Development of a Novel Aspiration Pump for Neurointerventional Procedures

ABSTRACT/PROJECT SUMMARY Strokes are the second leading cause of death worldwide. In the US they are the leading cause of disability, and cost the healthcare industry over $50 billion annually. Globally, almost 90% of strokes are ischemic in nature. Since 2015, the standard of care for large vessel occlusion (LVO) stroke has been mechanical

thrombectomy (MT). The improvements seen with MT have been so dramatic that urgent MT is now the recommended by the American Stroke Association Guidelines for the treatment of acute ischemic stroke (AIS). Over the years MT approaches have evolved from stent retrievers, to aspiration catheters, to a combination of

the two devices. Yet despite these advances, revascularization of occluded vessels is still not achieved in up to 33% of cases, and only ~50% of cases have good clinical outcomes. Aspiration pumps have much wider applications than just aspiration-first approaches; over 96% of neurointerventionalists we interviewed report using an aspiration pump during thrombectomies, regardless of

whether they are using an aspiration catheter or stent retriever. Almost 70% of clinicians interviewed said that they believed a better aspiration pump is needed. Despite dramatic evolution in catheters and stent retrievers in the last 5-years, currently the market is dominated by a single device with minimal updates. We are

addressing this clinical need with our innovative ALGO aspiration pump. Our pump has several prominent innovations that improve its usability and revascularization potential. These include a novel and unique aspiration system that operates through a mechanism unlike any other system on the market. Early testing of this system demonstrates incredibly high success rates for total revascularization

after the first pass, as well as significantly improved rates of revascularization compared to a leading competitor. Our system is also compatible with any standard catheter on the market; this avoids the need for the purchase of proprietary accessories and allows neurointerventionalists to use the devices they are most

comfortable with. Additionally, the ALGO offers real-time, nuanced feedback on procedure status. We expect this system will improve procedural success rates by notifying neurointerventionalists if the catheter tip is occluded due to sidewall contact and the position must be adjusted, or if the catheter is corked with a clot and

can be withdrawn. Finally, the ALGO is designed to be recyclable. This was an important innovation that neurointerventionalists indicated was desired. Together these innovations will result in an aspiration pump that improves first-pass efficacy rates while lowering costs and reducing medical waste. Based on our market analysis, these are highly desired

innovations and we expect rapid acceptance and utilization of this technology. This Phase I effort is designed to further refine and validate our paradigm-shifting technology using physiologically relevant soft and hard clots to optimize our approach for the full spectrum of conditions neurointerventionalists encounter in the clinic.