Gedea Biotech AB

Gedea has recently strengthened its team by hiring Anna-Karin Areskog as QA Director. Anna-Karin Areskog has been a consultant with the company since April 2023 and is now a permanent employee. In her new role, she will focus on the CE marking of pHyph and initiate the commercial-scale production of pHyph. A warm welcome to Gedea, Anna-Karin!

We are very happy to welcome Anna-Karin Areskog as our QA Director as of today! With our recent clinical data, paving the way for CE-mark application and commercial manufacturing -your expertise and commitment is greatly needed and appreciated! We are so glad to welcome you to the team!

Yesterday, at the Nordic Mentor Network For Entrepreneurship - NOME annual meeting in Copenhagen, we were honored to receive the Arvind Hundal Scale-up Award for “showing inspirational growth.” We are proud, humbled, and truly grateful for this recognition. Following in the footsteps of last year’s winner, Neola Medical, is a privilege and an inspiration. As a NOME alumni, Gedea has benefited immensely from access to world-class mentors with deep expertise in international pharma and medtech. Their honest, insightful, and encouraging guidance provided a valuable outside-in perspective, helping us grow and refine our business. We wholeheartedly recommend the NOME program to other companies looking to scale and thrive. Annette Säfholm and Eva Norell received the award in Copenhagen and was joined for a picture by Søren, Kirsten and Morten. Thank you to Soeren Anker Nielsen Kirsten Therkildsen Søndersted-Olsen Morten Faester Kati Kaijasilta Johan Kördel Lottie Olsson Norrsén #NOME #Growth #Innovation #MedTech

Emilia Lahtinen is an industrial Ph.D. student at Gedea and at Karolinska Institutet. You have been an industrial Ph.D. student since 2022, a position shared between Gedea Biotech AB and Karolinska Institutet. Was this your dream project? Yes, absolutely! I knew I wanted to work with bioinformatics, microbiome research, and be close to, or within the industry. As an industrial doctoral student, you can conduct research that is not only likely to be applied but also contributes to the general body of knowledge. What is your affiliation at Karolinska Institutet? I am located at the Center for Translational Microbiome Research (CTMR). I am fortunate to have an excellent supervisory team guiding my research. My main supervisor, Ina Schuppe Koistinen, PhD, is based at CTMR, where two of my co-supervisors are also affiliated. Additionally, I am supervised by Helena Strevens, MD, PhD, from Gedea Biotech. What difference can your research make to women or in the field of women’s health? Expanding our knowledge about the vaginal microbiome will help us to understand the underlying causes of conditions like bacterial vaginosis and guide the development of more effective, targeted treatments. What do we know about the vaginal microbiome to date? Is there a common understanding of what constitutes a healthy microbiome and what does not? A clear causal link between specific microbiome composition  and the symptoms experienced by women has not yet been established. Historically, infections have been attributed to specific pathogenic microbes, with the assumption that eliminating them resolves the problem.  But it's not that simple. The microbiome’s function is influenced by the dynamic interactions within and between microbial communities. The vaginal microbiome also varies significantly across different stages of life. Factors, such as pregnancy, childbirth, menopause, and hormonal changes can all affect the microbiome. Ethnicity also plays a role in microbiome diversity, though it is unclear whether this is due to differences in lifestyle, genetics, or immune system responses. One established observation, however, is that a microbiome dominated by Lactobacillus crispatus is associated with good health while a microbiome with a high microbial diversity is associated with various gynecological conditions and adverse pregnancy outcomes. What is your next milestone? Next year, my goal is to publish results related to Gedea’s CL3-study (NFERTITI) study, where I studied the changes in the vaginal microbiome of patients who were treated with pHyph. That’s exciting! At CTMR, we also have a mission to engage with the public and share our knowledge. We have an Instagram account called @fembiome https://lnkd.in/dt6EhPwm where we post “fact-based science about the vulva, vagina and their microbes”. Follow us to dive deeper into the world of microbes and their impact on women’s health!

Gedea Biotech AB carried out a rights issue of SEK 24.3 million during October. The interest from both existing owners and new investors exceeded the board’s mandate, and an extraordinary general meeting resolved a directed issue to include the oversubscription of SEK 13 million. In total, Gedea has after issue costs received SEK 34.8 million. Read the full press release here https://lnkd.in/dz3WyTAM

Annette Säfholm, CEO and Ton Berkien, Chairman of the Board at Gedea Biotech AB are in Stockholm for Bio Europe. If you're a business developer in women’s health and want to enhance your portfolio with a modern, effective, and sustainable treatment for vaginal infections, don’t miss the chance to meet them! #bioeurope #womenshealth #amr

pHyph is close to market      Gedea Biotech AB Biotech develops pHyph, an antibiotic free vaginal tablet for the treatment and prevention of bacterial vaginosis. The CE-marking process for pHyph is ongoing, estimated to reach EU approval in 2025 and to then be ready for initiating phase 3 trials for US approval as a prescription drug. Gedea aims to close partnerships with larger pharma companies for sales and marketing as well as development for regulatory approvals worldwide of the product. We also have a pipe-line with indications for vulvovaginal candidiasis and pre-term birth. pHyph meets pressing medical needs better than current treatments • Rapid symptom relief   • Long-term effect, low risk of recurrence   • Does not lead to secondary fungal infections   • Double effect in treating both BV and VVC     The company is located in Lund, Sweden. Since its foundation, Gedea has received several prestigious grants and awards, among them Horizon 2020 Grant  and Hoizon EIC 2023 Accelerator. Book a meeting with Annette Säfholm at Bio Europe in Stockholm, November 4-6.  https://lnkd.in/dcSJZtQy #womenshealth #bioeurope

Gedea Biotech is developing a treatment for vaginal infections that actually works, meaning an effective, antibiotic free and safe treatment for vaginal infections that treats the infection and minimizes the risk of recurrence. Meet one of our colleagues, Eva Norell. I work as Marketing and Communications Manager at Gedea and I have been here on and off for six years now. My background is sales, marketing and project management in the pharmaceutical industry and other organizations in or close to the health care sector. A broad range of experience and skills come in handy in a start-up where you I tackle a variety of tasks each day 😊 During the last week, I have received six emails and messages from women asking about our product pHyph and when it’ll be available in the US or Europe. The week before it was three emails.  The week before that it was five. Women from different parts of the world write to us and tell us about their suffering from bacterial vaginosis and how they cannot live their lives fully, because of recurrent infections. I am very thankful for their messages, because that reminds me that we are doing something very important that will improve lives of millions of women. It makes my workday meaningful. The lengthy timelines in product development can be frustrating. While it’s crucial to be meticulous with medical products, I can’t help but feel eager to launch! I am currently working on a thorough update of our webpage, that will reflect the development stage we are in now. It’s a process to decide how and what to communicate and there is a lot of discussion with my helpful colleagues. #womenshealth #AMR #gedeabiotech

Today Eva Norell from Gedea Biotech AB attended the Nordic-African Women’s Health conference Organized by the Women African Ambassadors in Sweden, Ferring Pharmaceuticals and United Nations Population Fund (UNFPA) at the Ferring headquarters in Copehagen. Topics for the day was innovation in women’s health and antimicrobial resistance. Antimicrobial resistance hits all parts of society; health care, agriculture, economic. There are no sex differentiated data on how AMR hits but women are like to receive antibiotics 27% more often than men, during life. AMR is projected to surpass cancer as the leading cause of death, by 2025. Thank you for the invite to this eye opening event, we are inspired to make a sustainable contribution to women’s health, globally. #amr #womenshealth

This post will be in Swedish beacuse it is about a radio program boradcasted by The Swedish Public Service Radio, Channel 1, Sveriges Radio P1. I "Vetenskapsradion På Djupet"  berättar Luisa Hugerth vid Uppsala universitet hur forskning om de bakterier som bor i kroppen kan hjälpa oss att lindra besvär i underlivet. I programmet slår man ihjäl några myter om underlivshälsa och förmedlar intressant och användbar kunskap om bland annat bakteriell vaginos. Louisa Hugerth är biträdande handledare till Gedeas industridoktorand Emilia Lahtinen vid Karolinska Institutet, vid sidan av handledare Ina Schuppe Koistinen. https://lnkd.in/dHwAYSPk