The Opportunity

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$20B+ LONG-TERM MARKET $4.5B U.S. EXPANSION MARKET $250M INITIAL MARKET

Route to Market

Starting Focused. Expanding With Validation.

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Regulatory
Strategy
Nurovo is evaluating a Class II medical-device pathway, with potential FDA pre-submission engagement to clarify device classification, intended use, and clinical evidence requirements. These discussions would inform future validation and regulatory activities, including the development of a potential 510(k) submission strategy.

From Entry Point
to Enterprise

Pain Clinics & Post-Operative Care High pain-assessment frequency creates an initial setting for integrating Nurovo alongside existing patient-reported measures and establishing repeat clinical use.
01
Specialized Care Expansion into hospice and other settings where pain may be difficult to communicate extends Nurovo into populations where conventional assessment can become less reliable or incomplete.
02
Hospital Systems Validated workflows can expand across departments through enterprise deployment, centralized device management, and integration with hospital clinical infrastructure.
03
Expansion Through
Clinical Evidence
Nurovo’s commercial pathway is designed around evidence generated within each deployment environment. Initial adoption establishes workflow fit and repeated-use data, while broader clinical validation supports expansion into additional departments, patient populations, and health systems.