Changes for page Nevro Corp

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--= Paragraph 1 =
++= Overview =
--==== Overview ====
--
  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.
  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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  The company believe Nevro has built competitive advantages through its proprietary technology, clinical evidence base, strong track record of execution with over 28,000 patients implanted with Senza, extensive intellectual property and a proven management team with substantial neuromodulation experience. With the well-demonstrated superior efficacy of its HF10 therapy, the company aim to continue to drive adoption and penetration in the U.S. market, which represents the largest opportunity in SCS, and expand patient access to HF10 therapy by investing in the development of evidence for new indications such as chronic upper limb and neck pain, painful neuropathies and non-surgical refractory back pain.
--==== Market Overview ====
++= Market Overview =
  **Existing Treatments for Chronic Pain and Limitations**
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  Traditional SCS technology involves the delivery of low frequency electrical impulses, or waveforms, to the spinal cord. Recent developments in traditional SCS have resulted in alternative waveforms, some of which are variations of low frequency waveforms. For example, Abbott Laboratories has developed a SCS system that offers an alternate low frequency waveform called BurstDR. Medtronic is testing a high-density programming approach. Additionally, Boston Scientific recently presented the results of a sub-threshold therapy through their Whisper study.
--==== Solution for Chronic Pain ====
++== Solution for Chronic Pain ==
  **HF10 Therapy**
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  * Anatomical lead placement for physicians. Since HF10 therapy relies on consistent anatomical lead placement, it removes the cumbersome process of paresthesia mapping that is required by traditional SCS therapy, reducing variability in the operating procedure and offering a significant benefit to both physicians and hospitals by reducing variability of procedures.
  * Ability to treat a broader group of chronic pain patients: The company's HF10 therapy is a platform technology that the company believe can provide treatment benefits for a broader group of chronic pain indications. Nevro is currently investigating the use of HF10 therapy to address additional indications such as chronic upper limb and neck pain, painful neuropathies and non-surgical refractory back pain. Based on analysis from its SENZA-RCT and European studies, the company believe HF10 therapy may be an attractive treatment option for some non-surgical refractory back pain patients due to its cost, reversibility and initial trial period. Due to the removal of paresthesia, HF10 may also be an effective therapy for patients with chronic upper limb and neck pain as it will not create the intense discomfort that traditional SCS generates for patients with chronic upper limb and neck pain when leads are placed in the cervical spine.
--==== Growth Strategy ====
++== Growth Strategy ==
  The company's mission is to be the neuromodulation leader in the treatment of chronic pain by developing innovative, evidence-based solutions. To accomplish this objective the company intend to:
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  Outside the United States, reimbursement levels vary significantly by country, and by region within some countries. Reimbursement is obtained from a variety of sources, including government-sponsored and private health insurance plans, and combinations of both. Some countries will require it to gather additional clinical data before granting broader coverage and reimbursement for its products. It is its intent to complete the requisite clinical studies and obtain coverage and reimbursement approval beyond what Nevro has today in countries where it makes economic sense to do so.
--==== Product Development and Research Development ====
++= Product Development and Research Development =
  The company's objective is to continue to improve patient outcomes and further expand patient access to HF10 therapy through enhancements to Senza and the development of new indications. Research and development (R&D) expenses were $21.4 million, $33.7 million and $37.6 million, for the years ended December 31, 2015, 2016 and 2017, respectively.
  Since the launch of the initial Senza system, Nevro has introduced a number of product enhancements. These include a short-tip version of the lead, new lengths of the lead, an active anchor with improved performance over silicon anchors, a second generation active anchor with smaller volume, lead adaptors that allow use of competitor leads already implanted in patients, second generation clinician programmer software, a second and third generation IPG with improved shape and compatibility for scans of the head and extremities with both 1.5 and 3 Tesla (T) MRI machines, conditional full body MRI approval for its Senza 1000 and 1500 IPG systems in Europe and Australia, and its Surpass surgical lead to complement its percutaneous lead. The company also expect to continue developing enhancements to Senza to further increase performance and introduce new benefits including next generation IPGs and enhanced MRI capabilities. There can be no assurance that the company will be successful in these efforts or in receiving any required regulatory approvals.
--==== Sales and Marketing ====
++= Sales and Marketing =
  **United States**
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  The company expect its competitors to launch new products and release additional clinical evidence within the next few years. For example, over the past two years, Abbott Laboratories received FDA approval for a SCS system that offers an alternate low frequency waveform called BurstDR, and in February 2016, the company gained approval for a neuromodulation system that stimulates the dorsal root ganglion for treatment of focal pain and complex regional pain syndrome, in each case, using pivotal clinical studies for each therapy to support the FDA approval process. Medtronic is performing studies to collect data on existing SCS products for back pain and also testing their high-density programming approach. Additionally, Boston Scientific has commenced a randomized clinical trial of a high-frequency SCS therapy in their Accelerate study and recently presented the results of a sub-threshold therapy through their Whisper study. Additionally, there are a number of emerging competitors at various stages of development. Stimwave has developed and is starting to commercialize a minimally invasive stimulation system that employs an externally worn power source and radio frequency transmitter. Nalu Medical, Inc. (Nalu Medical) and Neuspera Medical Inc. (Neuspera Medical) are also pursuing a similar approach as well. Saluda is developing and testing a low frequency closed loop system for the treatment of chronic pain. In November 2015, Nuvectra, a company that was spun-off from Greatbatch, received FDA approval for its SCS system, which is similar to many of the other traditional SCS systems currently on the market.
--==== Intellectual Property ====
++= Intellectual Property =
  The company actively seek to protect the intellectual property and proprietary technology that the company believe is important to its business, which includes seeking and maintaining patents covering its technology and products, proprietary processes and any other inventions that are commercially or strategically important to the development of its business. The company also rely upon trademarks to build and maintain the integrity of its brand, and the company seek to protect the confidentiality of trade secrets that may be important to the development of its business. For more information, please see “Risk Factors—Risks Related to Intellectual Property.”
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  The company also have other suppliers, including some sole-source suppliers, for certain of its components, with whom the company do not have agreements.
--==== Product Liability and Insurance ====
++= Product Liability and Insurance =
  The manufacture and sale of its products subjects it to the risk of financial exposure to product liability claims. The company's products are used in situations in which there is a risk of serious injury or death. The company carry insurance policies which the company believe to be customary for similar companies in its industry. The company cannot assure you that these policies will be sufficient to cover all or substantially all losses that the company experience.
  The company endeavor to maintain executive and organization liability insurance in a form and with aggregate coverage limits that the company believe are adequate for its business purposes, but its coverage limits may prove not to be adequate in some circumstances.
--==== Employees ====
++= Employees =
  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.
++
++= References =