Stimdia Medical Receives FDA Breakthrough Device Designation for the pdSTIM™ System Designed to Facilitate Weaning Patients from Mechanical Ventilation

“Mechanical ventilation is an essential intervention and is utilized in the management of over 10 million patients throughout the world each year. Unfortunately, they are also associated with a significant risk of complications. Ventilator-induced diaphragmatic dysfunction or VIDD is one common complication resulting from a weakened diaphragm due to disuse while on ventilation,” stated Daniel Talmor, M.D., Professor of Anesthesia and Critical Care at Beth Israel Deaconess Medical Center. “This enervated state further compromises the ability to liberate patients from mechanical ventilation and increases patient morbidity, mortality, and healthcare costs.”

“Receiving FDA Breakthrough Device designation for the pdSTIM System will help prioritize the process for obtaining regulatory authorization in the U.S.,” said Tim Miller, General Manager, Stimdia Medical. “Over 40% of ICU admissions in the U.S. require mechanical ventilation with an average length of stay of 14 days for ventilated patients and an estimated annual cost of over $27 billion. We believe the pdSTIM System will help to reduce both length of stay and costs by enabling more rapid weaning of patients from mechanical ventilators.”

About Stimdia Medical

Stimdia Medical, Inc. is a privately held company headquartered in Minneapolis, MN and has developed the pdSTIM System to facilitate weaning patients suffering from ventilator-induced diaphragmatic dysfunction (VIDD) who are on mechanical ventilation for 96 hours or more and who have failed at least 2 weaning attempts. The pdSTIM System is currently for investigational only and is not for sale in any country.

For more information, visit www.stimdia.com

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