Scope Fluidics Group, which operates in the life sciences sector and develops innovative technologies for the medical diagnostics and healthcare markets, had nearly PLN 120 million in cash and financial investments at the end of Q2 2026, including approximately PLN 66 million in investment fund units. The company also received its first proceeds from sales of the BACTEROMIC system.
So far this year, Scope Fluidics has reached a number of milestones for the BACTEROMIC project. Among other things, the company obtained IVDR certification for two panels (UNI and UNI FAST), initiated clinical trials of the PBC Panel, and established cooperation with three distributors of the system, covering a total of 12 European countries.
“For Scope Fluidics, 2026 is a period of intensive development and consistent work to build the value of our projects. BACTEROMIC is now much closer to fully realizing its commercial potential. It has two panels with IVDR certification, the company has established cooperation with distributors covering 12 countries in Europe, and its patent protection continues to expand. At the same time, we are preparing another panel for the certification process, working on expanding our production capacity, and taking steps toward FDA certification for the U.S. market,” says Piotr Garstecki, CEO of Scope Fluidics.
IVDR certification for the BACTEROMIC system with the UNI and UNI FAST Panels
In May 2026, Bacteromic obtained an IVDR certificate for the BACTEROMIC system with the UNI FAST Panel, which enables antibiotic susceptibility assessment in 6-8 hours. This was another important step, opening the way for the Group to introduce its solution to the European market and strengthening its commercial potential.
The UNI FAST Panel covers 24 antibiotics and 48 corresponding antibiotic-bacteria combinations, known as drug-bug combinations. Earlier, in February, the company obtained an IVDR certificate for the system with the UNI Panel, which covers 30 antibiotics and 56 corresponding antibiotic-bacteria combinations and enables antibiotic susceptibility assessment in 16 hours.
The next stage of the project will be the process of obtaining FDA certification in the United States for an extended version of UNI FAST, which will cover up to 52 antibiotics and three resistance mechanisms. In April this year, the company began working with a U.S. research center and is already conducting clinical trials for this certification.
Strong financial position
As of the end of June 2026, the Group held nearly PLN 120 million in cash and financial investments, including approximately PLN 66 million in investment fund units. The company also received its first proceeds from the commercialization of the BACTEROMIC system, totaling nearly PLN 300,000.
“Developing advanced technology projects requires not only the right competencies but also a solid financial foundation. That is why we maintain a safe level of liquidity, an appropriate financing structure and prudent use of available capital. This policy allows us to make investment decisions with long-term development in mind, regardless of market volatility. At present, our key investment area remains the BACTEROMIC project, whose further development is an important part of preparations for a potential M&A transaction. At the end of June, we had funds sufficient to ensure stable financing for our operations and the implementation of key projects through the end of 2027,” emphasizes Szymon Ruta, Vice President and CFO of Scope Fluidics.
Continued work on the semi-automated production line
Bacteromic is continuing work as planned to install and commission a semi-automated production line for BACTEROMIC system panels. In June, the company secured a new location for the line, which should be ready for production, with a capacity of approximately 350,000 panels per year, no later than the first half of 2027.
Should business needs increase, the company can raise this capacity to 750,000 panels per year within a few additional months.
As a reminder, Bacteromic currently has its own production capacity of approximately 100,000 panels per year, which meets the needs not only of research and development work but also of certification processes and the first commercial orders.
New U.S. patents for the BACTEROMIC system
In May this year, Bacteromic obtained a patent from the United States Patent and Trademark Office for the “Microfluidic Chip” technology used in the BACTEROMIC system. The patent covers microfluidic devices for processing sample volumes and methods of processing sample volumes using microfluidic devices. The patented solutions make it possible to divide liquid samples into multiple portions of equal volume, enabling the automated, simultaneous establishment of several hundred independent cultures from a single clinical bacterial isolate.
This is another patent obtained by Bacteromic for microfluidic devices and methods of using them. It extends the exclusivity arising from an earlier patent in force in the United States.
After the reporting period, in September 2026, Bacteromic obtained another patent from the United States Patent and Trademark Office, this time for a method and system for predicting the growth of microorganisms using artificial intelligence. The patent grants the company exclusive rights in the United States to commercially use the patented methods for predicting microorganism growth or growth inhibition in phenotypic antibiotic susceptibility tests, as well as systems for rapid antibiotic susceptibility testing.
Distribution network expanded to 12 European countries
In July 2026, Bacteromic signed a framework distribution agreement with Austrian company Biomedica Medizinprodukte, which has been active for nearly 50 years in the medical devices, in vitro diagnostics, life sciences products and clinical IT markets. This is another important element in building the international market position of the BACTEROMIC system.
Under the agreement, Biomedica will purchase BACTEROMIC systems and diagnostic panels from Bacteromic and will handle their promotion, evaluation and distribution in 10 European countries where Biomedica operates. Registration of the BACTEROMIC system in accordance with local regulations is the responsibility of the distributor. The next step will be the sale and distribution of the system and diagnostic panels to diagnostic laboratories in the private and public sectors.
The agreement with Biomedica is the third distribution agreement executed by Bacteromic in 2026. In January, agreements were signed with Turkish company Mefamed and Romanian company SC ELTA 90 Medical Research SRL (ELTA MR).
Start of clinical trials of the PBC Panel
Shortly after the end of the second quarter, Scope Fluidics signed an agreement with COMAC Medical to conduct clinical trials of the PBC Panel of the BACTEROMIC system. Conducting clinical trials is one of the important elements of the process of obtaining CE-IVDR certification confirming that the BACTEROMIC system with the PBC Panel complies with the requirements of the In Vitro Diagnostic Medical Devices Regulation.
As planned, IVDR certification for the BACTEROMIC system with the PBC Panel will be carried out with the participation of the notified body that issued this year’s IVDR certificates for the BACTEROMIC system with the UNI Panel and the UNI FAST Panel.
The trial schedule is consistent with the expected timing of IVDR certification for the PBC Panel in 2027. The other components of the BACTEROMIC system, namely the interpreter, analyzer and filling device, already have IVDR certification.
“The start of clinical trials of the PBC Panel brings us closer to another important stage in the development of the BACTEROMIC system. We want to consistently expand the system’s range of applications, which is why developing further panels and certifying them is an important part of our strategy. This is another step toward building a complete and scalable diagnostic solution that can address the needs of various applications in the area of antibiotic resistance,” says Piotr Garstecki, CEO of Scope Fluidics.
Development of the project portfolio
Scope Fluidics is consistently working on new initiatives, and Scope Discovery is the unit responsible for initiating and developing new concepts within the Group. To date, 71 projects have been registered for analysis within the Scope Discovery process, including 10 projects from the first edition of the Fellowship program and four projects from the second edition. Of these, 29 have been closed, 24 have not yet been analyzed, 16 are currently in the Scope Discovery process, and two projects, EDOCERA and HYBOLIC, have been selected for development through special purpose companies. Almost since Scope Discovery began operating, a dozen or so projects have been in the process at any one time.
