Scope Fluidics After Q1 2026: Strong Cash Position, Distribution Agreements, and IVDR Certification

15-05-2026

Scope Fluidics Group, which operates in the life science sector and develops innovative technologies for the medical diagnostics and healthcare markets, held more than PLN 138 million in cash at the end of Q1 2026, including approximately PLN 64 million in investment fund units.

In February 2026, Bacteromic received IVDR certification for the system with the UNI Panel, opening the way for the Group to introduce the solution to the European market and strengthening its commercial potential. The company also submitted documentation initiating the IVDR certification process for the BACTEROMIC system with the UNI FAST Panel.

“The beginning of 2026 was an extremely intensive and, at the same time, highly productive period for Scope Fluidics. In the first months of the year, we focused on the further development of our key project, the BACTEROMIC system, and on preparing it for market entry. An important milestone was obtaining CE IVDR certification for the BACTEROMIC system with the UNI Panel at the beginning of 2026. We also initiated the CE IVDR certification process for the UNI FAST Panel, signed our first distribution agreements in Turkey and Romania, and entered into cooperation with a U.S. research center to conduct clinical trials for the FDA registration process. We also continued to consistently develop Scope Discovery, which remains a source of new technology initiatives. In the coming months of 2026, we will focus on activities aimed at carrying out a Strategic Transaction for the BACTEROMIC project, launching sales of the BACTEROMIC system, and further developing the project portfolio within Scope Discovery,” said Piotr Garstecki, CEO of Scope Fluidics.

IVDR Certification for the BACTEROMIC System

In February 2026, Bacteromic, a subsidiary of Scope Fluidics Group, received IVDR certification for the BACTEROMIC system with the UNI Panel, enabling the BACTEROMIC system to be introduced to the European market and to other foreign markets that recognize CE-IVDR certification. The certificate was granted for the UNI Panel version with all 30 submitted antibiotics, 56 antibiotic-bacteria combinations (known as drug-bug combinations), detection of the ESBL resistance mechanism, and software enabling antibiotic susceptibility assessment within 16 hours.

One month later, in March 2026, the company also initiated the IVDR certification process for the BACTEROMIC system with the UNI FAST Panel, covering 24 antibiotics and 48 corresponding antibiotic-bacteria combinations (known as drug-bug combinations), enabling antibiotic susceptibility assessment within 6-8 hours.

Obtaining IVDR certification for the BACTEROMIC system with the UNI FAST Panel may open up new opportunities for Scope Fluidics in international markets, strengthen the commercial potential of the entire project, and increase interest in it from both strategic partners and investors.

Moreover, after the close of the reporting period – on April 21 – the company began cooperation with a research center in the United States to conduct clinical trials for the FDA registration process for the BACTEROMIC system with the UNI FAST Panel.

Scope Fluidics’ transaction advisor is Perella Weinberg Partners (PWP) – a global, independent advisory firm that has advised on transactions exceeding USD 1 trillion in total value, including more than USD 200 billion in healthcare since 2011. PWP’s healthcare team comprises more than 65 specialists, including 9 partners, and has extensive experience in the AST sector, having supported numerous successful transactions.

BACTEROMIC Distribution Agreements

In January 2026, Bacteromic signed an agreement with Turkish company Mefamed concerning the distribution and promotion of the BACTEROMIC system on the Turkish market. Mefamed is an experienced distributor of medical devices specializing in innovative technologies and working with international brands.

Also in January, Bacteromic signed another distribution agreement – this time with SC ELTA 90 Medical Research SRL (ELTA MR). The agreement concerns the distribution and promotion of the BACTEROMIC system on the Romanian market. ELTA MR is an international company operating in Romania, Bulgaria, Serbia, Greece, and other markets, specializing in the supply and distribution of high-quality laboratory equipment, specialist consumables and tests, general laboratory consumables, reagents, and laboratory furniture.

Before commencing distribution activities, the distributors registered the BACTEROMIC system in accordance with local regulations. The next step will be for the distributors to enter into agreements with end users of the BACTEROMIC system.

Secure Financial Position

At the end of March 2026, the Group held more than PLN 138 million in cash, including approximately PLN 64 million in investment fund units.

“Innovative technology projects require not only expertise and know-how, but also a responsible approach to finance. That is why we consistently focus on liquidity security, diversification of financing, and effective capital management. This allows us to maintain flexibility in executing our strategic plans and to continue developing our business without excessive dependence on current market conditions. At present, the key area of our investment commitment remains the BACTEROMIC project in the context of preparations for a potential M&A transaction. At the end of March, the Group maintained a cash position ensuring stable financing for our business objectives and the further development of our most important projects through the end of 2027,” said Szymon Ruta, Vice President and CFO of Scope Fluidics.

Development of the Project Portfolio and Expanded Financing Model

Scope Fluidics continues to consistently work on new initiatives, with Scope Discovery serving as the unit responsible for initiating and developing new concepts within the Group.

To date, 65 projects have been registered for analysis within the Scope Discovery process, of which 28 have been closed, 24 have not yet been analyzed, and 11 are currently in the Scope Discovery process, while two projects – EDOCERA (DSC001) and HYBOLIC (DSC027) – have been qualified for development within special purpose companies.

In March 2026, Scope Fluidics decided to expand the financing model for projects developed in subsidiaries originating from Scope Discovery, including the EDOCERA and HYBOLIC projects. At the same time, allowing the expanded model does not determine whether or when external financing at the level of the DSC companies will be obtained.

The previous model assumed that Scope Fluidics would retain a 100% stake in subsidiaries developing projects until a potential strategic transaction. By allowing the financing model to be expanded, it will be possible to obtain external financing at the level of companies originating from Scope Discovery at very early stages of their development – even at the stage of their establishment. The new approach also allows key individuals involved in project development to acquire equity stakes.

In the Management Board’s opinion, expanding the financing model will help create conditions for the parallel and repeatable development of a larger number of project companies, supporting the achievement of the Group’s strategic objectives. Thanks to additional financing sources for subsidiaries, Scope will be able to further diversify its operations through involvement in a greater number of projects, enabling more effective risk management.