Life Recovery Systems and FDA Agree to Conclude Pilot Stroke Cooling Study and Move Forward to Randomized Trial
ALEXANDRIA, La., June 13, 2023 /PRNewswire-PRWeb/ -- Life Recovery Systems (LRS) has received concurrence from the US Food and Drug Administration (FDA) to successfully end its pilot study (SISCO) with the ThermoSuit® System in the treatment of ischemic stroke. The FDA met with LRS on June 1, 2023, to review the SISCO study results, concluding that that the TSS had achieved its objectives of feasibility, safety, and rapid cooling, while showing a very strong trend for brain protection and better recovery. FDA recommended that LRS end the SISCO study and move forward with a prospective randomized trial of rapid cooling in acute ischemic strokes.
- Life Recovery Systems (LRS) has received concurrence from the US Food and Drug Administration (FDA) to successfully end its pilot study (SISCO) with the ThermoSuit® System in the treatment of ischemic stroke and move forward with a prospective randomized trial of rapid cooling in acute ischemic strokes.
- ALEXANDRIA, La., June 13, 2023 /PRNewswire-PRWeb/ -- Life Recovery Systems (LRS) has received concurrence from the US Food and Drug Administration (FDA) to successfully end its pilot study (SISCO) with the ThermoSuit® System in the treatment of ischemic stroke.
- FDA recommended that LRS end the SISCO study and move forward with a prospective randomized trial of rapid cooling in acute ischemic strokes.
- This greatly enhances the investment opportunity in LRS and we are looking forward to continuing to aggressively pursue the FDA clearance for the stroke market."