Healthcare Industry News: daytime sleepiness
News Release - May 22, 2007
Aspire Medical Announces First Implant in US and Start of Clinical Trial to Treat Sleep ApneaSUNNYVALE, Calif., May 22 (HSMN NewsFeed) -- Aspire Medical, Inc., announced today the initial clinical trial use in the United States of its Advance(TM) System, an implantable, minimally invasive medical device designed to treat tongue base obstruction for patients with obstructive sleep apnea (OSA). The first patient to receive the treatment was enrolled at an outpatient surgery center affiliated with St. Vincent Hospital in Indianapolis, Indiana.
"Based on our prior experience with the Advance(TM) System, we are quite pleased with the performance of the product," said Roseanne Varner, President and Chief Executive Officer of Aspire Medical. "Treatment of obstructive sleep apnea is a significant and growing unmet clinical need. Initiating the Advance(TM) trial in the US is an important milestone as we develop minimally invasive, effective solutions for moderate to severe OSA. We believe that the Advance(TM) System will provide an important new therapeutic option to physicians treating OSA patients."
The Advance(TM) Trial, which is being conducted under an investigational device exemption (IDE), will enroll up to 40 patients at up to five investigational sites in the United States. B. Tucker Woodson, MD of the Medical College of Wisconsin is the principal investigator for the study.
The procedure was performed by Tod C. Huntley, MD FACS of Head & Neck Surgery Associates. Dr. Huntley commented, "We are pleased with the ease of the Advance(TM) procedure. It is simpler to perform and is less invasive than other OSA surgeries, and thus far the patient has had minimal discomfort and no complications from it. In fact, he was back at work two days after the procedure. For years we have been looking for effective solutions for sleep apnea that are more tolerable to patients, and if this procedure proves to be as effective as the preliminary data suggest, I could see it becoming a first line of therapy in the treatment of this widespread and significant medical problem."
Upon completion of the IDE trial, Aspire Medical plans to seek FDA approval to commercialize the Advance(TM) System in the US. Aspire Medical is targeting its US commercial launch in late 2008 or early 2009, subject to the receipt of necessary regulatory approvals. The company's clinical investigation in Europe has so far yielded promising results.
About Obstructive Sleep Apnea
Obstructive sleep apnea (OSA) is a major heath problem. In the United States, at least 17 million people have moderate to severe OSA, which is characterized by heavy snoring, airway blockage and frequent awakenings during sleep. OSA is one of the major causes of severe daytime sleepiness, and is a major risk factor for automobile accidents and workplace injuries. If left untreated, OSA has been implicated as a major risk factor for cardiovascular disease, including hypertension and heart failure, as well as stroke.
OSA is caused by collapse of the upper airway during sleep, and treatment for the disorder is based upon therapies that keep the airway open. The most common treatment for OSA is continuous positive airway pressure (CPAP). At least 50% of patients with OSA find it difficult or impossible to use CPAP and are therefore candidates for surgery. However, current surgical options for these patients are very limited, particularly related to the tongue base.
About The Advance(TM) System
The Advance(TM) System is used in a minimally invasive surgical procedure to treat tongue base collapse in OSA. The procedure is performed by an otolaryngologist (ENT), and involves the placement of a small implant in the tongue. The system can then be adjusted to an individual patient's needs. These adjustments can be performed at the time of Advance(TM) placement, at a later date, or even on multiple occasions if needed.
About Tod C. Huntley, MD
Tod C. Huntley, MD FACS has been in practice since 1991 and is a partner in Head & Neck Surgery Associates in Indianapolis, IN. He is board certified in otolaryngology, and has completed a fellowship in head and neck surgery and microvascular surgery. He has contributed to numerous medical publications and has lectured internationally.
About St. Vincent Hospitals and Health Services
Driven by the faith of four Daughters of Charity who arrived in Indianapolis in 1881 with $34.77 in their pockets, the St. Vincent Hospital mission is to treat the poor and sick by following its Core Values of Service of the Poor, Reverence, Integrity, Wisdom, Creativity and Dedication. Its healthcare ministry has grown to include seven Centers of Excellence: Women's, Children's, Orthopedics, Cardiovascular, Neuroscience, Oncology and Bariatrics. The ageless mission of St. Vincent remains unchanged: to minister to the minds, bodies and spirits of those in need.
About Aspire Medical, Inc.
Aspire Medical was founded in 2004 and is a privately held medical device company focused on developing minimally invasive treatments for obstructive sleep apnea (OSA). Investors include Three Arch Partners and New Leaf Ventures.
For more information about Aspire Medical, please visit our website at http://www.aspiremedical.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.
Source: Aspire Medical
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