# Rapid and Effective Localized Neurovascular Cooling Using the Khione Insulative Catheter

> **NIH NIH R44** · FOCALCOOL, LLC · 2020 · $992,087

## Abstract

Project Summary
Stroke is the 5th leading cause of death and number one cause of adult disability in the United States. The
primary goal of acute ischemic stroke (AIS) treatment is quickly restoring blood perfusion. However, studies
have shown that this return of blood flow, while necessary, can also cause damage to local tissue leading to
poor patient outcomes. Therapeutic hypothermia (TH) has been shown to be a robust neuroprotectant in
preclinical studies, but has not been translated to clinical care.
The overall goal of this research is to improve AIS patient outcomes by combining TH with mechanical
thrombectomy (MT) as a neuroprotective strategy. FocalCool’s product, the Khione™ Catheter, is a
therapeutic hypothermia catheter with superior insulation used to rapidly and locally cool ischemic tissue at
risk. Our Phase I work demonstrated cooling effectiveness feasibility and brain tissue salvage and neurological
benefit in a canine stroke model. Phase II aims will confirm safety and tissue salvage results in the canine
model and take the Khione™ Catheter significantly closer to commercialization.
Specific Aims: 1) Using FDA pre-submission guidance and thermal design requirements show that the
Khione™ Catheter a) meets FDA standards for sterile and single-use intravascular catheters and b) is ready
for more extensive pre-clinical efficacy testing. 2) Demonstrate with greater statistical confidence Khione™
Catheter’s therapeutic potential in a clinically relevant canine stroke model. FocalCool will transfer the
Khione™ Catheter design into production methods and procedures. An ISO / GMP certified vendor will
manufacture catheters for device testing to assess structural, safety, and thermal performance. Finally, the
therapeutic benefit of the Khione™ Catheter will be evaluated in an appropriately powered canine study.
Relevance: Effective recanalization with today’s MT devices such as stent retrievers is a promising new
standard of care for ischemic strokes. Reperfusion injury however, following recanalization continues to be an
unmet problem in ischemic stroke care. Approximately 50% of stent retriever patients leave with modified
Rankin Scores greater than 3, indicating moderate disability to severe disability, including death. The
technological innovation of combining stroke treatment therapies – mechanical thrombectomy and precise well-
integrated reperfusion hypothermia – may yield synergistic benefits, resulting in reduced infarct size and
improved long-term neurological outcomes.

## Key facts

- **NIH application ID:** 10020807
- **Project number:** 5R44NS095573-04
- **Recipient organization:** FOCALCOOL, LLC
- **Principal Investigator:** THOMAS L MERRILL
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $992,087
- **Award type:** 5
- **Project period:** 2016-09-15 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10020807

## Citation

> US National Institutes of Health, RePORTER application 10020807, Rapid and Effective Localized Neurovascular Cooling Using the Khione Insulative Catheter (5R44NS095573-04). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10020807. Licensed CC0.

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