2019 - Device idea based on clinical need and market void

8/2020 - Napkin drafts

9/2020 - Professional drafts

10/2020 - Intellectual property lawyer engaged

12/2020 - Provisional patents submitted

12/2020 - Regulatory strategy established

1/2021 - Engineering work begins

6/2021 - Prototype

7/2021 - Prototype animal cases

9/2021 - Presubmission FDA meeting

12/2012 - Design freeze

03/2022 - FDA Guidance

05/2022 - Benchmark testing

06/2022 - Animal testing

09/2022 - Clinical study begins

04/2023 - Enrollment completed

09/2023 - CE Mark

10/2023 - FDA Approval