Gedea Biotech, based in Lund, Sweden, and led by chief executive Julie Waras Brogren, makes pHyph, an antibiotic-free vaginal tablet that restores a healthy vaginal environment and microbiome to treat and prevent infections. In February 2024 it announced a €2.5 million EIC Accelerator grant for the continued development and commercialisation of pHyph, according to Gedea Biotech. The project, "Breakthrough dual-action OTC tablet for treatment and prevention of both bacterial and fungal vaginitis", received €2,499,999 towards a total cost of €3,623,750 and ran from April 2024 to July 2026, according to CORDIS.
In August 2025 pHyph received a CE mark under the EU Medical Device Regulation for treating bacterial vaginosis, which Gedea said gave it unrestricted access to the European market and would support partnering discussions, according to Gedea Biotech. In July 2026 it completed a post-market study, BV2025, which met its safety endpoint. In September 2026 it completed a randomised study in vaginal fungal infection, VVC-2025, with an interim analysis of 36 women showing statistically significant clinical cure rates on day 14, and continued the review to extend the CE mark, according to Gedea Biotech.
Company file
- Legal entity
- Gedea Biotech AB, org. no. 559000-7026
- CEO
- Julie Waras Brogren
- Product
- pHyph vaginal tablet
- Approved use
- Bacterial vaginosis, CE-marked under MDR
- Pending use
- Vulvovaginal candidiasis
- Patents
- US patent on preventing preterm birth; new European patent 2026
- EIC funding
- Blended finance, €2.5M grant
Where Gedea Stands Now
Gedea says the BV2025 data are "valuable for the European market launch and executing collaborations for the US market", which indicates that neither a European launch nor a US partnership had been announced by July 2026. In 2025 it received a US patent covering the prevention of preterm birth, and in 2026 a new European patent for treating infections. Its accounts were not accessible in free sources for this article, as the Swedish company-data sites were blocked.
"It demonstrates our ability to efficiently execute clinical and regulatory commitments according to plan."
Julie Waras Brogren, CEO, July 2026The Technology: Treating Infection Without Antibiotics
Bacterial vaginosis affects nearly one in four women worldwide and is usually treated with antibiotics, which can disrupt the vaginal microbiome and lead to recurrence or resistant bacteria, Gedea says. pHyph instead works on the vaginal environment and microbiome, and is regulated as a medical device rather than a drug. A London sexual health consultant quoted by Gedea said new antibiotic-free options are needed because current treatments often lead to side effects and recurrence.
What the EIC Award Promised, and What the Record Shows
The project promised a dual-action over-the-counter tablet for both bacterial and fungal vaginitis. It ended in July 2026 with one indication approved and the clinical study for the second completed. The over-the-counter market launch has not yet happened.
- Bacterial vaginosis approvalDeliveredCE mark, 2025.
- Fungal infection evidenceStudy doneVVC-2025.
- Fungal infection approvalUnder reviewSeptember 2026.
- Market launchUnverifiedNot announced.
The Money
The EU covered 69% of the project. The award was blended finance, but Gedea announced only the grant, and no EIC Fund investment or recent private round has been announced.
What Cannot Be Checked
Questions for the EIC
Whether the EIC Fund invested, when pHyph will be on sale and through which partners, what Gedea's revenue and losses are, and when the fungal indication will be approved are not public.
Why Europe Should Care
Gedea and the clinicians it quotes point to recurrence and resistant bacteria as the cost of antibiotic treatment. A non-antibiotic treatment for one of the most common women's health complaints fits that goal. Gedea has the approval; the product now has to reach pharmacy shelves.
What the award promised
A dual-action OTC tablet for bacterial and fungal vaginitis.
What the record shows
A CE mark for one indication, the second in review, no launch yet.
The Verdict
Approved, not yet sold
Gedea hit its regulatory milestones. Getting pHyph to women is the step still missing.
Gedea Biotech and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.
