Miraculins Updates Market on Regulatory Progress in China for its Scout DS(R) Diabetes Screening Device

WINNIPEG, MANITOBA--(Marketwired - May 22, 2015) - Miraculins Inc. (TSX VENTURE:MOM) ("Miraculins" or 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 now completed all required preparations for the submission of its Scout DS^® device for product testing in compliance with Chinese Food and Drug Administration (CFDA) requirements. Product testing, which must precede clinical trials in China, relates to a series of safety and operational tests that the CFDA testing center and its engineers decide are suitable for a medical device including electrical testing, biocompatibility testing, mechanical testing, stability testing, integrity testing, and other related tests to verify the device's specified operating parameters.

Product testing is the first major step towards securing regulatory approval for the Scout DS^® in China, and the Company has been diligently working with its lead Chinese regulatory consultant, Emergo Global, towards compiling and translating all of the technical documentation required for submission to enable the product testing process to begin.

Preparation for CFDA product testing was significant and included the translation of Scout DS^® device engineering drawings, circuitry diagrams, operating manuals, ISO documentation, as well as all of the internationally-recognized electrical, safety, mechanical and related testing and performance documentation that the Company already had on file for the Scout DS^® related to its prior clearances in Canada and the European Union.

Miraculins has also been working with Emergo Global to evolve a comprehensive regulatory strategy in China overall, that additionally includes the development of a study protocol for the Scout DS^® clinical trials that will be conducted in China following the successful conclusion of the product testing process.

"The Company has completed a significant amount of work related to the preparation and translation of all required materials for its formal product testing submission," said Christopher Moreau, President and CEO of Miraculins. "While the regulatory process in China is involved and time consuming, we remain focused on the end goal which is to secure CFDA regulatory clearance and commence the sale and distribution of Scout DS^® diabetes screening devices into Mainland China under the terms of our previously announced agreement."