Stasys atlas platelet test: expanding test cartridge manufacturing under ISO 13485 regulatory controls for FDA trial submission

The National Heart, Lung, and Blood Institute awarded Stasys Medical Corp $325,648 on September 1, 2026, under the Cardiovascular Diseases Research program (CFDA 93.837) to establish ISO 13485–compliant manufacturing for test cartridges supporting the ATLAS platelet function diagnostic platform.

The project delivers a scalable production line for single-use test cards containing microfluidic chips with shear-activating force sensors designed to detect platelet micro-clots. Work includes validation testing of newly manufactured cartridges for regulatory compliance—aging, shipping, and storage stability—and a prospective clinical study directly comparing performance of newly manufactured cards against prior-generation cards to de-risk manufacturability while preserving clinical accuracy. The ATLAS platform uses high-resolution microfluidic imaging and machine learning to predict transfusion needs in trauma patients; prior emergency department research at Vanderbilt University Medical Center demonstrated that adding platelet force data to standard clinical variables improved predictive accuracy (ROC-AUC from 0.84 to 0.88). The award targets FDA clearance and deployment in emergency and military trauma care settings.

Place of performance is Seattle, Washington. The period of performance runs from September 1, 2026, through August 31, 2027. This is a Phase I Small Business Innovation Research award.

Abstract

Uncontrolled hemorrhage remains a leading cause of preventable death in trauma, yet no rapid, point- of-care diagnostic exists that can accurately guide transfusion decisions in the critical early hours of care. The stasys atlas platform has demonstrated strong predictive performance in a prior 750-patient emergency department (vanderbilt university medical center ED) study, but translation into a deployable medical device requires robust, scalable, and regulatory-compliant manufacturing. IT consumes single use cards that hold a microfluidic chip with shear activating force sensors to gather platelet micro-clots. This phase I project addresses the manufacturing need by establishing an ISO 13485-compliant card production line for higher card volumes to support commercial roll-out, testing cartridges for regulatory compliance needed for medical devices (aging, shipping, storage). Through a prospective clinical study, we will directly compare the performance of newly manufactured cards against prior-generation cards, thereby DE-risking manufacturability while preserving clinical accuracy. The innovation of this proposal lies in transforming a research-stage diagnostic into a durable, scalable, and clinically validated device, a necessary step toward FDA clearance and widespread adoption in emergency and military trauma care. The atlas system captures high-resolution microfluidic images and applies machine learning (ML) to predict transfusion needs before the bleeding becomes critical. In the previous ED study, adding platelet force data to standard clinical variables improved predictive accuracy (ROC-AUC from 0.84 to 0.88) and provided dysfunction information that standard blood panels and aggregometers missed. Our long-term goal is to give ED clinicians a fast, platelet-specific readout that changes patient care in the moment. In this phase I sbir, we will build manufacturing capacity for atlas consumables and validate them in a pilot observational trial. Aim 1: establish an ISO 13485 compliant line at stasys in seattle to perform manufacturing of cards that would be acceptable to submit to the FDA in an eventual multisite application for FDA 510K or DE novo approval. Test cards produced on this line for common medical cartridge tests: accelerated aging, altitude testing, thermal shock, vibrations. Install engineering and quality controls to gain ISO 13485 certification, which is a key step in FDA clearance of a manufactured medical consumable. Aim 2: conduct clinical testing through 70-person validation study. Our clinical partnership with vanderbilt university medical center (VUMC) under an existing IRB will lead testing to determine if stasys cartridges perform as well or better than our previous large VUMC study with prior process cards. Test atlas cartridges produced on the new manufacturing line against previously made cartridges on the same patient sample simultaneously on two atlas systems and analyze cross-machine variability.