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U.S. Market Holds Significant Potential for Non-Invasive Skin Cholesterol Test

Tue, 03/06/2012 - 2:45am
The Associated Press

(http://www.miraculins.com/)

Miraculins Inc. (TSX VENTURE:MOM), a medical diagnostic company

focused on acquiring, developing and commercializing diagnostic tests

and risk assessment technologies for unmet clinical needs, today

outlined the details of the FDA clearance for its PreVu@ Non-Invasive

Skin Cholesterol Point of Care (POC) Test. The FDA clearance was

issued prior to Miraculins' acquisition of the PreVu technology and

remains in effect in the U.S. marketplace.

"With the recent, significant announcements that the PreVu POC Test

has been cleared for sale by Health Canada and has been CE-Marked for

sale in the European Union, Management believes it is important to

remind the market that an FDA clearance for the PreVu POC Test was in

place at the time of our acquisition and was one of the key

considerations in our decision to purchase PreVu," said Christopher J.

Moreau, President and CEO of Miraculins. "PreVu's regulatory clearance

in the U.S. is a valuable asset that we will soon be capitalizing on

as we finalize our U.S. expansion strategy and begin to execute on our

plans."

The FDA has directed that "Skin cholesterol as measured by the PreVu

POC can be used as part of risk assessment for coronary heart disease

in persons with a history of myocardial infarction and/or in persons

suspected of having significant multi-vessel coronary artery disease

(greater than 50% stenosis in greater than 1 vessel as diagnosed by

coronary angiography) where further diagnostic evaluation is being

considered. Test results, when considered in conjunction with clinical

evaluation, blood cholesterol tests and other risk factors identified

for coronary artery disease, will aid the physician in focusing

diagnostic and patient management options."

"I am very energized and impressed by the clearance that PreVu has in

the U.S.," said Dr. Henry Solomon, MD, FACP, FACC, past Chief Medical

Officer of the American College of Cardiology and a U.S. member of the

PreVu Medical Advisory Board (PMAB). "While it is not currently

purposed for general risk screening, we do not believe this is

necessary in order for us to make the test available to those

individuals suspected of having serious coronary artery disease (CAD),

by virtue of easily attainable information from their personal and

medical history. The PMAB and Miraculins Management are working

together on a strategy to identify such individuals and we believe

they comprise a significant component of the American population."

Miraculins' recent appointment of Mr. Thomas Tsakeris, former

Director, Division of Clinical Laboratory Devices (DCLD), Office of

Device Evaluation, Center for Devices and Radiological Health (CDRH),

FDA, as a key regulatory consultant, is also part of the Company's

efforts to develop a fully integrated sales and marketing launch plan

in the U.S., in full compliance with PreVu's FDA clearance.

Currently, the Company is considering multiple distribution strategies

and partners, including both user pay and reimbursement models. With

regards to the latter, Miraculins has also launched a key, in-depth

study designed to generate a comprehensive, reimbursement

environmental assessment for its skin cholesterol technology,

including a review of coding and valuation, as well as coverage

assessments of applicable comparative technologies and clinical

procedures.

Miraculins can begin to market the PreVu test in the U.S. after

registering with the FDA as a device establishment, and after PreVu is

listed as a device under Miraculins. This step is strictly

administrative and is being timed to coincide with the finalization of

the Company's U.S. sales and marketing launch strategy and the

preparation of all related support materials and product labeling,

including a web site being built exclusively for the U.S. marketplace.

By registering and listing, Miraculins will be informing the FDA that

commercial distribution has commenced. Miraculins has indicated it

plans to register shortly and will update the market accordingly on

its specific U.S. launch plans at that time.

Skin cholesterol is the cholesterol that has been deposited and

diffused into tissue, as opposed to free circulating in the

bloodstream, and has been shown in clinical trials to be strongly

associated with significant CAD as measured by treadmill stress

testing, coronary angiography, coronary calcium and carotid artery

thickening. The PreVu test is completely painless, non-invasive,

involves no blood draw or needles, requires no overnight fasting and

involves no handling of potentially hazardous biomaterials. It has

been developed to provide new and additive information about CAD risk

that is independent of traditional risk factors, such as blood

cholesterol, to help physicians more effectively assess their

patients' risk.

The PreVu POC test has been cleared in Europe and Canada as a general

screening test to help uncover individuals with hidden, high levels of

risk of CAD across all demographics.

About Miraculins Inc.

Miraculins is a medical diagnostic development company focused on

acquiring, developing and commercializing non-invasive tests for unmet

clinical needs. The Company's PreVu 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. The PreVu Non-Invasive Skin Cholesterol

Point of Care (POC) Test technology has been cleared for sale by

Health Canada and CE-Marked in the European Union. 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.

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.

PreVu@ is a registered trademark of Miraculins Inc. All Rights

Reserved. 2012.

Neither TSX Venture Exchange nor its Regulation Services Provider (as

that term is defined in the policies of the TSX Venture Exchange)

accepts responsibility for the adequacy or accuracy of this release.

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