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Gedea
Gedea

pHyph
pHyph

Anette Säfholm
Spruta
Lund, Sweden, April 7, 2020. Gedea Biotech, an innovative women’s health company today received its certificate in accordance with ISO 13485: 2016 (Medical devices - Quality management system - Requirements for regulatory purposes). The scope of the certificate includes design, development, ENISO 13485 Q 3D Nmarketing, distribution and production of antibiotic-free vaginal tablets intended to treat bacterial vaginosis. The certificate has been issued by TÜV SÜD, an accredited notified body.

The ISO-certificate is a part of the company’s development towards a CE-marking of a product. Therefore, the ISO certificate is a very important step towards CE marking of pHyph, ensuring that Gedea´s quality management systems in design, development, marketing, distribution and production are sufficient.

Annette Säfholm, Gedea Biotech’s CEO comments: “I am delighted that we have now reached this important milestone as planned. The certification is a major step forward towards CE marking and launch of our vaginal tablet, pHyph for treatment of bacterial vaginosis. Gedea plans to apply for CE marking of pHyph, according to MDR, during 2020.”

There is currently a noticeable shortage of notified bodies designated for the new EU regulation MDR (Medical Device Regulation) and many medical device companies are struggling to have their products approved in time. Gedea chose to work with Tüv Süd over two years ago, as Tüv Süd was one of the first notified bodies to become designated for MDR.
PRESS RELEASE

Lund, Sweden, March 11, 2020. Gedea Biotech, an innovative women’s health company today reported results from a clinical study of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV). In this open-label, single-armed, multi-center study, 82% of the women were clinically cured after 7 days. The cure rate corresponds to existing antibiotic-based treatment. Bacterial vaginosis (BV) is the most common vaginal infection with a prevalence of 10–29% in the whole female population and rising up to 50% in pregnant women (1,2,3). The symptoms of BV include a vaginal discharge, a fishy odour and sometimes a burning pain. It can affect and limit many aspects of daily life. Gedea wishes to caution however, that whilst these results are highly promising, further studies are needed to confirm results. Larger studies including recurrence data are being planned.

The vaginal tablet, pHyph acts by restoring the patient’s pH to its normal level of pH 4,0 - 4,5 which is optimal for the protective lactobacilli pHyph also breaks down the biofilm formed during bacterial vaginosis in which the infectious bacteria begin to thrive. The naturally occurring active ingredient GDA 001 in pHyph has a well-documented safety profile and is already approved as a food additive.

The pHyph study* enrolled a total of 24 patients each of whom met at least three of the four Amsel criteria – a thin white yellow homogeneous discharge; clue cells on microscopy; a pH of vaginal fluid > 4.5 and release of a fishy odour on adding alkali. Patients were treated with pHyph for one week and primary endpoints were the clinical cure rate at Day 7 as well as safety and tolerability data. Patients were aged 18-49 and the median age was 33. In the Full Analysis Set (FAS, n=22) a total of 18 women (82%) were clinically cured, as defined by the absence of all the three Amsel criteria. Recurrence numbers at day 35 were found to be very low.

“Bacterial vaginosis is a common problem, and current remedies such as antibiotics are not always effective. There is need for new, effective treatments not involving antibiotics. The results of this study are promising and may lead to a much-needed treatment alternative”, says Dr. Monika Cardell, MD and senior consultant in obstetrics and gynecology at Skåne University Hospital, Lund. Dr. Monika Cardell was also the Principal Investigator of the clinical trial.

Annette Säfholm, Gedea Biotech’s CEO comments: “These results for pHyph are indeed highly promising, showing effectiveness equivalent to antibiotics in treating bacterial vaginosis. The cure rate and recurrence numbers gives us strong confidence to continue our pHyph program and to confirm the results in upcoming studies.”

*Details of the clinical trial can be found at here
This year´s International Womon´s Day, Gedea wants to support UN Women´s campaign “I am Generation Equality: Realizing Women’s Rights”.
The Generation Equality campaign is bringing together people of every gender, age, ethnicity, race, religion and country, to drive actions that will create the gender-equal world we all deserve.

One of Gedea´s  Sustainable Development Goals is Equality. Good Health improves  women and girl´s possibilities to participate in society.

Read more about UN Women here


Intl womens day 2020 UN Women

In 2019 Gedea gained good traction in media, both Swedish and international. Rapidus, BioStock, Life Science Sweden, Läkemedelsmarknaden and other Swedish business/medtech media published articles about us. American BioSpace published no less than three press items on Gedea. We are happy to now "be on their radar".

 

Here is a selection of press items

BioSpace Dec 13, 2019 read
BioSpace Dec 26, 2019 read
BioStock Dec 19, 2019 read

From BioSpace Dec 13, 2019:

BioSpaceGedea Biotech – Gedea Biotech received €3 million from the EU program Fast Track to Innovation to fund completion of the clinical trial program and preparation work for market introduction of the company’s antibiotic-free treatment for vaginal infections. Vaginal infections are a common problem and current treatments such as antibiotics are not always effective. Collaboration partners for the work are the CRO company Link Medical from Norway with whom Gedea Biotech has a long-standing relationship and the University of Nottingham Hospitals, home to the lead clinic for the work.

 

 

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In 2019, we conducted two clinical studies, developed the quality system, moved into new premises, received grants from SweLife and as a fantastic end to the year we could tell that we were granted 3 million Euro by the EU Horizon 2020. 

We look forward to 2020 together!
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Gedea Biotech today announced that it has received €3 M from the EU program Fast Track to Innovation (FTI), part of Horizon 2020. The grant will fund completion of the clinical trial program and preparation work for market introduction of the company’s antibiotic-free treatment for vaginal infections. Partners in the program are Link Medical Research in Norway and Nottingham University Hospitals in the UK.

Vaginal infections are a common problem, and current treatments such as antibiotics are not always effective. According to FTI, the justification to select Gedea Biotech as a recipient of the funding is based on, not only the significant medical need, but also on the resultant opportunity to replace current treatments involving antibiotics. Several strains of bacteria and fungi are already resistant to current treatments.

Annette Säfholm, CEO at Gedea Biotech, comments: “We believe that our new treatment, which has already shown promising results in a recently finalized clinical study in patients with bacterial vaginosis, will benefit both patients and healthcare. We are therefore delighted to have received this funding enabling us to launch the product earlier than otherwise would have been the case. We now look forward to initiating the work on our next clinical trial in Europe, together with our partners in Norway and the UK. We expect to launch our first product, that treats and prevents bacterial vaginosis in 2021.”

Collaboration partners for the work are the CRO company Link Medical from Norway with whom Gedea Biotech has a long-standing relationship and the University of Nottingham Hospitals, home to the lead clinic for the work.

For further information This email address is being protected from spambots. You need JavaScript enabled to view it., CEO Gedea Biotech

EU emblem HR
This project has received funding from the  European Union’s Horizon 2020 research and innovation programme  under grant agreement No 878775



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Gedea is spreading the message from the WHO:s Antibiotic Awareness Week 2019. 

The world urgently needs to change the way it prescribes and uses antibiotics. Even if new medicines are developed, without behaviour change, antibiotic resistance will remain a major threat. Behaviour changes must also include actions to reduce the spread of infections through vaccination, hand washing, practising safer sex, and good food hygiene.


All patients treated in Swedish women’s health company Gedea Biotech’s pHyph proof of concept study in women with bacterial vaginosis

Lund, Sweden, October 31, 2019. Gedea Biotech, an innovative women’s health company today reports that all 24 patients have been treated with its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis in a proof of concept clinical study. In this open-label, single-armed, multi-center study, promising results have been seen when it comes to clinical performance, tolerability, and safety. Final results of the trial are expected to be ready by the end of the year.
The vaginal tablet, pHyph acts by breaking down the biofilm formed during bacterial vaginosis under which the infectious bacteria begin to thrive. This restores the patient’s pH to its normal level of pH 4,5. The naturally occurring active ingredient GDA 001 in pHyph is well documented and is already approved as a food additive.

“Bacterial vaginosis is a common problem, and current remedies such as antibiotics are not always effective. There is a need for new, effective treatments not involving antibiotics. The results of this study are promising and may lead to a much-needed treatment alternative”, says Dr. Monika Cardell, MD and senior consultant in obstetrics and gynecology at Lund University Hospital. Dr. Monika Cardell is also the Principal Investigator of the clinical trial.

Annette Säfholm, Gedea CEO comments: “We are delighted to report that we already see promising results when it comes to efficacy of this treatment for which we have a use patent, of bacterial vaginosis intended to be curative. Furthermore, tolerability and safety were both excellent. We now look forward to analyzing and reporting the results later this year.”
Details of the clinical trial involving 24 patients at two sites in Sweden can be found here

For further information, please contact:
Annette Säfholm, CEO Gedea Biotech
Telephone: +46 708 - 91 86 81
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

About bacterial vaginosis
Bacterial vaginosis is the most common vaginal infection in women of reproductive age and is a disease of the vagina caused by excessive growth of bacteria producing an imbalance of the naturally occurring bacteria in the vagina. The condition is treated with antibiotics and/or antiseptic treatment products. Recurring bacterial vaginosis is common.

About Gedea Biotech
Gedea Biotech is a Swedish, innovative women’s health company developing  pHyph, an antibiotic free and effective treatment of bacterial vaginosis. Vaginal infections affect at least 400 million women every year worldwide and the market is worth over $ 1.5 billion. In addition to developing a treatment of bacterial vaginosis, Gedea Biotech is currently also pursuing a clinical trial with pHyph  in patients suffering from fungal vaginal infection.  Gedea Biotech was founded in 2015 in Lund, Sweden. 

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www.smileincubator.life   www.innovation.lu.se

Gedea Biotech will participate in RCOG's World Congress in London, June 17-19. Marketing Manager Eva Norell will participate and she is responsible for Gedea´s market insight:
-  We keep up-to-date with both the medical development in vaginal infections and we listen to what doctors and patients really need. A large congress, like this. gives opportunities to meet doctors from many different countries and different health care systems, says Eva Norell.

Gedea Biotech is currently closing two clinical studies on bacterial vaginosis and vaginal candidiasis. The next step is a CE marking of the product pHyph and then launch in Europe.

- It is important that of doctors, nurses and midwives feel confident about the effect of pHyph and the mechanism of action of the product when it is used, says Eva Norell.

For further information, please contact Eva Norell at This email address is being protected from spambots. You need JavaScript enabled to view it.

Gedea has received SEK 3 million  Swelife and MedTech4Health. Gedea applied for the grant to verify, in collaboration with Region Skåne, the effect of pHyph in a larger placebo-controlled clinical trial for a market launch in Europe. Swelife and MedTech4Health are part of Vinnova, the Swedish Energy Agency and Forma's joint venture on strategic innovation programs.

 

Read full article here
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Women's health is both a health issue and a gender issue. At the International Women's Day, WHO draws attention to important efforts in research and health, for and by women. Health issues have a huge impact on women´s possibilities to patyiciapte in sociaty and working life. 

Gedea Biotech works for women's health through the treatment of pelvic infections. We want an openness about this health problem at the health seeker, at workplaces or among family and friends. Most people know someone who suffers from a pelvic infection and wants to be able to support their loved ones in a good way.

Read the full article from WHO Celebrating Women
Gedea Biotech won third prize in the European Final of the EIT European Health Catapult, in the category of Biotech. Gedea also won the Crowd Award! This means that the company is one of Europe's absolute best start-up companies in the health sector. After months of a preparations and competitions, the final took place on December 4 at the EIT Health Summit in Poland Lodz.

Gedea Biotech won the prize money of € 10,000 for the third prize and received € 10,000 for being chosen for the audience's favorite, thus winning as much as the first prize winner, a total of € 20,000. The audience award became a landslide victory for Gedea. There was only one award for all the categories and Annette Säfholm and Gedea won by far over the other 11 companies. 350 people out of 400 participated in the voting and Gedea won. 

- Vaginal infections are painful and there is a huge need for new, modern solutions. I think the audience voted for us because our product, pHyph, solves a problem that is urgent for many people, says Annette Säfholm.

-Participation in EIT Health Catapult has given us in valuable contacts with investors, entrepreneurs and partners that we will benefit greatly from in the future," says Annette Säfholm

Gedea Biotech is based on research at Lund University of Olov Sterner, Sophie Manner and Ulf Ellervik at Chemistry Center together with Helena Strevens, senior doctor in gynaecology/obstetrics at the Women's Clinic at SUS. The first two clinical studies are ongoing in patients with vaginal fungal infection and bacterial vaginosis.

About EIT Health: Together for healthy living in Europe
EIT Health is a European network with over 140 qualified partners from industry, academia and healthcare professionals in Europe. Region Skåne is one of the main partners since 2018, which allows companies with relationships with the regional innovation system to seek funding for international growth. Innovation Skåne coordinates the program in the region. For more information, see eithealth.eu or contact This email address is being protected from spambots. You need JavaScript enabled to view it.

Gedea has been granted SEK 500,000 in appropriations from the SME Instrument phase 1 program within the EU Horizon 2020 framework program. The Horizon 2020 program is competitive and only a few percent of all grant applications are granted.

anette
- The grant from Horizon 2020 is both an important funding that enables us to maintain momentum and also an acknowledgement of the qualities of the company. We are very proud to receive the grant in such tough competition, says CEO Annette Säfholm.

 

Horizon 2020 is the EU's largest research and innovation program with nearly 80 billion euros in funding, available for 7 years (2014-2020). The program emphasizes high-quality science, industrial management and meeting social challenges. The goal is to ensure that Europe produces world-class science, removes barriers to innovation and facilitates the public and private sector to work together for innovation.

Gedea has received approval from the Swedish Medical Products Agency the first clinical study

Last week, the Medical Products Agency and Ethics Committee announced that they approved Gedea's first clinical study. The study is an important step towards CE marking of pHyph, which is a completely new type of treatment of vaginal infections. pHyph is expected to to treat both vaginal fungal infection and bacterial vaginosis and to become the first product on the market for the treatment of both infections.

In the study, patients with vaginal fungal infection will be treated with vaginal tablets of pHyph. The study is expected to start in late October. The aim of the study is to investigate the clinical effect of pHyph on the infection and to ensure that patients experience the treatment as user-friendly.

secundary packageapptab low resToday's treatments are often insufficient as they are either insufficiently effective or inadequate treatment, since the symptoms of bacterial and fungal infection may be similar.


- The study is a very important milestone for Gedea. We are very pleased that we can start the study as planned, says CEO Annette Säfholm. There are many, both within Gedea and our partners who have worked hard to get started with the study. It has been an extensive work.

Clinical results will form the basis for a CE marking later on.

The study is conducted at two gynecologist receptions in Skåne: Hoftekliniken in Helsingborg and Annerokliniken in Hofterup. Patients who have vaginal fungal infection will be asked if they want to participate in the study and try a new treatment. The study is estimated to last for three months and 24 patients will be included in the study. The study is conducted in cooperation with the Region Skåne and the Clinical Examination Unit at Lund University Hospital.

Later this fall, Gedea plans a further clinical study in which patients with bacterial vaginosis will be treated with pHyph.

- pHyph is expected to treat both vaginal fungal infection and bacterial vaginosis and thus becomes the first product on the market for the treatment of both infections. This reduces the risk that patients choose the wrong treatment for their infection, says Annette Säfholm.

About Smile Incubator
Gedea Biotech is a company in SmiLe Incubator, a business incubator in life science that helps entrepreneurs to commercialize their ideas, offering business advice, well-equipped laboratories and a large network.

Gedea Biotech has reached the final at European Health Catapult, a European startup competition. In tough competition by really strong companies, Gedea went on to the final in Lodz in December. Out of the 14 who reached to the semifinal, seven went on and Gedea is one of them. Another company from Smile Incubator; Sinntaxis also reached the final.

- Reaching the final shows that Gedea is a company with a really good idea and great potential. We are close to market and that is probably an advantage for us in the competition, says Annette Säfholm, CEO of Gedea.

The competition is organized by the EU to find the best European innovations in health, and support them in their commercialization. In the finals there are investment events and prize money. 

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Last Wednesday, Gedea Biotech won a shared first place and Akuru Pharma a third, in the pitch competition "Startup Challenge" at NLSDays, the Nordic region's largest partnering fair in life science. It is the second consecutive year that SmiLe companies take top positions in the competition.



Read full article here
Gedea Biotech has reached the finals in Serendipity Challenge that is  an annual entrepreneurship competition and tech venue open to all Swedish and Nordic startups and growth companies. The competition final takes place during Almedalsveckan (2-4 July) where 50 of the most innovative and promising companies compete for the titles. 

Read full article here.

Serendipty Challenge web site.
Today, Rapidus draws attention to the problem of antimicrobial resistance and the challenge of more and more antibiotics becoming ineffective. Gedea Biotech's forthcoming treatment is mentioned as a solution, among others, which will make us less dependent on antibiotics.
Read full article
Smile Company Gedea Biotech has received 1 MSEK  in Vinnova funding in Swelife and MedTech4Health's joint announcement "Project for better health". The money will finance the first clinical trial in patients with vaginal fungal infection.
Read more
Rapidus made a list of talented young professionals in the business environment in Skåne "that Stockholm based media missed". On the list is Annette Säfholm, CEO of Gedea Biotech.
Read full article here.
kartaGedea Biotech AB
Medicon Village
Scheelevägen 2
223 81 Lund
Sweden
Annette Säfholm, CEO
annette.safholm@gedeabiotech.com
+46 (0) 708 - 91 86 81

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