Event Cardio Group, Inc. Completes Next Step in Production of FDA-510k Cleared BreastCare DTS Device
NEW YORK, NY–(Marketwired – Apr 22, 2015) – Event Cardio Group, Inc. (www.eventcardiogroup.com) (OTCQB: ECGI), a medical device company specializing in the detection and preventive treatment of high-risk diseases, is pleased to announce that Ceres Technologies, based in Saugerties, New York, (www.cerestechnologies.com) has begun manufacturing the BreastCare DTS™ device. With production of units underway the FDA Code of Federal Regulations Title 21 required filing for Good Manufacturing Practices is in process.
This important milestone provides BreastCare DTS™ devices for testing and registration purposes while the fully automated manufacturing line is being completed. The fully automated manufacturing line will be capable of producing a high volume of BreastCare DTS™ devices for worldwide distribution.
The BreastCare DTS™ device is an easy-to-use device produced under patent which has FDA-510k clearance as an adjunct to mammography. The advantages of BreastCare DTS™ are that it is low-cost, portable and highly effective, making it a very attractive and accessible adjunct for detection of breast disease, including breast cancer, for use with and in between mammograms in the US and other developed countries. The BreastCare DTS™ device is not intended to replace mammography, ultrasound and other detection methods. It is to be used as an adjunct to these screening methods. The use of more than one screening method (as is true with most medical testing) provides the best opportunity to catch breast cancer early. (ECGI) President and CEO John Bentigvolio stated, “I believe that women should utilize all methods available to them to detect breast cancer as early as possible as no method is 100% effective alone. We are excited to move forward with the production of the BreastCare DTS™ and anticipate an automated manufacturing line will be ready later this year.”
Breast density is one of many risk factors for breast cancer. Women with high breast density are four to five times more likely to get breast cancer than women with low breast density. 40 percent of women have dense tissue and up to 50% have dense tissue of some degree.
Twenty-one states have passed laws requiring mammography providers to inform women in writing if they have dense breast tissue and that dense tissue makes it harder to detect cancer with mammography alone. The required letter also will suggest that women talk with their doctors about personal risks for breast cancer and additional screening options. New York Governor Andrew Cuomo was one of the first to sign legislation for this important issue, which took effect on January 19th, 2013.
Utilizing additional screening tests in addition to mammography for women with dense breast tissue could nearly increase detection by up to 100%. These invasive cancers, that could have been missed, are usually small, node negative and at an EARLY stage.
ECGI plans on retaining Ceres Technologies (www.cerestechnologies.com) to manufacture the devices in New York at their Saugerties location once the production line is completed. It is anticipated that the production will bring many new jobs to the region.
BREAST CANCER DETECTION MARKET: The global Point of Care market in 2011 was approximately $18.7 billion, up from $10.3 billion in 2005. In the U.S. alone, the combined breast cancer detection/diagnostic market was valued at more than $2.2 billion in 2008, and is expected to continue in a stable growth pattern over the next several years. Analysts have suggested a conservative growth rate of approximately 5.4% per year.
CARDIAC MONITORING MARKET: The combined U.S. cardiac equipment and services market in 2012 was estimated at $3.86 billion and is expected to grow to $4.19 billion in 2016. Globally, the cardiac monitoring market is anticipated at three to five times the US market. We believe that the market for ambulatory cardiac holter monitoring and event recording services will grow over the foreseeable future as a result of an aging and growing population, the increase in a prevalence of health conditions such as obesity that increase the likelihood of heart related diseases and the increasing awareness of cardiac diseases.
Note: The BreastCare DTS™ device is not intended to replace mammography, ultrasound and other detection methods. It is to be used as an adjunct to these screening methods. The use of more than one screening method (as is true with most medical testing) provides the best opportunity to catch breast cancer early. The advantages of BreastCare DTS™ are that it is low-cost, portable and highly effective, and does not expose the patient to radiation, making it a very attractive and accessible adjunct for screening for breast cancer for use with and in between mammograms in the US and other developed countries.
About Event Cardio Group, Inc.
Event Cardio Group, Inc. is a developer of medical diagnostic detection equipment focused on the detection, and preventive treatment, of high-risk diseases. The Company’s core products are its Now Cardio™, an advanced cardiac monitor which offers dual-functionality including both holter monitoring and event recording simultaneously, and FDA approved BreastCare DTS™ breast cancer detection device. For more information on the company please visit www.eventcardiogroup.com.
Statements in this release may be regarded, in certain instances, as “forward-looking statements” pursuant to certain sections of the Securities Act 1933 and the Securities Exchange Act 1934, respectively. “Forward-looking statements” are based on expectations, estimates and projections at the time the statements are made, and involve risks and uncertainties, which could cause actual results or events to differ materially from those currently anticipated, including, but not limited to delays, difficulties, changed strategies, or unanticipated factors or circumstances affecting Event Cardio Group Inc, and its business. There can be no assurance that such forward-looking statements will ever prove to be accurate and readers should not place undue reliance on any such forward-looking statements contained herein. Event Cardio Group Inc, will not republish revised forward-looking statements to reflect events or circumstances after the date hereof to reflect the occurrence of unanticipated events
Source: Marketwired Biotech
