Medistim sponsors RCT trial comparing the use of TTFM with non-use in CABG

(Oslo, February 24, 2026) – Medistim ASA (OSE: MEDI), a leading niche provider of ultrasound technology headquartered in Oslo, Norway, today announced the commencement of SMARTFLOW, a randomized clinical trial (RCT) comparing the use of Transit Time Flow Measurement (TTFM) with non-use in coronary artery bypass graft (CABG) surgery.

The SMARTFLOW trial is an expertise-based, multicenter, single-blind, randomized study enrolling 1,242 patients across approximately 20 centers worldwide. Its primary objective is to determine whether routine intraoperative assessment using TTFM reduces early graft failure. The primary endpoint is graft failure within 1 to 3 months after surgery, as assessed by coronary CT angiography (CCTA). The trial is designed with the potential for extension to evaluate the impact of TTFM on longer-term clinical outcomes, including myocardial infarction, repeat revascularization, survival, and patient-reported quality of life.

CABG remains the most commonly performed cardiac surgical procedure worldwide. TTFM provides direct, real-time quantification of graft flow, allowing immediate identification and correction of technical issues before chest closure. Importantly, most graft failures occur within the first postoperative month and are largely attributable to technical factors—such as kinking, overstretching, competitive flow, or anastomotic errors—all of which are potentially preventable through systematic intraoperative assessment. The TTFM technique is simple, safe, and reproducible. However, high-quality evidence from randomized studies of standardized intraoperative quality control with TTFM is limited.1)

The SMARTFLOW study will be led by Professor Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC, FAHA, at Weill Cornell Medicine in New York, NY. In addition to his numerous academic and clinical leadership roles, he serves as Editor-in-Chief of The European Journal of Cardio-Thoracic Surgery.

“Most existing studies evaluating TTFM are small, observational, and methodologically heterogeneous. Although expert consensus supports its use, the lack of adequately powered randomized evidence remains a barrier to widespread adoption in clinical practice,” said Professor Gaudino. “In this context, SMARTFLOW has been designed as the first appropriately powered randomized trial to rigorously evaluate intraoperative graft assessment with TTFM in CABG. By generating high-quality randomized data on the impact of TTFM on early graft failure—and by providing a platform that can be extended to assess clinical outcomes—the SMARTFLOW program has the potential to inform future guideline recommendations and promote a more consistent, evidence-based approach to intraoperative graft assessment.”

Medistim is a global leader in intraoperative quality assessment and surgical guidance in cardiac surgery, supporting approximately 40% of the more than 700,000 CABG procedures performed worldwide each year. Guided by its vision of establishing TTFM as a standard of care in every operating room, the company has achieved near-universal adoption in several regions, including Japan (approximately 90%) as well as Central Europe and the Nordic countries (around 80%).

TTFM is endorsed in multiple professional guidelines, including the joint recommendations of the European Association for Cardiothoracic Surgery (EACTS) and the European Society of Cardiology (ESC). In the United States, however, where adoption currently stands at approximately 40%, formal guideline endorsement has not yet been established.

“Medistim’s vision is to contribute to making CABG surgery safer, more effective, and an increasingly attractive revascularization strategy for the treatment of coronary artery disease—for the benefit of both patients and surgeons alike. We are honored to support this landmark trial with our MiraQ TTFM and High-Frequency Ultrasound (HFUS) technologies,” said Kari E. Krogstad, President and CEO of Medistim. “A sufficiently powered randomized trial has long been awaited and has the potential to provide the level of evidence needed to further accelerate adoption.”

Medistim is supporting the SMARTFLOW trial with USD 500,000 over the course of the study.

1) Time to Assess the Role of Quality Control in CABG: The SMARTFLOW Trial Program, Gaudino et al, European Journal of Cardio-Thoracic Surgery, Volume 67, Issue 12, December 2025

About Medistim: Medistim was established in 1984 and has a track record of profitable growth over the past 20 years. The company is a pioneer within its segment and continues to invest in new product development. Medistim has wholly owned subsidiaries with sales organizations in the USA, Canada, China, Germany, UK, Spain, Denmark, Sweden and Norway, in addition to around 60 distributors in Europe, Asia, Middle East, Africa, and South America. Medistim is listed on the Oslo stock exchange under the ticker OSE:MEDI. For more information, visit the Medistim home page: www.medistim.com For more information, contact:

President and CEO, Kari E. Krogstad, Medistim ASA Tel: + 47 918 38 110 Email: kari.krogstad@medistim.com

CFO, Thomas Jakobsen, Medistim ASA Tel: + 47 906 59 940 Email: thomas.jakobsen@medistim.com