Bacteromic sp. z o.o., a Scope Fluidics Group company developing the BACTEROMIC project, has signed an agreement with a notified body to have the notified body carry out the certification process in accordance with the IVDR. The BACTEROMIC system is an innovative diagnostic device designed to assess microbial drug susceptibility. Scope Fluidics S.A. (WSE: SCP) is a life sciences company listed on the sWIG80 index of the Warsaw Stock Exchange. In 2022, the company executed the largest transaction in the history of the Polish life sciences market.
Earlier in September, Scope Fluidics announced the commencement of the preliminary assessment of the documentation by the notified body for the certification process of the UNI panel (which allows for the evaluation of bacterial susceptibility to up to 31 antibiotics and the detection of one ESBL resistance mechanism) and the interpreter (software part) of the BACTEROMIC system. The aim was to evaluate Bacteromic’s readiness for the IVDR certification process and for the notified body to decide whether to proceed with such a process. The signing of the Agreement marks the beginning of the proper IVDR certification process for both the UNI panel and the interpreter.
“We are pleased with the swift signing of the agreement and the excellent cooperation with the notified body. We have successfully passed the first stage of verification, which allows us to optimistically look forward to the continuation of the certification process in accordance with IVDR requirements,” said Marcin Izydorzak, Vice President, co-founder, and significant shareholder of Scope Fluidics.
The participation of the notified body, necessary for the certification of the UNI panel and the interpreter, will not be required in the certification process of the analyzer and filler, which will be carried out through self-declaration.
“The IVDR certification of the BACTEROMIC system is crucial for us in terms of commercial introduction in Europe and achieving positive market verification. This is very important to us in the context of Bacteromic’s future strategic transaction,” said Szymon Ruta, Vice President, CFO, and shareholder of Scope Fluidics.
Market information from M&A indicates that it is currently at a stage where the interest of global manufacturers and distributors in acquisitions is directed towards medtech entities whose products generate revenue and which have been positively verified by the market. The company anticipates that, in line with market expectations, the reduction in interest rates in the USA may indicate the beginning of a process to increase the dynamics of the M&A market in the coming quarters, particularly for projects at earlier stages of development.
