2007 - 2011

2011 YOLO MEDICAL INC.

SCIENTIFIC PRESENTATIONS
2007 - 2011
INTRODUCTION
The 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 modifed for use in body contouring and spot fat reduction. In this study we explored the efcacy of the Lipo Laser
in body contouring and fat reduction on subjects waistlines as evidence by girth measurements and photographs.
OBJECTIVES
The 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 defned body con-
tour.
STATISTICAL METHODS
The diference in average reduction between the LAPEX 2000 Lipo Laser treatment / active arm, and the control / pla-
cebo for subjects in the modifed intent to treat group was compared using a two-sided two sample t-test with an alpha
of 0.05.
METHODS
Forty healthy men and women ages 18-65 with a BMI <30 kg/m2 were randomized in a 1:1 ratio to either an experimen-
tal or control treatment. Each subject was treated with the Lipo Laser on their waistlines 30 minutes twice a week for
four weeks. Standardized waist circumference measurements and photographs were taken before and after treatment
1, 3 and 8. Subjects were asked not to change their diet or exercise habits.
RESULTS
Each treatment with the Lipo Laser gave a loss of 0.4 - 0.5 cm in waist girth. On the third treatment, this diference, 0.405
cm (-0.059 + 0.708 vs. -0.19 + 0.47 cm (mean + SD)), was signifcant (p<0.05). The cumulative girth loss at treatment
three was 1.74 cm (-1.895 + 2.967 vs. -0.16 + 2.458 cm) (p<0.05). Cumulative girth loss at 4 weeks of treatment was 2.15
cm (-0.781 + 2.817 vs. 1.353 + 2.644 cm) in those who maintained their weight within 1.5 kg of their baseline weight
(p<0.05). The standardized pictures showed 1.21 (1.21 + 0.419 vs. 0 + 0) diference between the Lipo Laser and the
placebo treatment in appearance on a 0-3 scale favoring the Lipo Laser comparing the baseline to the week 4 pictures
(p<0.001).
SUMMARY & CONCLUSIONS
The Lipo Laser gives signifcant girth loss that is maintained over repeated treatments and is cumulative over 4 weeks of
8 treatments. This girth loss of approximately one inch from the waist was accompanied by a clinically and statistically
signifcant improvement in appearance.
Presented at NAASO Annual Scientic Meeting, New Orleans, LA. October 20-24, 2007
The Efcacy of the Lapex
2000 LipoLaser in Body
Contouring and Fat
Reduction
Caruso-Davis M, Guillot T, Yu Y, Bissoon L, Greenway F
Published in Obesity Journal 15:A99, 2007
Background
Local fat reduction for cosmetic purposes utilizes two diferent mechanisms. One is an ablative mechanism in which the
fat cells are destroyed, exemplif 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
emulsif er. The other mechanism of local fat reduction is non-ablative in which fat cells release their fat, exemplif 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.
Methods
We 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 bufer (p<0.001). DC, a detergent destroyed all the human fat cells at
10-1 M, destroyed half the cells at 10-2 M, at 10-3 M, the fat cells were not destroyed. Exposure to serum and heat inacti-
vated serum both destroyed the human fat cells in response to either LL or ambient light, conf rming that the creation
of pores in the fat cells was by a non-complement mediated mechanism. Human fat cells in culture exposed to LL and to
ambient light had the same number of non-viable cells, but cells exposed to LL had lower metabolism, consistent with
the stress of having pores in the cell membrane (p<0.0001).
Conclusions
The combination of PC and DC destroys fat cells by a detergent action based on the DC content. At low concentrations
of DC, PC can act as a lipolytic stimulator to reduce fat by a non-ablative mechanism. LL opens pores in fat cells and al-
lows egress of the triglycerides contained within them. LL open pores in the fat cells by a non-complement dependent
mechanism, but does decrease fat cell metabolism without afecting the viability of the fat cells.
Presented at NAASO Annual Scientic Meeting, Phoenix, Arizona. October 3-7, 2008.
Mechanistic Studies for
Local Fat Reduction
Caruso-Davis M, Guillot T, Yu Y, Mashtalir N, Bissoon L,
Dhurandhar N, Greenway F
Published in Obesity Journal 16(suppl. 1):S161, 2008.
BACKGROUND & OBJECTIVE
Low-level laser therapy (LLLT) has evolved as an efcient 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 efects
of low-level laser therapy on subcutaneous fat reduction and improvement in body contouring.
STUDY DESIGN /MATERIALS & METHODS
Retrospective 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.
RESULTS
272 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 frst 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 signifcant higher score in all patients. Only 6 patients (<3%)
of the 253 patients measured for their frst session experienced no loss from the treatment. No signifcant complications
were encountered in the patient population.
CONCLUSION
While there is a high demand for body shaping procedures, efective non-invasive body contouring alternatives for
non-surgical candidates are very few. Cosmetic surgery patients are reluctant to undergo procedures that require gen-
eral anesthesia and pose a multitude of potentially serious risks and complications with a possibility of several weeks of
recovery time. Low level laser therapy appears to be safe and an efcacious method for reducing subcutaneous fat in
the abdominal and torso areas where undesired fat is present.
Presented at ASLMS 30th Annual Conference Phoenix, Arizona, April 14-18, 2010
Effects of Low-level Laser Therapy in
Subcutaneous Fat Reduction and Improvement
in Body Contour
Vinod Podichetty MD, Daniel Bourassa, DC
Ofcial 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 scientifc studies of its efcacy and the
mechanism by which it causes loss of fat from fat cells for body contouring are lacking. This study examined the efec-
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 <30 kg/m2 were randomized 1:1 to laser or control treat-
ment. Subjects waistlines were treated 30 min twice a week for 4 weeks. Standardized waist circumference measure-
ments and photographs were taken before and after treatments 1, 3, and 8. Subjects were asked not to change their
diet or exercise habits. In vitro assays were conducted to determine cell lysis, glycerol, and triglyceride release.
RESULTS
Data were analyzed for those with body weight fuctuations within 1.5 kg during 4 weeks of the study. Each treatment
gave a 0.40.5 cm loss in waist girth. Cumulative girth loss after 4 weeks was 2.15 cm (0.78 2.82 vs. 1.35 2.64 cm
for the control group, p < 0.05). A blinded evaluation of standardized pictures showed statistically signifcant cosmetic
improvement after 4 weeks of laser treatment. In vitro studies suggested that laser treatment increases fat loss from
adipocytes by release of triglycerides, without inducing lipolysis or cell lysis.
CONCLUSIONS
LLLT achieved safe and signifcant girth loss sustained over repeated treatments and cumulative over 4 weeks of eight
treatments. The girth loss from the waist gave clinically and statistically signifcant cosmetic improvement.
Obes Surg. 2010 Apr 15 PMID: 20393809 [PubMed - indexed for MEDLINE]
Efcacy of Low-Level Laser Therapy for Body
Contouring and Spot Fat Reduction
Mary K. Caruso-Davis, Thomas S. Guillot, Vinod K. Podichetty, Nazar Mashtalir, Nikhil V. Dhurandhar,
Olga Dubuisson, Ying Yu, Frank L. Greenway.
BACKGROUND & OBJECTIVE
Removal of excess fat pocket in the chin can signifcantly defne a lower facial structure but is often neglected in reju-
venation eforts 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 efcacy 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 & METHODS
A 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.
RESULTS
Laxity of the skin improved in all 10 patients. Photographic assessment in 9 out of 10 patients studied revealed signif-
cant changes in submental profles after an average of 4 treatment sessions. Mean degree of improvement (0=none,
1=mild, 2=moderate, 3=signifcant) was 2.8 (+/-0.02). Physician/subject assessment of fat loss(FL), skin tightening(ST),
chin profle(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.
CONCLUSION
Treatment 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 efcacy 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 Rejuvenation
Vinod K Podichetty, MD,MS; *Jean-Claude Nerette Jr, DO.
BACKGROUND & OBJECTIVE
Removal of excess fat pocket in the chin can signifcantly defne a lower facial structure but is often neglected in reju-
venation eforts 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 efcacy 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 & METHODS
A 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.
RESULTS
Laxity of the skin improved in all 10 patients. Photographic assessment in 9 out of 10 patients studied revealed signif-
cant changes in submental profles after an average of 4 treatment sessions. Mean degree of improvement (0=none,
1=mild, 2=moderate, 3=signifcant) was 2.8 (+/-0.02). Physician/subject assessment of fat loss(FL), skin tightening(ST),
chin profle(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.
CONCLUSION
Treatment 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 efcacy 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 Rejuvenation
Vinod K Podichetty, MD,MS; *Jean-Claude Nerette Jr, DO.
INTRODUCTION
Although Low-level laser therapy (LLLT) has evolved as an efcient tool in aesthetic body contouring and spot fat re-
duction, there are no large sample studies reporting the efectiveness 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 efects of
LLLT on subcutaneous fat reduction and enhancing body contouring.
METHODS
Retrospective 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.
RESULTS
197 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 frst 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 signifcant higher
score. No signifcant 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).
CONCLUSION
While there is a high demand for body shaping procedures, efective non-invasive alternatives are few. Low level laser
therapy is safe and efcacious method for reducing subcutaneous fat in the abdominal and thigh region where unde-
sired fat is present.
Presented at IFATS 9
th
Annual Symposium Miami Beach, FL, Nov. 4-6, 2011
Low Level Laser Therapy for Body Contouring &
Spot Fat Reduction: Clinical Report of 222 Cases
Vinod Podichetty, MD,MS1; Daniel J. Bourassa, DC2
Research Practice Partners Inc., Miramar, FL 33027; Emerald Coast Medical Center, Pensacola,
Florida 32505
INTRODUCTION
Fat 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 diferent fat depots in women and their fat depot responses to sex hor-
mones has not been elucidated.
METHODS
Our 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-
fbrin 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.
RESULTS
The angiogenic response of abdominal and thigh fat tissue were similar, although thigh fat gave greater angiogenesis
at some time points. Breast fat gave signifcantly lower angiogenesis than the other 2 subcutaneous depots. Omental
fat, like breast fat, gave signifcantly 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 diferences were signifcant (p<0.05).
CONCLUSION
To the authors knowledge, this study demonstrates specifc angiogenesis diferences for the frst time in medical litera-
ture. Human female fat tissue has a depot dependent angiogenic response with thigh and abdominal fat being greater
than breast fat. The angiogenic response is greater in subcutaneous fat tissue than in omental fat and subcutaneous fat
has a greater angiogenic response to female physiologic levels of estrogen and testosterone.
Presented at IFATS 9
th
Annual Symposium Miami Beach, FL, Nov. 4-6, 2011
Angiogenesis of Fat Tissue and Its Response to Sex
Hormones in Human Females is Depot-Dependent
Vinod Podichetty, MD,MS 1; Frank L. Greenway, MD2
1-Research Practice Partners Inc. Miami, FL USA; 2-Pennington Biomedical Research Center, Louisi-
ana State University System, Baton Rouge, LA
INTRODUCTION
Advances 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 efcacy of semiconductor based low level laser device for noninvasive body contouring and
abdominal fat reduction.
METHODS
Eligible 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. Efcacy outcomes included reduction of waist circumfer-
ence, patient satisfaction and photographic assessment by blinded independent observers. Safety was monitoring by
study physician.
RESULTS
Nineteen 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 efect achieved within the frst 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 efects 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.
CONCLUSION
Low level laser therapy is an efective non-invasive method for reducing subcutaneous fat of the abdomen and photo-
graphic evaluation correlates well with clinical fndings..
Presented at IFATS 9
th
Annual Symposium Miami Beach, FL, Nov. 4-6, 2011
Noninvasive Body Contouring and Spot Fat Reduc-
tion by Low Level Laser Therapy: Efcacy of Lipo-
laser Technology from a Single Center, Controlled
Clinical Study
Vinod Podichetty, MD,MS 1; Jonas C. LaForge, BSc.,ND2;
1-Research Practice Partners Inc. Miami, FL USA; 2-YOLO Medical Inc., Whiterock, BC
BACKGROUND
Low-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.
METHODS
In 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.
RESULTS
Experiment 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 fndings 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 signifcantly 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 signifcantly greater increase in triglycerides (72.6 1.8 vs.
70.1 1.6 mg/dL, p = 0.008). Baseline glycerol levels were not diferent 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.
CONCLUSION
LLLT increases fat loss from adipocytes by release of triglycerides, without inducing cell lysis.
Presented at IFATS 9
th
Annual Symposium Miami Beach, FL, Nov. 4-6, 2011
In Vitro Analysis of Human Adipocyte Cell Response
to Low level Laser Therapy
Vinod Podichetty, MD,MS 1; Frank L. Greenway, MD2
1-Research Practice Partners Inc. Miami, FL USA; 2-Pennington Biomedical Research Center, Louisi-
ana State University System, Baton Rouge, LA