ALEXANDRIA, La., March 2, 2026 /PRNewswire/ — Life Recovery Systems (LRS) has received an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) for testing of the ThermoSuit System (TSS) in a pivotal trial of ischemic stroke patients. The previous SISCO pilot clinical study concluded that the TSS was feasible to use, cooled rapidly, and had acceptable safety, while showing trends for improved patient recovery in ischemic stroke patients. The results of the SISCO study were recently published in Frontiers of Neurology.
FDA’s IDE approved the enrollment of up to 160 patients overall in up to 8 hospitals. The study will randomize patients to receive standard care either with or without cooling to 32 ± 1°C. The primary endpoint will be post-stroke cognitive impairment (PSCI). Secondary outputs will include neurological recovery and mortality.
According to Dr. Robert Schock, VP of R&D at LRS, “Laboratory studies have predicted that rapid, early cooling would be effective in reducing brain injuries caused by ischemic strokes, while slow, delayed cooling has failed. Nearly 800,000 Americans suffer strokes each year, and we believe we could help many of them.”
The TSS uses liquid convection cooling. It typically cools to target in 40 minutes. Core temperature is monitored while cooling. At about 33°C the water and patient are removed from the suit. The patient is then maintained at target for 24 hours with conventional surface cooling.
Matt Center, LRS CEO, notes, “This is a testament to the unmatched cooling power of the ThermoSuit System. It enhances the investment opportunity in LRS. We are looking forward to pursuing FDA clearance for the stroke market.”
The IDE is for a clinical trial and is not the final clearance for the ischemic stroke indication. The current FDA-cleared indications for the ThermoSuit device are temperature reduction in patients where clinically indicated (e.g. in hyperthermic patients) and temperature monitoring.
About Life Recovery Systems
Life Recovery Systems focuses on innovative medical devices. Its mission is to save and preserve the quality of patients’ lives. LRS’ first product, the TSS, was developed with funding assistance of NIH NHLBI to provide a safe, rapid method for cooling patients. LRS has offices in Alexandria, LA and Kinnelon, NJ.
For investment inquiries contact Matt Center
mcenter@life-recovery.com
(678) 773-7033
Media Contact: Robert Schock
info@life-recovery.com
973-283-2800
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SOURCE Life Recovery Systems
