# Magnetically Enhanced Diffusion for Intra-Arterial Treatment of Acute Ischemic Stroke

> **NIH NIH R44** · PULSE THERAPEUTICS, INC. · 2022 · $1,061,579

## Abstract

Acute ischemic stroke (AIS) is the result of a blood clot in a cerebral artery. Currently, AIS remains a leading
killer and the leading cause of long-term disability, which annually impacts nearly 700,000 Americans. Because
brain tissue rapidly dies, time to reperfusion is critical in both preventing death and improving neurological
outcomes. While economic burden associated with ischemic stroke are high in the United States (US), it is
projected to increase from $72B in 2013 to $183B by 2030.
 Intravenous use of tissue plasminogen activator (tPA) is the standard of care for AIS, with thrombectomy
recommended for proximal large vessel occlusion in the anterior circulation. This strategy results in
improvements in long-term neurological outcomes over tPA alone. However, over half of thrombectomy-treated
patients die or are left moderately-to-severely disabled, despite a majority achieving complete or partially-
complete blood flow restoration. Inaccessible distal emboli post thrombectomy are a primary reason for poor
outcomes, which result in incomplete flow in up to half of cases. Patients not achieving complete recanalization
tend to be hospitalized longer, show weaker neurological improvements, have worse long-term neurological
outcomes, and experience more hemorrhage, versus those with complete recanalization. No options currently
exist for treating distal emboli given that current tools are too large and intra-arterial infusion of thrombolytic
agents has shown limited-to-no success due to distal occlusions creating stagnant columns of blood proximal
to the clot which restricts their diffusion to less than a few millimeters per hour.
 Pulse Therapeutics, Inc. (PTI) has made a breakthrough discovery using magnetic particles to adjunctively
convey thrombolytic agents over 100X faster. In vitro and in vivo work confirm that this technology improves
thrombolytic agent conveyance and clot lysis. It has also been shown that low doses of tenecteplase (TNK) are
superior to tPA. This project’s aims are to develop the technology for an intra-arterial procedure in the
treatment of AIS. For Phase I, benchtop, in vitro, and in vivo work will be conducted to demonstrate proof of
concept and optimize TNK and particle dosing and therapy delivery. FDA feedback using Phase I results will
be sought to improve Phase II aims. Phase II will assess the system’s impact on TNK pharmacokinetics and
aggravation of hemorrhage. In addition, an angiography suite-compatible workstation will be developed and
flow studies using neuro phantoms will be repeated under fluoroscopy to assess anticipated clinical workflow.
 Early FDA engagement indicates that the technology may be evaluated as a device given persuasive
mode of action and biocompatibility preliminary studies. Importantly, the PTI technology supports the FDA’s
mission to reinforce the value of comprehensive stroke centers and promises to improve care for the nearly
350,000 AIS victims showing visible clot in the ante...

## Key facts

- **NIH application ID:** 10488773
- **Project number:** 5R44NS107108-03
- **Recipient organization:** PULSE THERAPEUTICS, INC.
- **Principal Investigator:** Martin Omid Akhavan
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,061,579
- **Award type:** 5
- **Project period:** 2018-09-15 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10488773

## Citation

> US National Institutes of Health, RePORTER application 10488773, Magnetically Enhanced Diffusion for Intra-Arterial Treatment of Acute Ischemic Stroke (5R44NS107108-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10488773. Licensed CC0.

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