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Restech Dx-pH Measurement System Accurately Measures Laryngopharyngeal Reflux in Children Innovative pharyngeal pH probe helps differentiate baseline pH and potential etiology for various upper airway symptoms believed to be caused by Acid Reflux

San Diego, California, USA – January 14, 2009 - Today, Respiratory Technology Corporation (dba Restech) announced that the Restech Dx-pH Measurement System played a key role in a study by Dr. David J. Malis, MD, FACS, FAAP, of Melbourne, Florida, to accurately measure reflux in children. The study, entitled A New pH Probe for the Detection of Laryngopharyngeal Reflux (LPR) in Children©, was presented at the 2008 Annual Meeting of the American Society of Pediatric Otolaryngology (ASPO) as a podium presentation. The study of 100 pediatric patients helped differentiate baseline pH and potential etiology for various upper airway symptoms believed to be caused by acid reflux.

“Until recently, a definitive diagnosis has been challenging, and traditional test procedures, including dual lumen pH probe, are coming under scrutiny as to their effectiveness. LPR exists and accurate diagnosis is crucial to proper diagnosis and treatment of our smallest patients,” said Dr. Malis. “This study demonstrates that accurate diagnoses can be performed easily and comfortably using the Restech Dx–pH Measurement System.”

An alarming increase in the incidence of gastroesophageal reflux disease (GERD) and laryngopharyngeal reflux disease (LPRD) in Americans has led to the need for accurate diagnosis of extraesophageal acid reflux as provided by the Restech Dx–pH Measurement System. In determining the etiology of conditions such as chronic cough, recurrent laryngitis, sinusitis and asthma, it is important for physicians to be able to rule reflux in or out as a possible contributing factor. Instead of treating ‘in the blind’ with a medication based on symptoms alone, physicians will be able to prescribe treatment based on definitive quantification of acidic reflux in the upper airway.

Current Diagnostic Techniques Available to Pediatric Otolaryngologists
Current diagnostic techniques available to pediatric otolaryngologists include panendoscopy with biopsy, lipid-laden macrophages score and histology, the Bravo™ capsule, an esophagram / Barium swallow, or an empiric therapeutic trial with H2 Blockers or PPIs.

In contrast, the Restech Dx–pH Measurement System is a preferred method of testing as its highly sensitive Dx–pH Probe is specifically developed to detect aerosolized reflux. This provides more objective data, enabling physicians to determine a more accurate diagnosis and a more effective treatment plan.

Study Overview
Manifestations of LPR in children are protean. The most commonly attributed symptoms are nasal stertor, recurrent croup, stridor, hoarseness, chronic cough, medically refractory reactive airway disease (asthma), dysphagia and failure to thrive. Less commonly attributed symptoms are sleep disordered breathing (both central and obstructive apneas), Eustachian tube dysfunction, and recurrent sinusitis.

Materials and Methods
One hundred pediatric patients (presenting with symptoms consistent with LPR) were tested in a community-based private pediatric otolaryngology practice in Melbourne, Florida. Ten compelling cases were selected from the 100 patients. Patients received follow up six to ten months from initial presentation.

The main outcome measure was the ability to correlate patients with suspected LPR by testing with the new Restech pH probe. The secondary outcome measure was resolution of presenting symptoms after 12 weeks of medications and objective improvement by repeat Restech pH probe testing.

Conclusion
Laryngopharyngeal Reflux (LPR) in children may be more common than previously appreciated. Preliminary experience with the Restech Dx-System is encouraging in identifying children with LPR. Additional prospective studies are warranted to develop normative data and clinical guidelines in children.

Restech Dx–pH Measurement System
The Restech Dx–pH Measurement System is a revolutionary system that comfortably measures pH in the airway. Gastric reflux in the upper airway, or laryngopharyngeal reflux, commonly takes a gaseous form that cannot easily be measured using conventional technology. The miniaturized pH sensor at the tip of the Dx–pH Probe is unique in its ability to measure pH in a non-liquid environment, such as the pharynx. By monitoring the pH levels in the pharynx, the Dx–System enables physicians to determine the presence of laryngopharyngeal reflux, and its role in their patients’ symptoms.

The Dx–pH Probe has a 1.5mm, tear-drop shaped tip which houses the pH sensor. The tip rests comfortably in the throat, just behind the soft palate. pH testing before the development of the Restech Dx–System was done using trans-nasal esophageal catheters that were cumbersome, uncomfortable and interfered with a patient’s ability to perform their normal, everyday activities. The smaller shape and less-invasive position of the Restech Dx–pH Probe allows patients to more carry on normal, everyday behavior including eating, exercise, work, bathing, and sleeping with less disruption.

The measurements taken by the pH sensor are sent wirelessly to a recording device which the patient carries throughout the test period`. Upon completion of the test period (usually 24 hours), the patient returns to the physician’s office where the study data is downloaded and analyzed using Restech’s custom Dx–pH DataView software.


About Restech Corporation
Restech is a leader in engineering world class medical technologies that provide comfortable, reliable solutions to assist physicians in the diagnosis of reflux related health problems quickly and reliably. The innovative engineering team at Restech is led by professionals with over two decades experience each in medical device development. Together, the Restech staff hold over 30 patents in the areas of sensor technology, data recording & monitoring systems, and other medical devices.

For more information on the Dx-pH Measurement System, please contact Ms. Debra Krahel of Restech at (800) 352-1512 or visit http://www.restech-corp.com.