1. Design development from Aspivix v1.0 to Aspivix v1.1 and production set-up
Early tests proved Aspivix v1.0 to have limitations. A new design was prepared, with new suction head and vacuum release mechanism, delaying the clinical trial start. To avoid further delay, a fast production of Aspivix v1.1 was set up, with a 3D-printed parts.
2. Verification and Validation of Aspivix v1.1 and regulatory dossiers
Verification and validation were executed for Aspivix v1.1. Dossiers for Aspivix v1.1 CE marking, according to MDR, and 510k were submitted to the notified body and FDA. FDA cleared Aspivix v1.1.’s 510k in August 2021.
3. Clinical trial at CHUV with Aspivix v1.1
The pandemic prevented elective procedures for months. It affected the clinical trial phase 1 start at the University Hospital of Lausanne, which was eventually completed in November 2020, demonstrating strong safety and efficacy.
To accelerate the recruitment for the comparative phase, the protocol was reworked with a CRO, and the University Hospital of Geneva (HUG) joined the trial.
4. Industrialization of Aspivix v2.0
After redesign, 5 CMO were re-assessed for the manufacturing activities. one of them was selected according to best value for money analysis and set-up the industrialization of Aspivix v2.0.
5. Dissemination activities
Aspivix participated in five national and international congresses in 2020 and 2021.
• 2nd International Conference of Genecology and Obstetrics, in 2020
• 28th World congress on Controversies in Obstetrics, Gynecology, and Infertility, in 2020.
• Swiss Annual Congress of Gynecology, in 2021
• 14th European Society of Gynecology congress, in 2021
• 29th World congress Controversies in Obstetrics, Gynecology, and Infertility, in 2021
A scientific publication was published in a peer-reviewed journal (Frontiers Medicine in December 2021).
Following the completion of the Comparative Phase of the clinical trial, the investigators from CHUV and HUG submitted:
• the publication manuscript to Contraception, an Elsevier publication.
• an abstract to the 2 main Gynecology congresses in Europe in early 2022 (ESCRH & RCOG).
To build awareness, ASPIVIX published 27 original articles, interviewed with 10 national newspapers, magazines sand TV shows and created successful videos; one of them generated 197,000 views, rising our social media channel profile. ASPIVIX achieved+130% followers YoY with nearly 2500 followers on social medias. The website drives more than 4,000 unique visitors per month.
