Gedea Biotech AB

Besväras du av illaluktande va**nala flytningar? Det kan vara symptom på bakteriell vaginos. Vi söker kvinnor till en forskningsstudie med en behandling mot bakteriell vagnios.

I studien används en va**naltablett som är godkänd (CE-märkt) för en veckas behandling av bakteriell vaginos. Syftet med studien är att utvärdera effekt och säkerhet om behandlingen förlängs med en vecka.

Läs mer och anmäl dig här https://forskningsperson.se/aktuella-studier/studie-900-behandling-bakteriell-vaginos/

Har du bakteriell vaginos?
Vi söker kvinnor över 18 år med pågående bakteriell vaginos till en forskningsstudie.
Studien utvärderar en va**naltablett som behandling. Behandlingen innehåller ett ämne som förekommer naturligt i kroppen och studien undersöker effekt och säkerhet.
✔ Behandling i 12 dagar
✔ Få ersättning
✔ 4 besök i Stockholm (CTC) eller Uppsala (CMedical)
Läs mer och anmäl ditt intresse!
https://gedeabiotech.se/for-patienter/ -studie

PRESS RELEASE

Last week Gedea Biotech announced a planned CEO transition. After close to ten years as CEO, Annette Säfholm has decided to step down from her role. The Board of Directors has appointed Julie Waras Brogren as the new Chief Executive Officer. Julie has more than 20 years of experience from the pharmaceutical, biotech and medtech industries and she most recently served as Deputy CEO, Chief Commercial Officer and CFO at Ascelia Pharma. She will assume her role at Gedea in early April 2026.

Read the full press release here https://gedeabiotech.com/2026/01/27/gedea-biotech-appoints-julie-waras-brogren-as-new-ceo-to-lead-the-company-into-its-commercialization-phase/

As the year draws to a close, we would like to wish you all a happy holiday season, wherever you are in the world.

Women today increasingly expect good health and actively take action to achieve it. In this context, we strongly believe that pHyph represents a modern, antibiotic-free solution aligned with both medical needs and patient expectations.

During 2025, Gedea reached a major milestone as our lead product pHyph received CE marking under the EU Medical Device Regulation (MDR). This places pHyph among a limited number of products in women’s health that will remain on the European market beyond 2027, when non-compliant products must be withdrawn. The MDR approval further strengthens pHyph’s long-term commercial potential.

See you all in 2026.

The Gedea Team


Visa översättning

Redefining approaches to bacterial vaginosis through microbiome research

In her latest publication, Emilia Lahtinen, industrial PhD student at Karolinska Institutet and Gedea Biotech, investigates how treatments can influence the microbiome’s recovery following bacterial vaginosis.

There are always microorganisms, including bacteria and fungi, in and on our bodies, and the va**nal microbiome plays a crucial role in women’s health. In a healthy va**nal microbiome, there is a balance between different bacteria and fungi, depending on factors such as pH-level, medication, hormones, and other things.

A healthy va**nal microbiome is dominated by Lactobacillus species (spp)., which produce lactic acid, hydrogen peroxide, and various antimicrobial compounds. An imbalance in the normal bacterial flora of the va**na is called dysbiosis. This condition is characterized by a reduction in beneficial bacteria, such as Lactobacillus spp., and an overgrowth of potentially harmful bacteria. Dysbiosis is associated with adverse gynecological and obstetric outcomes, such as sexually transmitted infections, pelvic inflammatory disease, and preterm birth. One of the most common consequences of dysbiosis is bacterial vaginosis.
The study, based on Gedea’s CL3 clinical trial, provides new insight into how pHyph supports a favourable microbiome composition without relying on antibiotics.
- It was fascinating to observe the changes in the va**nal microbiome following treatment. The results give us valuable insight into how non-antibiotic treatments like pHyph can support va**nal health and aid in restoring va**nal balance.

pHyph is approved for treatment of bacterial vaginosis, the reduction of its symptoms, and the promotion of a healthy va**nal microbiome. Emilia’s research is important for the further development of pHyph into new therapeutic areas as the prevention of pre-term birth.

https://gedeabiotech.com/product/publications/

pHyph is an antibiotic-free va**nal tablet designed to both treat BV and promote a healthy va**nal microbiome. pHyph has now been approved for treatment of bacterial vaginosis in the EU.

Gedea Biotech’s lead product pHyph has received CE-marking under the EU Medical Device Regulation (MDR) for the treatment of bacterial vaginosis (BV).

The approval confirms the efficacy and safety of pHyph and opens up a large market opportunity in Europe. The novel, antibiotic free mode of action will improve treatment of bacterial vaginosis for millions of women and reduce use of antibiotics, and our ambition is to make pHyph available in pharmacies in the first markets in 2026, says Annette Säfholm, CEO of Gedea Biotech.

Bacterial vaginosis affects one in three women. While current treatments rely on antibiotics, pHyph offers a modern solution. It’s a va**nal tablet that restores the natural environment by lowering pH and promoting beneficial lactobacilli, treating the infection while also strengthening the natural microbiome to reduce the risk for future recurrence.

With its active ingredient already approved as a food additive, pHyph is safe and effective. Clinical studies show that it provides symptom relief from day one.

We are working woith leading medical companies in Europe to launch pHyph on the first markets in 2026. Sign up for our newspaper and we will keep ypo posted. https://gedeabiotech.com/news/

On the International Women's Day we want to address the THE WOMEN’S HEALTH GAP
Research in women’s health primarily focuses on diseases with high mortality, overlooking diseases leading to disability. Many gynecological conditions are neglected because research and investment focuses on saving lives rather than adding healthy years to lives. As pointed out in the report by McKinsey Health Institute: “In all, when tackling women’s health, the solution is not to divide more slices of one pie: it’s to make more pie.”

At Gedea Biotech AB, we know that many women spend years, literally, with recurring va**nal infections and even more time worrying about the next episode of BV or fungal infection. Our aim is to decrease years spent with debilitating gynecological conditions.

Source: Closing the women’s health gap: A $1 trillion opportunity to improve lives and economies by McKinsey Health Institute and World Economic Forum

https://www.mckinsey.com/mhi/our-insights/closing-the-womens-health-gap-a-1-trillion-dollar-opportunity-to-improve-lives-and-economies