MIPS Project Detail:
Company
Company Description:
CoolTech develops and commercializes products utilizing an internal evaporative cooling technology licensed from Johns Hopkins University. CoolTech has an exclusive, perpetual, worldwide license for this technology, which was formally executed in April, 2012.
MIPS Project
Therapeutic Cooling of Stroke Patients
Project #
6021.22
|
MIPS Round
72
|
Starting Date:
Aug 2023
MIPS Project Challenge:
The goal of this MIPS project is to conduct clinical testing of CoolTech’s trans-nasal body temperature cooling system, called the COOLSTAT® Transnasal Thermal Regulating Device, on stroke patients with fever.
Project Scope:
This MIPS project involves a 30-patient study to demonstrate the safety and functional ability of the COOLSTAT to effectively modulate patient temperature for up to 24 hours, followed by an expanded study (Phase 2) that includes traumatic brain injury patients. Both Phase 1 and Phase 2 studies will be performed at the University of Maryland Medical Center (UMMC) in the Neurocritical Care Unit (NCCU), and will exclusively enroll stroke patients who remain febrile for >2 hours after the standard-of-care antipyretic drug treatment. This study is essential for collecting the clinical data needed to file an FDA 510(k) submission for clearance to market the COOLSTAT for therapeutic temperature management.
Results:
Early feasibility testing with a prototype of the CoolStat was recently completed at Johns Hopkins University, showing safety and cooling efficacy. The MIPS-funded study will allow the company to use the actual CoolStat in a pilot study at the University of Maryland Medical Center, scheduled to start later this year.
The COOLSTAT device has already been developed into a clinically deployable device and has demonstrated efficacy in both preclinical studies, as well as early human feasibility studies. This development work has been funded through over $4.2 million in NIH SBIR grants and over $2.1 million in Series A equity and debt financing.
Principal Investigator:
Neeraj
Badjatia
Professor of Neurology
Project Manager:
Casey
Hannan
Director of Clinical Operations
Technologies:
Other
