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Vitestro’s automatic blood collection device meets test endpoints

Posted on by darion

The Vitestro device was designed using artificial intelligence, advanced imaging technology and robotics. Photo source: Vitestro / PR Newswire.

Dutch company Vitestro announced positive results from a study assessing the safety and effectiveness of its autonomous blood collection device.

The results come from a pivotal phase of the Autonomous Blood Collection and Optimization and Performance Testing (ADOPT) study (NCT05878483). The study results are expected to lead to approval of the device in Europe by the end of this year.

The Vitestro device was designed using artificial intelligence, advanced imaging technology and robotics. It is designed to ensure accurate and autonomous blood collection, reducing the need for manual handling. This could help reduce nurses’ workload and reduce staffing shortages.

The study enrolled 609 participants in parts of Phase B1 and C1-1, with Phase B1 designed to demonstrate equivalence and support CE marking, and Phase C1-1 being the first follow-up study after CE certification. the evaluation study has been completed.

The Vitestro device met the study’s primary endpoint with a first-insert success rate of 95%, which is comparable to the first-insert success rates for manual venipuncture of 93% to 97%, according to the company. The device demonstrated a hemolysis rate of 0.6%, below the hemolysis benchmark of ≤2% for best sampling practice defined by the American Society of Clinical Pathology. Incorrect sample collection may result in hemolysis, which may prevent analysis of blood samples.

The average procedure time using the device was one minute and 49 seconds, while for manual phlebotomy the processing time was five minutes, including the time needed to access the test order and the time needed to collect the sample. No serious or moderate adverse events were reported. Mild adverse events occurred in 1.3% of participants.

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The device also saw positive patient-reported results, with 98% accepting the automatic blood collection device. Moreover, 83% of patients rated the pain associated with the procedure as less or comparable to manual blood collection.

According to a GlobalData report, the value of the robotics industry will exceed $218 billion by 2030. In the healthcare sector, robotics are most commonly used in surgical settings. Recently, these surgical robots have used 5G for remote robotic surgery.

Last month, Vitestro raised $22 million to commercialize its automated blood collection device. In addition to financing commercialization in Europe, the financing will also support the company’s expansion into the US market.