Miraculins Highlights Accomplishments Related to 2014 Key Initiatives
WINNIPEG, Manitoba – January 14, 2015 – Miraculins Inc. (TSX-V: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, is pleased to provide a year-end review of accomplishments related to its 2014 key initiatives.
“Miraculins met a concentrated number of meaningful milestones over the past year,” said Christopher J. Moreau, President and CEO of Miraculins. “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.”
2014 Highlights:
Major Sales and Distribution Agreement Signed for China for up to $90M USD in Scout DS® Devices;
- 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.
- Cachet is a 4 Billion RMB market cap (or about $655 Million USD) wholesale/retail drug distribution and medical device distributor, with over 2.5 Billion RMB (or about $410 Million USD) in annual sales in China. Cachet is also listed on the Shenzhen Stock Exchange.
- The deal terms included upfront and milestone payments, an initial guaranteed $15 Million USD order activated on procurement of regulatory clearance in the territory and subsequent minimum orders for the remainder of the 5 year term totaling $75 Million USD.
New U.S. Based Manufacturer Appointed for the Scout DS®;
- 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. This is a major step forward towards the successful transition of the Scout DS® from the previous VeraLight in-house manufacturing facility to a third party contract manufacturer. At present, the parties are engaged in the transfer of manufacturing processes and engineering knowledge, while working through the steps involved in the initial production run. Avo is the photonics industry’s trusted source for exclusive, private label photonics design, development, and manufacturing for medical, military, industrial aerospace and communications applications (www.avophotonics.com).
- Related to this, the Company updated its quality management system to include the Scout DS®, and successfully passed the subsequent ISO audit with zero non-conformities.
Scout DS® Asset Purchase Agreement Amended;
- On December 23, 2014 the Company amended its 2013 asset purchase agreement with VeraLight Inc., thereby eliminating the majority of its obligations under the agreement, including the issuance of equity to VeraLight, in exchange for a one-time cash payment of $500,000 CDN and 1,000,000 options in the Company. Through the 2013 agreement, Miraculins acquired all of the relevant assets relating to VeraLight’s Scout DS® non-invasive diabetes screening technology.
Important Peer Reviewed Study on Scout DS® Published;
- On July 24, 2014, the Company announced that a peer-reviewed study had been published in which the authors concluded that “The elimination of overnight fasting, the absence of blood, and the rapid, real-time communication of screening results are aspects of noninvasive skin fluorescence spectroscopy that facilitate opportunistic screening of individuals at risk for type 2 diabetes while delivering performance that is comparable to FPG and A1C for detection of abnormal glucose tolerance.”
FDA Discussions Advanced;
- 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. The de novo process is generally considered to be appropriate for“novel” medical devices whose risk profiles do not warrant Class III designation which is a more expensive and time consuming approval process.
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 DS® diabetes screening 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 DS® 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 www.miraculins.com
For more information, please contact:
Christopher J. Moreau
President & CEO
Miraculins Inc.
Ph: 204-477-7599
Fax: 204-453-1546
info@miraculins.com
www.miraculins.com
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of theTSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Caution Regarding Forward-Looking Information
Certain statements contained in this press release constitute forward-looking information within the meaning of applicable Canadian provincial securities legislation (collectively, “forward-looking statements”). These forward-looking statements include statements regarding the settlement of agreement terms, the execution of the final Agreement, the placement of the initial order, and the impact of the final Agreement on the Company. These forward-looking statements relate to, among other things, our objectives, goals, targets, strategies, intentions, plans, beliefs, estimates and outlook, including, without limitation, our anticipated future operating results, and can, in some cases, be identified by the use of words such as “believe,” “anticipate,” “expect,” “intend,” “plan,” “will,” “may” and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.
These statements reflect management’s current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: Miraculins’ early stage of development, lack of product revenues and history of operating losses, uncertainties related to clinical trials and product development, rapid technological change, uncertainties related to forecasts, competition,potential product liability, additional financing requirements and access to capital, unproven markets, supply of raw materials, income tax matters,management of growth, partnerships for development and commercialization of technology, effects of insurers’ willingness to pay for products, system failures, dependence on key personnel, foreign currency risk, risks related to regulatory matters and risks related to intellectual property and other risks detailed from time to time in Miraculins’ filings with Canadian securities regulatory authorities, as well as Miraculins’ ability to anticipate and manage the risks associated with the foregoing. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this news release. Miraculins cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on Miraculins’ forward-looking statements to make decisions with respect to Miraculins investors and others should carefully consider the foregoing factors and other uncertainties and potential events.
These risks and uncertainties should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, Miraculins cannot provide assurance that actual results will be consistent with these forward-looking statements. Miraculins undertakes no obligation to update or revise any forward-looking statements.
Scout DS® and PreVu® are registered trademarks of Miraculins Inc. All Rights Reserved. 2015.