Miraculins Inc.

Miraculins Inc.

September 27, 2011 10:27 ET

Miraculins in Final Stages of Preparation for PreVu Market Launch

Company Nearing Commercial Sales and Marketing Phase

WINNIPEG, MANITOBA--(Marketwire - Sept. 27, 2011) - Miraculins Inc. (TSX VENTURE:MOM), a medical diagnostic company focused on developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces that it is in the final preparatory stages for the commercial launch of the PreVu* Non-Invasive Skin Cholesterol Test.

"We have made steady and significant progress over the last several months in preparing to launch and capitalize on the PreVu technology, and I am very pleased to provide this update to our shareholders, partners and stakeholders," said Christopher J. Moreau, President and CEO of Miraculins. "PreVu is a world class technology that will help Miraculins transition from being a research based company to becoming a manufacturing and sales based organization."

In January of 2011, Miraculins announced plans to make the PreVu technology available for commercial sale by the end of the year. At that time, the Company identified six critical activities of focus leading to this significant milestone, and is pleased to confirm that each of these steps is nearing completion, with progress as follows:

  1. Reestablish key manufacturing partnerships for the PreVu reagent test kits and the PreVu handheld spectrophotometer:
    • Announced a manufacturing agreement with International Aerospace/Medical Device Contractor HEI, Inc. for the handheld spectrophotometer.
    • Executed a manufacturing agreement for the reagent testing kits with Thermo Fisher Scientific Inc., the world leader in serving science.

  2. Coordinate the establishment of an ISO 13485 certified quality system at Miraculins in order to become the medical manufacturer of record:
    • Developed a complete Quality Management System for the manufacturing and sale of medical devices, including the comprehensive documentation and implementation of a quality manual, standard operating procedures, forms and work instructions, followed by the requisite training of Miraculins management and team.
    • Appointed the BSI Group to provide assessment and certification services with a certification audit planned prior to the end of the calendar year.
    • Engaged the Emergo Group to provide technical support during the implementation and certification process.
    • Continued commitment to align PreVu with world-class organizations, as both the BSI Group and the Emergo Group are global experts in their respective fields with numerous offices around the globe.

  3. Prepare for regulatory notifications required for medical device product marketing in Canada, the United States and Europe:
    • Completed a full review of all available historical regulatory documentation and developed detailed regulatory strategies for both the point of care (POC) and lab processed (LP) versions of the test.
    • Readied for Heath Canada regulatory clearance filings following ISO certification.
    • Appointed Emergo Europe as the European Authorized Representative in preparation for CE-marking for European marketing following ISO certification.
    • Received clarification from the FDA on PreVu's current Indication for Use, under which the POC technology can be sold into the US market.

  4. Refresh the PreVu brand across all marketing and promotional platforms to communicate technology value proposition:
    • Introduced revised PreVu logo and product positioning language to most effectively communicate the full value proposition of the technology.
    • Preliminary reconstruction of a new PreVu website.

  5. Evaluate multiple sales channels to more precisely target end consumers:
    • Conducted high level pre-sales discussions with key decision makers in a number of important markets including medical clinic chains, retail pharmacies, the life insurance industry, alternative healthcare and established medical device distributors.
    • Exhibited the PreVu technology to over 250 potential future customers at the Heath Fusion conference of the Canadian Association of Naturopathic Doctors (CAND) in Calgary, a three-day congress, with strong indications that PreVu will be incorporated into ND practices across the country once the product is launched.

  6. Conduct partnership discussions to seed sales and distribution channels:
    • Formed a critical partnership with Gamma-Dynacare Medical Laboratories, one of Canada's largest and most respected medical laboratories, for the final development and commercialization of the lab processed (LP) format of the technology – designed to become PreVu's over-the-counter retail test format.
    • Conducted meetings and discussions with interested parties for the licensing/distribution rights to PreVu in foreign markets including China, India, South Korea, Mexico, the European Union and Saudi Arabia.

Additional accomplishments during the first three quarters of 2011:

  • Awarded a grant of $100,000 for the commercialization of the PreVu technology from the Province of Manitoba's Technology Commercialization Program.
  • Supplemented and amplified internal capabilities by retaining key consultants in the areas of scientific research, manufacturing, technical development and clinical and regulatory affairs, including individuals who played an essential role in the initial development of the PreVu technology.
  • Coordinated and managed the PreVu patent portfolio to maintain an international Intellectual Property suite comprised of numerous patents in the United States, Canada and world-wide with issued and pending patents covering current and potential future applications of the PreVu technology.
  • Added new members to the Company's board of directors with a breadth of relevant experience, including appointing as Chairman, Mr. David Howard, an experienced life science executive who has a successful history with commercial stage medical device firms.

About The PreVu Non-Invasive Skin Cholesterol Test

PreVu is a non-invasive risk assessment technology that evaluates the additional risk a person may have for coronary artery disease (CAD) by conveniently and painlessly testing their skin cholesterol level. High levels of skin cholesterol have been shown to be correlated to CAD as measured by stress test, angiography, coronary calcium, and carotid intima-media thickness, inflammatory markers of vascular disease, previous heart attack incidents and Framingham risk score.

About Miraculins Inc.

Miraculins is a medical diagnostic development company focused on acquiring and advancing non-invasive tests for unmet clinical needs. The Company's PreVu test is a revolutionary new coronary artery disease (CAD) risk assessment technology that measures cholesterol levels in a patient's skin non-invasively, painlessly and without the need for fasting. PreVu has previously been successfully test marketed in North America on a limited basis. Miraculins additional programs include a research use only ELISA kit for the detection of PSP94; and a suite of biomarkers to aid in the early detection of the devastating disease of pregnancy known as preeclampsia. The Company's preeclampsia program is being advanced in partnership with Alere, Inc. (NYSE:ALR) (formerly known as Inverness Medical Innovations), one of the world's largest diagnostic companies. For more information on Miraculins please visit www.miraculins.com. PreVu Non-Invasive Cholesterol Test technology is not currently licensed for sale in Canada.

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 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 statement.

(*) Trademark

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