Restech Dx-pH Measurement System DETECT AIRWAY REFLUX

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Journal of Voice Selects Restech-Sponsored Article on Supresophageal Gastric Reflux as Best Paper Award in Clinical Medicine: Study led by Dr. Gregory J. Wiener validates cutting edge technology for detection of extraesophageal reflux

San Diego, CA– May 21, 2010 – Today, Respiratory Technology Corporation (“Restech”) announced that the Journal of Voice has selected the article Oropharyngeal pH Monitoring for the Detection of Liquid and Aerosolized Supraesophageal Gastric Reflux, as the recipient of the Award for Best Paper in the category of Clinical Medicine. The purpose of the award is to highlight noteworthy new research in the interdisciplinary field of Voice. It will be presented at the Voice Foundation’s Annual Symposium June 5, 2010, in Philadelphia, Pennsylvania.

The study, authored by Dr. Gregory J. Wiener, confirms the Restech Dx-pH System, a cutting edge acid reflux test, assists doctors in diagnosing patients more accurately, substantially improving treatment. It is a sensitive oropharyngeal pH device whose values correlate well with the gold-standard 24-hour pH device*, and appears to accurately detect pH events that originate in the stomach and travel through the distal esophagus and upward to the oropharynx.

The study’s authors are Gregory J. Wiener, MD, Michael Vaezi, MD, PhD, Ross Tsukashima, Colleen Kelly, PhD, Erich Wolf, Molly Schmeltzer, RN, Charles Bankert, and Lauren Fisk.

“Congratulations to Dr. Wiener and his distinguished team on their award from the Journal of Voice for their significant research utilizing the Restech Dx-pH probes,” said Leo Roucher, CEO, Respiratory Technology. “We are proud to be part of this important research which proves the value of the Dx–pH Probe in diagnosing and treating patients with extraesophageal symptoms.”

"The award from Journal of Voice helps to validate the clinical effectiveness of the Restech Dx-pH Measurement System in detecting "atypical/supraesophageal" acid reflux to the ears, nose and throat (ENT). There is a need to find accurate diagnostic devices for detection and confirmation of this prevalent clinical entity. This is exciting for the future of the Restech System and the entity of atypical reflux," said Gregory J. Wiener, MD, FACP, Principal Investigator and Lead Author of the article.

Background on Publication:
In 1989, Dr. Gregory Wiener was the lead author of the Journal of Gastroenterology publication, Chronic Hoarseness Secondary to gastroesophageal reflux disease: documentation with 24-hour ambulatory pH monitoring, one of the first published reports of the use of pH monitoring for evaluation of reflux above the esophagus. This was a groundbreaking study in itself, and Dr. Wiener has followed this up with his research using the Restech Dx-pH System.

Dr. Wiener, who runs a successful private gastroenterology practice in Southern California, has also remained active in research with pharmaceuticals. When approached about taking on the role of study investigator for the Restech device in 2004, he was enthusiastic about the study and its potential for treatment of patients. Since beginning the study, Dr. Wiener performs pH studies on enrolled subjects recruited from his patient population and patients referred for the study by other physician colleagues.

The study was completed and subsequently selected for oral presentation at Digestive Disease Week (DDW) in 2006 as part of the session New Techniques in Diagnosing Reflux. It was later named one of the Best of DDW 2006. The resulting article, Oropharyngeal pH Monitoring for the Detection of Liquid and Aerosolized Supraesophageal Gastric Reflux, was published online in Journal of Voice in May 2008 and in print in the July 2009 issue.

About the Study and Results
The population consisted of 15 patients complaining of symptoms from chronic cough to hoarseness. Each patient underwent simultaneous triple channel esophageal/pharyngeal pH monitoring, and oropharyngeal pH monitoring with the Restech Dx-System. One important aspect of the study was the suggestion for redefining the criteria by which a reflux event is identified in the supraesophageal region. A reflux event in the lower esophagus is characterized by a drop to pH 4 or below. In the oropharynx, this low of a pH is seldom seen, and it is inappropriate to continue to use this threshold for defining a laryngopharyngeal reflux event.

Journal of Voice Award in Clinical Medicine
Journal of Voice is the official journal of The Voice Foundation and the International Association of Phonosurgeons. It includes clinical and research articles that are of interest to all professionals of all backgrounds. Papers are solicited on all aspects of voice, including basic voice science, acoustics, anatomy, synthesis, medical and surgical treatment of voice problems, voice therapy, voice pedagogy, and studies in other areas that increase the knowledge of normal (including performance) and abnormal vocal function in adults and children. “The Best paper Awards began in 2007 to recognize notable work published each year in Journal of Voice. The Editorial Board votes for Best papers in three categories that represent the journal’s interdisciplinary content: Basic Science, Clinical Medicine and Speech-Language Pathology/Vocal Pedagogy. The awards are presented during the Voice Foundation’s Annual Symposium: Care of the Professional Voice.” For further information, please visit www.jvoice.org .

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 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 confirm or deny the presence of laryngopharyngeal reflux, and evaluate it as a possible contributor to their patients’ symptoms.

The Dx–pH Probe’s miniaturized, patented sensor is housed in the tear-drop shaped tip at the distal end of a thin trans-nasal catheter. An LED blinks during placement, allowing the medical personnel to confirm the proper placement in the oropharynx. The small size and minimally invasive position of the Restech Dx–pH Probe allows patients to carry on normal, everyday activities including eating, talking and sleeping with more comfort than conventional esophageal pH probes.

The measurements taken by the pH sensor are sent wirelessly to a recording device which the patient carries throughout the study period. Upon completion of the study (usually 24 hours), the patient returns to the physician’s office where the data is downloaded and presented graphically for analysis 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 holds over 30 patents in the areas of sensor technology, data recording & monitoring systems, and medical devices.

For more information on the Dx-pH Measurement System, please contact Ms. Debra Krahel of Restech at +1-858-679-2300, dkrahel@restech-corp.com, or visit http://www.restech-corp.com.

Note to Editors: * “Gold Standard 24 hour pH device” is a tube with a pH sensor that goes through the nose, into the esophagus, where it rests for 24 hours to measure acid reflux.