SAINT PAUL, Minn., April 20, 2017 /PRNewswire/ -- MGC
Diagnostics Corporation (NASDAQ: MGCD), 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 anomaly as 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
(NASDAQ: MGCD), 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.
Cautionary Statement Regarding Forward Looking
Statements
From time to time, in reports filed with the
Securities and Exchange Commission, in press releases, and in other
communications to shareholders or the investing public, MGC
Diagnostics Corporation may make forward-looking statements
concerning possible or anticipated future financial performance,
business activities or plans that include the words "believes,"
"expects," "anticipates," "intends" or similar expressions. For
these forward-looking statements, the Company claims the protection
of the safe harbor for forward-looking statements contained in
federal securities laws. These forward-looking statements are
subject to a number of factors, risks and uncertainties, including
those disclosed in our periodic filings with the SEC that could
cause actual performance, activities or plans after the date the
statements are made to differ significantly from those indicated in
the forward-looking statements. For a list of these factors, see
the sections entitled "Risk Factors" and "Cautionary Note Regarding
Forward Looking Statements," in the Company's Form 10-K for the
year ended October 31, 2016, and any
updates in subsequent filings on Form 10-Q or Form 8-K under the
Securities Exchange Act of 1934.
Contacts
Company
|
Investors
|
Todd M.
Austin
|
Joe Dorame, Robert
Blum, Joe Diaz
|
MGC Diagnostics
Corporation
|
Lytham Partners,
LLC
|
Chief Executive
Officer
|
(602)
889-9700
|
(651)
484-4874
|
mgcd@lythampartners.com
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/mgc-diagnostics-announces-clinical-study-to-evaluate-the-diagnostic-accuracy-of-the-forced-oscillatory-technique-fot-to-detect-lung-function-abnormalities-300442725.html
SOURCE MGC Diagnostics Corporation