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.
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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.”
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By GlobalDatapHyph 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.
