Swedish women’s health company Gedea Biotech has announced the appointment of Anna-Karin Areskog as QA Director.
She has experience from previous positions as QA/RA and senior QA manager in the pharmaceutical and mainly in medical device industries covering regulations, quality standards and guidelines such as 21 CFR 820, ISO13485, MDR, GMP and IVDR.
Additionally, the company has announced the approval of its ISO13485 re-certification.
It stated that these developments serve as key milestones to achieve CE marking for pHyph, an antibiotic-free treatment for bacterial vaginosis (BV).
Anna-Karin Areskog said: “I am passionate about contributing to small innovative companies like Gedea with my experience.
“Realising the large unmet need for Gedea’s product pHyph for relieving symptoms and preventing recurrence of bacterial vaginosis, I am so proud to be part of the development work.”
pHyph is a vaginal tablet that has been developed to treat BV and prevent a recurrence.
It restores the vaginal pH to its natural level, removes the infectious bacterial build-up of biofilm formed during BV, restricts the infectious bacteria growth and restores the healthy vaginal microbiome.
Together, these mechanisms of action provide a beneficial environment for a healthy vaginal microbiome.
In a clinical trial, 90% of patients treated with pHyph had symptom reduction and 70% of them had an absence of symptoms by day seven.
The vaginal tablet demonstrated excellent medical effect, with 50.4% of the patients clinically cured of BV by day seven.