MGC Diagnostics Corporation , a global medical technology company, today announced a new clinical study collaboration with Restech Srl to evaluate the diagnostic accuracy of the forced oscillation technique (“FOT”) to detect lung function abnormalities.
Worldwide enrollment, expected to begin mid-year 2017, will include subjects ranging from age six to adult. MGC Diagnostics will sponsor the study and Restech Srl will conduct the study.
Resmon™Pro Full Information
Measuring lung function is an important component in the diagnostic process for patients with suspected lung function abnormalities such as chronic obstructive pulmonary disease (“COPD”) and asthma. Not only does it help identify a specific diagnosis, it also provides valuable information regarding the severity of the condition so that appropriate therapy, including inhaled medications can be prescribed. Currently,spirometry is the most common lung function test, however, spirometry is not an easy test to perform because it requires repeated forced breathing maneuvers, good patient co-operation and a skilled technician.
Todd M. Austin, Chief Executive Officer of MGC Diagnostics commented, “We are excited about the opportunity to sponsor this large clinical study and our continued collaboration with Restech Srl, the manufacturer of the Resmon™ Pro Full device. We believe that the results of this clinical study will advance the widespread adoption of the Resmon™ Pro as a valuable tool for the diagnosis and management of COPD and asthma.”
“The main advantage of this technology is the elimination of repeated, forced breathing maneuvers. The FOT test allows the patient to breathe normally, at rest and with minimal technician instruction required.
Not only is FOT easy to use, it provides unique information about lung function not available with conventional spirometry,” concluded Mr. Austin. The multi-center, observational prospective accuracy study objective is to determine the diagnostic accuracy of within-breath FOT parameters, measured or calculated by the Resmon™ Pro Full, to detect a lung function anomalyas compared to spirometry in a prospective and consecutive cohort of subjects attending a pulmonary function testing lab for diagnostic examination. Sensitivity and specificity analysis along with the results of the trial will be compared with spirometry, considered the “gold standard,” to confirm the presence of a lung function anomaly.
About MGC Diagnostics
MGC Diagnostics Corporation , is a global medical technology company dedicated to cardiorespiratory health solutions. The Company, through its Medical Graphics Corporation and Medisoft SA subsidiaries, develops, manufactures and markets non-invasive diagnostic systems. This portfolio of products provides solutions for disease detection, integrated care, and wellness across the spectrum of cardiorespiratory healthcare. The Company’s products are sold internationally through distributors and, in the United States, France and Belgium, primarily through a direct sales force targeting heart and lung specialists located in hospitals, university-based medical centers, medical clinics, physicians’ offices, pharmaceutical companies, medical device manufacturers, and clinical research organizations (CROs).
For more information about MGC Diagnostics, visit www.mgcdiagnostics.com
About Restech Srl
Restech Srl is a spin-off from Milan Polytechnic University, established in 2010 by the Biomedical Technologies Laboratory (TBM Lab) in the Department of Bioengineering. For several years, the department has been focusing its research effort on developing new technologies for investigating the pathophysiology of the respiratory system and respiratory medicine more generally. Restech’s mission is to develop highly innovative medical devices and solutions in the respiratory sector, from research to product engineering, manufacturing and marketing. The company has designed and manufactures the Resmon™ Pro Full, a FOT based professional device for the assessment of lung function.
Todd M. Austin
MGC Diagnostics Corporation
Chief Executive Officer
Joe Dorame, Robert Blum, Joe Diaz
Lytham Partners, LLC