Gedea Biotech appoints Anna-Karin Areskog as QA Director and receives ISO13485 certification
Lund, Sweden April 12, 2023: Gedea Biotech announces today that Anna-Karin Areskog has been appointed QA Director and that their ISO13485* re-certification has been approved. Both the announcement and the approved certification are important milestones for achieving CE marking for pHyph, the company’s antibiotic-free treatment for bacterial vaginosis.
*ISO 13485 is the medical device industry’s most widely used international standard for quality management.
Anna-Karin holds a master’s degree from Mälardalen University majoring on Quality in the Life Science Industry, following a degree in chemical engineering from Lund University. She has extensive experience from positions as QA/RA and Senior QA Manager within the pharmaceutical and especially medical device industries covering quality standards, regulations and guidelines such as GMP, MDR, IVDR, ISO13485 and 21 CFR 820.
“I am passionate about contributing to small innovative companies like Gedea with my experience. Realizing 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”, says Anna-Karin Areskog.
For more information
For further information, please contact:
Annette Säfholm, CEO Gedea Biotech
Telephone: +46 708 - 91 86 81
Email: annette.safholm@gedeabiotech.com
Ton Berkien, Chairman, Gedea Biotech
Telephone: +46 70- 791 49 54
Email: ton.berkien@gedeabiotech.com
About pHyph
The vaginal tablet, pHyph will treat bacterial vaginosis (BV) and prevent recurrence by promoting a healthy vaginal microbiome, restoring the vaginal pH to its normal level of pH 4,0 - 4,5 and by breaking down the biofilm formed during BV under which the infectious bacteria begin to thrive. These mechanisms of actions, together provide a beneficial environment for the healthy vaginal microbiome. The naturally occurring active ingredient GDA 001 in pHyph is well documented and is already approved as a food additive. A clinical cure rate for BV on par with antibiotics on the market, has been proven in two phase 2 trials, with a superior safety profile and without causing secondary VVC infections as antibiotics do.
About Gedea Biotech
Gedea Biotech is a Swedish, innovative women’s health company developing pHyph, the first antibiotic free treatment that will both treat and prevent bacterial vaginosis. Vaginal infections affect at least 400 million women every year worldwide and the market is worth over $ 1.5 billion. Gedea Biotech was founded in 2015 in Lund, Sweden. https://gedeabiotech.com/
