Investor Presentaiton

IMDRF International Medical Device Regulators Forum ACCESSORIES • FDA Reauthorization Act of 2017 - Better benefit-risk-based regulation of accessories by de-coupling accessory classification from classification of the parent device • Enables accessories to be used with a wider range of devices • Streamlined process for classifying accessories into Class I via FR Notice: - https://www.federalregister.gov/documents/2018/08/17/2018- 17731/medical-devices-classification-of-accessories-distinct-from-other- devices-proposed-list-of 6

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