Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser, Pulsed ElectroMagnetic Fields and Vacuum Assisted Multipolar Radio Frequency for Non-invasive Fat Reduction of the Abdomen and Flanks
Phase: NA
Conditions: Adipose Tissue Atrophy
Sponsor: Venus Concept

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Clinical Evaluation of the Safety and Efficacy of a 
1064 nm Diode Laser, Pulsed ElectroMagnetic Fields 
and Vacuum Assisted Multipolar Radio Frequency for 
Non-invasive Fat Reduction of the Abdomen and 
Flanks 
Protocol Identifying Number: BL0319 
Funded by: Venus Concept Ltd. 
Version Number: v 5.0 
29 October 2019 
 
 
 
 
 
 
 
 
 
 
Sponsor Contact 
 
VP QA RA and Clinical Affairs 
Address: Venus Concept Ltd.  
235 Yorkland Blvd Suite 900 
Toronto, Ontario   M2J 4Y8  
Canada  
Telephone 888-907-0115  
 
 
 
 
            ________________________________  
____________________ 
             Signature of Sponsor Representative                       Date: (DD/MM/YYYY 

ii 
 
Table of Contents 
LIST OF ABBREVIATIONS ....................................................................................................................................... 1 
STATEMENT OF COMPLIANCE ............................................................................................................................. 2 
PROTOCOL SUMMARY ........................................................................................................................................... 3 
SCHEMATIC OF STUDY DESIGN .......................................................................................................................... 1 
1 
KEY ROLES .................................................................................................................................................... 1 
2  
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ........................ 1 
2.1 
Background Information ...................................................................................................................... 1 
2.2 
Rationale ............................................................................................................................................... 2 
2.3 
Potential Risks and Benefits .............................................................................................................. 2 
2.3.1 
Known Potential Risks ..................................................................................................... 2 
2.3.2 
Known Potential Benefits ................................................................................................ 3 
3 
OBJECTIVES AND PURPOSE .................................................................................................................... 3 
4 
STUDY DESIGN AND ENDPOINTS ........................................................................................................... 3 
4.1 
Description of the Study Design ........................................................................................................ 3 
4.2.1 
Primary EndpointS ........................................................................................................... 4 
4.2.2 
Secondary Endpoints ...................................................................................................... 4 
5 
STUDY ENROLLMENT AND WITHDRAWAL ........................................................................................... 4 
5.1 
Participant Inclusion Criteria .............................................................................................................. 4 
5.2 
Participant Exclusion Criteria ............................................................................................................. 4 
5.3 
Strategies for Recruitment and Retention ........................................................................................ 5 
5.4 
Participant Withdrawal or termination ............................................................................................... 5 
5.4.1 
Reasons for Withdrawal or Termination ....................................................................... 5 
5.4.2 
Handling of Participant Withdrawals or termination .................................................... 6 
5.5 
Premature Termination or Suspension of Study ............................................................................. 6 
6 
STUDY device ................................................................................................................................................ 7 
6.1 
Study device and Control Description .............................................................................................. 7 
6.1.1 
Acquisition ......................................................................................................................... 7 
6.1.2 
Device Specific Considerations ..................................................................................... 7 
6.2 
Study device Accountability Procedures .......................................................................................... 7 
7 
STUDY PROCEDURES AND SCHEDULE ................................................................................................ 8 
7.1 
Study Procedures/Evaluations ........................................................................................................... 8 
7.1.1 
Study specific procedures ............................................................................................... 8 
7.2 
Laboratory Procedures/Evaluations .................................................................................................. 8 
7.2.1 
Clinical Laboratory Evaluations ...................................................................................... 8 
7.3 
Study Schedule .................................................................................................................................... 8 
7.3.1 
Screening .......................................................................................................................... 8 
7.3.2 
Enrollment/Baseline ......................................................................................................... 9 
7.3.3 
FOLLOW UP and Final Study Visit ............................................................................. 11 
7.3.4 
Early Termination Visit .................................................................................................. 11 
7.3.5 
UNSCHEDULED Visit ................................................................................................... 11 
7.4 
Concomitant Medications, Treatments, and Procedures ............................................................. 12 
7.5 
Prohibited Medications, Treatments, and Procedures ................................................................. 12 
7.6 
Rescue Medications, Treatments, and Procedures ..................................................................... 12 
8 
ASSESSMENT OF SAFETY ...................................................................................................................... 12 
8.1 
Specification of Safety Parameters ................................................................................................. 12 

iii 
 
8.1.1 
Definition of Adverse Events (AE) ............................................................................... 13 
8.1.2 
Definition of Serious Adverse Events (SAE) .............................................................. 13 
8.1.3 
Definition of Unanticipated Problems (UP) ................................................................. 13 
8.2 
Classification of an Adverse Event.................................................................................................. 13 
8.2.1 
Severity of Event ............................................................................................................ 13 
8.2.2 
Relationship to Study Agent ......................................................................................... 14 
8.2.3 
Expectedness ................................................................................................................. 14 
8.3 
Time Period and Frequency for Event Assessment and Follow-Up .......................................... 14 
8.4 
Reporting Procedures ....................................................................................................................... 15 
8.4.1 
Adverse Event Reporting .............................................................................................. 15 
8.4.2 
Serious Adverse Event Reporting ............................................................................... 15 
8.4.3 
Unanticipated Problem Reporting ................................................................................ 15 
8.4.4 
Reporting of Pregnancy ................................................................................................ 16 
8.5 
Study Halting Rules ........................................................................................................................... 16 
8.6 
Safety Oversight ................................................................................................................................ 16 
9 
CLINICAL MONITORING ............................................................................................................................ 16 
10 
STATISTICAL CONSIDERATIONS .......................................................................................................... 17 
10.1 
Statistical and Analytical Plans ........................................................................................................ 17 
10.2 
Analysis Datasets .............................................................................................................................. 17 
10.3 
Description of Statistical Methods ................................................................................................... 17 
10.4.1 
General Approach .......................................................................................................... 17 
10.4.2 Analysis of the primary endpoints ...................................................................................................... 18 
10.4.3 
Analysis of the secondary endpoints ........................................................................... 19 
10.4.5 
Safety analysis ............................................................................................................... 19 
10.4.6 
Adherence and Retention Analyses ............................................................................ 20 
10.4.7  
Baseline Descriptive Statistics ..................................................................................... 20 
10.4.8 
Planned Interim Analyses ............................................................................................. 20 
10.4.10 
Tabulation of Individual Response Data ..................................................................... 20 
10.4.11 
Exploratory Analyses ..................................................................................................... 20 
10.5 
Sample Size ....................................................................................................................................... 20 
10.6.1 
Enrollment/ Randomization/ Masking Procedures .................................................... 21 
10.6.2 
Evaluation of Success of Blinding ............................................................................... 21 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ................................... 21 
12 
QUALITY ASSURANCE AND QUALITY CONTROL .............................................................................. 21 
13 
ETHICS/PROTECTION OF HUMAN SUBJECTS ................................................................................... 22 
13.1 
Ethical Standard ................................................................................................................................. 22 
13.2 
Institutional Review Board ................................................................................................................ 22 
13.3 
Informed Consent Process ............................................................................................................... 22 
13.3.1 
Consent/assent and Other Informational Documents Provided to Participants .... 22 
13.3.2 
Consent Procedures and Documentation .................................................................. 23 
13.4 
Participant and data Confidentiality ................................................................................................ 23 
13.4.1 
Research Use of Stored Human SAMPLES, SPECIMENS or Data ...................... 23 
14 
DATA HANDLING AND RECORD KEEPING .......................................................................................... 23 
14.1 
Data Collection and Management Responsibilities ...................................................................... 24 
14.2 
Study Records Retention .................................................................................................................. 24 
14.3 
Protocol Deviations ............................................................................................................................ 24 

iv 
 
14.4 
Publication and Data Sharing Policy ............................................................................................... 25 
15 
STUDY ADMINISTRATION ........................................................................................................................ 25 
15.1 
Study Leadership ............................................................................................................................... 25 
16 
CONFLICT OF INTEREST POLICY .......................................................................................................... 25 
17  
LITERATURE REFERENCES.................................................................................................................... 25 
APPENDIX ................................................................................................................................................................. 26 
 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
LIST OF ABBREVIATIONS 
 
 
AE 
ANCOVA 
BMI 
CFR 
CRF 
CW 
FDA 
GCP 
GUI 
ICH 
ICH E6 
ICMJE 
IRB 
ISO 14155:2011 
MedDRA 
PI 
QC 
SAE 
SAP 
SC 
SLIQ 
US 
UP 
 
Adverse Event 
Analysis of Covariance 
Body Mass Index 
Code of Federal Regulations 
Case Report Form 
Continuous Wave 
Food and Drug Administration 
Good Clinical Practice 
Graphical User Interface 
International Conference on Harmonisation 
International Conference on Harmonisation Guidance for Industry, Good Clinical  
Practice: Consolidated Guidance 
International Committee of Medical Journal Editors 
Institutional Review Board 
International Organization for Standardization Good Clinical Practices for Clinical 
Medical Dictionary for Regulatory Activities 
Principal Investigator 
Quality Control 
Serious Adverse Event 
Statistical Analysis Plan 
Subcutaneous  
Simple Lifestyle Indicator Questionnaire 
Ultrasound 
Unanticipated Problem 
 
 
 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 2 of 3 
 
STATEMENT OF COMPLIANCE 
 
The trial will be carried out in accordance with Good Clinical Practice (GCP) as required by the following:  
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812) or equivalent local 
regulatory regulations or guidelines 
• 
ICH E6 
• 
ISO 14155:2011  
 
All key personnel (all individuals responsible for the design and conduct of this trial) have 
completed Human Subjects Protection Training.  
 
I agree to ensure that all staff members involved in the conduct of this study are informed about their 
obligations in meeting the above commitments.  
Principal Investigator: ________________________________ 
Print/Type Name  
Signed: _____________________________________ Signature    Date: ______________  
 
 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 3 of 3 
 
PROTOCOL SUMMARY 
 
TITLE 
Clinical Evaluation of the Safety and Efficacy of a 1064nm Diode Laser, Pulsed 
ElectroMagentic Fields and vaccum assisted radio frequency for Non-Invasive 
Fat Reduction of the Abdomen and Flanks  
SUMMARY 
Open-label, baseline-controlled, multi-center study evaluating a 1064 nm diode 
laser, pulsed electromagnetic fields and vaccum assisted radio frequency for 
non-invasive fat reduction of the abdomen and flanks. The study will enroll up 
to 200 subjects requesting non-invasive lipolysis of the abdomen and flanks.  
Each subject will receive 3 study treatments of the diode laser and 3 treatments 
of the pulsed electromagnetic fields and vaccum assisted radio frequency study 
treatments.  Subjects will be followed at 16 and 24 weeks post diode 
treatments.  Sixteen week and 24 week post treatment outcome will be 
compared to baseline. 
OBJECTIVE 
The objective of this clinical study is to assess the safety and efficacy of using a 
1064 nm diode laser for non-invasive fat reduction of the abdomen and flanks. 
ENDPOINT 
Primary endpoints 
• 
Photographic evaluation by an independent, blinded reviewer with 
correct identification of pre-treatment baseline images when compared 
to post-treatment images taken at sixteen and 24 weeks  
Secondary endpoints  
• 
To assess subject satisfaction with 16 and 24 weeks using the 5-Point 
Likert Subject Satisfaction Scale and subject questionnaire  
Safety 
• 
Subject’s assessment of discomfort and pain post-treatment as 
measured by the Wong-Baker Faces Pain rating scale 
• 
Subjects experiencing a treatment-related adverse event (AE) 
POPULATION 
The study will enroll up to 200 male and female subjects, ≥ 18 years of age who 
are seeking fat reduction of the flanks and abdomen   
PHASE 
Post-Market 
NUMBER OF SITES Up to 20 sites   
DESCRIPTION OF 
DEVICE 
The investigational device (Venus Bliss™) is a non-invasive medical aesthetic 
device designed for body contouring.  The device is comprised of a console, four 
1064 nm (± 10 nm) diode laser applicators (60 mm x 60 mm).   A belt is included 
to allow the operator to secure the laser applicators on the lipolysis treatment 
area, allowing hands free operation. The device uses vaccum assisted 
radiofrequency (RF) and PEMF (pulsed electromagnetic field) technology which 
has been shown in clinical studies to be safe and effective in body 
circumferential reduction and skin tightening.   
STUDY DURATION 
Two years  
PARTICIPANT 
DURATION 
24 weeks 
 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
 
SCHEMATIC OF STUDY DESIGN 
Visit 
Week 
Event 
Screening 
0 
Obtain informed consent, physicial exam, medical history, concomitant medication, 
screen potential subjects by inclusion and exclusion criteria 
1 
1 
Urine pregnancy test, AE's, concomitant medication, baseline photographs, 
optional ultrasound imaging 
1 
1 
Diode and RF study tx, pain response 
2 
8 
Photos, optional ultrasound imaging, Diode and RF study tx, pain response, 
satisfaction questionnaire 
3 
16 
Photos, optional ultrasound imaging, Diode and RF study tx pain response, 
satisfaction questionnaire 
4 
24 
optional ultrasound imaging , Follow up, photography, satisfaction questionnaire 
17 
KEY ROLES 
 
 
VP QA RA and Clinical Affairs 
Address: Venus Concept Ltd.  
235 Yorkland Blvd Suite 900 
Toronto, Ontario   M2J 4Y8  
Canada  
Telephone 888-907-0115  
 
2  
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE  
2.1 
BACKGROUND INFORMATION  
There are multiple, non-invasive fat reduction procedures currently available for non-surgical body-
contouring.  Technologies include cryolipolysis, radiofrequency, high frequency focused ultrasound, and 
photobiomodulation.  All modalities deliver some form of energy that creates changes in the adipocytes.  
Studies show that these therapies are safe and effective.  
Many non-invasive laser technologies have been studied with the efficacy of laser therapy purported to 
be related to the wavelength and the energy delivered.  Initial lasers studied include the neodymium-
doped yttrium aluminum garnet (Nd:YAG) laser delivering 1064nm and 1320nm wavelengths.  Diode 
lasers were introduced delivering energy at 980nm, 924nm, 975nm and 920nm wavelengths.  The quest 
for the most effective laser diode wavelength for lipolysis with the least adverse effect continues, most 
recently with the 1064nm wavelength.   
The 1064nm laser diode leads to the injury of the adipocytes through direct heating of the tissue.  The 
energy delivered creates movement within the molecules of the exposed tissue, which then generates 
heat.  A controlled temperature of 42-47 °C must be maintained at the site of adipocytes.  At this 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 2 of 26 
 
temperature, the cell membranes of the adipocytes lose their structural integrity leading to cell death.  
Upon cell injury and death, the body naturally eliminates the contents of the adipocytes with results at 6 
weeks but optimally at 12 weeks.  The 1064nm wavelength has a particular affinity for adipocytes with 
low absorption within the dermis.  In addition, melanin is minimally targeted so the device can be used 
in all skin types.  (Schilling L et al) 
RF energy heats the tissue and subcutaneous fat to trigger collagen remodeling and a reduction in 
subcutaneous fat.  The body’s response to RF creates a smoother appearance to the skin and reduced 
circumference.  Pulsed electromagnetic fields increase the vascularity of the skin and creates new 
pathways for the blood to flow.  This increase in blood will provide more oxygen to the skin and bring 
more nutrients to the tissue.  Suction is applied to the surface of the skin tissue during treatment, 
increasing efficacy of the entire therapy. 
This study will investigate whether the Venus Bliss™ investigational device is safe and efficacious for fat 
reduction of the flanks and abdomen.   
 
2.2 
RATIONALE  
 
The objective of this clinical study is to evaluate the safety and efficacy of the use of the Venus Bliss™ 
investigational medical device for non-invasive fat reduction of the abdomen and flanks. 
 
The use of the Venus Bliss™ has been determined to present non-significant risk in accordance with 21 
CFR 812.3 for the intended use in this study, because the device is not: 
• 
Intended as an implant; 
• 
purported or represented to be for use supporting or sustaining human life; 
• 
for use of substantial importance in diagnosing, curing, mitigating, or treating disease, or 
otherwise preventing impairment of human health; or 
• 
Otherwise presenting a potential for serious risk to the health, safety, or welfare of a subject. 
This study will be conducted in compliance with the protocol and according to Good Clinical Practice 
(GCP) standards. 
2.3 
POTENTIAL RISKS AND BENEFITS  
 
2.3.1 KNOWN POTENTIAL RISKS  
Expected adverse events of the laser treatment procedure include transient tenderness, erythema, 
edema, and/or induration in the treated area lasting from one to three weeks after the treatment.  In 
addition, other adverse events may include and include localized firmness, ecchymosis, skin burn, 
hyperpigmentation, hypopigmentation, blister and changes in skin laxity.  Rarely, skin contour 
irregularities, dimpling, asymmetry (uneven appearance due to uneven anatomy or uneven treatment of 
the area), necrosis (tissue death), hardness and nodules occur.  Protective laser eyewear will be worn by 
the subject and operator providing the procedure.  

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 3 of 26 
 
The device has a contact tissue cooling system in place during the procedure to minimize thermal 
discomfort and prevent damage to the treatment area.   Expected adverse events related to the contact 
cooling include tingling, itching, decreased sensation, numbness, erythema and tenderness.  
The potential risks of RF for adverse effects of the treatment procedure include but are not limited to 
blistering, burns, excessive edema or erythema, infection, scarring and post-inflammatory hyper or hypo 
pigmentation. 
 There are no known adverse effects with PEMF. 
Should the research site choose to capture one baseline and up to three additional follow up ultrasound 
images, there are minimal risks associated with the use of ultrasound for imaging.  The use of the 
ultrasound may cause redness of the skin.  Skin rashes rarely occur with the use of ultrasound gel.   
Risks will be mitigated by conducting this protocol with an investigator experienced in the therapeutic 
area of the clinical investigation.  The investigator will be trained by the sponsor on the use of the 
device.  The device design incorporates safety mechanisms which minimize risks.  Patients will also be 
rigorously screened prior to their enrollment and rigorously followed over the course of the study.  
 
2.3.2 KNOWN POTENTIAL BENEFITS  
If the subject agrees to participate in this study, he/she will be contributing to the understanding of the 
safety and efficacy of the use of this investigational device for fat reduction of the abdomen and flanks.  
This understanding may lead to optimization of the treatment with this device.  In addition, the subject 
may benefit from reduction in unwanted adipocytes. 
3 
OBJECTIVES AND PURPOSE 
The objective of this clinical study is to assess the safety and efficacy of using a 1064 nm diode laser, 
vacuum assisted RF and PEMF  for non-invasive fat reduction of the abdomen and flanks. 
Primary objectives  
• 
To determine proportion of an independent, blinded reviewer,  who correctly identifies pre-
treatment baseline images and images taken at 16 and 24 weeks post-treatment  
Secondary objectives  
• 
To assess subject satisfaction with treatment at 16 and 24 weeks using the 5-Point Likert Subject 
Satisfaction Scale 
Safety 
• 
Subject’s assessment of discomfort and pain post-treatment as measured by the Wong-Baker 
Faces Pain rating scale. 
• 
Subjects experiencing a treatment-related adverse event (AE). 
 
4 
STUDY DESIGN AND ENDPOINTS 
 
4.1 
DESCRIPTION OF THE STUDY DESIGN 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 4 of 26 
 
This is an open-label, baseline-controlled, evaluator-blind, multi-center study evaluating treatments with 
a 1064 nm diode laser, vacuum assisted RF and PEMF for non-invasive fat reduction of the abdomen and 
flanks.   
4.2.1 PRIMARY ENDPOINTS 
• 
Photographic evaluation by an independent, blinded reviewer with correct identification of pre-
treatment baseline images when compared to post-treatment images taken at 16 and 24 weeks  
 
4.2.2 SECONDARY ENDPOINTS 
• 
To assess subject satisfaction with treatment at 16 and 24 weeks using the 5-Point Likert Subject 
Satisfaction Scale 
 
Safety Endpoints: 
• 
Report subject’s assessment of discomfort and pain as measured by the Wong-Baker Faces Pain 
rating scale. 
• 
Report subjects experiencing a treatment-related adverse event (AE). 
 
5 
STUDY ENROLLMENT AND WITHDRAWAL 
 
5.1 
PARTICIPANT INCLUSION CRITERIA 
1. Able to read, understand and voluntarily provide written informed consent. 
2. Healthy male or female, ≥ 18 years of age seeking treatment for unwanted fat in the flanks. 
3. BMI score is less than 35.  
4. Agree to not making any major changes in their diet or lifestyle during the course of the study. 
5. Able and willing to comply with the treatment/follow-up schedule and requirements. 
6. Women of child-bearing age are required to be using a reliable method of birth control at least 3 
months prior to study enrollment and for the duration of the study, and have a negative Urine 
Pregnancy test at baseline. 
 
5.2 
PARTICIPANT EXCLUSION CRITERIA 
1. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 
6 months. 
2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area 
in the past 12 months. 
3. History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) 
or use of immunosuppressive medications, 6 months prior to and during the course of the study. 
4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive 
bleeding. 
5. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, 
thrombolytics or anti-inflammatory medications within 2 weeks of treatment. 
6. Having a history of skin cancer or any other cancer in the areas to be treated, including presence 
of malignant or pre-malignant pigmented lesions. 
7. Having a permanent implant in the treatment area such as metal plates or an injected chemical 
substance such as silicone or parenteral gold therapy (gold sodium thiomalate). 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 5 of 26 
 
8. Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to 
light exposure at the wavelength used or history of photosensitivity disorder. 
9. Suffering from significant skin conditions in the treatment area or inflammatory skin conditions 
including but not limited to open lacerations, abrasions, herpes sores, cold sores, active 
infections. 
10. Tattoos in the treatment area.  
11. Poor skin quality  (severe laxity). 
12. Abdominal wall, muscular abnormality  or hernia on physical examination. 
13. Had an unstable weight within the past 6 months  
14. Use of retinoids such as oral isotretinoin (Accutane™) within the past six months or during 
course of the study. 
15. History of keloid or hypertrophic scar formation or poor wound healing in the treatment area. 
16. As per the investigator’s discretion, any physical or mental condition which may make it unsafe 
for the subject to participate.  
17. Unable or unlikely to refrain from sun exposure, artificial tanning, including the use of tanning 
booths, prior to (six weeks) and during the course of the evaluation. 
 
5.3 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Up to 200 subjects will be enrolled at up to 20 sites.  It is anticipated that it will take up to twelve 
months to complete the study.  Subjects requesting non-invasive lipolysis of the abdomen and / or 
flanks will be recruited primarily from the investigator’s clinic.  Any advertising campaigns and materials 
will be reviewed and approved by an institutional review board (IRB) before implementation.  Due to the 
duration of the study, subjects will be contacted by the investigative site on a regular basis in order to 
enhance retention. 
5.4 
PARTICIPANT WITHDRAWAL OR TERMINATION 
 
5.4.1 REASONS FOR WITHDRAWAL OR TERMINATION 
Subjects are free to withdraw from participation in the study without prejudice at any time upon 
request.  In the event that a subject drops out of the study or is withdrawn from the study, the End of 
Study/Early Discontinuation CRF form should be completed. On the withdrawal page, the Investigator 
should record the date of the withdrawal and the reason for withdrawal. 
Reasonable effort should be made to contact any subject lost to follow up during the course of the study 
in order to complete assessments and retrieve any outstanding data.  The records of subjects who 
terminate prior to completing the study will be retained and the reason for termination will be 
documented. 
An investigator may terminate participation in the study if: 
• 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the 
subject. 
• 
The subject meets an exclusion criterion (either newly developed or not previously recognized) 
that precludes further study participation. 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 6 of 26 
 
5.4.2 HANDLING OF PARTICIPANT WITHDRAWALS OR TERMINATION 
Every effort will be made to continue follow-up of withdrawn or terminated subjects or subjects who 
discontinue the intervention but remain in the study for follow-up, especially for safety and efficacy 
study endpoints.  Every effort will be made to conduct a final visit and undertake protocol-specified 
safety follow-up procedures to capture Aes, serious adverse events (SAEs), and unanticipated problems 
(Ups).  
5.5 
PREMATURE TERMINATION OR SUSPENSION OF STUDY 
 
The sponsor may suspend or prematurely terminate this study at an individual investigation site or the 
entire study for significant and documented reasons. 
 
A principal investigator (PI), IRB, or regulatory authority may suspend or prematurely terminate 
participation in the study at the investigation site for which they are responsible. 
 
If suspicion of an unacceptable risk to subjects arises during the study, or when so instructed by the IRB 
or regulatory authorities, the sponsor shall suspend the clinical investigation while the risk is assessed.  
The sponsor shall terminate the study if an unacceptable risk is confirmed. 
 
The sponsor shall consider terminating or suspending the participation of the investigation site or 
investigator in the study if monitoring or auditing identifies serious or repeated deviations on the part of 
an investigator. 
 
If suspension or premature termination occurs, the terminating party shall justify its decision in writing 
and promptly inform the other parties with whom they are in direct communication. The principal 
investigator and sponsor shall keep each other informed of any communication received from either the 
IRB or the regulatory authority. 
 
If, for any reason, the sponsor suspends or prematurely terminates the study at the investigation site, the 
sponsor shall inform the responsible regulatory authority as appropriate and ensure that the IRB is 
notified, either by the principal investigator or by the sponsor.  If the suspension or premature termination 
was in the interest of safety, the sponsor shall inform all other principal investigators. 
 
If suspension or premature termination occurs, 
a) the sponsor shall remain responsible for providing resources to fulfil the obligations from the 
protocol and existing agreements for following up the subjects enrolled in the study, and 
b) the principal investigator or authorized designee shall promptly inform the enrolled subjects at 
the investigation site, if appropriate 
 
In case of early termination, final study activities according to the protocol, including the follow-up visits 
and procedures to assess the safety and efficacy of the device will be conducted, regardless of the 
sponsor’s interest in the study.  Follow-up activities will be conducted so that device deficiencies can be 
identified, and appropriate safety measures can be implemented. 
 
At the completion or termination of the study, the Investigator will return all remaining clinical supplies 
to Sponsor along with a copy of the device supply and inventory records. 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 7 of 26 
 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants (examples of 
findings that might trigger a safety review are the number of SAEs overall, the number of 
occurrences of a particular type of SAE, severe Aes/reactions, or increased frequency of events – 
refer to section 8.5 STUDY HALTING RULES). 
• 
Demonstration of performance that would warrant stopping 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 
Study may resume once concerns about safety, protocol compliance, data quality and the like as the 
case may be are addressed and satisfy the sponsor, IRB and/or regulatory authorities. 
 
6 
STUDY DEVICE 
 
6.1 
STUDY DEVICE AND CONTROL DESCRIPTION 
 
 ACQUISITION 
The Venus Bliss™ investigational device will be shipped to the investigative site directly from the 
sponsor.  Training on the use of the device will be provided by the sponsor.  The investigative site will 
not perform any treatments until all regulatory and IRB approvals are in place and the site has received 
training for both devices and the study.  
6.1.2 DEVICE SPECIFIC CONSIDERATIONS 
The Venus Bliss™ investigational device is a 1064nm diode laser system intended for non-invasive 
lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 35 or less.  The device 
consists of a console, four laser applicators and a belt that secures the laser applicators in place securely 
to the subject’s selected treatment area.  Each applicator includes contact tissue cooling and has an 
active area of 60mm x 60mm.  
The clinician is able to control the settings from the graphical user interface (GUI) display on the main 
console. Treatment time is 25 minutes. The available settings for this applicator is: 
• 
Optical power up to 1.4 W/cm2 at 1064nm 
The vacuum assisted RF and PEMF applicator delivers the treatment radiofrequency and pulsed 
electromagnetic field therapy energy to the patient’s skin.  
The clinician is able to control the settings from the user interface (LCD GUI) display on the main 
Bliss console. The duration of treatment will be ≈15 minutes for a single treatment.  
 
6.2 
STUDY DEVICE ACCOUNTABILITY PROCEDURES 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 8 of 26 
 
The device and applicators will be shipped to the site by the sponsor.  Traceability shall be achieved 
during and after the clinical investigation by assignment of serial numbers to device and applicators and 
accounting for the device and applicators returned to the sponsor by each site.  
The device will be labeled as an investigational device and will require protocol and device training from 
the sponsor.  
7 
STUDY PROCEDURES AND SCHEDULE 
 
7.1 
STUDY PROCEDURES/EVALUATIONS 
7.1.1 STUDY SPECIFIC PROCEDURES  
The following procedures and evaluations will be done as part of the study: 
Demographics 
Medical / surgical history  
Physical examination (as per site’s standard of care) 
Assessment of eligibility 
Urine pregnancy test for women of child bearing potential (visit 1 only)  
Optional baseline ultrasound and up to three additional ultrasound images taken 
Study Treatment(s) 
Photographs 
Administration of questionnaires/scales for patient-reported outcomes (visit 1 and visit 3 only) 
Adverse event recording 
Concomitant medications 
7.2 
LABORATORY PROCEDURES/EVALUATIONS 
  
 
7.2.1 CLINICAL LABORATORY EVALUATIONS  
For women of child-bearing potential, urine pregnancy test to be performed according to local site 
standards within 24 hours of study intervention.  Results must be available prior to administration of the 
treatment.  
7.3 
STUDY SCHEDULE 
 
7.3.1 SCREENING 
Screening Visit 
If the subject meets the preliminary study criteria the study doctor, and/or his/her designee, will obtain 
an informed consent from the subject, clearly indicating his/her understanding of the requirements and 
possible risks involved with study participation and other applicable treatment options.  Subjects will 
receive a unique identifying number that will be composed of a two-digit site number and a three digit 
subject number in sequence.  This unique identifier will be used throughout the entire study and will be 
entered in the subject’s case report form (CRF) and for each treatment.  

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 9 of 26 
 
During screening visit, the study investigator, and/or his/her designee, will assess the subject for eligibility 
to participate in the clinical study using the inclusion/exclusion criteria.  A urine sample for the pregnancy 
test will be obtained for female subjects of child-bearing potential.  During screening, the study doctor 
will review the subject’s medical/surgical history and examine the target treatment areas to ensure they 
meet the study criteria.   
 
Subjects will be instructed to avoid sun exposure of the target treatment areas for at least six weeks before 
treatment and to use broad spectrum sunscreen of no less than 30 SPF daily.  In addition, tanning is to be 
strictly avoided.   
The investigator will ask women of child-bearing potential for the date of their last period.  The 
investigator shall inquire about the form of contraceptive they use to confirm they meet the inclusion 
criteria. 
The subject will complete screening and the treatment will be scheduled.  Treatment may be performed 
on the day. 
 
7.3.2 ENROLLMENT/BASELINE 
Enrollment/Baseline/Treatment Visit (Visit 1 – Day 0) 
Pre-Treatment 
The investigator will confirm that the subject continues to meet the inclusion and none of the exclusion 
criteria.  Adverse events and any changes to concomitant medications will be recorded.   
 
The location and size of the treatment area will be left to the principal investigator’s judgement based 
on his/her assessment of individual subject requirements for treatment.  The defined abdomen and or 
the flank treatment area will be marked with a white laser pencil using a treatment template as per the 
sponsor’s instructions.  Photographs of the marked treatment area. 
Treatment 
Protective eye goggles will be worn by both the patient and site staff performing the treatment for the 
duration of the treatment session.  
Based on the mild nature of treatment, anesthesia is not required. The treatment procedure should 
include positioning of the patient in a manner that enables access to the target treatment anatomical 
site.   
The belt will be positioned on the subject as per the marked treatment template.  Laser applicators will 
be secured in place by the belt with the areas treated for up to 25 minutes.  The laser energy will be 
delivered to the area while cooling is administered to the skin surface to increase subject comfort.  
Treatment will continue until the total treatment area has been treated.   
The assessment of discomfort/pain during the treatment procedure will be assessed using the Wong-
Baker Faces Pain rating scale with treatment parameters adjusted according to patient’s comfort level. 
Post Treatment 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 10 of 26 
 
Assessment 
The assessment of discomfort/pain based at the subject’s completion of the Wong-Baker Faces Pain 
rating scale should also be documented immediately after treatment.  
The normal response to this treatment is transient tenderness, edema and/or induration in the treated 
area which should resolve within one to two weeks.  If any other side effects occur or persist for longer 
than expected, they must be recorded in the adverse event (AE) section of the case report form (CRF).  
For post-treatment cooling and/or discomfort, cold packs can be applied to treatment area if needed 
with acetaminophen at recommended doses used to alleviate pain as needed. 
During the day following treatment, care should be taken to prevent any mechanical or thermal damage 
to the treated sites:  avoid hot baths, massage, contact sports, swimming, etc.  The treated areas should 
be kept clean to avoid contamination or infection.  The subject should be reminded to not make any 
major changes in their diet or lifestyle during the course of the study.  
Subjects will be discharged from the clinic and will be scheduled to return for the subsequent 
treatments at 8 and 16 weeks later. 
Optional vaccum assisted RF and PEMF treatments may be administered as per the discression of the 
physician (PI).  A 15 minute period should lapse between the diode therapy and the RF therapy. 
Treatment procedure should include positioning of the patient in a manner that enables access to the 
treated anatomical site. A layer of Glide™ is applied to the treatment area – the entire waist using an 8 
½ x 11 sheet of paper as a guide.  This area is to be drawn out using an eyeliner or skin pen on both sides 
of the umbilicus. 
Select the RF/PEMF applicator using the GUI and ATC.  The settings should populate to 75% RF output 
for the outer electrodes, 50% for the inner electrode 9only the 75% diplsays), Varipulse 2, time ≈15 
minutes and 0 interval time.  Set the target temperature to 42-45 degrees C.  Press the start button to 
begin treatment. The aim is to heat the skin’s surface to a minimum of 42°C and a maximum of 45°C. 
Always try to treat at the highest temperature the subject can tolerate comfortably for optimal clinical 
results. Tissue temperature reading will be displayed on the screen.  
Treat half the abdomen at time with slow steady movements never pausing.  Applicator movements 
should be performed in random patterns of “8’s”, circles, elliptical, or zigzags covering the entire area.  
At one minute the temperature should be approximately 42°C or higher.  Once the temperature reaches 
42°C or higher, treat the other side of the abdomen as described above for one minute or until the 
temperature reaches 42°C or higher. Once both sides have been treated for the initial minute, treat the 
entire abdomen in a random pattern assessing the patients comfort verbally.  If the patient is 
uncomfortable, speed up movements.  Slowing down movements increases the temperature in the skin. 
Note the final energy percentage at the end of treatment and the time spent treating the area at the 
final energy percentage.   
During the procedure, ensure that the electrodes of the applicator are gently pressed on the skin, 
making sure all electrodes are in contact with the skin at all times. In order to avoid overheating and to 
enhance the tolerance of the procedure, the applicator should be in constant motion.  If the measured 
skin surface temperature (when measured by an external digital thermometer) at endpoint is less than 
42°C on the body, treatment is not optimal and the desired results will not be accomplished.  Achieved 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 11 of 26 
 
skin temperature depends on applicator movement speed and energy level. The lower the energy the 
slower the movement should be and vice-versa. In the event that a subject experiences discomfort or 
show signs of pain during the treatment, either decrease the energy %, or apply more Glide™, or 
perform bigger and quicker movements or stop the treatment. The built-in thermal sensor is being used 
only to verify that the recommended temperature (endpoint) of the treated area is being achieved and 
maintained. In the event that a client suddenly does not feel good or in a distress, the Emergency Button 
MUST be pressed by the client or the operator.  By pressing the Emergency Button, the power supply 
will be switched off immediately. 
The Varipulse should be left at the default of 2 for best clinical outcomes but can be reduced or 
increased for a different feeling to the subject and for comfort, depending on the subject’s skin type, to 
ensure that the applicator can move in a comfortable fashion on the skin.  It should never feel like the 
skin is being dragged or pulled  
During treatment, subject reaction must be monitored and if the subject reports an intolerable level of 
pain, treatment shall be ceased immediately.  
The normal response to these treatments is transient erythema and edema and the sensation of heat. 
These will not be considered as adverse events unless they are severe enough to stop treatment or 
warrant intervention or if the principal investigator determines they are adverse events. If any other 
adverse effects occur, as indicated in the protocol, they will be recorded. 
 
7.3.3 FOLLOW UP AND FINAL STUDY VISIT 
Visit 24 (± 7 days)  
Subjects will return to the clinic 24 weeks after the first treatment.  Adverse events and any changes to 
concomitant medications will be recorded.   
If the site chose to capture ultrasound images, these would be captured during this visit.  
Photographs of the marked treatment area. 
Subjects will complete the satisfaction survey and the treatment satisfaction form.   
The End of Study form will be completed and subjects will be discharged from the clinic and terminated 
from the study.   
The PI will record all reportable events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious Aes) or 30 days (for SAEs) after the last day of study participation. 
7.3.4 EARLY TERMINATION VISIT 
Subjects who terminate the study early for whatever reason, will be asked to provide a reason for their 
early termination.  Adverse events and the reason for early termination will be recorded. 
7.3.5 UNSCHEDULED VISIT 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 12 of 26 
 
If an unscheduled visit occurs, the reason for the unscheduled visit will be documented.  If the 
unscheduled visit is the result of an adverse event, the event will be recorded on the adverse event CRF. 
 
7.4 
CONCOMITANT MEDICATIONS, TREATMENTS, AND PROCEDURES  
All concomitant prescription medications taken during study participation will be recorded on the case 
report forms (CRFs).  For this protocol, a prescription medication is defined as a medication that can be 
prescribed only by a properly authorized/licensed clinician.  Other medications to be reported in the CRF 
are concomitant over-the-counter medications and non-prescription medications. 
7.5 
PROHIBITED MEDICATIONS, TREATMENTS, AND PROCEDURES  
The use of immunosuppressive medications, antiplatelet medications, thrombolytics, anti-inflammatory 
medicatons and anticoagulant medications is to be avoided.  Herbal supplements, perfumes, cosmetics 
and/or medications that may affect sensitivity to light are prohibited.  The use of Accutane™ 
(Isotretinoin) within the past six months is also strictly prohibited.  
7.6 
RESCUE MEDICATIONS, TREATMENTS, AND PROCEDURES  
In the event that the subject experiences pain, the principal investigator may prescribe any analgesic 
deemed appropriate to the level of pain.  If a subject experiences any first, second or third degree burn 
or pain beyond narcotics, then the following procedure will be implemented: 
Immediate triage and treatment of the patient shall be determined by the treating physician and based 
upon severity and type of burn identified.  
The event will be reported to the study Director within 24 hours of occurrence. If the event meets the 
criteria of a SAE, then it must be reported on the SAE form. 
A copy of the patient chart and treatment parameters are to be forwarded to the study Director within 
24 hours.   
The study Director will be responsible for issuing a written report to the company and the IRB Chairman 
no later than 7 days from the incident.  
Long term follow up and care shall continue at the discretion of the treating physician.  
All patients experiencing a complication of the device will be followed a minimum of 2 years following 
the initial injury.  Longer care and observation will be at the discretion of the treating physician.   
All minor complications such as appearance or altered sensation, except for pain, can be reported within 
30 days of patient complaint.  Both chart and treatment parameters are to be provided to the study 
Director and shared with the company and IRB chairman. 
8 
ASSESSMENT OF SAFETY 
 
8.1 
SPECIFICATION OF SAFETY PARAMETERS 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 13 of 26 
 
In addition to spontaneous reports of adverse events, subjects will complete a Wong Baker 
discomfort/pain visual pain scale and the principal investigator will examine the treated area and report 
immediate response. 
8.1.1 DEFINITION OF ADVERSE EVENTS (AE) 
Adverse event means any untoward medical occurrence associated with the use of an intervention in 
humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
8.1.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) 
NOTE: The term serious is not synonymous with severity, which may be used to describe the intensity of 
an event experienced by the subject). An AE that does not meet any of the below criteria will be 
classified as non-serious. 
A serious AE is any event that: 
• 
Results in, or contributes to a death; 
• 
Is immediately life  threatening (injury or illness); 
• 
Results in hospitalization, or prolongs an existing hospitalization;  
• 
Results in permanent impairment of body structure or function, or in persistent or significant 
disability/incapacity;  
• 
Results in an injury that requires medical intervention to prevent permanent impairment of 
body structure or function; 
• 
Is a device malfunction or deterioration in the characteristics and/or performance of the device 
that results in death or serious deterioration in health; 
• 
Is a device malfunction or deterioration in the characteristics and/or performance of the device 
that, if it were to occur again, could result in death or serious deterioration in health; 
• 
Results in a congenital anomaly or birth defect. 
• 
Is any medically significant injury, event or experience that requires medical/surgical 
intervention to prevent one of the outcomes listed above; 
• 
Results in end  organ toxicity, including hematological, renal, cardiovascular, hepatic, 
gastrointestinal, and central nervous system events; 
8.1.3 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
This definition includes an unanticipated adverse device effect, any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or application), or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of 
subjects (21 CFR 812.3(s)). 
8.2 
CLASSIFICATION OF AN ADVERSE EVENT 
 
8.2.1 SEVERITY OF EVENT 
For Aes not included in the protocol defined grading system, the following guidelines will be used to 
describe severity. 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 14 of 26 
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities. 
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating. 
8.2.2 RELATIONSHIP TO STUDY AGENT 
The clinician’s assessment of an AE’s relationship to the study agent is part of the documentation 
process, but it is not a factor in determining what is or is not reported in the study. If there is any doubt 
as to whether a clinical observation is an AE, the event should be reported. All Aes must have their 
relationship to study agent assessed. In a clinical trial, the study product must always be suspect. To 
help assess, the following guidelines are used. 
• 
Related – The AE is known to occur with the study agent, there is a reasonable possibility that 
the study agent caused the AE, or there is a temporal relationship between the study agent and 
event. Reasonable possibility means that there is evidence to suggest a causal relationship 
between the study agent and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study agent 
caused the event, there is no temporal relationship between the study agent and event onset, 
or an alternate etiology has been established. 
8.2.3 EXPECTEDNESS  
Expected adverse reactions are Aes that are common and known to occur for the study agent being 
studied.  Expected adverse events of the treatment include transient tenderness, erythema, edema, 
and/or induration in the treated area lasting from one to three weeks after the treatment.   
The device has a contact tissue cooling system in place during the procedure to minimize thermal 
discomfort and prevent damage to the treatment area.   Expected adverse events related to the contact 
cooling include tingling, itching, decreased sensation, numbness, erythema and tenderness.   
An AE or suspected adverse reaction is considered “unexpected” if it is not known to occur for the study 
treatment being studied and at the specificity or severity that has been observed. 
8.3 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an AE or SAE may come to the attention of study personnel during study visits and 
interviews of a study participant presenting for medical care, or upon review by a study monitor. All Aes 
including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate CRF. Information to be collected includes event description, time of onset, clinician’s 
assessment of severity, relationship to study product (assessed only by those with the training and 
authority to make a diagnosis), and time of resolution/stabilization of the event. All Aes occurring while 
on study must be documented appropriately regardless of relationship. All Aes will be followed to 
adequate resolution. 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 15 of 26 
 
Any medical condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an AE. However, if the study participant’s condition deteriorates at any 
time during the study, it will be recorded as an AE. Ups will be recorded in the data collection system 
throughout the study. 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. Aes characterized as intermittent require documentation of 
onset and duration of each episode. 
The PI will record all reportable events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious Aes) or 30 days (for SAEs) after the last day of study participation. At 
each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events 
will be followed for outcome information until resolution or stabilization. 
8.4 
REPORTING PROCEDURES 
 
8.4.1 ADVERSE EVENT REPORTING  
All Aes will be recorded on the appropriate CRF and will include information about the start and stop 
dates, severity and relatedness. There should be an attempt to report a “diagnosis” rather than the 
individual signs, symptoms and abnormal laboratory values associated with the diagnosis. However, a 
diagnosis should be reported only if, in the Investigator’s judgment, it is relatively certain (i.e., definite 
or possible). Otherwise individual signs, symptoms and abnormal laboratory values should be reported 
as distinct adverse events. 
8.4.2 SERIOUS ADVERSE EVENT REPORTING  
All serious AE, whether or not deemed expected or device related, must be reported to the sponsor’s 
clinical research department immediately or within 24 hours by telephone (see contact details below). 
 
 
 
A written report prepared by the Principal Investigator must follow within seven working days to the 
clinical monitor and should include a full description of the event and sequence. 
The study investigator shall complete a Serious Adverse Event / Serious Adverse Device Effect Form and 
submit to the study sponsor and to the reviewing IRB as soon as possible, but in no event later than 10 
working days after the investigator first learns of the effect. The study sponsor contact information is 
provided in Section 1, Key Roles. The study sponsor is responsible for conducting an evaluation of an 
unanticipated adverse device effect and shall report the results of such evaluation to Health Canada, the 
FDA or local regulatory agency and to all reviewing IRBs and participating investigators within 10 
working days after the sponsor first receives notice of the effect. Thereafter the sponsor shall submit 
such additional reports concerning the effect as Health Canada, the FDA or local regulatory agency 
requests. 
8.4.3 UNANTICIPATED PROBLEM REPORTING  

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 16 of 26 
 
Incidents or events that meet the criteria for Ups require the creation and completion of an UP report 
form. It is the site investigator’s responsibility to report Ups to their IRB and to the study sponsor. The 
UP report will include the following information: 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project number; 
• 
A detailed description of the event, incident, experience, or outcome; 
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP; 
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
An investigator shall submit to the sponsor and to the reviewing IRB a report of any unanticipated 
adverse device effect occurring during an investigation as soon as possible, but in no event later than 10 
working days after the investigator first learns of the effect (21 CFR 812.150(a)(1)), A sponsor who 
conducts an evaluation of an unanticipated adverse device effect under 812.46(b) shall report the 
results of such evaluation to Health Canada, the FDA or local regulatory agency and to all reviewing IRB’s 
and participating investigators within 10 working days after the sponsor first receives notice of the 
effect. Thereafter the sponsor shall submit such additional reports concerning the effect as FDA (21 CFR 
812.150(b)(1)) or local regulatory agency requests.  
8.4.4 REPORTING OF PREGNANCY  
If a subject becomes pregnant during the course of the study, the subject will be terminated from the 
study. The pregnancy will be immediately reported to the sponsor on the Notification of Subject or 
Partner Pregnancy form and to the IRB using the same reporting timelines as a SAE. The investigator will 
follow the pregnancy until completion and will report the outcome of the pregnancy to the sponsor on 
the Notification of Subject or Partner Pregnancy Outcome form and the IRB within 10 business days. 
8.5 
STUDY HALTING RULES  
The study may be halted at any time by the sponsor, the IRB, Health Canada, the FDA or local regulatory 
agencies due to safety concerns.  Examples of findings that might trigger a safety review are the number 
of SAEs overall, the number of occurrences of a particular type of SAE, severe Aes/reactions, or 
increased frequency of events. If the study is halted, the sponsor will immediately notify all 
investigational sites, the IRB(s), Health Canada, the FDA or local regulatory agencies. 
8.6 
SAFETY OVERSIGHT 
Independent oversight is an important component to ensure human subjects’ protection.  Safety 
oversight will be under the direction of the sponsor and a medical monitor. 
9 
CLINICAL MONITORING 
Clinical site monitoring is conducted to ensure that the rights and well-being of human subjects are 
protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of 
the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with 
applicable regulatory requirement(s). 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 17 of 26 
 
• 
Monitoring for this study will be performed by the sponsor or designate. 
• 
On-site monitoring will occur within 4 weeks of first enrolled subject (s) and will occur as often 
as required per site. 
• 
The Study Director or designate will be provided copies of monitoring reports within 15 business 
days of visit. 
10 
STATISTICAL CONSIDERATIONS  
 
10.1 
STATISTICAL AND ANALYTICAL PLANS 
The Statistical and Analytical Plans (SAP) may be revised during the study to accommodate Clinical Trial 
Protocol Amendments and to make changes to adapt to unexpected issues in study execution and data 
that affect planned analyses.  If revised, a formal SAP will be completed and issued prior to database 
lock and unblinding of the study data. 
10.2 
ANALYSIS DATASETS 
The null and alternative hypotheses for the study’s primary, key secondary and safety endpoints are; 
• 
Primary Efficacy Endpoints: Statistical hypothesis will not be applied in the analysis of the study’s 
primary endpoint  
 
• 
Secondary Efficacy Endpoint(s):  
 
o Null Hypothesis (Ho: µd = µpost – µpre = 0) – There is no satisfaction with the treatment at 
twelve weeks using the 5-Point Likert Subject Satisfaction Scale as assessed by the 
subjects. 
 
Alternative Hypothesis (Ha: µd = µpost – µpre ≠ 0) – There is satisfaction with the treatment 
at twelve weeks using the 5-Point Likert Subject Satisfaction Scale as assessed by the 
subjects. 
• 
Safety Endpoint: Statistical hypothesis will not be used in the analysis of the study’s safety 
endpoint. 
10.3 
DESCRIPTION OF STATISTICAL METHODS 
The Intention-to-Treat Analysis Dataset will be used; efficacy and safety analyses will be carried out on all 
subjects who underwent Venus Bliss™ treatment. 
10.4.1 GENERAL APPROACH 
This is an open-label, baseline-controlled, evaluator-blind multi-center study evaluating treatment with 
a 1064 nm diode laser, vaccum assisted radio frequency and pulsed electromagnetic fields for non-
invasive fat reduction of the abdomen and flanks.   

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 18 of 26 
 
All summary tables for quantitative parameters will display mean, standard deviation, median, range 
(minimum and maximum), percentages as well as number of missing data (if relevant).  All summary 
tables for qualitative parameters will display counts, percentages and number of missing data if 
relevant. Baseline data are defined as the last photograph and measurement performed before the first 
treatment on Visit 1.  
All statistical tests will be two-sided, where applicable. The level of statistical significance for 
effectiveness analyses is 5% (α = 0.05) for all tests of differences. Where appropriate, t-test and/or two-
proportion z-test will be used to compare outcome at twelve weeks post-treatment as compared to 
baseline. This test will enable us to accept or reject the null hypotheses. Rejection of null hypotheses will 
establish that: 
• 
The two-sided 95% confidence interval for the difference between the means excludes zero. 
• 
The two means are statistically significantly different at the 5% level (P < 0.05) two-sided. 
Upon rejection of null hypotheses, further statistical test tools such as Confidence Interval, and/or One-
way ANOVA and/or descriptive statistical tools may be used to determine the performance of the 
treatment. 
In order to accommodate imbalances of some baseline of scores or measurements, covariate adjustment 
analysis may be performed in SAP to estimate adjusted treatment effects for the primary endpoint 
analysis. 
The assumption for the statistical test is that variables are normally distributed within study group and 
the variation of scores or measurements at twelve weeks post-treatment as compared to baseline is not 
reliably different. 
The safety analysis will be done by analyzing spontaneous reports of adverse events (AE), subjects’ 
completed Wong Baker visual pain scale and immediate response reports by the principal investigator 
from his/her observation/examination of the treated area.  Appropriate Medical Dictionary for 
Regulatory Activities (MedDRA) code will be used to describe all spontaneously reported or other study 
related adverse events. 
10.4.2 ANALYSIS OF THE PRIMARY ENDPOINTS 
The following will be consider for the analysis primary endpoints: 
The results of a Blinded Reviewer’s evaluation of photographs taken at 16 and 24 weeks compared to 
baseline will be analyzed and the results will be reported as a % of the correctly identified post treatment 
photographs chosen per Blinded Reviewer. An average of the % of the correctly identified post treatment 
photographs chosen by Blinded Reviewer will be calculated and used to determine  
 
Bar, pie charts or graphs indicating percentages of the correctly identified post treatment photographs 
chosen by Blinded Reviewer may also be used to analyse efficacy. 
The efficacy endpoint to treatment will be defined by an average of the 65% of the correctly identified 
post treatment photographs chosen by Blinded Reviewer This will be used to determine if the study meets 
the primary endpoint expectation. 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 19 of 26 
 
The % of the correctly identified post treatment photographs chosen by Blinded Reviewer of all subjects 
who received at least one treatment of Venus Bliss™  and for whom at least one valid post-baseline 
assessment were obtained will be analysed for these primary endpoints. Mutiple imputation  method or 
modelling of available data may be used for missing data as appropriate. 
10.4.3 ANALYSIS OF THE SECONDARY ENDPOINTS 
For the analysis of subjects’ assessment of satisfaction with the treatment secondary endpoints the 
following analysis will be considered: 
Bar charts, pie chart, graphs or any other descriptive statistical displays indicating scores, percentages 
and/or proportions of subjects assessment of satisfaction at 16 and 24 weeks post-treatment will be used 
where applicable to analyse efficacy. 
 
All statistical tests that will be two-sided. The level of statistical significance for effectiveness analyses is 
5% (α = 0.05) for all tests of differences. Where appropriate, two-proportion z-test will be used to compare 
the subjects’ assessment of satisfaction at twelve weeks post-treatment.  Analysis of Covariance 
(ANCOVA) may also be used where appropriate.  
Mutiple imputation  method or modelling of available data may be used for missing data as appropriate. 
10.4.5 SAFETY ANALYSIS 
The safety analysis will be done by analyzing spontaneous reports of adverse events (AE), subjects’ 
completed 10 point Wong Baker visual pain scale and a response questionnaire. Appropriate Medical 
Dictionary for Regulatory Activities (MedDRA) code will be used to describe all spontaneously reported or 
other study related adverse events. 
Summaries of spontaneously reported or other study related adverse events will be presented as: 
o Number (%) of subjects with any AE, 
o Number (%) of subjects with any serious adverse events (SAE), 
o Number (%) of subjects permanently withdrawn from treatment due to AE 
Summaries of analysis of immediate response reports by the principal investigator examination will be 
displayed on a  bar or pie chart as; 
o the overall frequency of subjects with each event (pain during treatment, hemorrhage, burn, 
erythema, edema, purpura) 
o Frequency of subjects with specific severity/intensity for each event using a 5 points scale: 
1=none; 2=trace; 3=moderate; 4=marked; 5=severe 
o The overall percentage or proportion of subject observed with marked or severe intensity of any 
event will be calculated and compared to those with none, trace or moderate severity/intensity 
with the aid of a bar or pie chart. 
The following will be considered for the analysis of 10 Wong Baker visual pain scores safety data: 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 20 of 26 
 
A summary table of the 10 wong baker visual pain scores post treatment will be displayed as mean 
difference, standard deviation and standard error.  The Wong baker visual pain scale is a 11-level (0 to 10) 
ordinal scale tool for assessing pain. 
 
The overall percentage or proportion of subject that recorded marked or severe post treatment 
discomfort/pain visual pain scores may be calculated and compared to those with none, trace, low or 
moderate discomfort/pain using a bar or pie chart.  
10.4.6 ADHERENCE AND RETENTION ANALYSES 
Adherence to the protocol will be assessed by calculating the number or (%) subjects’ data for each 
endpoint assessment that is not provided in subjects Case Report Forms. This will be further analyzed as 
per frequency of each endpoint data that is not available due to loss to follow-up, discontinuation of the 
intervention or any other reason. 
10.4.7  BASELINE DESCRIPTIVE STATISTICS 
Subjects baseline measurements and scores of all applicable endpoints will be compared using 
descriptive statistics such as mean score, standard deviation, standard error, range and graphical 
presentations.  
10.4.8 PLANNED INTERIM ANALYSES  
No interim analysis is planned.   
10.4.8.1 
SAFETY REVIEW 
There will be no interim analysis during this study. However, this study may be temporarily suspended or 
prematurely terminated if there is sufficient reasonable cause as per section 5.5 and 8.5.  
10.4.8.2 
EFFICACY REVIEW 
There will be no interim analysis during this study. However, this study may be temporarily suspended 
or prematurely terminated if there is sufficient reasonable cause as per section 5.5 and 8.5. 
10.4.9 ADDITIONAL SUB-GROUP ANALYSES 
Not applicable.  Primary or secondary endpoints may be analyzed based on age, sex, race/ethnicity or 
other demographic characteristic(s). 
10.4.10 
TABULATION OF INDIVIDUAL RESPONSE DATA 
Individual participant data will be listed by measure and time point as appendix to the study report. 
10.4.11 
EXPLORATORY ANALYSES 
Not applicable.  
10.5 
SAMPLE SIZE 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 21 of 26 
 
 
10.6.1 ENROLLMENT/ RANDOMIZATION/ MASKING PROCEDURES 
At screening, once a subject has signed the informed consent, and inclusion/exclusion criteria has been 
met, a subject number will be assigned. Subjects will receive a unique identifying number that will be 
composed of a two-digit site number and a three digit subject number in sequence.  This unique 
identifier will be used throughout the entire study and will be entered in the subject’s case report form 
(CRF) and for each treatment. Subjects are not randomized; this is an open-label, baseline-controlled, 
evaluator-blind multi-center study. 
 
10.6.2 EVALUATION OF SUCCESS OF BLINDING  
This is an open-label, baseline-controlled, evaluator-blind multi-center study; only the independent 
reviewers will be blinded. 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
Each participating site will maintain appropriate medical and research records for this trial, in 
compliance with ICH E6, ISO 14155:2011, HIPAA and regulatory and institutional requirements for the 
protection of confidentiality of participants.  Each site will permit authorized representatives of the 
study sponsor and regulatory agencies to examine (and when permitted by applicable law, to copy) 
clinical records for the purposes of quality assurance reviews, audits, and evaluation of the study safety, 
progress, and data validity.  
Source data are all information, original records of clinical findings, observations, or other activities in a 
clinical trial necessary for the reconstruction and evaluation of the trial. Examples of these original 
documents and data records include, but are not limited to, hospital records, clinical and office charts, 
laboratory notes, memoranda, participants’ memory aids or evaluation checklists, pharmacy dispensing 
records, recorded audio tapes of counseling sessions, recorded data from automated instruments, 
copies or transcriptions certified after verification as being accurate and complete, microfiches, 
photographic negatives, microfilm or magnetic media, x-rays, and participant files and records kept at 
the pharmacy, at the laboratories, and medico-technical departments involved in the clinical trial.  
It is acceptable to use CRFs as source documents. The 5-point Likert Subject satisfaction Scale, treatment 
evaluation and visual pain scale data for this study will be collected on the CRF.  The immediate 
response as assessed by the principal investigator will be collected on the CRF with the remainder of the 
data collected from other sources.  It is not acceptable for the CRF to be the only record of a subject’s 
participation in the study. This is to ensure that anyone who would access the patient medical record 
has adequate knowledge that the patient is participating in a clinical trial. 
12 
QUALITY ASSURANCE AND QUALITY CONTROL 
Prior to any independent use of the Venus Bliss™ investigational device, study personnel will receive 
proper training from the sponsor.  Site personnel will be trained on the use of the device prior to study 
initiation at the site.  Additional training requirements will be discussed during study initiation and will 
include site responsibilities, and study documentation.   In addition, the sponsor will provide protocol 
specific training for the site.  The site will document which individual has been assigned to a specific task 
and will ensure that appropriate training has occurred for that task. 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 22 of 26 
 
Regular monitoring and an independent audit, if conducted, must be performed according to ICH-GCP 
and ISO 14155:2011. See also Section 9, Clinical Monitoring. 
Quality control (QC) procedures will be implemented beginning with the data entry system and data QC 
checks that will be run on the database will be generated. Any missing data or data anomalies will be 
communicated to the site(s) for clarification/resolution. 
Monitors will verify that the clinical trial is conducted and data are generated, documented (recorded), 
and reported in compliance with the protocol, GCP, and the applicable regulatory requirements. 
The investigational site will provide direct access to all trial related sites, source data/documents, and 
reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and 
regulatory authorities. 
13 
ETHICS/PROTECTION OF HUMAN SUBJECTS  
 
13.1 
ETHICAL STANDARD  
The investigator will ensure that this study is conducted in full conformity with Regulations for the 
Protection of Human Subjects of Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 
and/or the ICH E6, the Declaration of Helsinki, Council for International Organizations of Medical Science 
(CIOMS), ISO 14155:2011, International Ethical Guidelines for Biomedical Research Involving Human 
Subjects (2002), or another country’s ethical policy statement, whichever provides the most protection 
to human subjects. 
13.2 
INSTITUTIONAL REVIEW BOARD  
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval.  Approval of both the protocol and the consent form must 
be obtained before any participant is enrolled.  Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study.  All changes to the consent form 
will be IRB approved; a determination will be made regarding whether previously consented participants 
need to be re-consented. 
13.3 
INFORMED CONSENT PROCESS  
 
13.3.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
Informed consent is required for all subjects in a study.  In obtaining and documenting informed 
consent, the investigator should comply with applicable regulatory requirements and should adhere to 
45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, or equivalent local regulatory regulations or guidelines 
and/or ICH GCP.  Prior to the ̭̼ͮbeginning of a trial, the investigator should have the IRB’s written approval 
for the protocol and the written informed consent forms(s) and any other written information to be 
provided to the participants.  Consent forms describing in detail the study agent, study procedures, and 
risks are given to the participant and written documentation of informed consent is required prior to 
starting intervention/administering study product. 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 23 of 26 
 
13.3.2 CONSENT PROCEDURES AND DOCUMENTATION 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation.  Extensive discussion of risks and 
possible benefits of participation will be provided to the participants and their families.  Consent forms 
will be IRB-approved and the participant will be asked to read and review the document.  The 
investigator will explain the research study to the participant and answer any questions that may arise. 
All participants will receive a verbal explanation in terms suited to their comprehension of the purposes, 
procedures, and potential risks of the study and of their rights as research participants.  Participants will 
have the opportunity to carefully review the written consent form and ask questions prior to signing. 
The participants should have the opportunity to discuss the study with their surrogates or think about it 
prior to agreeing to participate.  The participant will sign the informed consent document prior to any 
procedures being done specifically for the study.  The participants may withdraw consent at any time 
throughout the course of the trial.  A copy of the informed consent document will be given to the 
participants for their records.  The rights and welfare of the participants will be protected by 
emphasizing to them that the quality of their medical care will not be adversely affected if they decline 
to participate in this study. 
13.4 
PARTICIPANT AND DATA CONFIDENTIALITY  
Participant confidentiality is strictly held in trust by the participating investigators, their staff, and the 
sponsor(s) and their agents.  This confidentiality is extended to cover testing of biological samples and 
genetic tests in addition to the clinical information relating to participants.  Therefore, the study 
protocol, documentation, data, and all other information generated will be held in strict confidence.  No 
information concerning the study or the data will be released to any unauthorized third party without 
prior written approval of the sponsor. 
The study monitor, other authorized representatives of the sponsor, representatives of the IRB or device 
company supplying study product may inspect all documents and records required to be maintained by 
the investigator, including but not limited to, medical records (office, clinic, or hospital) and pharmacy 
records for the participants in this study.  The clinical study site will permit access to such records. 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study.  At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the sponsor, local IRB and any other regulations. 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored at the sponsor’s office.  This will not include the participant’s contact or 
identifying information.  Rather, individual participants and their research data will be identified by a 
unique study identification number.  The study data entry and study management systems used by 
clinical sites and by sponsor’s research staff will be secured and password protected.  At the end of the 
study, all study databases will be de-identified and archived by the sponsor. 
13.4.1 RESEARCH USE OF STORED HUMAN SAMPLES, SPECIMENS OR DATA 
The investigator will store all data according to the local regulatory standards. 
14 
DATA HANDLING AND RECORD KEEPING  

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 24 of 26 
 
 
14.1 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
PI.  The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of 
the data reported. 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data.  Black ink is required to ensure clarity of reproduced copies.  When making changes or 
corrections, cross out the original entry with a single line, and initial and date the change. DO NOT 
ERASE, OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON THE ORIGINAL. 
Copies of the paper CRF will be provided for use as source documents and maintained for recording data 
for each participant enrolled in the study.  Data reported in the CRF derived from source documents 
should be consistent with the source documents or the discrepancies should be explained and captured 
in a progress note and maintained in the participant’s official study record.  Self-reported subject data 
recorded on the non-carbon copy CRF page is permitted.  The original form will be collected by the 
sponsor and the copy will remain at the site. 
Clinical data (including Aes, concomitant medications, and expected adverse reactions data) and clinical 
laboratory data from paper CRFs will be collected by the study sponsor and will be entered directly onto 
paper CRFs from the source documents. 
14.2 
STUDY RECORDS RETENTION  
Study documents, including copies of the paper CRFs, signed informed consent forms, photographs, 
laboratory results, medical records, data clarification forms and regulatory documents, should be 
retained for a minimum of 2 years after the last approval of a marketing application in an ICH region and 
until there are no pending or contemplated marketing applications in an ICH region or until at least 2 
years have elapsed since the formal discontinuation of clinical development of the investigational 
product.  These documents should be retained for a longer period, however, if required by local 
regulations.  No records will be destroyed without the written consent of the sponsor, if applicable. It is 
the responsibility of the sponsor to inform the investigator when these documents no longer need to be 
retained. 
14.3 
PROTOCOL DEVIATIONS  
A protocol deviation is any noncompliance with the clinical trial protocol or GCP requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly. 
These practices are consistent with ISO 14155:2011 and ICH E6: 
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3 
• 
5.1 Quality Assurance and Quality Control, section 5.1.1 
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2. 
It is the responsibility of the site to use continuous vigilance to identify and report deviations within 10 
working days of identification of the protocol deviation, or within 10 working days of the scheduled 

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 25 of 26 
 
protocol-required activity. All deviations must be addressed in study source documents. Protocol 
deviations must be sent to the local IRB per their guidelines. The site PI/study staff is responsible for 
knowing and adhering to their IRB requirements.  
14.4 
PUBLICATION AND DATA SHARING POLICY 
The International Committee of Medical Journal Editors (ICMJE) member journals have adopted a 
clinical trials registration policy as a condition for publication. The ICMJE defines a clinical trial as any 
research project that prospectively assigns human subjects to intervention or concurrent comparison or 
control groups to study the cause-and-effect relationship between a medical intervention and a health 
outcome. Medical interventions include drugs, surgical procedures, devices, behavioral treatments, 
process-of-care changes, and the like. Health outcomes include any biomedical or health-related 
measures obtained in patients or participants and adverse events.  The ICMJE policy, and the Section 
801 of the Food and Drug Administration Amendments Act of 2007, requires that all clinical trials be 
registered in a public trials registry such as ClinicalTrials.gov, which is sponsored by the National Library 
of Medicine. Other biomedical journals are considering adopting similar policies. The ICMJE does not 
review specific studies to determine whether registration is necessary; instead, the committee 
recommends that researchers who have questions about the need to register err on the side of 
registration or consult the editorial office of the journal in which they wish to publish. 
The sponsor or designated principal investigator will register and report results of certain “applicable 
clinical trials”: 
• 
Trials of Devices: Controlled trials with health outcomes of a product subject to Health Canada 
or FDA regulation (other than small feasibility studies) and pediatric post market surveillance 
studies. 
15 
STUDY ADMINISTRATION 
 
15.1 
STUDY LEADERSHIP 
The study will be administered by the sponsor. 
16 
CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence, such as by the device industry, is 
critical.  Therefore, any actual conflict of interest of persons who have a role in the design, conduct, 
analysis, publication, or any aspect of this trial will be disclosed and managed.  Furthermore, persons 
who have a perceived conflict of interest will be required to have such conflicts managed in a way that is 
appropriate to their participation in the trial.  The sponsor will ensure that all study group members 
disclose all conflicts of interest and will establish a mechanism for the management of all reported 
dualities of interest. 
17  
LITERATURE REFERENCES  

1064 Diode Laser, vaccum assisted RF and PEMF for Non-invasive Fat Reduction of the Abdomen and Flanks 
Version 5.0 
Protocol #BL0319 
29 October 2019 
Page 26 of 26 
 
Alizadeh Z, Halabchi F, Mazaheri R, et al.  Review of the Mechanisms and Effects of Noninvasive Body 
Contouring Devices on Cellulite and Subcutaneous Fat.  Int J Endorcrinol Metab. 2016 Oct; 14(4): 
e36727. 
Auh SL, Iyengar S, Weil A, Bolotin D et al.  Quantification of Noninvasive Fat Reduction:   A Systematic 
Review.  Laser in Surg Med.  2018 50:  96-110. 
Bass LS, Doherty ST. Safety and Efficacy of a noninvasive 1064nm Diode Laser for Fat Reduction of the 
Abdomen.  J Drugs Dermatol. 2018 17(1):  106-112 
Chilukuri S, Mueller G.  “Hands Free” Noninvasive Body contouring Devices:  Review of Effectiveness and 
Patient Satisfaction.  J Drugs Dermatol. 2016 15(11):  1402-1406.  
Decorato JW, Chen B, Sierra R.  Subcutaneous Adipose Tissue Response to a Non-Invasive Hyperthermic 
Treatment using a 1064nm Laser.  Lasers in Surg Med.  2017 49(5):  480-489.  
Godwin M, Pike A, Bethune C et al. Concurrent and Convergent Validity of the Simple Lifestyle Indicator 
Questionnaire.  ISRN Family Medicine Volume 2013, Article ID 529645, 6 pages. 
Katz B, Doherty S.  Safety and Efficacy of a Noninvasive 1064nm Diode Laser for Fat Reduction of the 
Flanks.  Dermatol Surg. 2018 44(3):  388-396. 
McBean JC, Katz BE.  Laser Lipolysis:  An Update.  J Clin Aesthetic Derm.  2011 4(7): 25-34. 
Schilling L, Saedi N, Weiss R. 1064 nm Diode Hyperthermic Laser Lipolysis: The Latest in Non-Invasive 
Body Contouring. J Drugs Dermatol. 2017 Jan 1;16(1):48-52. 
Amir R. Clinical Evaluation on the Efficacy and Safety of the VelaShape III Device for Abdominal 
Circumferential Reduction Treatments. Syneron 2013. 
APPENDIX 
 
Version 
Date 
Significant Revisions  
V2 
July 2, 2019 
Spelling errors for the word vacuum corrected, header 
corrected from 1064nm to 1064nm 
V3 
July 29, 2019 
Added “and abdomen” to page 3 and 4 as a correction a sit 
stated flanks. 
V4 
August 21, 2019 
Updated date, V4, post market product not pre, added a 
follow up to subject visits, clarified three treatments and 
updated timeline, added a photographic evaluation to visit 8, 
16, 24 and updated monitoring timeline 
V5 
October 29,2019 
Updated version number, date, contact info, 1060nm change 
to reflect tested wavelength of 1064nm ±10nm, added 
optional ultrasound images (baseline and up to three 
additional)