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 markets, namely:
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
chain/independent pharmacies
-- 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
pharmacy chain
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 Providers:
-- 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
Other Activities
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 Test.
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 milestones.
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 pregnancy 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 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 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 Reserved. 2013.
FOR FURTHER INFORMATION PLEASE CONTACT:
Miraculins Inc.
Paul J. Moreau
Vice President, Sales & Marketing
204-478-5603
204-453-1546 (FAX)
Miraculins Inc.
Christopher J. Moreau
President & CEO
204-477-7599
204-453-1596 (FAX)
info@miraculins.com
www.miraculins.com
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