Miraculins Updates Market on 2013 Plans for PreVu(R)
WINNIPEG, MANITOBA -- (Marketwire) -- 01/28/13 -- Miraculins Inc.
(TSX VENTURE: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 the market with an
overview of the Company's plans for its PreVu(R) Non-Invasive Skin
Cholesterol Test technology for the 2013 year.
-- Market development to be the primary focus of PreVu activity in 2013
-- Business model to continue to establish and leverage relationships with
leading distribution, developmental and strategic partners
-- Second PreVu testing format expected to be advanced
-- International market expansion to be explored
"While the previous year was one of market and product preparation,
the coming year will be one of targeted market development," said
Christopher J. Moreau, President and CEO of Miraculins Inc. "The
progress made to date, including the initial market introduction of
PreVu through a major Canadian retail pharmacy chain, has positioned
us for an upcoming year of opportunity and anticipated growth for the
PreVu technology and for our Company."
The following provides an update on plans, activities and goals for
the PreVu technology.
PreVu Business Model
The PreVu business model is to sell products in key market segments
through established distribution companies that will purchase PreVu
products from the Company and then resell them through their networks
of retailers, or market them directly to the end consumer.
The Company's PreVu revenues will be generated from the sale of test
kit consumables and the custom designed hand-held readers that are
utilized to read the PreVu Non-Invasive Skin Cholesterol Point of
Care (POC) Test result and guide the test operator through the test
process. PreVu POC Test reagent kits contain all of the components
required to deliver 40 complete tests. The testing format requires
basic operator training and therefore the test is not currently sold
as an over-the-counter product.
Additional revenues may be derived from territorial licensing or
marketing partnerships with corporate or brand partners who have an
interest in promoting skin cholesterol as a new biomarker for risk of
coronary artery disease ("CAD"), as a way of differentiating their
health and wellness, pharmaceutical, or consumer/grocery products.
The Company has identified four principal market segments for PreVu,
and has been actively working to explore and/or develop these
1. Retail Pharmacy
2. Primary Care Physicians
3. Life Insurance
4. Health and Wellness Service Providers
1. Retail Pharmacy Sector:
The retail pharmacy market is believed to represent a significant
opportunity for PreVu based on access to millions of
patients/consumers globally. Additionally, there is a growing role
for neighbourhood pharmacists in delivering health and wellness
products and health awareness programs to the public, providing a
clear opportunity for the PreVu POC Test.
The Company plans to continue to focus on the introduction of the
PreVu POC Test through Canadian retail pharmacy locations in
conjunction with its distribution partner Pear Healthcare Solutions
Inc. While there are similar retail pharmacy models worldwide, the
Canadian marketplace is a very important market for the Company,
given the Company is headquartered in Canada and considering the
presence of over 6,000 retail chain pharmacy locations, along with a
significant number of well-organized and professionally operated
independent pharmacies. Canada also presents a cost-effective
opportunity to refine the PreVu pharmacy model before exporting the
concept to other international markets.
Successful market development in the retail pharmacy segment requires
the participation of pharmacy partners, coordinated management of
distribution logistics, sophisticated point of sale material and
store level advertising, test operator training, physician education
and public relations management. These major areas are being advanced
as the PreVu roll-out continues in this market segment.
Efforts continue towards evolving a plan for a United States market
introduction that would allow the test to be offered through
pharmacies in accordance with the cleared indication for use.
Miraculins plans to engage in exploratory meetings with select
pharmacies in the U.S. to discuss the potential opportunity further.
Efforts have also begun to identify a pharmacy partner in the
European Union, with a focus on English or French speaking markets
due to the Company's current marketing materials and labeling being
available in those languages.
Summary of Goals/Plans for 2013 - Retail Pharmacy:
-- Manage a successful PreVu expansion in Western Canada, as recently
announced, through London Drugs pharmacy locations (76 Stores)
-- Manage a successful PreVu rollout in Eastern Canada, as recently
announced, through select PharmaChoice locations
-- Launch PreVu into the Quebec marketplace through retail
-- Continue to work with distribution partner Pear Healthcare to develop,
sustain and expand PreVu's distribution network throughout the retail
pharmacy market in Canada
-- Hold exploratory discussions with U.S. based pharmacies towards a PreVu
U.S. launch strategy
-- Seek to establish a PreVu pilot program with a European Union based
2. Primary Care Physicians:
Miraculins is continuing to analyze the potential of the PreVu POC
Test in the Primary Care Physician ("PCP") market segment. It is
generally viewed by medical device distributors in the Canadian
market that the wide spread sale of a point-of-care test into the
physician market will need to be preceded by reimbursement by the
Canadian healthcare system. In the U.S. market, there is a greater
precedence for a user pay model for a point-of-care test within the
PCP market segment. However, significant adoption of the PreVu POC
Test may require recognition and/or reimbursement from private health
insurers or other organizations.
A strategic review of the reimbursement landscape was commissioned by
the Company for Canada and the U.S. and was provided by industry
experts including OptumInsight, a leading health services business
specializing in improving the performance of the health system by
providing analytics, technology and consulting services that enable
better decisions and results. The initial phase of this review
process has been completed and the Company is considering
opportunities to implement the results into its ongoing strategy.
Summary of Goals/Plans for 2013 - Primary Care Physicians:
-- Continued exploration of the Canadian PCP market segment and
determination of potential market size for PreVu POC Test and estimated
market development costs
-- Engage in discussions with U.S. based medical device distributors with
access to broad PCP networks across the U.S.
3. Life Insurance:
The second format of the PreVu test technology, the PreVu
Non-Invasive Skin Cholesterol Lab Processed (LP) Test, has been in
further development through the Company's partnership with
Gamma-Dynacare Medical Laboratories, one of Canada's largest and most
respected providers of laboratory services and solutions (discussed
further under "Other Activities" below).
The PreVu LP Test was originally designed to service the life
insurance market in the U.S. for certain insurance policies where the
provider does not typically require the applicant to submit to a
physical or to provide a blood sample for traditional CAD risk
factors such as serum cholesterol, due to the time and expense
associated with such tests. The strategy was that with the provision
of at least one risk marker for CAD, namely skin cholesterol using
the convenient PreVu LP Test, the insurance company could better
understand the risk profile for each applicant on a much more timely
and cost effective basis and proceed accordingly.
Miraculins has been steadily working on reactivating the life
insurance market for PreVu and has engaged in discussions with
leading U.S. based life insurance companies and potential
distribution partners who are active in the life insurance market.
The Company has found that there is continuing interest in the PreVu
technology from key companies, and expects to continue discussions
with a goal of developing a clear strategy for this market.
At present, the PreVu LP Test has not been cleared in the United
States for use in the life insurance industry (or for any other use).
An earlier version of the PreVu LP Test has previously been cleared
for use in Canada and CE Marked in the European Union.
Summary of Goals/Plans for 2013 - Life Insurance:
-- Continue to engage in discussions with key industry companies and
establish an action plan for this market segment
-- Provide further market updates regarding the PreVu LP Test and life
insurance market segment
4. Health and Wellness Services Providers:
The health and wellness service provider market segment is comprised
of highly trained, generally registered or accredited, providers of
health and wellness services including naturopaths, dieticians and
chiropractors. Additionally, this market segment could also include
mobile or public setting health risk screening service providers. It
is thought that the non-invasive aspect of the PreVu POC Test could
allow this segment to become more involved in CAD screening, or
supplement current CAD screening activities.
The primary focus of the Company in this market segment to date has
been on introducing the PreVu POC Test to registered Naturopathic
Doctors ("NDs") in Canada through industry trade shows, industry
specific advertising and direct communication, in conjunction with
distribution partner, The Stevens Company. The ND market holds
potential as a robust market for PreVu based on the focus of the ND
community on preventative health and optimum wellness. According to
the Canadian Association for Naturopathic Doctors, there are over
1800 registered NDs in Canada and efforts continue to promote PreVu
to registered NDs.
Miraculins also plans to begin to explore the potential of the PreVu
POC Test with other health and wellness service providers working
with patient and customer groups who would benefit from access to
new, non-invasive tools for CAD risk assessment.
Summary of Goals/Plans for 2013 - Health and Wellness Service
-- Work with distribution partner, The Stevens Company, to continue to
develop the naturopathic doctor market in Canada
-- Evaluate potential opportunities with additional accredited medical
professionals including dieticians and chiropractors
-- Explore alternatives for additional Canadian retail clinic opportunities
including executive health clinics, public settings, and large employer
health screening services
-- Look for potential distribution partners and key stakeholders for this
market segment internationally
Laboratory Processed Test (LP) Format
Considerable product development activity is being directed towards
the PreVu LP Test, Miraculins' second testing format for skin
cholesterol. Gamma-Dynacare Medical Laboratories, the Company's
exclusive Canadian partner for the PreVu LP Test, has been making
steady and continued progress towards the development and
implementation of an in-house system for processing the PreVu LP
The PreVu LP Test non-invasively measures the amount of cholesterol
that has been deposited in skin tissues by painlessly and rapidly
collecting skin cells from the palm of the hand using a proprietary
medical adhesive collection device, which is then sent to a central
reference laboratory for processing. Results are then reported to
test providers and/or patients a short while later. This format could
ultimately be distributed, to varying degrees, in all of the
identified market segments.
Scientific Awareness and Development
The Company is continually evaluating opportunities to highlight
existing, or develop additional scientific support that will build
upon the awareness of skin cholesterol as an emerging biomarker for
the assessment of CAD risk.
Expansion of PreVu Medical Advisory Board
The addition of members to the PreVu Medical Advisory Board is
continually being considered, in part to support the Company's plan
to expand PreVu into new markets.
PR Activities/Healthcare Community Education
The Company continues to engage in an expansive and integrated public
relations and educational campaign to enhance the awareness of the
science of skin cholesterol as an emerging new biomarker for risk of
CAD, and the PreVu technology designed to measure it. This campaign
is two-pronged, with one focus being the general public, and the
other being medical/healthcare community members, including
specialists working in areas of cardiovascular and heart health.
Public relations and promotional activities are ongoing, however,
they tend to be intensified around specific market development
The Company's plans, activities and goals with respect to PreVu
outlined in this press release are dependent on the Company's ability
to secure additional financing on a timely basis. While the Company
will strive to achieve these plans, activities and goals, there is no
assurance that these and other strategies will be achieved or
additional financing will be available or obtained on favourable
terms or obtained at all.
About the PreVu Non-Invasive Skin Cholesterol Test
The PreVu(R) Non-Invasive Skin Cholesterol Point of Care (POC) Test
is a non-invasive, risk assessment technology designed to measure
Skin Cholesterol - an important new biomarker in assessing risk of
coronary artery disease ("CAD"). The PreVu(R) POC Test is completely
painless, non-invasive, involves no blood draw or needles, and
requires no overnight fasting. This in vitro diagnostic test is
conducted on the palm of the hand in less than 5 minutes with results
being immediately available, facilitating point of care consultation
and a next steps discussion. Skin Cholesterol is the cholesterol that
has been deposited and diffused into tissue, as opposed to freely
circulating in the bloodstream, and the skin contains approximately
11% of all the cholesterol found in the human body, by weight.
Elevated Skin Cholesterol has been shown in clinical studies to be
strongly associated with significant CAD as measured by treadmill
stress testing and coronary angiography, as well as measured by
testing for coronary calcium, carotid artery thickening, and carotid
artery plaque. The PreVu POC Test does not diagnose the presence or
absence of CAD, but helps to identify patients who may be at higher,
hidden risk for CAD by measuring this new biomarker. For more
information visit www.prevu.com.
About Miraculins Inc.
Miraculins is a medical diagnostic company focused on acquiring,
developing and commercializing non-invasive tests 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 PreVu(R) technology 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. Miraculins is also
advancing a suite of biomarkers to aid in the early detection of the
devastating disease of pr
egnancy known as preeclampsia. The Company's
preeclampsia program is partnered with Alere Inc., one of the world's
largest diagnostic companies. For more information visit
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 Company's plans for its PreVu Non-Invasive Skin
Cholesterol Test technology, the business model and opportunities for
PreVu, and the Company's plans and goals for the retail pharmacy,
primary care physician, life insurance and health and wellness
service provider markets. 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 and the ability of the Company to
obtain the additional financing necessary to achieve its plans,
activities and goals, 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 publicly or revise any forward-looking statement contained
herein whether as a result of new information or future events or
otherwise, except as may be required by law. If the Company does
update one or more forward-looking statements, no inference should be
drawn that it will make additional updates with respect to those or
other forward-looking statements.
PreVu(R) is a registered trademark of Miraculins Inc. All Rights
Neither the 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.
Paul J. Moreau
Vice President, Sales & Marketing
Christopher J. Moreau
President & CEO
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