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Old 02-18-2015, 07:14 AM   Nav to Top 
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Default Miraculins (TSX VENTURE:MOM) Provides Pre-Submission De Novo Documentation to the FDA

Miraculins (TSX VENTURE:MOM) Provides Pre-Submission De Novo Documentation to the FDA for Its Scout® Diabetes Technology

Next Step Towards Securing Market Clearance in the U.S.

WINNIPEG, MANITOBA--(Marketwired - Feb. 18, 2015) - Miraculins Inc. (TSX VENTURE:MOM) (the "Company"), a medical diagnostic company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces that it has provided pre-submission documentation to the U.S. Food and Drug Administration ("FDA") regarding the de novo classification of its Scout® diabetes device, as a next step towards securing marketing clearance in the United States.

There is a three-tier classification system in the U.S. that the FDA has established for medical device clearance based on the risks and types of controls required to assure the public's safety:
•Class I devices are the lowest risk, require only general controls, and typically do not require premarket notification or approval.*

•Class II devices are moderate risk, require general and special controls, and typically require a 510(k) application. A 510(k) is a premarket submission that demonstrates that a device is substantially equivalent to a legally marketed device that is not subject to premarket approval (called a predicate device).*

•Class III devices are considered to have the highest risk and require general controls, special controls, and premarket approval. If a low to moderate risk product does not have a predicate device it receives an automatic Class III designation.*

For automatic Class III designations, the FDA amended its de novo classification process in 2012 to provide a pathway to Class I or Class II for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.

Based on interactions with the FDA in 2014, including a meeting between a Miraculins delegation and FDA representatives in Washington, D.C., the Company is of the view that there is no predicate device for the Scout®, and that the de novo process could provide the appropriate regulatory pathway for market clearance in the U.S. The de novo process may be less burdensome than would be the case if the Company sought a premarket approval for the Scout® device.

* Source: Cato Research

About Miraculins Inc.

Miraculins is a medical diagnostic company focused on acquiring, developing and commercializing non-invasive technologies for unmet clinical needs. A significant number of promising diagnostic opportunities remain un-commercialized because of the sizable gap between the discovery stage, when research institutions are typically involved, and the commercialization stage, when the larger commercial enterprises become interested. Miraculins has direct experience in bridging this gap. The Company's Scout® device is the first non-invasive diabetes testing system designed to provide a highly sensitive and convenient method for measuring diabetes related biomarkers in the skin, the accumulation of which are accelerated by abnormal blood sugar levels and oxidative stress. Unlike current testing methods, a Scout® test requires no blood draw, no fasting, and no waiting for a lab result. The product has been used and validated in thousands of patients around the world. The Company's PreVu® POC Test is a revolutionary new coronary artery disease risk assessment technology that measures cholesterol levels in a patient's skin non-invasively, painlessly and without the need for fasting. For more information visit 301 Moved Permanently
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