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Miraculins (MOM.V) Announces Shares for Debt Settlement

Discussion in 'Canadian Stocks' started by mickymoose99, Dec 29, 2014.

  1. mickymoose99

    mickymoose99 Member

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    Miraculins (MOM.V) Announces Shares for Debt Settlement




    WINNIPEG, MANITOBA--(Marketwired - Dec. 29, 2014) - Miraculins Inc. (TSX VENTURE:MOM) (the "Company"), a medical diagnostic company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces that it has entered into a shares for debt agreement with an officer of the Company and a member of the senior management team pursuant to which, and subject to regulatory approval, Miraculins will issue 133,660 of its common shares to said individuals at a deemed price of $0.245 per common share to satisfy $32,746.70 of outstanding amounts owing to them.

    All of the shares to be issued will be subject to resale restrictions for a period of four months from the date of issuance under applicable securities legislation
     
  2. mickymoose99

    mickymoose99 Member

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    Miraculins (TSX:MOM) Highlights Accomplishments Related to 2014 Key Initiatives

    Miraculins (TSX:MOM) Highlights Accomplishments Related to 2014 Key Initiatives




    WINNIPEG, MANITOBA--(Marketwired - Jan. 14, 2015) - 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 a year-end review of accomplishments related to its 2014 key initiatives.

    "Miraculins met a concentrated number of meaningful milestones over the past year," said Christopher J. Moreau, President and CEO of Miraculins. "We were able to drive forward on select key initiatives despite difficult financial markets, which resulted in operational constraints and forced the Company to be highly focused on its priorities. Despite these challenges, we are entering 2015 well-positioned to capitalize on our 2014 progress."

    2014 Highlights:
    •Major Sales and Distribution Agreement Signed for China for up to $90M USD in Scout DS® Devices;

    ◦The Company announced on August 14, 2014 that it signed an agreement with Catalyn Medical Technologies of Hong Kong and co-appointed Cachet Pharmaceutical Co., Ltd. ("Cachet") as the exclusive distributor of the Scout DS® device in Mainland China for a term of 5 years from the procurement of regulatory approval in the territory.


    ◦Cachet is a 4 Billion RMB market cap (or about $655 Million USD) wholesale/retail drug distribution and medical device distributor, with over 2.5 Billion RMB (or about $410 Million USD) in annual sales in China. Cachet is also listed on the Shenzhen Stock Exchange.


    ◦The deal terms included upfront and milestone payments, an initial guaranteed $15 Million USD order activated on procurement of regulatory clearance in the territory and subsequent minimum orders for the remainder of the 5 year term totaling $75 Million USD.



    •New U.S. Based Manufacturer Appointed for the Scout DS®;

    ◦In November 2014, Miraculins appointed Avo Photonics as the manufacturer for the Scout DS® following a systematic evaluation of potential vendors with necessary technical capabilities. This is a major step forward towards the successful transition of the Scout DS® from the previous VeraLight in-house manufacturing facility to a third party contract manufacturer. At present, the parties are engaged in the transfer of manufacturing processes and engineering knowledge, while working through the steps involved in the initial production run. Avo is the photonics industry's trusted source for exclusive, private label photonics design, development, and manufacturing for medical, military, industrial aerospace and communications applications (www.avophotonics.com).


    ◦Related to this, the Company updated its quality management system to include the Scout DS®, and successfully passed the subsequent ISO audit with zero non-conformities.

    •Scout DS® Asset Purchase Agreement Amended;

    ◦On December 23, 2014 the Company amended its 2013 asset purchase agreement with VeraLight Inc., thereby eliminating the majority of its obligations under the agreement, including the issuance of equity to VeraLight, in exchange for a one-time cash payment of $500,000 CDN and 1,000,000 options in the Company. Through the 2013 agreement, Miraculins acquired all of the relevant assets relating to VeraLight's Scout DS® non-invasive diabetes screening technology.

    •Important Peer Reviewed Study on Scout DS® Published;

    ◦On July 24, 2014, the Company announced that a peer-reviewed study had been published in which the authors concluded that "The elimination of overnight fasting, the absence of blood, and the rapid, real-time communication of screening results are aspects of noninvasive skin fluorescence spectroscopy that facilitate opportunistic screening of individuals at risk for type 2 diabetes while delivering performance that is comparable to FPG and A1C for detection of abnormal glucose tolerance."

    •FDA Discussions Advanced;

    ◦Based on interactions with the United States Food and Drug Administration (FDA) regarding the appropriate regulatory pathway for the Scout DS®, the Company filed pre-submission documentation with the FDA and attended a subsequent meeting with FDA representatives in Washington. The Company plans to file additional pre-submission documentation with the FDA regarding the de novo classification of its Scout DS® device, as a next step towards securing marketing clearance in the United States in the first quarter of 2015. The de novo process is generally considered to be appropriate for "novel" medical devices whose risk profiles do not warrant Class III designation which is a more expensive and time consuming approval process.


    About Miraculins Inc.

    Miraculins is a medical diagnostic company focused on acquiring, developing and commercializing non-invasive technologies 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 Scout DS® diabetes screening device is the first non-invasive diabetes testing system designed to provide a highly sensitive and convenient method for measuring diabetes related biomarkers in the skin, the accumulation of which are accelerated by abnormal blood sugar levels and oxidative stress. Unlike current testing methods, a Scout DS® test requires no blood draw, no fasting, and no waiting for a lab result. The product has been used and validated in thousands of patients around the world. The Company's PreVu® POC 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. For more information visit www.miraculins.com
     
  3. mickymoose99

    mickymoose99 Member

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    Miraculins (MOM.V) Announces 2015 Plans for Its Scout DS® Non-Invasive Diabetes Scree

    Miraculins (MOM.V) Announces 2015 Plans for Its Scout DS® Non-Invasive Diabetes Screening Technology





    WINNIPEG, MANITOBA--(Marketwired - Jan. 20, 2015) - Miraculins Inc. (TSX VENTURE:MOM) (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 an overview of the Company's plans for its Scout DS® diabetes screening technology for 2015.

    "Pursuing Chinese FDA Approval, establishing full production capabilities, and establishing proof of concept for various revenue models will be the primary focus of our Scout DS® activity in 2015," said Christopher J. Moreau, President and CEO of Miraculins. "Diabetes is being described now as the world's fastest growing disease and Miraculins is well-positioned with its proprietary Scout DS® technology to make a significant impact on screening for pre-diabetes and type 2 diabetes and moving at-risk patients on to their physicians for confirmatory testing, diagnosis, and treatment."

    Scout DS® Business Model Overview

    The Company's business model is to sell Scout DS® devices to established distributors in key market segments, which will then subsequently be rented or leased to their network of customers on a weekly, monthly or annual basis. These customers will utilize the devices to offer diabetes testing to the end user. The Company's revenues will be generated from the initial sale of the devices to the distributors and, in the majority of markets, from a percentage of the ongoing rental or leasing revenue as well. In some markets, the Company may lease Scout DS® devices directly to specific market channels.

    Additional revenue may be generated through the sale of proprietary consumable cleaning materials, software upgrades, device calibration, as well as warranty and service programs. Further revenues may also be generated through territorial licensing or through marketing/sponsorship agreements with corporate brand partners who have an interest in further linking their brands and products with health and wellness, and the convenient, non-invasive screening for pre-diabetics and type 2 diabetics afforded by the Scout DS®. This may involve the payment of upfront, milestone and maintenance fees.

    Scout DS® Plans For 2015

    The following provides an update on the five key areas Miraculins will be working within throughout 2015 related to the Scout DS® technology:

    1) Developing Primary Sales & Distribution Channels

    The Company has identified two primary market segments for the Scout DS®, and is actively working to develop these in Canada, namely:

    Retail Pharmacy/Grocery Chain

    This market segment involves delivering retail Scout DS® diabetes screening to consumers through the regular leasing of stand-alone kiosks to participating stores for test delivery to customers in neighborhood/community settings.

    Several Scout DS® diabetes screening clinics have been conducted in the Retail Pharmacy/Grocery Chain segment in Canada, by both national and independent store owners. Data collected through surveys of participating pharmacy staff and patients has been positive.

    The next stage of piloting is to work towards a formalized program that produces a measurable return on investment for the stores hosting the Scout DS® screening clinic. This will be achieved by conducting a new series of pilots where specific end-points will be established and measured, including the identification of:
    •undiagnosed pre-diabetic patients who can be converted into long-term customers for preventative consultations and care, which can include medication prescriptions and other healthcare related products as well;
    •undiagnosed type 2 diabetic patients who can be converted into long-term customers. Independent research has shown that diabetes patients spend an average of $6,000 per year on costs for treating their disease and that upwards of $3,000 of this may be spent at the pharmacy1;
    •customers that may be eligible for government reimbursable services offered by the host store such as a medications review - if they are on more than 3 medications or confirmed to be diabetic - and smoking cessation programs;
    •customers that attend the Scout DS® clinics but fill their prescriptions at various stores, who can be converted into single-store customers and consolidate their prescriptions there; and
    •customers who participate in the Scout DS® clinic as a result of direct referrals from family and friends, who can be converted into regular customers at that location.

    The Company will be working aggressively in the next calendar year to establish a number of these pilots and to work towards making the screening program available to both national chain and independent store operators on a regular basis.

    Workplace Screenings

    This market segment involves partnering with established health and wellness service providers to introduce Scout DS® diabetes screening devices into the workplace - through weekly and monthly leasing programs that can be repeated annually - targeting private and public sector companies, as well as large government employers.

    The Company plans to begin pilot programs with a number of Canadian employers in 2015. The objective will be to make the business case to these companies and their insurance providers that workplace diabetes screenings can delay or prevent the economic impact of employees being affected by diabetes, which includes absenteeism, loss of productivity, co-morbidities and cost of medications2.

    Wellness initiatives in general are estimated to save employers an average of $394 per employee per year, while costing an average of $159 per employee per year, resulting in a significant return3. More specifically, people with diabetes incur medical costs that are two to three times higher than those without diabetes and a person with diabetes can face direct costs for medication and supplies ranging from $1,000 to $15,000 a year3.

    Canada is an ideal market for the Company to conduct its pilot programs in for various revenue models, because Canada currently represents the most readily accessible and the least expensive market for the Company to access.

    However, the Company's proof of concept pilots for its proposed, primary revenue models are also being designed with a view towards replicating them in additional international markets once they have been executed and refined in Canada. Each market has its own unique attributes and considerations, however, there are general consistencies in how medical tests, health care products and wellness programming is made available to the general public across many different international markets, especially in the EU.

    The Scout DS® is Health Canada cleared, has been CE-Marked for the EU (compliant with European Union legislation) and the Company is working with the FDA to establish a market pathway for the device in the United States (read more below).

    2) Advancing Chinese SFDA Clearance

    The Company announced on August 14, 2014 that it signed a major sales and distribution agreement with Catalyn Medical Technologies of Hong Kong for up to $90 Million USD in Scout DS® devices and co-appointed Cachet Pharmaceutical Co., Ltd. ("Cachet") as the exclusive distributor of the Scout DS® device in Mainland China for a term of 5 years from the procurement of regulatory approval in the territory.
     
  4. mickymoose99

    mickymoose99 Member

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    Miraculins (MOM.V) Announces Retail Pharmacy Pilot for Its Scout DS(R) Non-Invasive D

    Miraculins (MOM.V) Announces Retail Pharmacy Pilot for Its Scout DS(R) Non-Invasive Diabetes Screening Technology

    First Scout DS(R) Diabetes Screening Kiosks to be Introduced in Ontario



    WINNIPEG, MANITOBA--(Marketwired - Jan. 27, 2015) - Miraculins Inc. (TSX VENTURE:MOM) (the "Company"), a medical diagnostic company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces that it will be commencing a pilot program with Lovell Drugs Ltd. ("Lovell") and Pear Healthcare Solutions Inc. ("Pear") that will see the placement of the first stand-alone, Scout DS® diabetes screening kiosks in Lovell's retail pharmacy locations in Ontario beginning in February 2015. Lovell is the oldest and one of the largest, independent drug store chains in Ontario and has been family-owned and community-minded for more than 100 years, with a reputation for innovative programming and forward-thinking product/service delivery.

    This proof of concept pilot is being conducted to demonstrate that a stand-alone Scout DS® diabetes screening kiosk set up inside a pharmacy location, has the ability to not only deliver a rapid, non-invasive and superior diabetes screening clinic, but can be additionally purposed to generate a meaningful financial return on investment (ROI) for the pharmacy that would not have otherwise, or readily been achievable.

    With a proven ROI model that could be easily reproduced in any pharmacy setting - independent as well as national chains - Miraculins could then make the business case for pharmacies to lease Scout DS® screening kiosks on a regular basis throughout the calendar year, to both meet the diabetes screening needs of their customers and to generate new retail revenue. The Company believes that the model it is developing will have application for retail pharmacy and pharmacy/grocery operations in North America and for similar retail settings in Europe and other countries as well.

    There are over 9,000 pharmacies in Canada comprised of national chains and independent brands. Combined with the Canadian Pharmacists Association's own advocacy for pharmacists to take on an increased role in diabetes screening as part of their daily practice1, Miraculins believes the timing is right for the introduction of the Scout DS® non-invasive screening technology throughout the pharmacy sector. This could result in a dramatic increase in screenings, working towards harnessing greater diabetes education and awareness to delay or prevent the onset of type 2 diabetes in patients at risk, provide more effective management of disease conditions and complications, and reduce diabetes related costs to the Canadian healthcare economy.

    Scout DS® Diabetes Screening Kiosk Pilot Program

    The screening kiosk will be managed by a qualified Scout DS® Test Operator, although a brief post-screening consultation with a Pharmacist will be offered to every customer who has an elevated score, which will be an integral touchpoint with the customer to reinforce the pharmacy's role in ongoing care and service.

    The kiosks will have the ability to screen 8-10 customers per hour and will be in operation during the highest store traffic periods. Participants will receive free screenings during the pilot in exchange for completing a short consumer health questionnaire (delivered by touch screen tablet in the time it takes to perform the Scout DS® screen - about 90 seconds), which will provide the company with valuable data towards building out its revenue model and facilitate the delivery of retail revenue to the pharmacy. In addition to their screening results, participants will also receive educational materials on diabetes and be given a recommendation to see their doctor for a follow-up consultation and confirmatory testing if their score is elevated.

    The Lovell pilot represents the next stage of formalizing a robust retail model that can generate meaningful ROI for pharmacies using Scout DS® kiosks, both related to diabetes directly, as well as other healthcare products and services offered in-store. Specific ROI end-points are being established for the pilot and will be measured against the screening participants in Ontario, including the identification and tracking of:
    •undiagnosed pre-diabetic patients who are subsequently diagnosed by their doctors and can be converted into long-term customers of the pharmacy for preventative consultations and care, which can include medication prescriptions and other healthcare related products as well (including enhanced grocery buys in pharmacy/grocery settings);


    •undiagnosed type 2 diabetic patients who are subsequently diagnosed by their doctors and can be converted into long-term customers for the pharmacy. Independent research has shown that diabetes patients spend an average of $6,000 per year on costs for treating their disease and that upwards of $3,000 of this may be spent at the pharmacy2 (not including enhanced grocery buys in pharmacy/grocery settings);


    •customers that may be determined to be eligible for government reimbursable services offered by the host pharmacy such as a medications review - if they are on more than 3 medications or confirmed to be diabetic - and smoking cessation programs;


    •customers that fill their prescriptions at various pharmacies, who can be converted into single-store customers and consolidate their prescriptions there; and


    •new customers who participate in the Scout DS® clinic as a result of direct referrals from family and friends previously screened, or through print or radio advertising, who can be converted into ongoing, loyal customers at the host location.



    The Scout DS® is Health Canada cleared, has been CE-Marked for the EU (compliant with European Union legislation) and the Company is working with the FDA to establish a market pathway for the device in the United States.

    (1) Canadian Pharmacists Association: Diabetes Strategy for Pharmacists (2013)

    (2) Smart Retailing RX: The Full Value of a Diabetes Patient (February 6, 2012)

    About Miraculins Inc.

    Miraculins is a medical diagnostic company focused on acquiring, developing and commercializing non-invasive technologies 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 Scout DS® diabetes screening device is the first non-invasive diabetes testing system designed to provide a highly sensitive and convenient method for measuring diabetes related biomarkers in the skin, the accumulation of which are accelerated by abnormal blood sugar levels and oxidative stress. Unlike current testing methods, a Scout DS® test requires no blood draw, no fasting, and no waiting for a lab result. The product has been used and validated in thousands of patients around the world. The Company's PreVu® POC 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. For more information visit www.miraculins.com.
     
  5. mickymoose99

    mickymoose99 Member

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    Miraculins (MOM.V) Moves Closer to Commercialization

    Miraculins (MOM.V) Moves Closer to Commercialization




    WHITEFISH, MT / ACCESSWIRE / February 9, 2015 / Diabetes is the seventh leading cause of death in the United States with over a million new cases each year, according to the American Diabetes Association, costing the healthcare system $176 billion in direct costs and the economy $76 billion in lost productivity in 2012.

    The metabolic disease is characterized by the body's inability to produce enough insulin, or more commonly, to not be able to effectively use the insulin it does produce, both of which cause elevated and damaging glucose levels in the blood. While companies like Eli Lilly & Co. (NYSE:LLY) and Novo Nordisk A/S (NYSE:NVO) provide artificial insulin to fill the void, there are no cures for diabetes that alleviate a patient's need for costly lifelong treatment. One of the best ways to prevent or slow down the onset of diabetes and its disastrous complications is to make dietary and lifestyle changes that inhibit its formation from the start.

    Unfortunately, it's difficult to predict when diabetes is becoming a major risk as you can have it for years without any symptoms while it causes unseen internal damage. Pre-diabetes affects some 86 million Americans over the age of 20 (9 out of 10 are undiagnosed), but the only way to diagnose it is through invasive blood testing. Patients often delay undergoing these tests, which means that the preventable stage of the disease is often ignored and undiagnosed until it's too late and full-blown diabetes is developed requiring lifelong treatment.

    The Advantages of a Non-Invasive Test

    Miraculins Inc. (MOM.V) (MCUIF), a medical device company that acquires, develops and commercializes non-invasive screening tests to aid physicians in the earlier diagnosis of disease, is introducing a non-invasive diabetes screening test that takes just 90 seconds to complete. It has the potential to affect real change by making early diabetes screening easily accessible without requiring needles, blood draw, fasting, or waiting and by creating a tipping point for action, motivating patients at risk to seek medical care and attention before the disease becomes uncontrollable.


    The Scout DS(R) non-invasive diabetes screening technology works by using visible light to scan a patient's skin for specific biomarkers associated with pre and type 2 diabetes, and then generating a numerical result after running more than 200 data points through a complex and proprietary algorithm that determines one's level of risk. The accuracy of the test has been confirmed in a number of successful clinical studies involving more than 15,000 subjects, which has paved the way to regulatory clearance in multiple countries and a ramp-up to commercialization.

    Market Testing Underway

    Miraculins acquired the Scout DS(R) non-invasive diabetes screening technology from VeraLight Inc. in August of 2013. The device was cleared in Canada and Mexico, and had been CE-Marked in the European Union. Management plans to file pre-submission documentation with the FDA regarding the de novo classification of the Scout DS(R) device in the first quarter of 2015 as a next step towards securing marketing clearance in the U.S., which represents a potentially enormous market.

    To Get Miraculins updates click here or go to http://www.tdmfinancial.com/emailassets/mom/mom_landing.php.

    In Canada, the company will soon be piloting the Scout DS(R) in the Lovell Drugs pharmacy chain, where it hopes to secure a proof-of-concept ahead of a larger rollout. The pilot aims to demonstrate that a stand-alone Scout DS(R) diabetes screening kiosk set up inside a pharmacy during peak traffic periods, can deliver rapid screening of to up to 10 customers an hour and leverage the customer experience to generate a meaningful financial return on investment for the pharmacy (the commercial program on rollout would call for the pharmacies to lease the kiosks and devices on a weekly or monthly basis). During the initial pilot, participants will receive free screenings in exchange for completing a short consumer health questionnaire delivered via a touchscreen tablet, designed to capture data to help Miraculins further build its business case for pharmacy expansion. Those screened would also receive free educational materials on diabetes, and receive a recommendation to consult with the pharmacist and see their doctor if their score is elevated.

    The economic conversion would be accomplished not only through the identification of undiagnosed pre-diabetics and type 2 diabetics - who are worth many thousands of dollars a year combined in medications and preventive/treatment supplies to the pharmacy - but also by target selling those being screened related reimbursable services such as medication reviews and smoking cessation products/consultation. Also, by working to consolidate customer prescriptions to the one store and develop new customer relationships with those attracted by word-of-mouth to the store about the new screen.

    Miraculins will also be piloting the Scout DS(R) at large companies to prove the value of workplace screenings to reduce incidences of diabetes and their related economic and productivity costs. The goal will be to evolve a commercial platform that would see Scout DS(R) devices leased by employers as part of a company's health and wellness program. This would facilitate employees receiving free screenings (to encourage widespread participation), diabetes awareness and education, and a pathway to preventive measures or treatment delivered through healthcare providers, when elevated test scores resulted in subsequent diagnoses. Miraculins believes this program could hold significant interest for employers and insurance companies alike based upon its belief that the economic argument and attendant health and wellness benefits are strong. The Company also believes such a program could be exportable worldwide.

    In addition to these end markets, the company has executed a sales and distribution agreement for Scout DS(R) in China, ahead of Chinese FDA regulatory approval that's expected to take about a year and a half to secure. The deal is valued at USD$90 Million and CFDA approval will trigger initial and subsequent minimum device orders in the world's most populous country where diabetes and pre-diabetes are at epidemic proportions, and this could potentially add long-term shareholder value over the coming years. Combined, these elements contribute to the evolution of a global distribution and sales strategy.

    Potential Opportunity to Watch

    Many investors in the diabetes space are focused on new medical devices that aim to make treatment options more palatable. For instance, Insulet Corp. (PODD) is developing tubeless insulin pumps that are easier to use for patients, while DexCom Inc. (NASDAQ:DXCM) is developing continuous glucose monitoring systems for patients in ambulatory care as an alternative to manual blood tests that must be drawn periodically.

    Miraculins represents a dramatic departure from traditional plays in the industry, as a company focused on eliminating the problem at the source. With its non-invasive diabetes screening technology, the company hopes to help patients address prediabetes before it's too late in order to prevent lifelong treatment and to provide a pathway for undiagnosed type 2 diabetics into effective disease treatment and management. Success in doing so could save the healthcare system billions of dollars and unlock significant long-term shareholder value at the same time.

    For more information, visit the company's website at www.miraculinsir.com
     
  6. mickymoose99

    mickymoose99 Member

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    Miraculins (TSX VENTURE:MOM) Provides Pre-Submission De Novo Documentation to the FDA for Its Scout® Diabetes Technology

    Next Step Towards Securing Market Clearance in the U.S.



    WINNIPEG, MANITOBA--(Marketwired - Feb. 18, 2015) - Miraculins Inc. (TSX VENTURE:MOM) (the "Company"), a medical diagnostic company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces that it has provided pre-submission documentation to the U.S. Food and Drug Administration ("FDA") regarding the de novo classification of its Scout® diabetes device, as a next step towards securing marketing clearance in the United States.

    There is a three-tier classification system in the U.S. that the FDA has established for medical device clearance based on the risks and types of controls required to assure the public's safety:
    •Class I devices are the lowest risk, require only general controls, and typically do not require premarket notification or approval.*

    •Class II devices are moderate risk, require general and special controls, and typically require a 510(k) application. A 510(k) is a premarket submission that demonstrates that a device is substantially equivalent to a legally marketed device that is not subject to premarket approval (called a predicate device).*

    •Class III devices are considered to have the highest risk and require general controls, special controls, and premarket approval. If a low to moderate risk product does not have a predicate device it receives an automatic Class III designation.*

    For automatic Class III designations, the FDA amended its de novo classification process in 2012 to provide a pathway to Class I or Class II for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.

    Based on interactions with the FDA in 2014, including a meeting between a Miraculins delegation and FDA representatives in Washington, D.C., the Company is of the view that there is no predicate device for the Scout®, and that the de novo process could provide the appropriate regulatory pathway for market clearance in the U.S. The de novo process may be less burdensome than would be the case if the Company sought a premarket approval for the Scout® device.

    * Source: Cato Research

    About Miraculins Inc.

    Miraculins is a medical diagnostic company focused on acquiring, developing and commercializing non-invasive technologies 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 Scout® device is the first non-invasive diabetes testing system designed to provide a highly sensitive and convenient method for measuring diabetes related biomarkers in the skin, the accumulation of which are accelerated by abnormal blood sugar levels and oxidative stress. Unlike current testing methods, a Scout® test requires no blood draw, no fasting, and no waiting for a lab result. The product has been used and validated in thousands of patients around the world. The Company's PreVu® POC 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. For more information visit www.miraculinsir.com
     
  7. mickymoose99

    mickymoose99 Member

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    (TSX VENTURE:MOM) Reports on Positive Results as the First Pharmacy Pilot for the Sco

    Miraculins (TSX VENTURE:MOM) Reports on Positive Results as the First Pharmacy Pilot for the Scout DS(R) Diabetes Screening Kiosk Nears Completion

    Combination of non-invasive diabetes screening and customized surveying reveals kiosk potential as new retail tool for capturing valuable consumer information



    WINNIPEG, MANITOBA--(Marketwired - March 5, 2015) - Miraculins Inc. (TSX VENTURE:MOM) (the "Company"), a medical diagnostic company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces today that its Scout DS® Diabetes Screening Kiosk pilot being conducted in partnership with Lovell Drugs Ltd. and Pear Healthcare Solutions Inc., has to date identified 145 individuals, or 41% of those screened in just 16 days, to be at elevated risk for pre-diabetes or type 2 diabetes. All customers who were identified as being at risk by the Scout DS® were recommended to follow-up with their physician for confirmatory blood testing.

    The Company also reports that pilot participants were pleased to complete a touch-screen survey while seated for their complimentary and non-invasive Scout DS® diabetes test, which resulted in the acquisition of valuable and traditionally difficult to procure consumer information. The survey was specifically tailored to help identify opportunities for the provision of enhanced healthcare and customer service, while isolating pathways for the pharmacy to potentially increase its revenues related to diabetes care and corresponding lifestyle change management. Both the screening and survey were preceded by participating individuals signing a consent form.

    "Based upon the willingness of pharmacy pilot customers to complete a survey while being tested, we believe that our diabetes screening and consumer survey kiosk may also have the potential to be integrated into retail store operations with large customer bases in other major sectors, as well as into shopping malls, airports and a variety of public settings," said Paul Moreau, Vice President Sales and Marketing for Miraculins. "Retailers, organizations and marquee brands in North America and abroad highly value actionable consumer information, which in practice is very hard to get. We believe they could use our kiosk to procure that data and deliver a brand message, while providing an important, complimentary healthcare screen to their customers for what is now being described as the fastest growing disease in history."

    As a result of these promising pilot results, the Company plans to continue to develop a business model for the pharmacy sector (adaptable for non-pharmacy applications as well) where retailers could lease the turn-key and fully-staffed Scout DS® diabetes screening and consumer survey kiosks on a weekly, monthly, or longer-term basis. As individuals with normal Scout DS® results are recommended to be re-tested annually, the kiosk has a recurring customer contact and outreach feature built-in. Additional pilots for the pharmacy sector are being planned.

    Scout DS® Diabetes Screening Kiosk Pilot - Key Findings

    To date the pilot has screened and surveyed over 350 individuals at two pharmacy locations in southern Ontario, and it is anticipated that up to 500 individuals will visit the kiosk by the pilot's conclusion in mid-March. A review of the data supports the value of the Scout DS® kiosk in providing both a public health service and a tool to help pharmacies achieve greater performance:
    •Type 2 Diabetics - 10% (35 individuals) were identified by the Scout DS® as being at risk for type 2 diabetes. Individuals who went on to be diagnosed by their doctor could represent a potential ongoing revenue stream to the pharmacy of up to $3,000 annually for medication prescriptions and other diabetes related products such as needles, test strips, sterile dressings, foot creams, bandages etc.(1) In addition, diabetics often have co-morbidities that drive additional spending for conditions that may include high blood pressure, fluid and electrolyte disorders, chronic pulmonary disease, anemia and kidney failure, potentially adding to pharmacy revenue streams.(1)
    •Pre-Diabetics - 31% (110 individuals) were identified by the Scout DS® as being at risk for pre-diabetes. Individuals who went on to be diagnosed by their doctor could represent an annual revenue stream to the pharmacy for medication prescriptions and other pre-diabetes related products designed to stop or slow down progression of the disease.(1) 15%-30% of pre-diabetics will develop type 2 diabetes within five years,(2) and will be in need of ongoing treatment products and services provided by the pharmacy.(1)
    •Medication Reviews - 13% (29 individuals from a smaller sampling of 224), indicated they were taking three or more prescription medications, without having had a formal medication review with a Pharmacist within the last year. In most Canadian provinces, these patients can receive a free medication review annually, which the pharmacy is reimbursed for by the provincial government. In Ontario, the reimbursement amount is $60 per patient (more if they are diabetic), which could represent another potential annual revenue stream to the pharmacy if these customers were confirmed for medication reviews.
    •New Prescriptions - 41% (144 individuals) indicated they had never had a prescription filled at the pharmacy, underscoring the opportunity for acquiring new prescription business from customers presenting in-store.
    •Prescription Consolidation - 19% (67 individuals) indicated they had their ongoing prescriptions filled at more than one store, underscoring the opportunity to generate increased revenue by migrating customer prescriptions over from other pharmacies.
    •Dietary and Fitness Counselling - 56% (197 individuals) indicated they were interested in receiving dietary or fitness counselling in the future, while 69% (244 individuals) indicated they did not have a gym or fitness club membership. These individuals would be candidates for complementary service offerings.

    Additional survey findings that underscore the opportunity for the pharmacy to enhance customer healthcare and service, build store traffic, increase its retail revenue, and further strengthen customer loyalty include:
    •18% indicated they were smokers* and would be candidates for government reimbursable smoking cessation programs provided in pharmacy, which the Ontario Government pays up to $125 per qualifying patient;
    •52% indicated they were overweight* and would be candidates for supplements, vitamins, and other related products;
    •16% came into the pharmacy specifically for a Scout DS® screen, which can result in pharmacy revenue through convenience purchases while that customer is in-store;
    •97% said they would recommend a Scout DS® screening to family or friends, underscoring significant word-of-mouth potential to increase store traffic;
    •99% planned to see their doctor and make changes to their diet/lifestyles if their Scout DS® scores were elevated, suggesting that Scout DS® can be a tipping point for personal action.

    There are over 9,000 pharmacies in Canada comprised of national chains and independent brands. Combined with the Canadian Pharmacists Association's own advocacy for pharmacists to take on an increased role in diabetes screening as part of their daily practice,3 Miraculins believes that its Scout DS® diabetes screening and consumer survey kiosks could help pharmacies play a greater role in diabetes risk assessment, education and awareness, while identifying actionable pathways to increase related in-store revenues and providing enhanced service to customers.

    (1) Smart Retailing RX: The Full Value of a Diabetes Patient (February 6, 2012); (2) Centers for Disease Control and Prevention: National Diabetes Statistics Report (2014); (3) Canadian Pharmacists Association: Diabetes Strategy for Pharmacists (2013) *Designates risk factor for diabetes

    About Miraculins Inc.

    Miraculins is a medical diagnostic company focused on acquiring, developing and commercializing non-invasive technologies 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 Scout DS® diabetes screening device is the first non-invasive diabetes testing system designed to provide a highly sensitive and convenient method for measuring diabetes related biomarkers in the skin, the accumulation of which are accelerated by abnormal blood sugar levels and oxidative stress. Unlike current testing methods, a Scout DS® test requires no blood draw, no fasting, and no waiting for a lab result. The product has been used and validated in thousands of patients around the world. The Company's PreVu® POC 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. For more information visit www.miraculins.com.
     
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    (TSX VENTURE:MOM) Appoints Leading Occupational Health Physician to the Scout DS(R) M

    Miraculins (TSX VENTURE:MOM) Appoints Leading Occupational Health Physician to the Scout DS(R) Medical Advisory Board




    WINNIPEG, MANITOBA--(Marketwired - March 10, 2015) - Miraculins Inc. (TSX VENTURE:MOM) (the "Company" or "Miraculins"), a medical diagnostic company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces today that it has appointed leading occupational health physician and workplace wellness expert Dr. Alain Sotto, Hon. B.Sc., M.D., CCFP (E.M.), F.C.B.O.M to the Scout DS® Medical Advisory Board.

    Dr. Sotto is the Toronto Transit Commission's Occupational Medical Consultant, Investigative Coroner for York Region, and Director of the Medcan Wellness Clinic, Canada's largest executive healthcare clinic with more than 70 physicians and specialists. He is the former Chief Physician at Ontario Power Generation - Wellness Division, where he was the lead on the utility's corporate health and wellness strategy. He was also the Medical Director at Boeing Toronto for 17 years and the Medical Director for many other large employers in Toronto including Pratt and Whitney, ****ardier and McDonnell-Douglas Canada. Additionally, Dr. Sotto has served as Regional Medical Officer for the Great Lakes region at CN Railways and has been an occupational medical consultant to Stelco and several other companies.

    Dr. Sotto is a certified specialist in Emergency and Family Medicine and is on staff in Family Medicine at William Osler Hospital in Brampton, where he has worked in the Emergency Department for 19 years. He has also had an active part-time Family Practice in Brampton for the last 26 years. Dr. Sotto serves on numerous medical advisory boards including the Ministry of Health and Long Term Care - Scientific Advisory Council (Ontario), Canadian Board of Occupational Medicine Executive, Benefits Canada, and the Morneau Shepell Mental Health Advisory Board. He also serves on the Sanofi Canada Healthcare Survey Advisory Board (2013, 2014, 2015), which publishes an annual report of the same name that since 1998 has been nationally tracking feedback from Canadians with employer-sponsored health benefit plans to help facilitate industry being more aware and responsive to healthcare issues and needs in the workplace. He is a highly regarded guest speaker, writer, and medical guest commentator and in November 2012, he was the Keynote Speaker at the Annual International Foundation of Employee Benefit Plans (IFEBP) speaking to 1,330 attendees on aging and wellness. The IFEBP is the largest association serving the employee benefits and compensation industry with 33,000 members.

    "I am very pleased to become a member of the Scout DS® Medical Advisory Board," said Dr. Sotto. "Having seen the extraordinary capability of the Scout DS® to provide rapid, needle-free and accessible diabetes screenings to employees when it was used under my direction at Ontario Power Generation, I am excited to be providing guidance for this innovative medical device. It has every potential to be integrated into workplace health strategies for delaying the onset of chronic diseases, saving healthcare costs, lowering corporate insurance spends, reducing workplace absenteeism and presenteeism and is aligned with my own personal mission of helping to save lives in the workplace one life at a time."

    "Dr. Sotto is a globally recognized expert on workplace wellness strategies and a leading medical professional," said Christopher J. Moreau, President and Chief Executive Officer of Miraculins. "His extensive experience in developing and managing chronic disease prevention programs for a number of Canada's largest and most recognizable workforces provides Miraculins with a considerable advantage as we work to accelerate development of commercial models for the Scout DS® in workplace settings and adapt key wellness concepts to other major market segments."

    About Miraculins Inc.

    Miraculins is a medical diagnostic company focused on acquiring, developing and commercializing non-invasive technologies 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 Scout DS® diabetes screening device is the first non-invasive diabetes testing system designed to provide a highly sensitive and convenient method for measuring diabetes related biomarkers in the skin, the accumulation of which are accelerated by abnormal blood sugar levels and oxidative stress. Unlike current testing methods, a Scout DS® test requires no blood draw, no fasting, and no waiting for a lab result. The product has been used and validated in thousands of patients around the world. The Company's PreVu® POC 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. For more information visit www.miraculins.com.
     
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