yolo scientific presentations 112011

2007 - 2011

2011 YOLO MEDICAL INC.

SCIENTIFIC PRESENTATIONS

2007 - 2011

INTRODUCTIONThe Meridian LAPEX Lipo Laser System is a semi-conductor based low energy laser device that emits light at 632 nm, is non-thermal and non-invasive. This Lipo Laser System was originally developed to treat carpel tunnel syndrome, but was modified for use in body contouring and spot fat reduction. In this study we explored the efficacy of the Lipo Laser in body contouring and fat reduction on subjects waistlines as evidence by girth measurements and photographs.

OBJECTIVESThe 2 primary objectives are: (a)To improve the body contour as evidenced by girth measurement reduction of the waistline. (b)To improve body contour as evidenced by photographs showing a better and more defined body con-tour.

STATISTICAL METHODSThe difference in average reduction between the LAPEX 2000 Lipo Laser treatment / active arm, and the control / pla-cebo for subjects in the modified intent to treat group was compared using a two-sided two sample t-test with an alpha of 0.05.

METHODSForty healthy men and women ages 18-65 with a BMI

BackgroundLocal fat reduction for cosmetic purposes utilizes two different mechanisms. One is an ablative mechanism in which the fat cells are destroyed, exemplifi ed by the combination of phosphatidylcholine (PC) and deoxycholate (DC). PC with DC is felt to cause local fat reduction secondary to the detergent action of DC, and it is also believed that PC acts only as an emulsifi er. The other mechanism of local fat reduction is non-ablative in which fat cells release their fat, exemplifi ed by LipoLaser (LL) which emits low energy laser light. The LL has been shown by electron microscopy to open pores in fat cells allowing the triglyceride to leak out into the interstitial space. We performed studies to elucidate the mechanism of the two types of local fat reduction.

MethodsWe measured the lipolytic response and appearance of human fat cells in culture to PC and DC exposure. We exposed human fat cells in culture to laser light or an ambient light condition in the presence of serum, heat inactivated serum, or no serum. We also evaluated human fat cells in culture for metabolic activity and cell viability when exposed to LL or ambient light.

Results PC stimulated lipolysis 2.3 fold compared to assay buffer (p

BACKGROUND & OBJECTIVE Low-level laser therapy (LLLT) has evolved as an efficient tool to provide therapeutic outcomes for a variety of medical indications. Currently, this is a U.S. Food and Drug Administrationapproved technology for improving pain alleviation. However, recent studies on LLLT indicate liquefaction or release of stored fat in adipocytes by opening of the cell mem-brane after a short treatment. Nonetheless, clinical data is limited. The aim of the study was to assess the clinical effects of low-level laser therapy on subcutaneous fat reduction and improvement in body contouring.

STUDY DESIGN /MATERIALS & METHODSRetrospective data review of patients (n=311) treated with Low-level laser therapy (658nm, 150 mW array/40 mW+/-20% diode laser radiation source) for a period of 26 months. All patients were meticulously screened and advocated on proper diet and exercise before treatment initiation. The LLLT was applied topically to skin of the abdomen and torso to areas where undesired fat was present.

RESULTS272 females, 39 males (age range: 18-81 yrs) underwent from 1 to 24 laser treatments to the abdominal and torso areas. 54.6% (n=170) patients had 6 or more treatment sessions. Measured loss from a single first session treatment in 81% of the sample (n=253) averaged 2.79 cm (range: 0-9 cm) or 1.4cm in girth reduction covering all application times. Overall, 130 patients who completed all 6 and 12 sessions achieved an average sustained losses of 6.55 cm and 11.04 cm corre-sponding to an average girth reduction of 0.48 -0.55 cm per session. With weight loss of a minimum of 0.68 kg per week results averaged 9.0 cm for the 6 session group and 16.1 cm for the 12 session group corresponding to an average girth reduction 0.67-0.75 cm per session. 75.2% were able to sustain at least 4 cm or more loss in 6 or more sessions. Patient satisfaction and photographic assessment demonstrated significant higher score in all patients. Only 6 patients (

Official Journal of The International Federation For The Surgery Of Obesity And Metabolic Disorders

BACKGROUND Low-level laser therapy (LLLT) is commonly used in medical applications, but scientific studies of its efficacy and the mechanism by which it causes loss of fat from fat cells for body contouring are lacking. This study examined the effec-tiveness and mechanism by which 635680 nm LLLT acts as a non-invasive body contouring intervention method.

METHODS Forty healthy men and women ages 1865 years with a BMI

BACKGROUND & OBJECTIVERemoval of excess fat pocket in the chin can significantly define a lower facial structure but is often neglected in reju-venation efforts of the face and neck. A complete rejuvenation of the neck should address contours in the chin area reducing the subcutaneous fat to provide angularity between the various planes of the lower face and neck. The aim of the study is to evaluate the efficacy of low level laser therapy (LLLT) applied on subcutaneous fat in the chin area in patients with undesirable accumulation of submental fat.

STUDY DESIGN/MATERIALS & METHODSA total of 10 subjects were examined for the study. All patients received LLLT using a AlGaInP laser diode source (Merid-ian Medical Inc. Vancouver BC) at 658nm wavelength with a maximum output power of 30mW/beam. Subjects received 5 treatment sessions lasting 20 mins each over a two week period with a minimum follow-up of 6 months and post-treatment assessment. Two clinicians performed the therapy, physical examination, skinfold-caliper measurement and blinded photographic evaluation.

RESULTSLaxity of the skin improved in all 10 patients. Photographic assessment in 9 out of 10 patients studied revealed signifi-cant changes in submental profiles after an average of 4 treatment sessions. Mean degree of improvement (0=none, 1=mild, 2=moderate, 3=significant) was 2.8 (+/-0.02). Physician/subject assessment of fat loss(FL), skin tightening(ST), chin profile(CP), and overall performance(OP) averaged a score of 9.5/9.0(FL); 9.0/9.0(ST); 8.5/9.0(CP) and 9.5/9.5(OP) (on a 1-10 scale; with 1=minimum;10=maximum improvement). Results were consistent at 6-month follow-up. One patient had transient erythema and local swelling which resolved in 24 hours without intervention.

CONCLUSIONTreatment choice to address skin changes and subcutaneous fat deposition in chin area is typically surgical and non-invasive options are currently unavailable. The current novel study clearly demonstrates efficacy of low level laser in reducing chin fat with restoration of neck contour and overall aesthetic result.

Presented at ASLMS 31st Annual Conference Grapevine, TX, Mar. 30- Apr. 3, 2011

Novel Non-invasive Technique Using Low Level Laser for Chin RejuvenationVinod K Podichetty, MD,MS; *Jean-Claude Nerette Jr, DO.

INTRODUCTIONAlthough Low-level laser therapy (LLLT) has evolved as an efficient tool in aesthetic body contouring and spot fat re-duction, there are no large sample studies reporting the effectiveness of this method. The authors have previously presented a large cohort study with 272 patients. The aim of the study is a follow-up and evaluation of clinical effects of LLLT on subcutaneous fat reduction and enhancing body contouring.

METHODSRetrospective data review of patients (n=222) treated with LLLT (range=635nm-680nm, center wavelength=658nm, 150mW array/40mW+/-20% diode laser radiation source) during a period of three years. The laser (YOLO Medical Inc) was applied directly on the skin of the abdomen and thighs where undesired fat was present.

RESULTS197 females, 25 males (range:19-75yrs) underwent from 6 to 13 laser treatments (abdominal area) and 6 to 10 (thighs). In abdominal sample, measured loss from single first session treatment in 81% of the sample (n=194) averaged 3.01 cm (range: 0.5-8.8 cm). Overall, 194 patients who completed a minimum of 6, maximum of 29 sessions achieved an average cumulative loss of 8.6 cm. Correspondingly 28 patients who had between 6 and 12 sessions on the thigh had a mea-surable change of 2.5cm in right and 2.8cm in left thigh. 77.2% were able to sustain at least 4 cm or more abdominal loss in treatments of 6 or more sessions. Patient satisfaction and photographic assessment demonstrated significant higher score. No significant complications were encountered in the patient population. Using a threshold of at least 75% self reported satisfaction and improvement post procedure, 86% of patients treated at abdominal site and 89.2% of thigh patients were considered responders (p=0.4228).

CONCLUSIONWhile there is a high demand for body shaping procedures, effective non-invasive alternatives are few. Low level laser therapy is safe and efficacious method for reducing subcutaneous fat in the abdominal and thigh region where unde-sired fat is present.

Presented at IFATS 9th Annual Symposium Miami Beach, FL, Nov. 4-6, 2011

Low Level Laser Therapy for Body Contouring & Spot Fat Reduction: Clinical Report of 222 CasesVinod Podichetty, MD,MS1; Daniel J. Bourassa, DC2Research Practice Partners Inc., Miramar, FL 33027; Emerald Coast Medical Center, Pensacola, Florida 32505

INTRODUCTIONFat tissue is composed primarily of fat and blood vessels. Fat tissue grows and recedes throughout life, a property demonstrated to be due to angiogenesis. In fact, inhibitors of angiogenesis have been demonstrated to reverse rodent models of obesity. The angiogenic potential of different fat depots in women and their fat depot responses to sex hor-mones has not been elucidated.

METHODSOur group has described an assay in human fat tissue that more faithfully predicts the human angiogenic response than commonly used non-human assay systems. Small pieces of fat tissue from human surgeries are placed in a thrombin-fibrin matrix in 96 well plates with 20% fetal bovine serum. Over the course of 15 days the growth of blood vessels is graded and plotted as an indication of angiogenesis (scale 0-1). Female fat from the breast, abdomen and thigh were compared as was fat from the abdomen and omentum. The angiogenic response to physiologic concentrations of es-trogen (1.3 x 10-9 M) and testosterone (3.5 x 10-9 M) were compared in abdominal and omental fat tissue.

RESULTSThe angiogenic response of abdominal and thigh fat tissue were similar, although thigh fat gave greater angiogenesis at some time points. Breast fat gave significantly lower angiogenesis than the other 2 subcutaneous depots. Omental fat, like breast fat, gave significantly less angiogenesis than abdominal subcutaneous fat. Subcutaneous abdominal fat had a greater angiogenic response to physiologic female concentrations of estrogen and testosterone than omental fat. All described differences were significant (p

INTRODUCTIONAdvances in laser technology, particularly the use of low level laser therapy (LLLT) for body contouring and spot fat reduction has the potential to greatly decrease the need for invasive procedures. We report results from a cohort of patients assessing the efficacy of semiconductor based low level laser device for noninvasive body contouring and abdominal fat reduction.

METHODSEligible healthy adult subjects were enrolled into a study and all patients received nine 30 minute laser treatments uti-lizing low level laser device at 658nm wavelength (Lapex BCS, YOLO Medical Inc.), 3 times per week for 3 weeks totaling nine treatment sessions and evaluated over a 9-week period. Efficacy outcomes included reduction of waist circumfer-ence, patient satisfaction and photographic assessment by blinded independent observers. Safety was monitoring by study physician.

RESULTSNineteen healthy men and women between the ages of 23-58 years (average age=39.9 years) formed the study sample (n=19). 4 men and 15 women received a complete nine treatment session protocol which was well tolerated producing a mean waist circumference reduction of 5.7inches with majority of the inch loss effect achieved within the first week. Responses after three treatment sessions in both genders were comparable, with a mean circumference reduction of 0.9 inches in men and 1.0 inches in women. (p=0.302). Overall at the end of the 9th treatment session, the average circumference reduction above the umbilicus=1.76 inches, at umbilicus =2.05 inches and below the umbilicus =1.98 (average cumulative loss =5.76 inches or 14.6 cms) Results varied between a range of 1 3/8 inch to 9 inches lost over the series of treatments. The effects were sustained at mean follow-up of 3 months post therapy. Independent observers found 75-100% improvement in abdominal contour in 90% of subjects and 50-74% improvement in 10% of subjects. No adverse event was reported.

CONCLUSIONLow level laser therapy is an effective non-invasive method for reducing subcutaneous fat of the abdomen and photo-graphic evaluation correlates well with clinical findings..


Noninvasive Body Contouring and Spot Fat Reduc-tion by Low Level Laser Therapy: Efficacy of Lipo-laser Technology from a Single Center, Controlled Clinical StudyVinod Podichetty, MD,MS 1; Jonas C. LaForge, BSc.,ND2; 1-Research Practice Partners Inc. Miami, FL USA; 2-YOLO Medical Inc., Whiterock, BC

BACKGROUNDLow-level laser therapy (LLLT) is commonly used in medical applications, but mechanistic studies by which it causes loss of fat is lacking. The study examined mechanism by which 635680 nm LLLT (YOLO Medical Inc) acts on adipocyte cell.

METHODSIn vitro assays on human adipose-derived stem cells obtained from subcutaneous fat during abdominal surgery were conducted to determine evidence of cell lysis, and possibility to increase glycerol and triglyceride release.

RESULTSExperiment 1: Fat cells that came in contact with plasma or plasma with white blood cells were lysed in both laser treated and the control plate, but cells in control wells or in wells with heat-inactivated plasma were not lysed. This indicates that serum complement does lyse fat cells, but the laser does not activate a complement cascade. The mecha-nism by which fat leaked from the fat cells into the interstitial space is by formation of transitory pores. Experiment 2: Laser does not kill adipocytes. The number of viable cells in the laser-treated or untreated group as determined by the propidium iodide assay were similar, but calcein levels were lower in the laser-treated cells. These findings suggest that laser-treated cells show micropores in the membrane, which presumably contributed to leakage of fat. Experiment 3: Laser increases triglyceride release, but not by lipolysis from adipocytes. The laser-irradiated wells containing serum had significantly greater increases in triglycerides than the non-irradiated wells containing serum (69 1.7 vs. 66.7 1.5 mg/dL, p = 0.004). Similarly, heat-inactivated serum had a significantly greater increase in triglycerides (72.6 1.8 vs. 70.1 1.6 mg/dL, p = 0.008). Baseline glycerol levels were not different in the laser-treated or the non-irradiated groups (0.11 0.01 vs. 011 0.01 mmol/L, p = 0.44). Before and after laser irradiation in the presence of serum, cells continued to appear intact without evidence of lysis.

CONCLUSIONLLLT increases fat loss from adipocytes by release of triglycerides, without inducing cell lysis.


In Vitro Analysis of Human Adipocyte Cell Response to Low level Laser TherapyVinod Podichetty, MD,MS 1; Frank L. Greenway, MD21-Research Practice Partners Inc. Miami, FL USA; 2-Pennington Biomedical Research Center, Louisi-ana State University System, Baton Rouge, LA

yolo scientific presentations 112011

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