Miraculins Inc.

Miraculins Inc.

February 08, 2011 08:00 ET

Miraculins Announces Key Technical and Scientific Appointments

WINNIPEG, MANITOBA--(Marketwire - Feb. 8, 2011) - Miraculins Inc. (TSX VENTURE:MOM), a medical diagnostic company focused on developing and commercializing diagnostic tests and risk assessment tools for unmet clinical needs is pleased to announce it has appointed key consultants in the areas of scientific, manufacturing, technical development and clinical and regulatory affairs. Key consultants include Dr. Michael J. Evelegh, Dr. Peter Horsewood, Mr. James Overbeck, and Mr. Jan-Ake Westin.

"Miraculins is undergoing important changes to its operations in order to prepare for the launch of the PREVU* Skin Cholesterol test," commented Christopher Moreau, President and CEO of Miraculins. "In addition to building up our infrastructure, we are also supplementing our human resources in key strategic areas."

Dr. Michael J. Evelegh provides Miraculins with an important strategic planning resource, possessing both a continuity of knowledge regarding the technical aspects of the PREVU technology and an established track record of high level regulatory guidance. Dr. Evelegh is the former Executive Vice President, Clinical and Regulatory Affairs at PreMD Inc. and he has over 20 years of experience in researching and developing human diagnostics, including product development, clinical trials, regulatory submissions and manufacturing. Of considerable note, Dr. Evelegh was the Director of Research and Development for Biomira Diagnostics Inc., a medical technology company, where he managed the regulatory approval process for the Truquant BR Radioimmunoassay (RIA) test kit, the first blood test ever cleared for detecting breast cancer. 

Dr. Peter Horsewood adds considerable scientific knowledge and capacity to Miraculins in bringing contract manufacturing online for production of the reagent testing kits, one of two components of the PREVU test. He was a key member of the research team responsible for moving the PREVU technology from the lab bench towards the market place and is an inventor on a number of patents supporting the technology in his former role with PreMD Inc. as Director of Scientific Affairs. Dr. Horsewood is also a part time Associate Professor in the Department of Pathology and Molecular Medicine at McMaster University.

Mr. James Overbeck is the technical lead and project manager responsible for leading the contract manufacturing process for the handheld reader (spectrophotometer) on Miraculins behalf. Mr. Overbeck provides services to the company through Q Product Management LLC, and has provided comparable services to PreMD Inc. including playing a leading role in the redesign of the handheld reader from a tethered (wired to laptop) format, to a self contained wireless unit. His 20 plus years of experience in technology driven markets include a number of leadership roles with X-Rite Incorporated, a NASDAQ listed global leader in color science and technology, where Mr. Overbeck was the key customer contact on major OEM accounts including Kodak, Xerox, Heidelberg, Komori, Ford, Sun Chemical, Sullivan Schein and Dentsply.

Additionally, to Miraculins has retained GVI Clinical Development Solutions (CDS) for clinical development services including quality assurance, regulatory affairs and clinical trial support such as facilitating new clinical trial opportunities and clinical economic support of the PREVU technology. CDS is lead by Mr. Jan-Ake Westin who has been appointed Vice-President, Clinical Operations for Miraculins. In this role, Mr. Westin's department is responsible for the establishment of an ISO 13485 certified quality system and coordinating the regulatory notifications required for medical device product marketing in Canada, the United States and Europe. Mr. Westin is an accomplished clinical scientist and business executive with close to 40 years of experience in the life science industry and has held major management positions in several of the leading Pharmaceutical, Biotechnology and Contract Research Organizations in the US, Canada and Europe, including Pfizer, Pharmacia, Astra Zeneca, i3/Innovus Research Inc. and Medicure Inc.

About Miraculins Inc.

Miraculins is a medical diagnostic development company focused on non-invasive tests for unmet clinical needs. Miraculins is bridging the gap between commercially available risk assessment and diagnostic tests and research conducted at leading research institutions around the world. The Company recently acquired the PREVU* Skin Cholesterol Test, a non-invasive, inexpensive and painless tool for cardiovascular risk assessment that generates results in minutes. PREVU* has been previously cleared for sale by the FDA, Health Canada and CE-marked for sale in Europe. PREVU* has been successfully test marketed on a limited basis in North America. Additionally, the Company's preeclampsia program, a suite of biomarkers to aid in the early detection of the devastating disease of pregnancy, 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

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.

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