Scope Fluidics S.A. (WSE: SCP) – a Venture Studio biotechnology company included in the sWIG80 index, which in 2022 led the largest transaction in the history of the Polish life science market, announced an update of the objectives for the BACTEROMIC project, responding to the identified expectations of potential acquirers. The project is thus entering the phase of building an optimal position from the point of view of conducting a strategic transaction.
Szymon Ruta, executive vice president and CFO of Scope Fluidics, said: – Many signals received from international advisors and global medtech corporations indicate that attractive valuations in transactions today can be obtained primarily in case of projects that are already generating revenues and have been positively reviewed by the market. At the same time, there is much to suggest that in the next stages of the M&A market cycle these preferences will change, and more attention will again be attracted to projects at earlier stages of development. We are ready to meet the expectations of the market by building the value of the BACTEROMIC system in accordance with the expectations of potential acquirers. We are fine-tuning our development plans, while trying to maintain maximum flexibility. We are convinced that this is the optimal tactic, oriented towards strengthening the position of our flagship technology on the way to the next strategic transaction.
Prof. Piotr Garstecki, co-founder, significant shareholder and CEO of Scope Fluidics, adds: – We are focused on introducing the BACTEROMIC system to the international market as soon as possible, which is to be served, among other things, by the Early Access Program that has already begun. We are securing internal production capacity for these needs. At the same time, we are focusing on securing European contracts for the system with IVDR certification, which will not be formally required until mid-2027, but before that can be a significant competitive advantage. We plan to obtain certification in accordance with IVDR as early as 2025, and by then we want to have external production capacity to address demand from mature European markets.
– In parallel with the activities leading up to market entry, we will be working on new panels – the UNIMAX panel, which handles all key antibiotics, and the Positive Blood Culture panel, which focuses on blood infections – as well as “fast detection” software, which is expected to reduce testing time from the current 16 hours to even 6 hours. We plan to use specialized analytical algorithms supported by artificial intelligence modules in this regard.
Bacteromic’s activities will focus on two key areas: the commercial launch of the BACTEROMIC system on the international market and the expansion of its product portfolio. In addition, work will continue on the development of the patent portfolio – both for current solutions and future technologies.
Commercial introduction of the BACTEROMIC system to the international market
Bacteromic plans to undertake activities leading to the launch of commercial sales of the system. It is building important business relationships in this regard in Poland and abroad. One element of the activities undertaken is the Early Access Program, which was launched at the end of 2023 and is currently being implemented in two domestic centers. Oriented work is underway to launch more centers, including outside Poland. At the same time, Bacteromic is identifying opportunities to launch system sales in markets that do not require IVDR or FDA certification.
Bacteromic’s internal production capacity is currently being used for EAP and ongoing R&D work. The production line, with a target capacity of about 50,000 panels per year, will also potentially be used in the future to handle the first commercial contracts, even before IVDR certification is obtained.
Scope Fluidics’ and Bacteromic’s ongoing market access activities indicate that for European Union markets, it will make the most business and economic sense to market a version of the BACTEROMIC system that already has IVDR certification. Accordingly, sales activities in Europe will focus on obtaining contracts directly for the IVDR-certified version of the system, which is expected to be obtained in 2025.
In parallel, Bacteromic continues to work to secure external panel production capacity in cooperation with international partners. When evaluating bids, Bacteromic takes into account, among other things, experience, numerous operational and economic aspects and the ability to scale production in the future. Securing quality resources in this area through cooperation with international counterparties will help strengthen the Company’s position in M&A talks. Bacteromic plans to have external capacity to enable commercial production of panels at the latest when IVDR certification is obtained.
Development of product portfolio and patents
Commercial introduction of the BACTEROMIC system is planned first based on the UNI25 panel for determining antibiotic resistance of bacteria to the most common antibiotics. Bacteromic plans to continue work on the UNIMAX panel, with the help of which the susceptibility of bacteria to all key antibiotics will be assessed and the presence of resistance mechanisms identified, which will translate into providing the broadest possible information on the drug susceptibility of microorganisms. At the same time, it is planned to develop a Positive Blood Culture (PBC) panel for rapid diagnosis of bloodstream infections and selection of optimal therapy from among key antibiotics for the treatment of the most common bacterial pathogens in bloodstream infections.
Large-scale market research conducted indicates that it is also reasonable, from the point of view of increasing the value of the BACTEROMIC system, to develop “fast detection” software. While the current version of the system allows a test result to be obtained in 16 hours from the introduction of the panel into the analyzer, the “fast detection” version, thanks to the use of analytical algorithms and artificial intelligence, among other things, is expected to reduce this time to about 6-8 hours. The Bacteromic Company has already been granted patents for its method of rapid detection of bacterial growth.
In past quarters, Bacteromic has significantly strengthened patent protection for the Bacteromic system in the United States. The company plans to further expand its patent portfolio in key markets.
Financing
Szymon Ruta, executive vice president and CFO of Scope Fluidics, said: – Scope Fluidics has a secure cash position, allowing us to consistently develop the Bacteromic system. We are pursuing an ambitious development plan, using accumulated funds very judiciously. We are prioritizing activities, focusing our efforts on areas that have a key impact on the value of our technology and its attractiveness from the point of view of potential buyers. At the same time, we are constantly pursuing activities that may result in additional financing, allowing us to further expand our plans.
As of April 30, 2024, Scope Fluidics S.A. Group held approximately PLN 75 million.
