Siesta Medical’s Encore™ System Receives Broad Obstructive Sleep Apnea Clearance

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Siesta Medical, Inc. (Private), a leading provider of minimally invasive implants and tools for obstructive sleep apnea (OSA), announced FDA clearance for expanded indications for its Encore™ System. The Encore System, used to the perform AIRLIFT™ hyoid suspension, can be used to treat airway obstructions without any patient restrictions regarding airway anatomy, body mass index, or obstructive sleep apnea severity. AIRLIFT hyoid suspension provides immediate therapy, treating the entire hypopharynx and working without the need for patient compliance after surgery.

Siesta Medical, Inc. (Private), a leading provider of minimally invasive implants and tools for obstructive sleep apnea (OSA), announced FDA clearance for expanded indications for its Encore™ System.

The Encore System, used to the perform AIRLIFT™ hyoid suspension, can be used to treat airway obstructions without any patient restrictions regarding airway anatomy, body mass index, or obstructive sleep apnea severity. AIRLIFT hyoid suspension provides immediate therapy, treating the entire hypopharynx and working without the need for patient compliance after surgery.

Most surgery for OSA is performed by otolaryngologists and it is an exciting time in the field. Patient awareness for the various surgical options to treat sleep apnea has been rising and they now they have many options for successfully treating their OSA. With over 2,000 patients treated to date, the AIRLIFT has emerged as a leading procedure for providing robust and consistent results in treating OSA.

Dr. Jason Van Tassel with Washington Hospital in Fremont, CA, an expert in airway surgery for sleep apnea commented, “More and more patients are aware that they can get long-term, effective treatment of their sleep apnea with surgery, particularly when they do not get relief from CPAP therapy. AIRLIFT hyoid suspension has been one of my primary procedures for alleviating the sleep apnea burden on patients. My AIRLIFT patients feel better, snore less, and their follow up sleep studies confirm the effectiveness of the procedure.”

Dr. Michael Abidin, with Metropolitan ENT in Alexandria, VA, has performed over 2,000 sleep surgeries and noted, “I am so grateful to have made sleep surgery a significant part of my practice. It’s an area where the long-term benefit to my patient’s quality of life and long-term health outcomes is very meaningful. The AIRLIFT is a key procedure in my approach. It’s simple, broadly effective, economical, and recognized for coverage within today’s healthcare system.”

Obstructive Sleep Apnea
Obstructive sleep apnea is a major health problem in the United States. An estimated 23 million people in United States have moderate to severe sleep apnea (Harvard Medical School, The Price of Fatigue), which is characterized by frequent awakening during sleep, heavy snoring and daytime sleepiness. Left untreated, sleep apnea increases the risk for cardiovascular disease, including hypertension and heart failure. Sleep apnea remains largely under diagnosed and treated.

Though currently less common than continuous positive airway pressure (CPAP) therapy, sleep surgery provides an important and effective alternative for those patients having difficulty with CPAP. Surgical therapy reduces morbidity and risk of death associated with untreated sleep apnea (Weaver, Sleep 2004;27:A208, Marti, Eur Resp J 2002;20:1511-18). There are over 1 million new diagnoses of sleep apnea in the U.S. each year and over 100,000 surgical procedures for sleep apnea performed annually.

About Siesta Medical
Siesta Medical is a privately held, medical device company providing minimally invasive implants and tools for obstructive sleep apnea.

For more information about Siesta Medical please visit our website at http://www.siestamedical.com

This press release contains forward-looking statements that are based upon management’s current expectations and are inherently uncertain. Forward-looking statements are based upon information available to us as of the date of this press release and we assume no obligation to revise or update any such forward-looking statement to reflect any event or circumstance after the date of this release. Actual results and the timing of events could differ materially from current expectations and from any forward-looking statements made by the company.

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