FDA approves Inspire to begin STAR clinical trial to evaluate UAS therapy for OSA

Inspire Medical Systems, a leading developer of neuro-stimulation therapies for the treatment of obstructive sleep apnea (OSA), announced today that the company has received approval from the U.S. Food and Drug Administration (FDA) to begin its STAR pivotal clinical trial. The STAR trial (Stimulation Therapy for Apnea Reduction), is a multi-center study that will evaluate both the safety and effectiveness of Inspire™ Upper Airway Stimulation (UAS) therapy in patients with moderate to severe obstructive sleep apnea (OSA). The STAR trial will be conducted at leading medical centers across the United States and Europe. The results of this study will be the basis for a Pre-market approval (PMA) application to the FDA.

“The Inspire implant procedure is less invasive than most OSA surgical techniques which will likely contribute to faster patient recovery times. The STAR trial will provide valuable information on the potential role of upper airway stimulation therapy.”

"OSA is a prevalent disorder affecting over 15 million adults in the U.S. alone. Current front line therapies for OSA, including CPAP, can have a significant impact on the lifestyle and comfort for both the OSA patient and their bed partner. As a result, patient compliance for these front line therapies is sub-optimal. A substantial number of patients suffering from OSA are looking for a new approach to treat this challenging condition," commented Tim Herbert, President and CEO of Inspire Medical Systems. "Our goal with Inspire therapy is to significantly reduce the burden of sleep apnea and restore restful sleep without the lifestyle tradeoffs that some other therapies require."

"Patients with untreated sleep apnea are at higher risk of developing hypertension, heart failure and stroke," said Dr. Meir Kryger, Director of Sleep Medicine Research and Education at Gaylord Hospital in New Haven, Connecticut. "There is a growing need for new treatment options for those patients who are non-compliant with current therapies."

Inspire also announced today that it has received CE Mark for Inspire™ Upper Airway Stimulation (UAS) therapy. "The receipt of the CE Mark is an important validation of our internal quality system and it authorizes the commercial sale of Inspire therapy in Europe," commented Mr. Herbert. "The company's current focus is to conduct a robust pivotal trial. We will begin initial European market development activities in late 2011."

Leading medical centers in Germany, Belgium and The Netherlands are currently approved to implant patients into the STAR trial. Professor Paul Van de Heyning, Director of Otolaryngology and Head and Neck Surgery at the University of Antwerp in Antwerp Belgium recently implanted the first patient in the STAR trial. "Inspire's stimulation therapy is well suited to address the root cause of OSA for many patients which is a decrease in airway muscle tone during sleep," said Professor Van de Heyning. "The Inspire implant procedure is less invasive than most OSA surgical techniques which will likely contribute to faster patient recovery times. The STAR trial will provide valuable information on the potential role of upper airway stimulation therapy."

The first U.S. implants in the STAR trial are targeted for early 2011. Prior to the approval of the STAR trial, Inspire Medical Systems completed three independent feasibility studies in the U.S., Europe and Israel. Clinical data from those studies served as the basis for initiating the STAR trial.