Dr. Rachael Callcut's lab at the University of California Davis, compared traumatic patient blood samples across Thromboelastography (TEG) and Stasys ATLAS devices.
From the conclusions: "Our study demonstrated that the Stasys assays, using shear stress-inducing microfluidics, appear to allow for a near real-time evaluation of in vivo clot formation and predict transfusion requirements at time of admission as well as requirements in the first 24 hours."
Led by Dr. Michael Mazzeffi, adult Extracorporeal Membrane Oxygenation (ECMO) patients and cardiac surgical patients were compared before heparinization and cardiopulmonary bypass. Measurements were performed using the Stasys ATLAS for it's novel identification of platelet force and microclot thrombus generation. Recombinant Von Willebrand factor (vWF) and lyophilized platelets were identified as improving thrombus function compared to untreated ECMO patient samples. The combination of ATLAS measurement and guided response using lyophilized platelets can potentially improve patient outcomes.
In conjunction with Vanderbilt University Medical Center, this follow-on grant allows for a 1000 patient study at the renowned VUMC Emergency Medical Center. This large multi-year study focuses on using ATLAS outputs to predict bleeding, blood product transfusion requirements, and patient outcomes, as well as developing an AI powered model for improving detection of platelet dysfunction. Principal investigators include Stasys Director of Research & Development Dr. Lucas Ting, and VUMC Professor Dr. Sean Collins, M.D. (Executive Vice Chair, Emergency Medicine).
Grant Title: Rapid platelet dysfunction detection in whole blood samples using machine learning powered micro-clot imaging.
The grant facilitates Stasys Medical to further develop and improve machine vision and machine learning driven analysis of images captured by the ATLAS. It is led by Stasys Director of Research & Development Dr. Lucas Ting.
Abstract: Platelets contract forcefully after their activation, contributing to the strength and stability of platelet aggregates and fibrin clots during blood coagulation. Viscoelastic approaches can be used to assess platelet-induced clot strengthening, but they require thrombin and fibrin generation and are unable to measure platelet forces directly. Here, we report a rapid, microfluidic approach for measuring the contractile force of platelet aggregates for the detection of platelet dysfunction. We find that platelet forces are significantly reduced when blood samples are treated with inhibitors of myosin, GPIb-IX-V, integrin αIIbβ3, P2Y12, or thromboxane generation. Clinically, we find that platelet forces are measurably lower in cardiology patients taking aspirin. We also find that measuring platelet forces can identify Emergency Department trauma patients who subsequently require blood transfusions. Together, these findings indicate that microfluidic quantification of platelet forces may be a rapid and useful approach for monitoring both antiplatelet therapy and traumatic bleeding risk.
Read the paperSEATTLE, Wash. – March, 2015 – Stasys Medical Corporation has received a National Science Foundation Small Business Innovation Research Phase IIb grant (NSF SBIR PIIb), and a National Institute of health Small Business Innovation Research grant (NIH SBIR PI) totaling $725K. The company will use these grants to conduct product development and research to understand the ways that Stasys’ technology can be utilized to help manage bleeding and coagulation in surgical, ER, and personalized medicine applications. This is the latest grant award in addition to receiving a NSF SBIR PII award, and investment led by Table10 group bringing the recent investment into Stasys to $2.1M.