Investor Presentaiton

IMDRF International Medical Device Regulators Forum ● ● ● VOLUNTARY SUMMARY MALFUNCTION REPORTING PROGRAM MDUFA IV Agreement - Expand the number and types of devices for which malfunction reports (MDRs) could be submitted summarily rather than individually Allows FDA to focus postmarket oversight on devices with greatest risks to public health Eligible: Procodes FDA explicitly identifies https://www.federalregister.gov/documents/2018/08/17/2018- 17770/medical-devices-and-device-led-combination-products-voluntary- malfunction-summary-reporting-program Ineligible: - Procodes in existence <2 years Procodes FDA finds reason to exclude Companies FDA finds reason to exclude 7

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