Completion of the pivotal clinical investigation is considered a major milestone in the development of the ONIRY device, paving the way to its marketing in European Union and beyond!
Some of you remember, that on September 22, 2023, the face-to-face Investigators Meeting, also with online attendance, was held in Prague, Czech Republic, with the objective to present topline results of the pivotal clinical investigation of the ONIRY device (NCT04903977) to its investigators. The meeting took place at the Mother and Child Care Institute (ÚPMD), which had also served as one of the investigation sites. The results on diagnostic performance and safety of ONIRY for detection of obstetric anal sphincter injuries were presented by Katarzyna Borycka, CEO, and Piotr Iwanowski, CMO.
A public disclosure of the results of this clinical investigation will follow.
OASIS Diagnostics is committed to development of innovative technologies for rapid detection of pathologies of the perineal organs and tissues, including the obstetric anal sphincter injuries, with the vision of transforming the practice of obstetric and maternity care.
Please follow OASIS Diagnostics’ webpage on LinkedIn to stay up to date with the latest news and information about our projects. More exciting challenges and discoveries to come soon!
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