg pain, limiting its market adoption. The company's SENZA-RCT study, along with its European studies, represents what the company believe is the most robust body of clinical evidence for any SCS therapy. The company believe the superiority of HF10 therapy over traditional SCS therapies will allow it to capitalize on and expand the approximately $2.0 billion existing global SCS market by treating both back and leg pain without paresthesia.{{footnote}}https://fintel.io/doc/sec-nvro-nevro-10k-2019-february-21-17950{{/footnote}}
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9 9  The company launched Senza commercially in the United States in May 2015, after receiving a label from the U.S. Food and Drug Administration (FDA) which supports the superiority of its HF10 therapy over traditional SCS. The Senza system has been commercially available in certain European markets since November 2010 and in Australia since August 2011. Nevro has experienced significant revenue growth in the United States since commercial launch. Senza is currently reimbursed by all of the major insurance providers. In early 2017, the company commenced a controlled commercial launch of its new surgical lead, marketed as the SurpassTM surgical lead, which the company believe will provide it access to approximately an additional 30% of the U.S. SCS market. In January 2018, the company received FDA approval for its next generation Senza IITM SCS system.
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183 183  
184 184  The company sell Senza in Europe and Australia through a combination of its direct sales force and a network of sales agents and independent distributors. The company began its direct sales operations in the United Kingdom in late 2010 and to date have expanded its direct sales operations to Austria, Australia, Belgium, Germany, Luxembourg, Norway, Sweden and Switzerland. The company utilize sales agents and independent distributors to sell in an additional seven countries.
185 185  
186 -==== Competition ====
186 +== Competition ==
187 187  
188 188  The company compete in the SCS market for chronic pain. The company also compete with spine surgeries, in particular re-operations. Currently, its major competitors are Medtronic, Boston Scientific and Abbott Laboratories, who have obtained regulatory approval for SCS systems. The company believe that the primary competitive factors in the market are:
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225 225  
226 226  The Mayo License terminates upon the expiration of (1) the last to expire of the licensed patents or (2) its obligation to pay royalties, whichever is later. We, the Mayo Foundation or VGL may terminate the Mayo License upon 60 days’ notice of a party’s material breach if such breach remains uncured after such 60-day period.
227 227  
228 -==== Manufacturing and Supply ====
228 += Manufacturing and Supply =
229 229  
230 230  The company rely upon third-party suppliers for the manufacture and assembly of its Senza SCS system and its components, some of which are single- or sole-sources of the relevant product component. Nevro has not yet identified and qualified second-source replacements for several of its critical single-source suppliers. Thus, in the event that its relationship with any of its single- or sole-source suppliers terminates in the future, the company may have difficulty maintaining sufficient production of its products at the standards the company require. Where practicable, the company seek out and validate second-source manufacturers for its single-source components. The company believe that existing third-party facilities will be adequate to meet its current and anticipated manufacturing needs. The company do not currently plan to manufacture the Senza SCS system components itself .
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284 284  As of December 31, 2017, the company had 676 employees globally. The company believe the success of its business depends, in part, on its ability to attract and retain qualified personnel. Nevro is committed to developing its employees and providing them with opportunities to contribute to its growth and success. The company's employees are not subject to a collective bargaining agreement, and the company believe that Nevro has good relations with its employees.
285 285  
286 286  = References =
287 +
288 +{{putFootnotes/}}
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