Vaginal atrophy, the thinning, drying and inflammation of vaginal tissue, is part of what doctors now call the genitourinary syndrome of menopause. According to the EU project AVeta Medical won, it affects around 80% of women, particularly menopausal women and breast cancer survivors. AVeta, founded in Galway in 2019, is developing a self-administered device that applies controlled suction to cause micro-trauma, prompting the tissue to regenerate without hormones.
The European Innovation Council granted €2.5 million towards a €3.81 million project to run first-in-human studies in Europe and the US and to obtain regulatory approval. The project ended in December 2024 with FDA clearance still a plan. In September 2026 the company's website says the device has not been approved in the US or the EU, and invites investors.
Company file
- Legal entity
- AVeta Medical Limited, Irish company no. 660947
- Incorporated
- November 2019
- Headquarters
- University of Galway Business Innovation Centre, Ireland
- Founders
- Paula Newell (founder), Brian Ledwith (co-founder, CEO by 2024)
- Product
- Non-hormonal suction device for vaginal atrophy (in development)
- Other funding
- Crowdfunding campaign (2024)
- EIC project
- AVeta, 1 Apr 2022 to 31 Dec 2024, closed
- EIC funding
- Grant first
Where AVeta Stands Today
AVeta's website states that the product "is currently under development and has not been approved for sale by the U.S. Food and Drug Administration (FDA) or under the EU Medical Device Regulation (MDR)", and carries an "open for investment" call. Its milestone list shows an FDA investigational device exemption for a pilot trial in the third quarter of 2024, completion of the first-in-human trial in the third quarter of 2025, and a US reimbursement strategy in early 2026.
The Irish register, via SoloCheck, lists the company as a normal, small company with its accounts for 2024 filed in November 2025 and no overdue filings.
The Technology: Suction Instead of Hormones
CORDIS presents AVeta's device as an alternative to hormone therapy or ineffective treatments. It uses controlled suction to create micro-trauma that triggers the body's own healing response and rejuvenates the tissue. In a 2024 crowdfunding profile, Women of Wearables described a self-administered treatment of five minutes over four months, giving up to ten months of relief, and quoted the company: "Early in-human trials demonstrate patient relief for 80% of trialists." The number of trialists was not given, and we found no published trial results.
"This funding will bring the AVeta device a step closer to providing a much-wanted hormone-free, safe solution to millions of women suffering from vaginal atrophy."
Paula Newell, founder, AVeta Medical, to Silicon Republic, October 2021What the EIC Project Promised, and What CORDIS Shows
When the award was announced, Silicon Republic reported it among five Irish EIC winners. The CORDIS report describes human exploratory studies on healthy vaginal tissue and IRB approval for a feasibility study using "an approved medical suction device with geometry similar to the AVeta prototype", after preclinical sheep studies showed tissue rejuvenation without fibrosis. It sets out a plan in which "FDA clearance will enable marketing of the device with unique indications in the US with first patient being treated in month 6 post project", followed by CE marking in Europe.
- First-in-human studiesPartialExploratory and feasibility studies; trial completion listed for 2025; no published results.
- FDA clearanceNot achievedPilot trial exemption only; not approved as of 2026.
- CE marking in EuropeNot achievedNot approved under the EU MDR.
- Private investment for launchNot shownCrowdfunding in 2024; website still seeking investment.
What Has Happened Since the Award
The public accounts of AVeta's progress do not line up neatly. The 2024 crowdfunding profile said the company had "successfully completed" a first-in-human trial and was running randomised controlled trials ahead of FDA and MDR submissions. The company's website lists completion of the first-in-human trial in the third quarter of 2025. Leadership also changed: Paula Newell was chief executive in 2021, and Brian Ledwith was co-founder and CEO by 2024.
The Money
We found no announced venture round. Besides the EIC grant, AVeta ran a crowdfunding campaign on Spark in 2024. Its award was "grant first", under which any EIC equity is decided later, and we found no EIC Fund investment. SoloCheck records a single shareholder.
What cannot be checked
The size and results of AVeta's human trials, how much the crowdfunding raised, and how long the company's money lasts are not public. Its filed accounts are not freely displayed.
Why Europe Should Care
For women who cannot or will not use hormones, a safe, non-hormonal device would fill a gap the EIC chose to fund. The company's chosen route, US clearance first and European CE marking later, also means European women would get it second.
What the project promised
First-in-human studies in Europe and the US, regulatory approval and market launch of a hormone-free device.
What the record shows
Early human studies and an FDA pilot exemption, but no approval, no published results and no disclosed investment.
The Verdict
An unmet need, an unfinished device
The EIC funded AVeta to reach approval, and it did not. The project moved the device into early human testing, but the plan to treat the first US patient six months after the project is well past, and the public record contains no trial data. With the company still seeking investment, the €2.5 million grant has so far bought progress, not a product.
AVeta Medical has not been asked for comment for this article. It is based entirely on public records, company statements and EU project data, linked throughout.
