Press May 17, 2007 NASD OTC-BB MRDAF - Meridian Co., Ltd. ("Meridian" or the "Company") (OTC BB:MRDAF.OB - News), an industry leader in the research, development, manufacturing and sales of integrative medical equipment, is pleased to announce that it has just co mpleted its double-blind clinical research study under the investigation of Dr. Frank Greenway and Dr. T.S. Guillot, at LSU School of Human Ecology in Louisiana.
The study explored the efficacy of the LAPEX 2000 LipoLaser in body contouring and fat reduction on subjects' waistlines as evidence by girth measurements and photographs. The study concluded that within the study population the LAPEX 2000 LipoLaser provided a significant girth loss that was maintained over repeated treatments that were cumulative over the entire duration of the study.
"The improvement in appearance was evident both clinically and statistically" reports Dr. Frank Greenway, the primary investigator for the study and Medical Director and Professor at the Biomedical Research Center at the Louisiana State University in Baton Rouge.
Meridian President Hyeon-Seong Myeong commented "we are excited that the study exceeded our objectives in both girth measurements and that there are visible improvements in the photographs."LAPEX 2000 LipoLaser
Frank Greenway, M.D.
Medical Director and Professor
Clinical Investigator, Lapex BCS
Pennington Biomedical Research Center
LOUISIANA STATE UNIVERSITY SYSTEM
August 16, 2007
Re: Mechanism and Safety of the LifeStyle Laser
I have tried to summarize my understanding of the mechanism by which the LifeStyle Laseraccomplishes local fat reduction and my reasons for believing that the mechanism by which it works is Safe.
Low-level, laser energy disrupts the fat cell membrane. This releases intracellular fat and causes the cell to lose its round shape by changing the permeability of the fat cell membrane (Neira, 2002). The disruption of the fat cell membrane does not affect neighbouring structures such as the skin, blood vessels, or peripheral names (Neira. 2002).
This suggests that the fat is being deposited in the interstitial space between the fat cells. The other mechanism is through the lymphatics, which drain the Interstitial space into the venous system. Triglycerides released through the broken fat cell membranes are deposited into the interstitial cellular space and carried away by the lymphatic system. The lymphatic system drains into the venous system where the released triglycerides are broken down in to free fatty acids and glycerol by lipoprotein lipase. These fatty acids and glycerol are taken up and re-esterified by other fat cells in the body, unless they are burned for fuel. Fat eaten as food is processed into chylomicrons in the gut and absorbed through the gastrointestinal tract into the lymph system, which drains into the venous system. Therefore, the fat released by the Lapex BCS and the fat eaten in the diet, both enter the venous system in a similar manner, from two different sites and are processed from that point in a similar manner.
Since the waist decreases by 0.5 cm with a single treatment, 52 grams of fat are mobilized during a treatment session, if one assumes a waist size of 80 cm and a cylindrical torso. This is the equivalent of 468 kcal of fat. This amount of fat is easily processed by the body from a standard meal. Thus, the body has the ability to process the amount of fat mobilized by a Laser Lipo treatment with a great margin of safety giving reassurance that treatment with the LifeStyle Laser is safe. The safety of the mechanism of action by which the LifeStyle Laser gives local fat reduction is consistent with the safety observed using the low level lasers in clinical practice for more than a decade.
Ultimately, the LifeStyle Laserreleases fat from fat cells as triglycerides (energy) that are transported in the body using the normal transport channels for fat and processed metabolically in the normal manner in which fat is processed. This process does not put people at risk for adverse physiological events such as disruption of body functions or injury to organs such as the liver, kidney, lung or pancreas. In fact, the triglycerides released from the fat are used by the body as a primary energy source or are re-esterified into fat cells in other body locations.
I hope this explanation will prove helpful and give reassurance that the observed safety of the low level laser in over a decade of clinical use is consistent with the understanding of human physiology and mirrors the peer-reviewed medical literature concerning the low energy laser.
Frank Greenway, M.D.
Medical Director and Professor
Clinical Investigator, Lapex BCS
Louisiana State University Study:
Objectives:
To demonstrate, confirm and quantify the improvements in body contouring and reduction in the appearance in cellulite as evidenced by photography
Summary:
The scientific evidence provided in this article shows that the laser-assisted lipoplasty technique will serve as a valuable contribution to this specific field of medicine and will generate the same expectations as other techniques previously described by other authors. Among its benefits are the reduced risk and improved quality of life for patients. Random samples taken from 12 patients and submitted to scanning electron and transmission electronmicroscopic studies demonstrated that the application of the tumescent technique is an important co-adjuvant to laser beam application because it facilitates beam penetration, and as a result, fat extraction.
Clinical Study Revealing Girth Reduction with Non-invasive Laser to be Presented at the NAASO Meetin
October 18, 2007 NASD OTC-BB: MRDAF - Results from a Louisiana State University study in which the LAPEX 2000 LipoLaser was used to reduce girth around study participants' waistlines is scheduled to be presented at the North American Association for the Study of Obesity (NAASO) Annual Scientific Meeting, Oct. 20, in New Orleans. Study leaders will reveal that within the study group the new LAPEX 2000 LipoLaser, manufactured by Meridian Co., Ltd., provided "significant girth loss that is sustained over repeated treatments". The forty study participants (both men and women between the ages of 18 and 65) experienced an average girth loss of one inch over the course of the study.
"We sincerely appreciate all the efforts of Dr. Frank Greenway and the entire study team at LSU for their efforts to prove the LAPEX 2000 LipoLaser is effective for its intended use," said Anna Brazier, President of Meridian Medical, Inc., the exclusive North American distributor for the LipoLaser. "This study was a significant part of our FDA submission for body contouring and girth reduction indications which, to our knowledge, will be the first laser in the entire aesthetics industry for this 100% non-invasive modality."
Brazier is currently awaiting a response from the FDA regarding a submission for the two new aesthetic indications. The LAPEX 2000 has already received clearance for sale and use in the United States for general hand and wrist pain associated with Carpal Tunnel Syndrome.
"Due to the uniqueness of our claims regarding how the device reduces fat within the body, we needed to address additional questions. We feel we have successfully fulfilled that obligation," said Brazier. "Based on our very recent CE clearance, which allows us to market the device for body contouring and girth reduction throughout the entire European Union, combined with our submission to FDA, we look forward to updating all our stakeholders with favorable information in the near future."
In related news, Meridian is currently reviewing proposals for the distribution of the LAPEX 2000 LipoLaser in France, Turkey, Dubai and Mexico.
The Company has hired Jay Hopkins, a sales and marketing professional with several years of experience in the aesthetics industry, to oversee the North American launch of the LAPEX 2000 LipoLaser once the new indications are approved. Most recently, Hopkins sold Class IV laser equipment from Iridex and Laserscope to the dermatology and plastic surgery market. Hopkins plans to conduct LipoLaser sales and marketing out of his Seattle, Washington-based offices.
To: Anna Brazier
Meridian Medical Inc.
300-B 2150 West Broadway
Vancouver, BC, Canada,V6K 4L9
From Dr. Lionell Bisson
LAPEX 2000 LIPO LASER
Dear Anna RE: LAPEX 2000 LIPO LASER
After my initial pessimisms about the above device, I am pleased to report that after my ongoing research I have changed my opinion. I have been studying the effects of the Lipo Laser on fat in my New York clinic for almost nine months and I have seen significant results with a number of satisfied patients. I have concluded the Lipo Laser is a safe and effective device for targeting localized fatty deposits that assists with aesthetic body contouring.
Regardless how one looses weight, the mechanism is the same, whether it is via diet, exercise or modalities which facilitate weight loss. The fat is broken into Free Fatty Acids, Water and Glycerol. The body will use the fat as calories or re deposit it into the same or other areas. Which is why, we recommend an exercise program in conjunction with the laser. Weight loss is not known 1o stimulate plaque formation. Once fat is broken down or released, it is broken down from Triglycerides into; Free Fatty Acids (FFA) + Water + Glycerol.It is a common misconception that fat broken down with modalities such as the Lipo laser is excreted in the urine, FFA's are utilized by the body as calories or can be restored as fat. Water is utilized or excreted. Glycerol is taken to the fiver and stored. Fat is not metabolic waste and it is not excreted into the urine. The presence of fat in the urine is not normal. FFA can only be used as energy or re-deposited as triglycerides. Which i$ why, exercise is important following the use of the Lipo laser.
Ultimately, the Lipo Laser breaks the fat cells down in a manner such that they are released as triglycerides which is then transported through the body's natural metabolic functions. This process does not have the potential for adverse physiological effects (e.g. impacting organs or body functions). In fact, triglycerides are used by the major organs as a primary energy source.
This type of low level laser has been used in medicine for years with no serious reported side effects, (I have not seen any complications with this laser) There are no special recommendations for different ethnic groups, in feet, none of my Afro American patients have reported any side effects, such as skin discoloration. This type of laser is painless, does not burn the skin and is well tolerated by patents. This laser has been used to treat pain conditions, where the device has been placed directly on muscles and bony prominences without any reported adverse effects. This device, and other lasers of its type, has a long standing history record of safety. In our studies, there were no reported adverse effects. Doctors, currently using the device have not reported any adverse effects.
I truly believe that the LAPEX 2000 Lipo Laser holds the potential to revolutionize the aesthetic market for the reduction of cellulite and will offer clients a fantastic new non-invasive alternative to help them meet their goals.
Sincerely,
Dr. Lionel Bissoon
Author, The Cellulite Cure Meridian Co.
Medical Endorser
MESOTHERAPIE . ESTETIC PUC
10 West 74th St Suite
New York. NY 10023
August 10, 2007
Korean Clinical Study:
Objectives:
The objectives of the study were to demonstrate, confirm, and quantify the improvements in body contouring and inch loss.
Summary:
Korean FDA cleared the modifications contained in this submission. 28 subjects (11males and 17 females) in the laser only treatment group experienced an average 2.05cm in reduction. There was also a visual appearance in skin tightening, as well as improved body contouring. 20 subjects treated with both the laser procedure as well as negative pressure experienced a 3.34cm reduction, a 50% improvement with the addition of suction or negative pressure. The medium age of the laser only group was 49, and the laser and suction treatment group's median age was 46. None of the subjects experienced adverse device experience as a result of the treatment.
