Periodic Reporting for period 2 - Aspivix (Vacuum Medical Device for Safe and Gentle Cervix Grasping Gynecological Applications)
Reporting period: 2020-11-01 to 2022-01-31
Worldwide, 44% of pregnancies are unintended, representing 85M/year pregnancies and thousands of life-threatening situations for women and billions of euros of costs for the healthcare system. 95,000 maternal deaths can be prevented annually if women who desired to postpone or avoid childbearing had adopted effective contraception.
The intra-uterine device (IUD), the most cost-effective reversible contraceptive method, remains under-utilized, its adoption is limited by the pain at the placement.
For years, IUD insertions have featured little attention to patients’ pain. In these procedures, the practitioners require the use of a cervical tenaculum to grasp, pull and steady the cervix. Yet, the use of the cervical tenaculum is painful and traumatic, triggers systematic lesions and bleeding, and can be a vector of cross-contamination.
Aspivix is a simple patented solution. Instead of clamping the cervix with sharp teeth of the tenaculum, Aspivix grasps the tissue by a gentle suction effect.
Aspivix has a huge market potential by addressing tenaculum-related pain affecting 93M women worldwide and bringing values to end-users, IUD manufacturers and healthcare systems.
After the completion of the comparative phase of the clinical trial, it is established that Aspivix v1.1 reduces pain by 30% for all women and by 55% for nulliparous women. It reduces bleeding frequency by 90%.
The intra-uterine device (IUD), the most cost-effective reversible contraceptive method, remains under-utilized, its adoption is limited by the pain at the placement.
For years, IUD insertions have featured little attention to patients’ pain. In these procedures, the practitioners require the use of a cervical tenaculum to grasp, pull and steady the cervix. Yet, the use of the cervical tenaculum is painful and traumatic, triggers systematic lesions and bleeding, and can be a vector of cross-contamination.
Aspivix is a simple patented solution. Instead of clamping the cervix with sharp teeth of the tenaculum, Aspivix grasps the tissue by a gentle suction effect.
Aspivix has a huge market potential by addressing tenaculum-related pain affecting 93M women worldwide and bringing values to end-users, IUD manufacturers and healthcare systems.
After the completion of the comparative phase of the clinical trial, it is established that Aspivix v1.1 reduces pain by 30% for all women and by 55% for nulliparous women. It reduces bleeding frequency by 90%.
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.
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.
Aspivix addresses tenaculum-related issues and consequently, besides the reduction of pain and trauma for women, it brings values to end-users, IUD, and healthcare systems:
1. Gynecologists/Nurses/Midwives
The main physicians’ problem is the time expended to relieve the secondary effects caused by current tenaculum: the need for anesthesia (cervical bloc, lidocaine gel, etc.), waiting time to reach the sedative effect, and the systematic need of stopping the bleeding (pressuring, silver nitrate, stitch, etc.). Aspivix will allow a reduction of the steps in an IUD placement procedure, down from 7 potential steps to 2 steps. With Aspivix, practitioners will gain up to 7min per consultation which represents a potential revenue increase of 30% from the additional 5 daily consultations. The procedure practitioners’ margins would increase from 8% to 17%.
2. IUD manufacturers and surgical gynecological distributors our main customers
By bundling Aspivix with IUD, the IUD manufacturers will specifically benefit from Aspivix, as many women will reconsider IUD adoption if the pain is avoided during its insertion. Considering our survey results, Aspivix would boost IUD sales by up to 46%, adding €1.5bn to the IUD Market.
3. Healthcare system and health insurers
The Health Care System and insurers companies currently cover the associated costs of unintentional pregnancies. We estimate that if Aspivix could increase the adoption of IUD by 8%, this would represent savings for the European Health system of €2.9bn.
1. Gynecologists/Nurses/Midwives
The main physicians’ problem is the time expended to relieve the secondary effects caused by current tenaculum: the need for anesthesia (cervical bloc, lidocaine gel, etc.), waiting time to reach the sedative effect, and the systematic need of stopping the bleeding (pressuring, silver nitrate, stitch, etc.). Aspivix will allow a reduction of the steps in an IUD placement procedure, down from 7 potential steps to 2 steps. With Aspivix, practitioners will gain up to 7min per consultation which represents a potential revenue increase of 30% from the additional 5 daily consultations. The procedure practitioners’ margins would increase from 8% to 17%.
2. IUD manufacturers and surgical gynecological distributors our main customers
By bundling Aspivix with IUD, the IUD manufacturers will specifically benefit from Aspivix, as many women will reconsider IUD adoption if the pain is avoided during its insertion. Considering our survey results, Aspivix would boost IUD sales by up to 46%, adding €1.5bn to the IUD Market.
3. Healthcare system and health insurers
The Health Care System and insurers companies currently cover the associated costs of unintentional pregnancies. We estimate that if Aspivix could increase the adoption of IUD by 8%, this would represent savings for the European Health system of €2.9bn.