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Leadership Through Innovation Tm

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Presentation on theme: "Leadership Through Innovation Tm"— Presentation transcript:

1 Leadership Through Innovation Tm
Nevro

2 Nevro: Advancing Spinal Cord Stimulation
Novel Rechargeable Spinal Cord Stimulator Implantable device placed minimally invasively by Pain Specialists and Spine Surgeons Unique high-frequency waveform up to 10kHz Anatomic lead placement without paresthesia mapping The Senza® System is an investigational device in the U.S.

3 Company Milestones 2006 2007 2008 2009 2010 2011 2012 IDE initiated
US IP issued European launch International pivotal clinical Pilot short term testing in US study Early external prototype testing Validation in additional large animal model: UC Davis Animal work: Stanford University Founded at Mayo: Initial idea generation roundtable

4 US Senza-RCT Study Underway
Negotiated with the FDA First study to compare SCS device systems Non-inferiority study on safety and efficacy Largest randomized SCS study ever conducted Senza compared to commercially available SCS The Senza® System is an investigational device in the U.S.

5 Safety and Effectiveness Endpoints
Primary Non-inferiority comparison: change in back pain VAS and neurological status from baseline Secondary Assessments such as % change in back pain, leg pain, function Adverse event rates Paresthesia perception Tertiary Includes sleep quality, quality of life, depression level, pain med usage The Senza® System is an investigational device in the U.S.

6 Pain Gaining Recognition as a Challenge

7 Opportunity for SCS Community
Expansion Opportunity Physical therapy & conservative therapies Interventional techniques (i.e. blocks) Spine surgery Oral opioids Spinal cord stimulation Drug Pumps

8 Difficult Funding Environment for Innovation

9 Opportunity for Neuromodulation
Significant opportunity for neuromodulation to improve healthcare To accomplish this, additional effort needed in: Clinical Evidence Education for HCP and Payers Patient Experience


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