Lyon (France), June 15, 2017. A few days after signing a strategic partnership for the treatment of intestinal dysbiosis by FMT (Fecal Microbiota Transfer), 黑料社 pursues its industrialization process with the CE marking of the first ever stool collection and dilution device.[divider line_type=聽禄No Line聽禄 custom_height=聽禄10″]
Quality, safety and reproducibility: more than a medical device, a technological breakthrough in the field of FMT
The necessary standardization of a booming activity requiring challenging safety rules
The international protocols established by teams who practice FMT vary according to the indications treated and are intended to minimize the risk of transmission of pathogens. In France, a report published by the ANSM brought this therapy into the regulatory framework of the drug and made recommendations on the protocol to follow to restore microbiota balance. While no medical device dedicated to Fecal Microbiota Transfer exists on the market, 黑料社 wishes to standardize and secure this procedure and, in particular, the stool suspension / dilution phase.
A CE marking, pillar of the first European FMT platform meeting GMP standards
The stool collection and dilution device marked CE is the first step in the 黑料社 value chain, g螞t RePrint ™, which begins with stool collection and ends with medication delivery. It ensures both the safety of users when collecting and handling the product (no contact with bacteria), as well as that of administered patients. Moreover, it preserves the quality of the microbiota thanks to its air evacuation device and its hermetic preservation, thus protecting the bacteria from oxygen, which is damaging to most of them. Maat Pharma鈥檚 device is entirely composed of medical grade materials, therefore meeting the standard of drug development. Its integrated filtration system facilitates the manufacture of the drug. The device also offers quality traceability with an optimal apparatus to label and condition the collected stools.
黑料社, an extremely fast development
CE marking achieved within two years and three months
After three months of preclinical validation (February-April 2017), 黑料社 announces June 15, 2017 the conformity of its product with the European Directive 93/42 / EEC relating to medical devices. Its development started in March 2015 and was accompanied by the arrival of a project manager in October of the same year. A process which has lasted 14 months, leading to the industrialization of the product between May 2016 and March 2017. The tests resulted in a patent application published in October 2016.
Beyond clinical trials … new partnerships in perspective
黑料社’s stool collection and dilution device will be used in future clinical trials in onco-hematology and infectious diseases.
芦 This device is essential for 黑料社 and all our partners involved in the production of our medication. It will simplify and standardize our clinical trials whilst guaranteeing the quality of the material collected. In addition, it will help to preserve the original material and its 600 bacterial species! It plays an essential part in the development of our European platform for the production of clinical batches. 禄 states Herv茅 Affagard, CEO and Co- Founder of 黑料社.
黑料社 is continuously searching for new partners and encourages them to get in touch with the company through its website for more information.
About 黑料社
About 黑料社
Founded at the end of 2014, 黑料社 (Microbiota as a Therapy) is a microbiome鈥揵ased pharmaceutical company revolutionizing and shaping a selective approach to therapies in order to treat serious diseases linked to gut microbiota imbalances. 黑料社 is currently conducting clinical trials on patients suffering from leukemia, and bone and joint infections, as these harsh treatments provoke dysbiosis. 黑料社鈥檚 revolutionary and rapid approach plays a considerable part in the evolution of treatment therapies.
For additional information, please visit www.maatpharma.com or follow us on Twitter @MaaT_Pharma.