|By Marketwired .||
|June 18, 2014 06:30 AM EDT||
WINNIPEG, MANITOBA -- (Marketwired) -- 06/18/14 -- 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, today announces that it has executed a Letter of Intent ("LOI") with Citizen Doctor Pvt. Ltd. ("CDPL"), an Indian healthcare services company, to appoint CDPL as the exclusive distributor for the PreVu® Non-invasive Skin Cholesterol Point-of-Care (POC) Test in India. The LOI also provides for the assignment of non-exclusive distribution rights for PreVu® POC to CDPL in certain other Asian countries.
The non-binding LOI has established the principal terms and conditions of the proposed distribution agreement (the "Agreement") between Miraculins and CDPL, exclusively for India and non-exclusively for certain other Asian countries, including PreVu® POC Spectrophotometer and Reagent Kit pricing, upfront and milestone payments, product ordering and diligence requirements, and ongoing responsibilities of the parties. In addition, CDPL would place a guaranteed first order for 20,000 PreVu® POC tests on signing of the Agreement, which would be activated upon Indian regulatory clearance. The LOI provides the parties with a period of 90 days within which to finalize definitive documentation for the Agreement.
The term of the Agreement would extend for five years from the date of Indian regulatory clearance, subject to minimum annual order quantities by CDPL. If minimum orders were met, this would represent a total order value of approximately $4 Million USD in projected PreVu® Spectrophotometer and Reagent Kit sales over the length of the term. Miraculins would be responsible for leading the Indian regulatory clearance process, with its related costs being the responsibility of CDPL. Guidance and support for the regulatory process would be provided by CDPL as necessary.
With India being a country that relies heavily on predicate country regulatory clearances as regards healthcare products, it is anticipated that the regulatory clearances PreVu® POC has already received in Canada, the European Union, and the U.S., will be advantageous to the process.
Upon clearance of the PreVu® POC in India, CDPL would be responsible for all sales and marketing costs. Miraculins would provide sales and marketing guidance and training support as required. Miraculins would retain the right to establish programs for ongoing device servicing and maintenance once the PreVu® POC devices begin to be sold into the field.
"This is a very important development in the continuing effort to establish PreVu® POC as a new clinical tool to assist with coronary artery disease risk assessment worldwide," stated Paul Moreau, Vice-President, Sales and Marketing for Miraculins. "CDPL is changing how risk assessment is delivered throughout India, and the recognition of PreVu's value by medical professionals in that country where cardiovascular disease is a leading killer, is extremely significant".
According to the World Health Organization, cardiovascular diseases will be the largest cause of death and disability in India by 2020. India has a present population of 1.237 billion.
About Citizen Doctor Pvt. Ltd.
Citizen Doctor Pvt. Ltd. operates Checkitsa, an Indian healthcare company headquartered in Hyderabad that is revolutionizing the way risk assessment and ongoing monitoring of disease conditions is delivered throughout the country. Checkitsa leverages new generation e-health medical devices, products and services based on internet, wireless, mobile and Bluetooth technology. The company advocates a shift away from acute care to preventative care that promotes awareness of personal health risks, enabling patients to assess, monitor and manage their health anytime, anywhere, under the supervision and guidance of medical experts. Checkitsa services are designed to work around a patient's schedule and preferences and are predominantly delivered outside of hospital and clinical settings including in the home, the office or workplace, at neighbourhood pharmacies, as well as at shopping malls. Checkitsa Workplace is India's first and the only on-site, end-to-end workplace wellness program that converts company wellness strategies into an "Organizational Human Performance Strategy", with guaranteed health risk reduction of individual employees and improvement of the overall health status of a company. Management behind Citizen Doctor Pvt. Ltd have been involved in direct-to-consumer health care initiatives for over ten years in the Indian market and were responsible for starting one of the first corporate chains of hospitals in the country, taking that company to a successful IPO. Management has also been involved in drafting many medical and healthcare laws in India. For more information visit www.checkitsa.com.
Miraculins is a medical diagnostic company focused on acquiring, developing and commercializing non-invasive technologies for unmet clinical needs. The Company's Scout DS® system 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.
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.
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 completion of definitive documentation and the execution of the Agreement, the receipt of Indian regulatory clearance, and the impact of the Agreement on the Company. 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 statements.
PreVu® and Scout DS® are registered trademarks of Miraculins Inc. All Rights Reserved. 2014.