Vacuum Medical Device for Safe and Gentle Cervix Grasping Gynecological Applications

Project Information

ASPIVIX

Grant agreement ID: 815991

DOI

10.3030/815991

Project closed

EC signature date 30 April 2018

Start date 1 May 2018

End date 31 August 2018

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

ASPIVIX SA
Switzerland

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

Reporting period: 2018-05-01 to 2018-08-31

Summary of the context and overall objectives of the project

Current gynecological examination turns to be, in most of the cases, a nightmare for the patients. Intra-Uterine Contraceptive Device (IUCD) insertions, curettage and several other common indications, require the use of an instrument, called tenaculum, to grasp and pull on the cervix inside the vaginal cavity. Tenaculum provokes pain, and eventually trigger lesions and bleeding, not to mention the cross-contamination when the device is reusable and not well sterile. Aspivix SA has developed a simple, thoughtful and patented device to replace the current painful device.
The objectives were focused on defining the technological, commercial and financial tasks to reach the industrial manufacturing scale-up, and the CE mark compliance to start commercialization in the European market by Q1 2021.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

We finalized the current prototype, Design 5, to feature a reliable suction force to grasp the cervix during the gynecological examination, and analysed its traction force. Also, we analysed the technical aspects to complete the final design for Aspivix manufacturing at large scale, and to reach commercialization after CE-Mark approval and validation through patients with two clinical trials.. Last, we developed a financial plan for the commercialization of Aspivix.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Instead of the clamping made by the tenaculum sharp hooks, Aspivix has been designed to grasp the cervix tissue through a gentle suction effect while ensuring a firm control of the cervix tissue. Aspivix is able to shorter practitioner intervention workflow from 7 steps to 2 steps, getting rid of waiting time for sedative effect, for the bleeding to stop, for the use of stiches on cervix, and for device sterilization. It only remains the cervix grasping and the insertion of IUCD/surgery instrument.
Aspivix economic benefits for physicians reach up to 30%. It enhances the adoption of the 99% effective IUCD, as Aspivix eliminated the pain during IUCD insertion, adding a value of €565M/year to the IUCD market. It represents potential savings of €2.9bn for the European health system if unintentional pregnancies are reduced through the adoption of IUCD triggered by Aspivix.
With Aspivix, after 4-years of commercialization, we expect to reach sales of 7.45M units, triggering cumulative revenues, profits and employment of €104 M, €43.31 and 30 FTE, respectively. Also, when considering the total investment of €3.23M it will give a return of investment (ROI) of €14.8 per euro invested.

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