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MGC Diagnostics Corporation Receives FDA 510(k) Clearance for Resmon™ PRO FULL, Forced Oscillation Technique (FOT) Device

MGCD has exclusive worldwide distributorship rights


News provided by

MGC Diagnostics Corporation

Jun 28, 2016, 08:00 ET

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SAINT PAUL, Minn., June 28, 2016 /PRNewswire/ -- MGC Diagnostics Corporation (NASDAQ: MGCD), a global medical technology company, today announced that the U.S. Food and Drug Administration ("FDA") has granted 510(k) clearance for the Resmon PRO FULL, Forced Oscillation Technique ("FOT") device. This instrument provides U.S. healthcare professionals the ability to non-invasively monitor a patient's lung mechanics and normal breathing pattern, without forced efforts needed with traditional measurements. The Resmon PRO FULL is suitable for patients, such as the elderly, children aged 4 and up and very severely ill patients with limited forced capacity.

MGC Diagnostics is the exclusive worldwide distributor of the Resmon PRO FULL, designed and manufactured by Restech Respiratory Technology ("Restech Srl"), a privately held company based in Milan, Italy. Restech Srl is a spin-off from Milan Polytechnic University, established in 2010 by the medical engineers of Biomedical Technologies Laboratory in the Department of Bioengineering. Restech's mission is to develop highly innovative medical devices and solutions in the respiratory sector.

Todd Austin, Chief Executive Officer of MGC Diagnostics, commented, "We are extremely pleased to have received FDA clearance on the Resmon PRO FULL. This regulatory clearance now allows us to offer technology specifically designed for simple, patient independent, measurement of the mechanical properties of the respiratory system. The Resmon PRO FULL is designed to provide medical professionals the ability to measure mechanical properties of the respiratory system during normal tidal breathing, providing a simple, effort-independent assessment for both clinicians and patients.  We are pleased with our progress, as we continue to execute on our strategic objectives in our long range plan to position the company for future growth and enhance shareholder value by introducing new technologies to the market."

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.

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, 2015, and any updates in subsequent filings on Form 10-Q or Form 8-K under the Securities Exchange Act of 1934.

Contacts

Company

Investors

Wesley W. Winnekins

Joe Dorame, Robert Blum, Joe Diaz

MGC Diagnostics Corporation

Lytham Partners, LLC

Chief Financial Officer

(602) 889-9700

(651) 484-4874

[email protected]



SOURCE MGC Diagnostics Corporation

Related Links

www.mgcdiagnostics.com

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