Gradientech: Year-end report 2025

Increased commercial traction and regulatory progress strengthen the foundation for continued expansion

Fourth quarter 2025

• Net sales amounted to SEK 2,548 thousand (1,194). Please note that quarterly sales may vary as Gradientech’s sales to distributors vary throughout the year.
• Net profit/loss amounted to SEK -18,072 thousand (-16,666).
• Earnings per share before and after dilution were SEK -0.56 (-0.58).
• Cash flow from operating activities amounted to SEK -16,805 thousand (-18,740).
• Cash and cash equivalents amounted to SEK 6,965 thousand (24,596) as of December 31, 2025.
• Equity amounted to SEK 22,699 thousand (35,424) as of December 31, 2025.
• In the middle of October Gradientech announced that the results from a new scientific study were published in the high-ranked European Journal of Clinical Microbiology & Infectious Diseases. The study confirms the QuickMIC® system to deliver accurate antibiotic susceptibility testing (AST) results up to 75% faster than current gold-standards automated solutions, enabling faster treatment decision for sepsis and blood stream infections.
• At the end of October Gradientech announced that its QuickMIC® diagnostic test for ultra-rapid antibiotic susceptibility testing (AST) of sepsis samples, has been officially certified under the European Union’s In Vitro Diagnostic Medical Device Regulation (IVDR) – the new stringent regulatory framework for diagnostic devices.
• In November Gradientech announced that its distributor Biomedica Medizinprodukte successfully installed the QuickMIC® system for ultra-rapid antibiotic susceptibility testing (AST) at the Wels-Grieskirchen Clinic in Austria, marking a pivotal step in the company’s European expansion.
• Gradientech announced at the end of November that the company submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its QuickMIC® diagnostic system for ultra-rapid antimicrobial susceptibility testing (AST) of bacterial isolates.

 

January-December 2025 period

• Net sales amounted to SEK 5,889 thousand (4,457).
• Net profit/loss amounted to SEK -72,284 thousand (-63,620).
• Earnings per share before and after dilution were SEK -2.28 (-2.50).
• Cash flow from operating activities amounted to SEK -72,445 thousand (-62,044).
• Gradientech announced in January to have started its third FDA 510(k) clinical study site in the US for the QuickMIC® system to ensure comprehensive clinical data collection for the regulatory FDA submission of the QuickMIC system and its gram-negative CSLI panel.
• In the beginning of February Gradientech announced the outcome of the new issue of shares with preferential rights for existing shareholders, resolved by the board on 17 December, 2024. The rights issue was fully subscribed, which meant that Gradientech received approximately SEK 60.6 million before deduction of issue costs. Part of the issue was registered on 11 February and affected the first quarter’s cash flow by SEK 31.7 million before deduction of issue costs. The registration increased the number of shares by 1,813,908 shares and the share capital by SEK 181,390.80. The registration meant that the share capital as of 31 March 2025 amounted to a total of SEK 3,068,108.10 and the number of shares to 30,681,081. On 7 April, 2025, the second of two registrations was carried out. After the second registration, the cash flow of which affected the second quarter of 2025, the share capital amounts to SEK 3,233,123.20 and the number of shares to 32,331,232.
• Gradientech announced at the end of February that a.d.a. SRL, its exclusive distributor for the Italian market, is starting a multicenter study in the Milan area of Italy for the QuickMIC® system. The multicenter study will be performed at four hospitals in collaboration with the Italian Society for Clinical Microbiology (AMCLI) and aims at developing new recommendations for rapid AST for Italian healthcare.
• Gradientech announced in March that the company will present new study data from clinical, real-world evaluations with its QuickMIC® system for ultra-rapid antibiotic susceptibility testing (AST) at ESCMID Global 2025 in Vienna, Austria, April 11th-15th.
• During March Gradientech announced that Mark Lischeid was appointed as the company’s new Sales Manager for Central Europe. Mark has extensive knowledge from strategic sales and commercial organisations, with over 25 years of experience in the diagnostic sector.
• In the beginning of April Gradientech announced that its new CU product that comes with its already award-winning QuickMIC® system has received the prestigious Red Dot Design Award: Product Design 2025.
• Gradientech announced at the end of April that Prof. Gian Maria Rossolini, Professor of Microbiology and Clinical Microbiology at the University of Florence, joins as a new member of the company’s prominent international Scientific Advisory Board.
• At the AGM on May 21, Veronica Byfield Sköld was elected as new member of Gradientech´s Board of Directors. Laura Chirica did not stand for re-election.
• Gradientech announced at the end of May that their distributor Biomedica installed the QuickMIC® system for routine use at the Clinical Center University of Sarajevo, one of the largest hospitals in Bosnia and Herzegovina.
• In June Gradientech announced that its distributor a.d.a. SRL, the company´s exclusive distributor at the Italian market was awarded direct tenders at two Italian hospitals.
• In the beginning of July, Gradientech announced a significant order from its North American distributor, Hardy Diagnostics. The order making an important milestone in Gradientech´s U.S. market expansion strategy.
• In July Gradientech completed its clinical sample testing in ongoing FDA 510(k) clinical study of the QuickMIC® system.
• In the beginning of August, Gradientech announced that the company was awarded the Clinical Diagnostics Campaign of the Year at the prestigious Scientists’ Choice Awards® 2025, presented by SelectScience®.
• At the end of August Gradientech today announced the publication of a new peer-reviewed scientific study led by the renowned Italian research group of Professor Gian Maria Rossolini. The study confirms that QuickMIC® is fast and accurate targeting multidrug-resistant bacteria.
• At the end of September Gradientech announced the collaboration with Vienna-based Cellectric on a new proof-of-concept study of a direct-from-blood application to speed up sepsis diagnostic workflows. Cellectric is developing a direct-from-blood application for sepsis samples, selectively destroying human cells in the patient sample with the aim to bypass the need for culturing of the bacteria.

Significant events after the end of the period

• In January 2026 Gradientech´s distributor Iberlab won a direct tender for QuickMIC® in Portugal and the Portuguese Hospital Unidade Local de Saúde da Guarda (ULS Guarda) has selected QuickMIC® for integration into their clinical workflow for AST of sepsis samples. This award underscores the growing clinical adoption of QuickMIC® for routine use and further strengthens Gradientech’s commercial footprint in Southern Europe.
• Gradientech entered in February into an exclusive distribution agreement with ELTA 90 MGR for the commercialisation of QuickMIC® in Greece. The agreement marks another important step in Gradientech’s European expansion strategy and strengthens the company’s presence in Southern Europe.
• In February Gradientech announced a long-term agreement with ELBLAB GmbH in Germany for the use of its QuickMIC® system. The agreement strengthens Gradientech’s presence in one of its key European markets and demonstrates its commitment to providing advanced diagnostic solutions to healthcare providers.
• Gradientech did in February receive feedback from the U.S. Food and Drug Administration (FDA) regarding the company’s submitted 510(k) premarket notification for its QuickMIC® system for ultra -rapid anti microbial susceptibility testing (AST) of bacterial isolates. Following submission of the 510(k) application and an initial period of interactive review, the FDA has issued a hold letter requesting additional information related to the application. The requested clarifications primarily relate to cybersecurity aspects of the system, as well as limited additional performance testing. Gradientech is working closely with the FDA and has initiated activities to address the requested information as part of the ongoing review process.

CEO statement

The fourth quarter concludes a year of solid progress for Gradientech, with increasing commercial traction and regulatory and clinical milestones as we prepare for continued growth in 2026.

During 2025, we exceeded our internal forecasts for the number of QuickMIC® instruments sold, reflecting growing confidence in the system as a same-shift, ultra-rapid phenotypic AST solution in routine clinical microbiology. We enter 2026 with 16 European hospitals operating QuickMIC® in routine use or advanced implementation, with expected annual test volumes typically in the several-hundred range and scaling beyond 1,000 tests per site. This demonstrates the strength of our strategy of modular and cost-efficient instruments, enabling efficient scaling adapted to hospitals with varying testing volumes.

Commercial expansion continued across Europe. In early 2026, we signed ELTA 90 MGR as our exclusive partner in Greece, a strategically important market with very high antimicrobial resistance levels. ELTA 90 MGR combines deep clinical microbiology expertise with a complementary diagnostics portfolio that positions QuickMIC® as part of a broader, value-based solution for antibiotic stewardship and sepsis care. The team has already completed commercial and application training at our Uppsala headquarters, enabling a rapid market launch. In Italy, our distributor delivered record performance, including replacing multiple Accelerate sites with QuickMIC® following the withdrawal of the Pheno system. We also welcomed our first routine clinical installation in Portugal and secured our second large routine customer in Germany, one of the country’s leading infectious disease diagnostic service providers. To support this momentum, we strengthened our German organisation with additional local clinical expertise.

On the regulatory front, we submitted our first FDA 510(k) application for the QuickMIC® gram-negative panel adapted to the US market and including isolate testing. Following an excellent interactive review with the FDA, we received a formal response outlining requested complements, primarily related to new cybersecurity guidance issued in 2025. We view this as a manageable and expected step in an evolving regulatory landscape.

Clinically and strategically, we continued to strengthen our differentiation. We entered into an agreement with the supplier of one of the newest approved antibiotics, not yet available on any other automated AST system. We are now initiating European clinical regulatory studies for an additional gram-negative panel, incorporating newly approved antibiotics and addressing both high-resistance Southern European markets and lower-resistance, high-volume markets such as the UK, where stewardship initiatives and national sepsis pathways drive demand for rapid AST.

Product development remains focused on result quality, system robustness, and test yield. At the same time, we are executing cost-of-goods reduction initiatives to support margin expansion as volumes grow.

While clinical champions already recognise the value of rapid phenotypic AST for critically ill patients, broader adoption will require large outcome and health-economic studies. Together with our clinical partners, we are contributing to this evidence generation, which is essential for scaling rapid AST into mainstream global standard of care, starting with critical sepsis patients.

With a growing installed base, accelerating commercial momentum and clear regulatory and clinical progress, Gradientech ends 2025 well positioned for continued expansion in 2026. To support continued growth and strengthen working capital, we are therefore preparing a rights issue with a planned subscription in March. We look forward with confidence to a successful and value-creating 2026.

Sara Thorslund, CEO Gradientech

Uppsala, 20 February 2026

 

For further information, please contact:
Sara Thorslund, PhD, CEO 
Tel: +46 736 29 35 80 

Urban Adolfsson, CFO
Tel: + 46 708 20 72 09

 

About Gradientech

Gradientech is a leader in ultra-rapid antibiotic susceptibility testing, developing next-generation diagnostics for infectious disease medicine. Our innovative diagnostic solutions aim to save lives, reduce healthcare costs, and combat the spread of antibiotic resistance – one of our greatest global health threats. Gradientech is headquartered in Uppsala, Sweden. Visit gradientech.se for more information.