Aspivix: The EIC Accelerator IUD Suction Tool That Reached the US

To fit an intrauterine device (IUD), most gynaecologists still grab the cervix with a tenaculum, a forceps with sharp hooks that pierce the tissue. Aspivix, a Swiss start-up founded in 2015, built a plastic device that holds the cervix by suction instead. In the EIC SME Instrument Phase 2 round of 3 April 2019, the pilot that became the EIC Accelerator, the European Commission selected it for a grant-only award, according to the Commission's list of selected companies, which names ASPIVIX SA of Lausanne as the project's only beneficiary. The EU contributed €2,492,068.25 to a €3,560,097.50 project that ran from 1 November 2019 to 31 January 2022, according to CORDIS.

Seven years after the award the device, sold as Carevix, is cleared by the US Food and Drug Administration, carries a CE mark and is on sale in the US and in Europe. It reached that point later than the company planned, and the revenue it now earns is not public.

Where Aspivix Stands Now

Aspivix is active and still raising money. The Swiss commercial register shows the company as existing, with its latest entry published on 21 July 2026 for a change to its articles of association, according to Zefix and Moneyhouse. In September 2026 it closed a second crowdfunding campaign on the Capital Cell platform with €836,285 against a target of €675,545, and said Carevix is marketed in 19 countries and "generating commercial revenue", according to BioAlps. When the campaign opened in June 2026, the Biopôle science park reported a target valuation of €26,318,642 and "commercialization underway in more than a dozen countries", according to Biopôle. Neither source gives sales or unit figures, and no annual accounts of the company could be found in public sources.

The proceeds are meant for commercial expansion in the US and Europe and for a next-generation device, carevix EVO, BioAlps reports. Mathieu Horras, co-founder, remains chief executive, according to the same release, although the register shows he left the board in February 2024, when the US executives Susan Nicholson and Jessica Federer joined it, Nicholson as chair.

The Technology: Suction Instead of Hooks

The tenaculum has been used to grip and pull the cervix for more than a century. The CORDIS summary says it causes pain for 84% of women, lesions and bleeding in 29% and cross-contamination in 5% to 10%, and argues that the fear of pain holds back use of the IUD, one of the most effective reversible contraceptives. Aspivix's single-use device applies a soft suction head to the cervix, which lets the clinician hold and pull it without piercing it. The company claimed this cuts an IUD insertion from up to seven steps to two, by removing local anaesthesia, waiting time and the need to stop bleeding, according to the project's final report on CORDIS.

The clinical record supports the pain claim, with caveats on the first design. A pilot study of the first version at Lausanne University Hospital (CHUV), published in December 2021, succeeded in placing the device in 7 of 13 women, with very little pain, according to Frontiers in Medicine. The CORDIS report confirms that "early tests proved Aspivix v1.0 to have limitations" and that a redesign delayed the trial. The randomised comparison of the redesigned device with the tenaculum in 100 women at CHUV and Geneva University Hospitals, published in Contraception in July 2023, found pain scores during grasping of 14.9 against 31.3 and mean blood loss of 0.336 grams against 1.336 grams, with IUD insertion successful in 94% of all women.

What the EIC Project Promised, and What CORDIS Shows

The award followed a €50,000 SME Instrument Phase 1 feasibility study from May to August 2018. Its report on CORDIS set the goal of CE mark compliance "to start commercialization in the European market by Q1 2021", and forecast 7.45 million units sold, €104 million of cumulative revenue and 30 jobs after four years on the market.

The Phase 2 grant agreement was signed on 18 October 2019. Its final report lists five work streams. The pandemic stopped elective procedures for months and delayed the first clinical phase at CHUV until November 2020; to speed up recruitment the protocol was reworked with a contract research organisation and Geneva University Hospitals joined. To avoid further delay, the company built version 1.1 with 3D-printed parts. The FDA cleared it under 510(k) number K203820 on 17 August 2021, according to the report and to the 510(k) record. The CE dossier under the EU's Medical Device Regulation was submitted, but no CE mark was granted before the project ended in January 2022. The company selected a contract manufacturer from five candidates to industrialise version 2.0.

1. Redesign and build a trial-ready deviceDeliveredVersion 1.1 built after v1.0 showed limitations, per the CORDIS report.
2. Comparative clinical trialDelivered100-woman randomised trial completed, published in Contraception, July 2023.
3. US clearanceDeliveredFDA 510(k) K203820, 17 August 2021, during the project.
4. CE mark for Europe (Phase 1 target: Q1 2021)LateSubmitted during the project, granted in December 2023, per Biopôle.
5. Industrial version with a contract manufacturerDeliveredInjection-moulded Carevix cleared by the FDA on 25 January 2023 (K223866).
6. 7.45M units in four years (Phase 1 forecast)Not publicNo sales or unit figures disclosed.

On the measure the EIC funds, the project worked: the device exists, passed a randomised trial and holds US and European approvals. It did so about two years and nine months behind the European launch date the company set in 2018, with the pandemic and limitations found in the first design as the documented causes.

What Aspivix Has Achieved Since the Award

The second FDA clearance, for the version made by plastic injection moulding instead of 3D printing, was the one that made the device economic to sell, according to Startupticker; the 510(k) record dates the decision 25 January 2023. In November 2022 Aspivix announced a USD 5 million Series A+ led by HEMEX, with existing investors 4FOx ventures and Zürcher Kantonalbank and new investor LaunchPad APAC, and a Eurostars grant co-funded by Innosuisse, according to FemTech Insider; funding.tech.eu records the round as €4,845,431 on 17 November 2022. The register shows a matching capital increase decided on 11 November 2022 that included CHF 2,511,682.78 of converted claims.

Commercial partners followed the CE mark. In April 2024 Aspivix and Bayer (Schweiz) AG, part of one of the largest IUD makers, announced a collaboration to introduce Carevix in Switzerland, according to Biopôle; the financial terms were not disclosed. In September 2024 the US clinic network Tia agreed to use the device in nine clinics in Los Angeles, New York, San Francisco and Scottsdale, after deployments at Indiana University Health and Columbia University, according to FemTech Insider. TIME listed Carevix among its best inventions of 2024. In June 2025 Titus Health Care became distributor for the Netherlands, Belgium and Luxembourg, according to a company release. The broader US launch, in Los Angeles, Orange County and New York, was announced on 21 October 2025, according to GGBA.

The Money

After the Series A+, Aspivix turned to retail investors. Its first Capital Cell campaign, which closed in March 2025 against a target of €2.15 million, is reported three ways: €1.95 million from 85 investors by GGBA, €2.6 million from 315 investors by Biopôle, and "over €1.9 million" from more than 300 investors by BioAlps in 2026. The register shows capital increases in October 2024 and March 2025, taking nominal share capital to CHF 263,547.92; the October 2024 entry is the first to list a class of B shares, 2,230,555 of them, rising to 3,419,020 in March 2025. Since the Series A+ in 2022, no announcement of an institutional funding round could be found.

Aspivix is not in the portfolio of the EIC Fund: it appears on none of the 16 pages of the Fund's list of invested companies, which is consistent with a 2019 award that was grant only. CORDIS lists no EU projects of the company other than its two SME Instrument grants.

Why Europe Should Care

Aspivix is a Swiss company that received Horizon 2020 money as a Swiss SME, and its case shows what that money buys in medical devices: most of a clinical trial and the regulatory files. Its US clearance came more than two years before its CE mark, under the EU's Medical Device Regulation, which applied from May 2021. The sequence, US first and Europe later, is one the CORDIS report documents in this case; whether the regulation caused the delay is not stated in any source found. The device addresses a common procedure in women's health, a field where the tenaculum has barely changed in a century.

The Verdict

Aspivix has not been asked for comment for this article. It is based entirely on public records, company statements and EU project data, linked throughout.