Vitestro Secures $70M Series B to Advance Autonomous Blood Collection Robot for US Market Entry
核心洞察
Vitestro (搜索) raised $70 million in Series B funding to prepare its autonomous diagnostic blood collection robot Aletta (搜索) for US market launch via FDA's de novo pathway.
The Aletta (搜索) device combines near-infrared imaging, ultrasound, and artificial intelligence to identify veins and automate the entire blood collection process from tourniquet application to bandage placement.
Clinical data demonstrates that Aletta (搜索) achieves first-time blood draw success rates and procedure durations comparable to manual phlebotomy, while maintaining similar hemolysis (搜索) rates.
Vitestro (搜索) announced Tuesday it has secured $70 million in Series B funding to advance its autonomous diagnostic blood collection robot toward US market entry, addressing critical staffing challenges and quality issues in healthcare facilities worldwide.
The company's Aletta (搜索) device represents a significant technological advancement in diagnostic blood collection, utilizing a sophisticated combination of imaging technologies, robotics, and artificial intelligence to fully automate the phlebotomy process. The system integrates near-infrared and ultrasound imaging to locate suitable veins, employs Doppler ultrasound to confirm vein selection and avoid arteries, and precisely positions and inserts needles for blood sample collection.
Technology Platform and Clinical Performance
Aletta (搜索) automates the entire blood collection workflow, from applying the tourniquet to placing the bandage over the needle puncture site. This comprehensive automation addresses current challenges in blood sample collection, where trained healthcare workers primarily perform the task manually while facilities struggle with staffing shortages and blood sample quality issues.
Clinical validation data demonstrates that Aletta (搜索) achieves first-time blood draw success rates and procedure durations comparable to manual phlebotomy. Critically, the rate of in vitro hemolysis (搜索)—the destruction of red blood cells that can render samples unusable—was also comparable to traditional methods, ensuring diagnostic accuracy is maintained.
The system is designed to improve operational efficiency, with one supervisor capable of overseeing up to three Aletta (搜索) systems simultaneously, potentially addressing staffing requirements in collection facilities.
Regulatory Strategy and Market Expansion
Following its CE mark approval in 2024, Vitestro (搜索) initiated a limited market release at selected European hospitals and clinical laboratories. The company is now pursuing FDA authorization through the de novo pathway, a regulatory route typically used for novel medical devices that don't have predicate devices.
The $70 million funding round attracted investment from prominent healthcare organizations, including Labcorp Venture Fund (搜索), Mayo Clinic, and Sutter Health. Megann Vaughn Watters, head of Labcorp Venture Fund, stated that "applying robotics, multimodal imaging and AI to clinically validated diagnostic blood collection is an exciting approach."
Strategic Development Plans
The Series B proceeds will support multiple strategic initiatives, including funding the FDA de novo pathway pursuit and preparing for expanded device access beginning in Europe. Vitestro (搜索) plans to scale up manufacturing and commercial activities while enhancing the platform's technical capabilities and integration into existing technology infrastructure.
The company's roadmap includes clinical trials and pilot programs designed to embed the technology into real-world workflows, supporting broader adoption across healthcare systems. These activities build upon ongoing clinical trials in the US that support Vitestro (搜索)'s global expansion strategy.