Bacteromic – a subsidiary of Scope Fluidics – has established cooperation with the German BIT Analytical Instruments GmBH, belonging to the Messer Group, regarding the preparation of commercial production of the BacterOMIC system, Scope Fluidics announced.
“As part of the cooperation, BIT will produce 10 devices (device means an analyzer and a filling machine), which will be used as part of the implementation of Objective II described in current report No. 15/2023, which is to start the commercial production of the BacterOMIC system and can be used under the Early Access Program ( EAP) as the number of external centers participating in the EAP is planned to increase (the start of tests of the BacterOMIC system under the EAP will take place using CE-IVD certified devices that Bacteromic already has). Devices manufactured by BIT will require certification in accordance with IVDR, but the participation of a notified body will not be necessary,” we read in the announcement.
According to the terms of cooperation, BIT will deliver most of the analyzers in the first quarter of 2024, and the estimated total remuneration of BIT will be approx. PLN 600,000. euro net and includes the preparation of documentation and infrastructure for series production and the cost of producing a pilot series of 10 devices, it was announced.
“We are pleased to have chosen a reputable partner for the series production of BacterOMIC devices. We expect to deliver the first batch of devices already in the first quarter of 2024. In addition to R&D work, preparing the system for scale production is one of the key activities increasing the value of the BacterOMIC technology,” said Piotr Garstecki, co-founder, significant shareholder and president of Scope Fluidics, quoted in the release.
“We are happy to welcome a new partner! We are looking forward to the successful implementation of the project, which will contribute to the development of the BacterOMIC system. We therefore count on long-term, successful cooperation. Based on our existing relationships, we are convinced that the jointly defined project goals will be successfully achieved,” added Managing Director BIT Analytical Instruments GmbH Thomas Eck.
The company emphasized that the BacterOMIC system is a response to the growing global medical threat of antibiotic resistance in bacteria. According to estimates by the World Health Organization, by 2050 the annual number of deaths due to infections caused by drug-resistant microorganisms will increase from 700,000 to 10 million per year, which means that they will become one of the main causes of death in the world.
BacterOMIC technology is intended to accelerate and increase the effectiveness of patient treatment by identifying the best targeted therapies for a given patient. Within up to 16 hours, it will precisely assess the sensitivity of bacteria to all clinically important antibiotics and provide the doctor with extensive information about a given pathogen. The highest informativeness of the survey on the market is the key among several competitive advantages of the system, it was reported. BacterOMIC has had the European CE-IVD certificate since 2021, authorizing it to be traded in the European Union. Work on the development of the system began in 2016, and in 2017 a special purpose vehicle was established – Bacteromic sp. z o.o.
BIT Analytical Instruments is a German company belonging to the Messer Group, specializing in the design, development and production of high-quality diagnostic, medical and life science devices for OEM customers.
Scope Fluidics was established in 2010 at the Institute of Physical Chemistry of the Polish Academy of Sciences with the aim of creating solutions for medicine based on microfluidic technologies. The company is engaged in the development of technological projects in the field of diagnostics and health care. In January 2023, the company moved from NewConnect to the main market of the WSE. It is included in the sWIG80 index.