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Vacuum Medical Device for Safe and Gentle Cervix Grasping Gynecological Applications

Periodic Reporting for period 1 - Aspivix (Vacuum Medical Device for Safe and Gentle Cervix Grasping Gynecological Applications)

Reporting period: 2019-11-01 to 2020-10-31

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 being 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 80M women worldwide and bringing values to end-users and healthcare systems.
1. Design development from Aspivix v1.0 to Aspivix v1.1 and production set-up
Early performance tests on simulators proved Aspivix v1.0 design to have 3 limitations:
• The traction force was insufficient
• The suction head was unleashing the cervix tissue in certain traction angle cases
• The vacuum release mechanism was hard to trigger in a clinical setting

Hence, a new design was prepared, with new suction head and vacuum release mechanism, both developed by HELBLING, and a larger vacuum volume. The redesign delayed the clinical trial start. To avoid delaying further the clinical trial, fast production of Aspivix v1.1 was set up, with 3D-printed parts at PROFORM and ASPIVIX, plastic injected parts at MODEL SOLUTION, assembly at STATICE and sterilization at LEONI. All those manufacturing sept-up costs are counted in SUBCONTRACTING WP1.

2. Verification and Validation of Aspivix v1.1 and regulatory dossiers
Packaging, transport, ageing, biocompatibility/cytotoxicity and sterilization were validated for Aspivix v1.1.
Dossiers for Aspivix v1.1 CE marking, according to MDR, and 510k were prepared and submitted to the notified body. The Aspivix v1.1.’s 510k, will serve as a predicate to speed-up Aspivix v2.0’s registration on the US market.

3. Clinical trial at CHUV with Aspivix v1.1
COVID-19 delayed the clinical trial at CHUV by preventing elective procedures for 3 months and slowed down patient recruitment. Yet, the trial phase 1 started in July 2020 was finalized in November 2020, establishing strong safety and efficacy. A scientific publication is being prepared by the investigators.

Additional hospitals will join the trial phase 2 to accelerate recruitment. The delay of clinical data availability prevented further business development with IUD manufacturers (pre-requisite to get a commitment from IUD manufacturers) and delayed the industrialization of Aspivix v2.0.

4. Preparation for industrialization of Aspivix v2.0
After the redesign, 5 CMO assessed again the costs for manufacturing. FLEX offered higher investment and less attractive conditions than MECAPLAST and STERIPACK. Options with them are being explored for Aspivix v2.0. The manufacturing set-up costs will be counted in SUBCONTRACTING WP1, replacing the budget allocated to FLEX.

5. Dissemination activities
Aspivix participated in 2 conferences and presented posters/abstracts in 2 other international scientific conferences. Aspivix established a social media strategy with regular postings on different channels and blogs.
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. Gynaecologists/Nurses/Midwives
The main physicians’ problem is the time expended to relieve the secondary effects caused by current tenaculum: need for anaesthesia (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 gynaecological 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 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 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.
Side by Side of tenaculum (forceps) sharp teeth vs Aspivix v1.0 instrument
Side by side of tenaculum (forceps) sharp teeth vs Aspivix v1.0