# Flow Acceleration for Stroke Thrombolysis (FAST) System

> **NIH NIH R44** · UNANDUP, LLC · 2022 · $17,074

## Abstract

Acute ischemic stroke (AIS) results from a blood clot in the neurovasculature and is the 5th leading cause of
death and 1st leading cause of neurological disability in the United States (US). AIS impacts more than 700,000
Americans annually, with a 65% chance of death or severe disability. By 2030, it is expected that the AIS
economic burden will exceed $180B in the US alone.
 Standard of care AIS therapies include the use of the FDA approved thrombolytic agent alteplase (i.e.,
tissue plasminogen activator) within 4.5 hours of stroke onset and earliest-possible thrombectomy for large
vessel occlusions (out to 24hrs). In contrast to thrombectomy, thrombolysis does not require confirmation of a
vessel occlusion. Because only ~10% of AIS victims are eligible for thrombectomy, thrombolysis remains a
critical first line tool to treat those diagnosed with AIS. When employed, thrombolysis is associated with a
~15% improvement in stroke outcomes with ~10% fully recovering. However, due to the ~7% dose-dependent
associated hemorrhage rate of alteplase, thrombolysis is contraindicated for mild and wake-up strokes which
together make up ~60% of all AIS events. Due to safety concerns and limited reliability, usage of thrombolysis
in the US remains low (~10%) with 90% of all AIS victims receiving only palliative care. There remains an
urgent need to improve first line use of thrombolysis which can be expanded to all AIS victims.
UNandUP has invented a novel thrombolysis platform to safely accelerate alteplase to the obstructing
blood clot, thereby overcoming the restrictive hemodynamics known to prevent alteplase from quickly reaching
the occlusion. The proposed magnetic infusion platform overcomes this barrier by 1) adjunctively conveying
alteplase to the clot’s surface more than 100X faster than normal biological diffusion (i.e., minutes vs. hours),
and 2) mechanically mixing alteplase at the clot’s surface so that lysis is more reliable. Because alteplase is
not conjugated and the mode of action is purely mechanical in nature, FDA meetings confirmed a CDRH IDE
pathway is appropriate in support of an FDA Early Feasibility Study, which is a shorter and less expensive
pathway compared to a CDER IND process. Importantly, the technology is affordable, does not require precise
focusing, and can be configured to travel with patients transferred between hospitals for thrombectomy. Once
proven safe and effective using current FDA approved alteplase labeling, UNandUP intends to expand
thrombolysis to mild and wake up strokes by increasing the lysis efficacy of smaller alteplase doses known not
to induce hemorrhage. If successful, thrombolysis could be safely extended to all 700,000 AIS victims for the
first time, which is 10X more than currently treated. The project’s aims include 1) building the magnetic infusion
subcomponents (magnetic workstation, silica coated iron nanoparticles, nanoparticle delivery system), and
conducting 2) mechanism of action, 3) in vivo sa...

## Key facts

- **NIH application ID:** 10464028
- **Project number:** 3R44NS122604-01S1
- **Recipient organization:** UNANDUP, LLC
- **Principal Investigator:** Francis Milton Creighton
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $17,074
- **Award type:** 3
- **Project period:** 2022-02-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10464028

## Citation

> US National Institutes of Health, RePORTER application 10464028, Flow Acceleration for Stroke Thrombolysis (FAST) System (3R44NS122604-01S1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10464028. Licensed CC0.

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