Utrecht, The Netherlands, April 14, 2026 – Vitestro, the pioneer in medical robotics advancing automated diagnostic blood collection, today announced the publication of its multicenter clinical trial manuscript, “Performance, Safety, and Patient Experience of an Autonomous Robotic Phlebotomy Device: A Multicenter Trial,” in Clinical Chemistry, the world’s leading journal in clinical chemistry. It represents healthcare’s first peer-reviewed multicenter clinical study evaluating a fully autonomous robotic system using multimodal imaging to perform diagnostic venous blood draws in routine clinical practice. This multicenter study forms part of the premarket Autonomous Blood Drawing Optimization and Performance Testing (ADOPT) clinical trial (ClinicalTrials.gov: NCT05878483). The multicenter ADOPT trial is being conducted at leading healthcare institutions in the Netherlands, including Amsterdam University Medical Center, St. Antonius Hospital, OLVG Lab, and Result Laboratory. The publication also includes patient acceptance data collected separately at Mayo Clinic in Rochester, MN, U.S.

The study reported impressive performance and safety results from 1,633 patients enrolled in three outpatient phlebotomy departments. The overall first-stick success rate, when a suitable vein was identified, was 94.5 percent, including a 97.4 percent first stick success rate in high BMI patients (>30 kg/m2), 92.7 percent in self-reported difficult venous access patients, and 93.4 percent in elderly patients (age >65 years). The rate of hemolysis was 0.3 percent, well below rates reported in the literature for manual phlebotomy. The adverse event rate was 0.6 percent, also lower than published rates for manual phlebotomy. All events were categorized as mild.

Additionally, 90 percent of patients reported far less, less, or similar pain compared with manual phlebotomy, and 82 percent of patients indicated they would strongly prefer or prefer the use of Aletta® in the future or had no preference.

In addition to the multicenter clinical study results, the publication also reported findings from a U.S. patient acceptance study. This study demonstrated that 86 percent of patients reported they were very willing or willing to use Aletta® for their blood draw.

“This multicenter study represents a significant milestone in the clinical validation of autonomous robotic phlebotomy in routine practice,” says Robert de Jonge, PhD, Professor and Head of the Department of Laboratory Medicine at Amsterdam University Medical Center. “The demonstration of strong performance and safety outcomes is critical to building clinical and laboratory confidence in this new approach. As laboratories advance automation across the diagnostic workflow, innovations like Aletta in the preanalytical phase will be instrumental in enabling more standardized, scalable, and integrated care delivery.”

“This publication is a major milestone for the company and our study partners and the culmination of many years of research and development, technology advancements, and clinical research,” said Luuk Giesen, MD, Chief Medical Officer of Vitestro. “This publication sets the stage for our mission to establish automated phlebotomy as the standard for diagnostic blood collection.”

“From a laboratory perspective, consistency in the preanalytical phase is critical, yet often difficult to achieve in daily practice,” says Thijs van Holten, PhD, Clinical Chemist at St. Antonius Hospital. “Aletta introduces a standardized approach to diagnostic blood collection, with the potential to reduce variability, improve sample quality, and support more reliable diagnostic outcomes.” Martine Deckers, PhD, Clinical Chemist at OLVG Lab, adds, “Equally important is how patients experience the procedure. In this study, most patients reported less or similar pain compared with a manual draw, and almost all patients indicated they would prefer or be open to using the system again, supporting its potential for broader adoption in routine clinical practice.”

Read the full paper here

About Aletta® ARPD™

The Aletta® ARPD™ is designed to autonomously perform diagnostic blood collection. The system combines multimodal imaging, including near-infrared vein visualization, real-time ultrasound imaging, and Doppler ultrasound to help distinguish between veins and arteries. It combines these capabilities with advanced robotics, and artificial intelligence to identify suitable veins, guide needle insertion, and collect blood samples with high precision and consistency. Aletta® is designed to support phlebotomy departments by performing routine diagnostic blood draws, helping address staffing challenges, reducing human-dependent variability, standardizing quality, enhancing the overall patient experience, and enabling greater operational predictability and scalability in high-volume outpatient care settings.

About Vitestro

Vitestro is a global leader in medical robotics advancing diagnostic blood collection through autonomous technology. Headquartered in the Netherlands, the company brings deep expertise in engineering, robotics, artificial intelligence, and commercialization. Vitestro has developed Aletta®, the world’s first and only CE-marked Autonomous Robotic Phlebotomy Device™ (ARPD™), establishing a new category and benchmark for diagnostic blood collection. By integrating advanced robotics, multimodal imaging, and AI, Vitestro is enabling greater precision, operational efficiency, and an improved patient experience in clinical settings. Aletta® is currently CE-marked and being deployed in clinical and pre-commercial settings in Europe and has not yet received FDA authorization in the U.S. Vitestro is actively advancing its U.S. regulatory pathway while expanding global clinical collaborations to support the future commercialization of autonomous diagnostic blood collection worldwide.

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