JUNO-Checked - Clinical Validation

Purpose and goal:

The main goal of the project was to facilitate accelerated clinical evaluation of JUNO-Checked via international collaborations and

knowledge transfer which will further be instrumental in obtaining the CE- certification in EU, as well as other regulatory approvals and market positioning globally. Our purpose was to focus on Design History Files, Study Plan, Pilot Study Execution and Reporting in accordance with IVDR and Spermosens’ Quality Policy as well as compile QMS documentation beyond the scope, but within the timeframe of the project

Expected results and effects: Regulatory: Fully transitioned to E-QMS platform from which we are generating our Design History File Pilot Clinical Evaluation:

JUNO-Checked sensor was evaluated using samples from donors at OsloMet Hospital. Using these samples, it was possible to observe the response of our sensors, JUNO and ZP3, to different concentrations of sperms samples

Additionally, the data obtained from the donor samples were applied to develop an algorithm used to create the first version of the JUNO-Score which indicate which IVF treatment is recommended based on the binding capacity of the sperm sample Approach and implementation: WP -1: Study Design and Ethics

Layout: Identification of appropriate sites to conduct pilot study; Outline study design; Prepare Study Submission and Registration with Ethics Committees (ECs). Implementation: All activities completed successfully WP-2: Study Conduct and Monitoring Layout: Start and end of the study Implementation: All activities completed successfully

WP-3: Analysis and Clinical Performance Report Layout: Statistical Plan and Analysis; Clinical performance study report Implementation: Completion of Statistical analysis Performance Report.