June 21, 2006 NASD OTC-BB: MRDAF
Meridian Announces 510k Submission to the FDA for the Lipo-Laser
Meridian Co., Ltd. ("Meridian") (OTC BB:MRDAF.OB - News) announced that it has reached a major milestone in the execution of its strategic business plan of establishing a significant role in the 9 billion dollar aesthetic market in North America. The company filed a Premarket Notification, or a 510(k) with the US FDA, to allow it to market the non-invasive Lipo-Laser device for the indication of body contouring and temporary reduction in the appearance of cellulite. Using cutting edge laser technology intended specifically for this use, this device will be the first of its kind that would be cleared by the US FDA.
Meridian President Hyeon-Seong Myeong commented, "This is a major step in the company's overall execution of a plan that has included comprehensive clinical studies that were conducted to support the utility of this device." Mr. Myeong continued, "We look forward to working with the FDA in bringing this much needed technology to the marketplace, and more importantly, positioning ourselves as a key player in this market."
The market clearance of the Lipo-Laser system in the U.S. market would be a very significant event for the Company in that it would open up an enormous market for the sales and marketing of the Lipo-Laser system. The Lipo-Laser has already been approved in the Korean market and the company expects to realize approximately $6 million in revenues this year alone from Korean sales of this product. Meridian Co. believes that with the expected clearance in the U.S., the Lipo-Laser device will become a major frontrunner in the advent of the next billion dollar industry of laser fat reduction.
The Lipo-Laser is primarily based on an existing Meridian Co. product, the Lapex 2000, which already has received a FDA 510(k) clearance. The main difference between the two devices is the enhanced laser probes on the new Lipo-Laser. Therefore, the only clearance required from the FDA will be for the different probes. Based on this, Meridian Co. expects FDA clearance in the second half of this year.
The Lipo-Laser was designed to target the aesthetic market, specifically to address obesity. The Lipo-Laser's non-invasive treatment is considered one of the most innovative methods to remove adipose fat tissue, and the demand for this type of treatment is expected to grow rapidly, not only in the plastic surgery profession but in any clinical setting such as spas and wellness centers that treat localized body fat deposits which may not have responded to diet and exercise.
Light-based treatments are now the mainstays of medical aesthetic practices. In 2004, over 26 million hair removal, skin rejuvenation, tattoo and pigmented lesion removal, acne reduction, vascular lesion and other treatments were performed. These treatments earned more than $8 billion for practitioners and almost $550 million for equipment manufacturers. By 2009, this is expected to grow to over 84 million treatments annually earning practitioners $13.9 billion and manufacturers nearly $1 billion.
The company recently announced the results of a physician sponsored study involving the Lipo-Laser lead by Dr. Chubaty of Aestheticmd. Dr. Chubaty is a world renowned physician with a practice focusing on cellulite and spot fat reduction and is the founder and president of the International Mesotherapy Society. He has trained over 500 physicians and has collaborated with leading medical institutes worldwide. Dr. Chubaty reported very positive overall results in the six week study including an average fat loss of 5.51 inches per patient. Results were also demonstrated by photographs which showed a positive and observable improvement in both the reduction and the appearance of cellulite and improved body contour and tone. Dr. Chubaty was ecstatic with the results he was able to obtain with the Lipo-Laser for his patients and predicts a rapid uptake for the product once it is cleared by the FDA.
About Meridian
Meridian is an established leader in the research/development, manufacturing and sales of integrative medical diagnostic equipment. The company sells its products and equipment to a wide array of customers in the global health care industry. The company presently holds a total of 18 worldwide patents on its technology, and has received FDA, as well as other international regulatory approvals for many of its products.
On Behalf of the Board of Directors,
Hyeon-Seong Myeong, President
This press release may contain certain forward-looking information and statements concerning the company's operations, performance and financial condition. These statements are based upon a number of uncertainties and contingencies, many of which are beyond the control of the company. Actual results may differ materially from those expressed or implied by such forward-looking statements. This document is not intended to be and is not an advertisement for any securities of the company.
Contacts:
Belgium Medical Inc.
Peter Holeczek
Corporate Communications
1-866-736-3306
https://MeridianMedical.ca
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