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Miraculins (TSXV:MOM) has released a review of accomplishments from 2014, highlighting a $90 million distribution deal in China, the finding of a new U.S. based manufacturer for the Scout DS and discussions with the US Food and Drug Administration continuing to discuss regulatory pathway for the Scout DS.
According to the press release, highlights include:
- The Company announced on August 14, 2014 that it signed an agreement with Catalyn Medical Technologies of Hong Kong and co-appointed Cachet Pharmaceutical Co., Ltd. (“Cachet”) as the exclusive distributor of the Scout DS® device in Mainland China for a term of 5 years from the procurement of regulatory approval in the territory.
- In November 2014, Miraculins appointed Avo Photonics as the manufacturer for the Scout DS® following a systematic evaluation of potential vendors with necessary technical capabilities.
- Based on interactions with the United States Food and Drug Administration (FDA) regarding the appropriate regulatory pathway for the Scout DS®, the Company filed pre-submission documentation with the FDA and attended a subsequent meeting with FDA representatives in Washington.The Company plans to file additional pre-submission documentation with the FDA regarding the denovo classification of its Scout DS® device, as a next step towards securing marketing clearance in the United States in the first quarter of 2015.
Christopher J. Moreau, president and CEO, said:
We were able to drive forward on select key initiatives despite difficult financial markets, which resulted in operational constraints and forced the Company to be highly focused on its priorities. Despite these challenges, we are entering 2015 well-positioned to capitalize on our 2014 progress.
Click here to read the Miraculins Inc. (TSXV:MOM) press release