The Safety and Efficacy of Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System
Phase: NA
Conditions: Laser Assisted Liposuction
Sponsor: Alma Lasers

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 1 of 42 
CONFIDENTIAL 
 
 
 
 
 
 
 
 
The Safety and Efficacy of Laser Assisted 
Liposuction and Facial Autologous Fat Grafting 
with the LipoLifeTM System 
 
 
Protocol No: ALM-Lipo-002 
Version: 2.1 
Date: 25 Oct 2018  
 
SPONSOR 
Alma Lasers Ltd.  
14 Halamish Street, POB 3021 
Caesarea Industrial Park 
Caesarea, Israel 38900 
Phone: 972-54-7866020  
Fax: +972-4-627-5368 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 2 of 42 
CONFIDENTIAL 
 
Prepared by: 
Name 
Function 
Date 
Signature 
Ronit Lipson 
Clinical Manager 
25-Oct-18 
 
 
Approved by: 
Name 
Function 
Approval Date 
Signature 
Dr. Hanit Brenner-Lavie 
VP of Clinical Affairs, R&D  
 
 
Prof. Lior Heller 
Principal Investigator  
(Assaf Harofeh Medical Center, Israel)  
 
 
Dr. Jason Pozner 
Principal Investigator  
(Sanctuary Plastic Surgery, Boca Raton, 
Florida, US) 
 
 
 
Revision History: 
Revision 
Description of Change  
Amendment 
Effective Date 
1.0 
Original 
- 
04-July-18 
2.0 
Adding requirement for Photo consent by 
subjects and minor modifications 
 
31-July-18 
2.1 
Adding a facial MRI evaluation, after a 
facial fat grafting procedure at Sanctuary 
Plastic Surgery, Boca Raton site 
 
25-Oct-18 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 3 of 42 
CONFIDENTIAL 
 
STUDY ACKNOWLEDGMENT / CONFIDENTIALITY 
By signing this Protocol, the Investigator(s) acknowledges and agrees: 
The Protocol contains all necessary details for conducting the study.  The Investigator 
will conduct this study as detailed herein, in compliance with Good Clinical Practice 
(GCP) and the applicable regulatory requirements, and will make every reasonable 
effort to complete the study within the time designated. 
The Protocol and all relevant information on the device relating to pre-clinical and 
prior clinical experience, which was furnished by the Sponsor, Alma Lasers Ltd., will be 
made available to all physicians, nurses and other personnel who participate in the 
conducting of this study.  The Investigator will discuss this material with them to 
assure that they are fully informed regarding the device(s) and the conduct of the 
study. 
This is indicated as privileged or confidential. 
Alma Lasers Ltd. will have access to any source documents from which Case Report 
Form information may have been generated.  The Case Report Forms and other data 
pertinent to this study are the sole property of, Alma Lasers Ltd., which may utilise the 
data in various ways, such as for submission to government regulatory authorities, or 
in publication of the results of the study. 
The conduct and results of this study will be kept confidential.  The results of this study 
may be published. Upon completion of the Study it is the intention of the parties to 
prepare a joint publication regarding or describing the Study and all the results there 
from and both parties shall co-operate in this regard.  
PRINCIPAL INVESTIGATOR  
 
Name:______________________________ 
Signature: ___________________________ 
Date: _______________________________ 
 
 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 4 of 42 
CONFIDENTIAL 
 
Table of Contents 
3.1 
Indication for Use .................................................................................................... 12 
3.2 
Device description ................................................................................................... 12 
4.1 
Primary objective: ................................................................................................... 15 
4.2 
Secondary objectives: .............................................................................................. 15 
5.1 
Study Endpoints ....................................................................................................... 15 
5.1.1 
Primary endpoint ............................................................................................. 15 
5.1.2 
Secondary endpoints ....................................................................................... 15 
5.1 
Study Duration ......................................................................................................... 17 
6.1 
Source and sample size ........................................................................................... 17 
6.2 
Eligibility .................................................................................................................. 18 
6.2.1 
Inclusion Criteria .............................................................................................. 18 
6.2.2 
Exclusion Criteria ............................................................................................. 18 
6.3 
Subject Withdrawal and Replacement .................................................................... 19 
7.1 
Screening visit .......................................................................................................... 20 
7.1.1 
Subject Enrollment .......................................................................................... 20 
7.1.2 
Subject Identification....................................................................................... 20 
7.1.3 
Scheduling surgery visit and referral to pre-surgery examinations ................ 21 
7.2 
Pre-Surgery evaluation visit ..................................................................................... 21 
7.2.1 
Pre-surgery evaluations ................................................................................... 21 
7.2.1 
Pre surgery instructions ................................................................................... 22 
7.2.2 
Baseline assessments ...................................................................................... 22 
7.3 
Surgery visit ............................................................................................................. 22 
7.3.1 
Reevaluation .................................................................................................... 22 
7.3.2 
Surgery Procedure ........................................................................................... 23 
7.3.3 
Post-surgery instruction .................................................................................. 23 
7.4 
Follow-Up visits ....................................................................................................... 23 
7.5 
Termination visit ...................................................................................................... 24 
7.6 
Summary of study procedures ................................................................................ 25 
8.1 
Collecting demographic information ....................................................................... 27 
8.2 
Physical examination ............................................................................................... 27 
8.3 
Subject's satisfaction questionnaire ........................................................................ 27 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 5 of 42 
CONFIDENTIAL 
 
8.4 
Blinded digital photography evaluations................................................................. 28 
8.5 
Fat vitality assessment ............................................................................................ 30 
9.1 
Definition of an Adverse Event (AE) ........................................................................ 30 
9.2 
Anticipated Outcome Related Adverse Events ....................................................... 30 
9.3 
Unanticipated Outcome Related Adverse Events ................................................... 31 
9.4 
Definition of a Serious Adverse Event (SAE) ............................................................ 31 
9.5 
Recording of AEs and SAEs ...................................................................................... 31 
9.6 
Prompt Reporting of SAEs to Alma Lasers Ltd. ........................................................ 32 
9.7 
Evaluating AEs and SAEs .......................................................................................... 32 
10.1 
General Considerations ........................................................................................... 34 
10.2 
Disposition of Subject .............................................................................................. 34 
10.3 
Safety Analysis ......................................................................................................... 34 
10.4 
Interim Analysis ....................................................................................................... 34 
11.1 
Investigator Responsibility ...................................................................................... 35 
11.2 
Ethic committee Approval ....................................................................................... 35 
11.3 
Informed Consent .................................................................................................... 35 
11.4 
Case Report Forms (CRF) ......................................................................................... 36 
11.5 
Monitoring and Quality Assurance .......................................................................... 36 
11.6 
Financial Aspects ..................................................................................................... 37 
11.7 
Device Use/Accountability ...................................................................................... 37 
11.8 
Protocol Amendments ............................................................................................. 37 
11.9 
Protocol Compliance ............................................................................................... 38 
11.10 Archives: Retention of Study Records ..................................................................... 38 
11.11 Early Termination of the Study ................................................................................ 38 
11.12 Reporting Requirements ......................................................................................... 39 
13.1 
Appendix A: Subject's satisfaction questionnaire ................................................... 41 
13.2 
Appendix B: Global Aesthetic Improvement Scale (GAIS) ....................................... 42 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 6 of 42 
CONFIDENTIAL 
 
ABBREVIATIONS AND DEFINITIONS OF TERMS  
 
 
 
 
 
AE 
Adverse Event 
BMI 
Body Mass Index 
CBC 
Complete Blood Count 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CW 
Continuous Wave 
DoB 
Date of Birth 
EKG 
Electrocardiography 
GCP 
Good Clinical Practice 
FU 
Follow Up 
ICH 
International Conference on Harmonisation 
MC 
Medical Center 
MRI 
Magnetic Resonance Imaging  
NSAIDs 
Non-Steroidal Anti-Inflammatory Drugs 
PI 
Principal Investigator 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
 
 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 7 of 42 
CONFIDENTIAL 
 
 Protocol Synopsis 
Protocol Number 
ALM-Lipo-002 
Study Title 
The Safety and Efficacy of Laser Assisted Liposuction and Facial Autologous Fat 
Grafting with the LipoLifeTM System 
Projected Study 
Period 
Initiation Date: 
October 2018 
Completion Date: 
October 2019 
Study Device 
Alma Lasers LipoLifeTM system 
Study Sites and 
Participants 
Sanctuary Plastic Surgery Boca Raton FL, US and Assaf Harofeh MC, Israel\  
20 participants 
Device 
Description 
The Alma Lasers LipoLifeTM system consist of FDA cleared LipoDiode 1470 system 
(K160952) and LipoFlow system (K171242).  
The LipoDiode 1470 system is intended for use in dermatology and general surgery 
procedures and indicated, among other indications, for laser assisted lipolysis. The 
Alma LipoFlow System is used in the aspiration, harvesting, filtering and transferring 
of autologous adipose tissue and infiltration for aesthetic body contouring.  
The LipoLifeTM system will be used in this study for laser assisted liposuction and 
facial fat grafting.  
Study Design and 
Duration 
Multi-center, prospective, open label, single arm study. 
Following the screening visit, eligible subjects will be enrolled into the study. Each 
subject will undergo laser assisted liposuction surgery w/wo facial fat grafting (5-20 
subjects), using the LipoLifeTM system. Pre-surgery evaluation visit will be carried out 
1 week prior to the surgery. Follow up visits to evaluate safety and efficacy will take 
place at 1, 3 and 6 months after the surgery.  
Study duration from first subject enrollment to the last subject completion is 
expected to be up to 11 months. 
Study Objectives 
Primary objectives 
 
To evaluate the efficacy of Laser Assisted Liposuction procedure with the 
LipoLifeTM system.  
Secondary objectives 
 
To evaluate the efficacy of facial fat grafting procedure using autologous fat 
harvested with the LipoLifeTM system. 
 
To evaluate subjects' satisfaction. 
 
To evaluate procedure related safety.  
 
To evaluate fat vitality of the harvested fat with the LipoLifeTM system (optional). 
 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 8 of 42 
CONFIDENTIAL 
 
Study Endpoints 
Primary endpoint 
 
Improvement in aesthetic appearance as determined by blinded comparison of 
before and after 2D or 3D (at the Israeli site)/ 3D (at US site) digital photographs, 
at 3 months follow up visit compared to baseline.  
Secondary endpoint 
 
Improvement in aesthetic appearance as determined by blinded comparison of 
before and after 2D or 3D (Israel)/ 3D (US) digital photographs, at 1 and 6 
months follow up visits compared to baseline. 
 
Improvement in facial aesthetic appearance in subjects that had a procedure of 
facial fat grafting, as determined by blinded comparison of before and after 2D 
or 3D  (Israel)/ 3D (US) digital photographs at 1, 3 and 6 months follow up visits 
compared to baseline. 
 
Reduction in body weight measurement at 1, 3 and 6 months follow up visits 
compared to baseline. 
 
Reduction in abdominal fat thickness, among five (5) subjects that had a 
procedure of abdominal liposuction, as assessed by Magnetic Resonance Imaging 
(MRI) at 3 months follow up visit compared to baseline. This test will be held at 
the US site.  
 
Increase in facial fat volume, among five (5) subjects that had a procedure of 
facial fat grafting, as assessed by Magnetic Resonance Imaging (MRI) at 3 
months follow up visit compared to baseline. This test will be held at the US site.  
 
Subject's satisfaction, following liposuction procedure, as evaluated by subject's 
satisfaction questionnaire (based on 5 point Likert scale) at 1, 3 and 6 months 
follow up visits. 
 
Subject's satisfaction, following facial fat grafting procedure, as evaluated by 
subject's satisfaction questionnaire (based on 5 point Likert scale) at 1, 3 and 6 
months follow up visits. 
 
Safety endpoints will include adverse events (AE's) and serious adverse events 
(SAE's) occurring at any time during the trial or follow-ups. 
 
Fat vitality, as evaluated by cell viability assessment of 10 samples of the 
harvested fat (optional). 
Study Population 
Twenty (20) subjects, Ten (10) with excessive fat in the lower abdomen (w/wo 
flanks) and Ten (10) with excessive fat in the outer thighs (w/wo inner thighs), that 
are willing to undergo laser assisted liposuction. Five- Twenty (5-20) subjects out of 
this study group should also be eligible for facial fat grafting.  
Five (5) subjects will be recruited at Dr. Pozner's clinic in Sanctuary Plastic Surgery 
Boca Raton FL, US and will undergo abdominal liposuction and facial fat grafting. The 
rest fifteen (15) subjects will be recruited at Prof. Heller's at Assaf Harofeh Medical 
Center in Israel. Facial fat grafting will be optional in the Israeli site. 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 9 of 42 
CONFIDENTIAL 
 
Inclusion Criteria 
 
Subjects with excessive fat in the lower abdomen w/wo flanks or subjects with 
excessive fat in the outer thighs w/wo inner thighs that are willing to undergo 
laser assisted liposuction. 
 
Estimated fat harvesting of 1-3 liters. 
 
Subjects (5-20) eligible for facial fat grafting of at least 5 cc for each cheek. 
 
Between 18 and 70 years of age. 
 
Provided written Informed Consent. 
Exclusion Criteria 
 
Body Mass Index (BMI) >35. 
 
Sever skin laxity. 
 
Positive pregnancy test. 
 
Current smoker. 
 
Presence of known malignancy. 
 
Active infection in the treatment area. 
 
History of autoimmune disorder (e.g., Systemic Lupus Erythematosus [SLE]). 
 
History of connective, metabolic or atrophic skin disease. 
 
History of keloid scarring. 
 
Chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs 
within 15 days prior to enrollment. 
 
Subjects with immune system diseases. 
 
Subject unable to follow post treatment instructions. 
 
Any other reason that in the opinion of the investigator, prevents the subject 
from participating in the study or compromise the subject safety. 
 
 
 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 10 of 42 
CONFIDENTIAL 
 
 Introduction 
The dramatic evolution of contemporary plastic surgery has brought liposuction to 
become the second-most commonly performed elective aesthetic procedure 
performed in the USA 1.  In this minimally invasive procedure, excess fat deposits are 
removed, and either discarded or exploited in subsequent lipo-sculpturing procedures 
aiming to restore the normal appearance of a range of body regions suffering from 
surgical, accidental or traumatic tissue loss, or disease- or aging-related cosmetic 
defects 2.  Autologous fat tissue has become a popular filling material, particularly in 
the face and hands 3–5, largely due to its circumvention of complications associated 
with allogenic fillers and implants, high and simple accessibility, cost-effectiveness and 
host-compatibility 6,7. Yet, relatively high resorption rates have been reported, 
averaging 55% within one year of transplantation, with sample composition, purity 
and viable adipocyte content flagged as key determinants of implanted fat longevity 
8–14.   
The most commonly used liposuction techniques rely on mechanical, thermal, 
ultrasonic or hydric forces to harvest the desired sample.  Laser-assisted liposuction 
(LAL) induces temperature elevations that lead to liquefication of the adipose tissue 
and eventual adipocytolysis, enabling removal of larger volumes of fat than traditional 
liposuction techniques 15.  In addition, the thermal effect elicits collagen deposition 
and rearrangement, coagulation of vasculature, skin contraction and reduced laxity.  
Multiple wavelengths can be used to provide for selective photothermolysis, each 
providing distinct ratios of penetration and scatter, fat absorption, and tissue 
tightening.  In general, high absorption lasers (1370, 1440 and 1470 nm) generate 
localized thermal damage, while the lower absorption lasers (980, 1064 and 1320 nm) 
lead to more diffuse tissue response 16. Overall, LAL is considered safe and tolerable, 
and has been associated with a lower touch-up rate and improved precision as 
compared to conventional liposuctioning techniques 17. 
Alma Surgical’s LipoLife integrates a 1470 nm diode laser, emitting light preferentially 
absorbed by water, rendering it ideal for gentle fat tissue collection, with reduced risk 
of burning and scarring. In addition, its radially emitting fiber reduces emission 
intensity and subsequently, the risk of burns and internal scarring. Abdominal fat 
samples harvested with the LipoLife device were more homogenous, demonstrated 
higher viable adipocyte counts and contained fewer fibrous and blood contaminants 
as compared to those collected via mechanical liposuctioning 18. These virtues are 
expected to yield more long-lasting clinical outcomes, thereby reducing the need for 
correction or repeat procedures. When deploying the device for Teimourian grades I-

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 11 of 42 
CONFIDENTIAL 
 
II arm contouring in a single-session laser lipolysis procedure in 45 patients, Leclere 
and colleagues reported an average 4.7-5.5 cm decrease in arm circumference 
(p<0.01), with slightly better results for grades IIa and IIb patients.  Similarly, the 
average skin pinch decreased by 0.7 cm for grade I patients and 2.1 cm and 2.9 cm for 
the grade IIa and IIb patients, respectively.   Patient-evaluated pain was minimal, and 
mean downtime was shorter than one day.  Complications included prolonged edema 
in 11 patients 19. The same group reported on a 26.6-degrees reduction in 
cervicomental angle in patients presenting Rohrich type IV aging neck undergoing a 
single LipoLife treatment session; 2/10 patients requested complementary surgery 6 
months following LAL 20.  When deployed to address gynecomastia, Trelles et al. 
(2013) reported no complications, skin burns, edema or areolar congestion. In 
addition, nipple sensitivity was not compromised.  Mean chest and areola diameter 
reductions 6 months posttreatment, were 11.93 cm and 1.80 cm, respectively 
(p<0.05). A significant degree of skin retraction was observed among all patients and 
patients resumed their normal activities within three days of surgery 21. 
The present multi-center, open-label, prospective study aims to assess the safety and 
efficacy of LipoLife, laser-assisted liposuction of abdominal and outer thigh fat 
samples, as well as the efficacy of facial autologous fat grafting with the harvested fat 
tissue. Contouring and volumetric enhancement outcomes will be assessed up to 6 
months following the procedure. 
 
 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 12 of 42 
CONFIDENTIAL 
 
 The Investigational Device 
3.1 Indication for Use 
The Alma Lasers LipoLifeTM system (see Fig.1) consist of FDA cleared LipoDiode 1470 
system (K160952) and LipoFlow system (K171242).  
 
system
 
TM
Figure 1: Alma Lasers LipoLife
 
The LipoDiode 1470 system is intended for use in dermatology and general surgery 
procedures and indicated, among other indications, for laser assisted lipolysis. 
The Alma LipoFlow System is used in the aspiration, harvesting, filtering and 
transferring of autologous adipose tissue and infiltration for aesthetic body 
contouring. If the harvested fat is to be re-implanted, the harvested fat is only to be 
used without any additional manipulation.  
The complete operating manual describing the LipoLifeTM system will be attached 
separately. 
3.2 Device description 
3.2.1 LipoDiode 1470 system 
The Alma LipoDiode 1470 system operates with a wavelength of 1470nm which is 
absorbed in water and supports laser-Assisted liposuction.  
The Alma LipoDiode 1470 system comprised of: 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 13 of 42 
CONFIDENTIAL 
 
 Alma 1470 diode laser device 
 LipoDiode kit, including: 30cm, 25cm and 15cm cannulas (see Fig.2) 
 Laser optical fibers- Angel fibers 400µm/600µm 
 Footswitch 
 Safety eyewear 
 Operator's Manual 
3.2.2 LipoFlow system  
The LipoFlow system provides two modes of operation: 
- 
Peristaltic mode: used for tumescent injection. 
- 
Vacuum mode: used for liposuction and fat transplant procedures. 
User can activate only one mode at a time.  
The Alma LipoFlow system comprised of: 
 LipoFlow system console 
 Overflow filter  
 Re-usable Canister 2000 ml  
 Infiltration kit, including: 15cm and 25cm Infiltration cannulas (see Fig.3) 
 LipoFlow kit, including tubes and disposable waste bags 
 Fat grafting sterile kit, including: sterile canister and sterile tube (see Fig.4) 
 Footswitch 
 Operator's Manual 
 
 
Figure 3: Infiltration Kit 
Figure 4: Fat grafting sterile kit 
3.2.3 Procedure and parameters 
Prior to performing the liposuction procedure, local anaesthesia is administered using 
the LipoFlow peristaltic mode. Tumescent fluid usage is 150 cc to 500 cc for a 10 x 10 
cm2 area, while the anticipated total mg/kg dosage of tumescent lidocaine should not 
exceed 45 mg/kg. 
       
Figure 2: LipoDiode 
 
 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 14 of 42 
CONFIDENTIAL 
 
Approximately 20–30 minutes should be allowed to enable an adequate diffusion of 
the tumescent solution and provide effective vasoconstriction. 
Liposuction with the LipoLifeTM system involves simultaneous work of laser and 
suction. Alma 1470 diode laser is used in Continuous Wave (CW) emission mode, Pulse 
mode and Repeat mode. Power settings are recommended to be selected as a 
function of the liposuction area: 10-13W (chin, arms and knees), 13W (abdomen, 
back), and 15W (thighs, hips and buttocks). The laser energy is conveyed into the fat 
layer using a 3mm cannula which incorporates a 400 or 600μm optical single-use fiber. 
The suction tube is connected directly to the cannula so laser and suction will work 
simultaneously. 
The LipoLifeTM system is designed to be operated only by licensed medical 
practitioners properly trained in its handling and use. Personnel operating the device 
must read the operator's manual. 
 
 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 15 of 42 
CONFIDENTIAL 
 
 
Study Objectives 
4.1 Primary objective:  
To evaluate the efficacy of Laser Assisted Liposuction procedure with the LipoLifeTM 
system. 
4.2 Secondary objectives: 
 To evaluate the efficacy of facial fat grafting procedure using autologous fat 
harvested with the LipoLifeTM system. 
 To evaluate subjects' satisfaction. 
 To evaluate procedure related safety. 
 To evaluate fat vitality of the harvested fat with the LipoLifeTM system (optional). 
 Study Design 
This is a multi-center, prospective, open label, single arm study. 
The study will include 6 visits at the medical center: screening, pre-surgery evaluation 
visit, laser assisted liposuction surgery w/wo facial fat grafting and 3 follow up visits. 
Following the screening visit, eligible subjects will be enrolled into the study. Each 
subject will undergo laser assisted liposuction surgery w/wo facial fat grafting (5-20 
subjects), using the LipoLifeTM system. Pre-surgery evaluation visit will be carried out 
1 week prior to the surgery. Follow up visits to evaluate safety and efficacy will take 
place at 1, 3 and 6 months after the surgery (See Figure 5 for an illustration of the 
study design). 
5.1 Study Endpoints 
5.1.1 Primary endpoint  
Improvement in aesthetic appearance as determined by blinded comparison of 
before and after 2D/3D digital photographs, at 3 months follow up visit compared 
to baseline (2D or 3D  at Assaf Harofeh MC, Israel and 3D at Sanctuary Plastic 
Surgery, US). 
5.1.2 Secondary endpoints  
 Improvement in aesthetic appearance as determined by blinded comparison of 
before and after 2D/3D digital photographs, at 1 and 6 months follow up visits 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 16 of 42 
CONFIDENTIAL 
 
compared to baseline (2D or 3D  at Assaf Harofeh MC ,Israel and 3D at Sanctuary 
Plastic Surgery, US). 
 Improvement in facial aesthetic appearance in subjects that had a procedure of 
facial fat grafting, as determined by blinded comparison of before and after 2D/3D 
digital photographs at 1, 3 and 6 months follow up visits compared to baseline  (2D 
or 3D  at Assaf Harofeh MC, Israel and 3D at Sanctuary Plastic Surgery, US). 
 Reduction in body weight measurement at 1, 3 and 6 months follow up visits 
compared to baseline. 
 Reduction in abdominal fat thickness, among five (5) subjects that had a procedure 
of abdominal liposuction, as assessed by Magnetic Resonance Imaging (MRI) at 3 
months follow up visit compared to baseline. This test will be held at Sanctuary 
Plastic Surgery, US. 
 Increase in facial fat volume, among five (5) subjects that had a procedure of 
facial fat grafting, as assessed by Magnetic Resonance Imaging (MRI) at 3 months 
follow up visit compared to baseline. This test will be held at the US site.  
 Subject's satisfaction following liposuction procedure, as evaluated by subject's 
satisfaction questionnaire (based on 5 point Likert scale) at 1, 3 and 6 months 
follow up visits compared to baseline. 
 Subject's satisfaction following facial fat grafting procedure, as evaluated by 
subject's satisfaction questionnaire (based on 5 point Likert scale) at 1, 3 and 6 
months follow up visits. 
 Safety endpoints will include adverse events (AE's) and serious adverse events 
(SAE's) occurring at any time during the trial or follow-ups. 
 Fat vitality, as evaluated by cell viability assessment of 10 samples of the harvested 
fat (optional). 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 17 of 42 
CONFIDENTIAL 
 
5.2 Study Duration 
Duration of subject's participation: Up to 8 months from enrollment to termination. 
Study duration for entire study sample: Estimated to be 11 months from the 
enrollment of the first subject to the termination of the last subject. This is based on 
an estimate of 3 months for recruitment and up to 8 months subject participation. 
Figure 5: Study Design – ALM-Lipo-002 
 
 Study Population and Subject Selection 
6.1 Source and sample size 
Twenty (20) subjects, Ten (10) with excessive fat in the lower abdomen (w/wo flanks) 
and Ten (10) with excessive fat in the outer thighs (w/wo inner thighs), that are willing 
to undergo laser assisted liposuction, will be recruited for the study. Five- Twenty (5-
20) subjects out of this study group should also be eligible for facial fat grafting. 
Five (5) subjects will be recruited at Dr. Pozner's clinic in Sanctuary Plastic Surgery, US 
and will undergo abdominal liposuction (w/wo flanks) and facial fat grafting. The rest 
fifteen (15) subjects will be recruited at Prof. Heller's plastic surgery department at 
Assaf Harofeh Medical Center in Israel and will undergo abdominal liposuction (w/wo 
flanks) or outer thighs (w/wo inner thighs) liposuction. Facial fat grafting will be 
optional at the Israeli site. (See Figure 6 for subjects' selection and source). 
The subjects will be recruited by the investigator from within the investigator’s patient 
population and if needed from the general population by use of an IRB\Helsinki 
approved advertisement.  

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 18 of 42 
CONFIDENTIAL 
 
Figure 6: Subjects selection and source – ALM-Lipo-002 
 
For fat vitality assessment (optional), ten (10) samples of the harvested fat, from 10 
subjects at Assaf Harofeh MC will be collected. 
6.2 Eligibility 
Each subject will be evaluated by the Investigator to assess his/her suitability for entry 
into this study according to the following inclusion/exclusion criteria: 
6.2.1 Inclusion Criteria 
Subjects must meet all of the following inclusion criteria to be entered into the 
study: 
 Subjects with excessive fat in the lower abdomen w/wo flanks, or subjects with 
excessive fat in the outer thighs w/wo inner thighs that are willing to undergo 
laser assisted liposuction. 
 Estimated fat harvesting of 1-3 liters. 
 Subjects (5-20) eligible for facial fat grafting of at least 5 cc for each cheek. 
 Between 18 and 70 years of age. 
 Provided written Informed Consent. 
6.2.2 Exclusion Criteria 
Any of the following will exclude the subject from the study: 
 Body Mass Index (BMI) >35. 
 Sever skin laxity. 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 19 of 42 
CONFIDENTIAL 
 
 Positive pregnancy test. 
 Current smoker. 
 Presence of known malignancy. 
 Active infection in the treatment area. 
 History of autoimmune disorder (e.g., Systemic Lupus Erythematosus [SLE]). 
 History of connective, metabolic or atrophic skin disease. 
 History of keloid scarring. 
 Chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs 
within 15 days prior to enrollment. 
 Subjects with immune system diseases. 
 Subject unable to follow post treatment instructions. 
 Any other reason that in the opinion of the investigator, prevents the subject 
from participating in the study or compromise the subject safety. 
6.3 Subject Withdrawal and Replacement 
The participating subjects may withdraw their consent to participate in the study at 
any time during the study without prejudice as written in the informed consent form. 
The reason should be clearly stated in the subjects' medical records. Only the data, 
collected up to the point of consent withdrawal, will be analysed by the Sponsor.  
The investigator may withdraw a subject if, in his clinical judgment, it is in the best 
interest of the subject or if the subject cannot comply with the protocol or if the 
subject is unable to adhere to appointments. In the event that a subject drops out of 
the study or is withdrawn from the study, before the primary end point (3 months FU 
visit), the Termination CRF form should be completed and the subject should be 
replaced by the investigator, with the sponsor's approval. 
The sites will be required to complete treatment and follow-ups for 20 subjects and 
therefore should enroll 10% more subjects to account for any subject dropouts or 
subjects that will be lost to follow-up during the course of at least 6 months. 
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. The sponsor must be 
notified of all withdrawals. Subject that have a complete data for the primary endpoint 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 20 of 42 
CONFIDENTIAL 
 
FU (3 months follow-up after the surgery) is considered as a subject that completed 
the study. 
 Study Procedures 
See table 1 for a summary of the study procedures. 
7.1 Screening visit  
7.1.1 Subject Enrollment 
If the subject has met the preliminary study criteria the PI, and/or his designee, will; 
 Obtain an informed consent from the subject, clearly stating that the subject 
is willing to undergo the screening procedure and indicating subject 
understanding of the requirements and risks involved with study participation 
and other applicable treatment options. The informed consent will also include 
photo release consent, stating that the subject is allowing the sponsor (Alma 
Ltd.) to use the photos taken during the study for educational and marketing 
purposes (subject identity will be masked to the best possible extent in these 
pictures). 
 Collect demographic characteristics and general information (DoB, Ethnicity, 
BMI, previous smoking habits and physical activity). 
 Review the subject's medical history and concomitant medications use.  
 Screen the subject for eligibility to participate in the clinical study using the 
Inclusion and Exclusion criteria.  
 Confirm negative results of pregnancy urine test. 
 Perform physical examination and vital signs assessment.  
 Document the designated treatment area (lower abdomen w/wo flanks or 
outer thighs w/wo inner thighs) 
 Document if the subject is eligible for facial fat grafting. 
If the subject has met the eligibility criteria, he/ she will be recruited to the study.  
7.1.2 Subject Identification 
At enrollment, each subject will receive a unique identifying number that will be 
composed of a consecutive number and subject initials. This unique identifier will be 
used throughout the entire study and will be entered in the subject's CRF for each 
visit. 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 21 of 42 
CONFIDENTIAL 
 
7.1.3 Scheduling surgery visit and referral to pre-surgery examinations 
Subjects recruited to the study will be scheduled for a surgery up to 2 months after 
enrollment and for pre-surgery evaluation visit one week prior to the surgery. 
 Subjects will be instructed to perform the following optional examinations, per 
local institution regulation, prior to the pre-surgery evaluation visit;  
o Blood tests including; CBC (complete blood count), chemistry screening 
and blood clotting test (coagulation tests). 
o Staph MRSA screen test – nasal swab test. If positive, the subject will 
receive treatment for 5 days prior to the surgery. 
o E.K.G (for subjects > 40 years old). 
o Chest X-ray (for subjects > 50 years old or with relevant background 
diseases). 
All examinations should be performed up to 2 months prior to the surgery. 
 At Sanctuary Plastic Surgery, US site subjects will be referred to perform 
Magnetic Resonance Imaging (MRI) for abdominal fat thickness assessment 
and facial fat volume assessment. 
7.2 Pre-Surgery evaluation visit 
At the pre-surgery evaluation visit the study investigator, and/or his designee will 
perform pre-surgery evaluations, provide instructions to the subjects and perform 
baseline assessments. 
7.2.1 Pre-surgery evaluations 
The study investigator, and/or his designee will; 
 Review examinations results (detailed in section 7.1.3) and evaluate subject's 
suitability to the surgery. 
 Perform physical examination. 
 Evaluate any change in Inclusion/ Exclusion Criteria. 
In addition, the subject will meet with an anaesthesiologist, who will give his 
approval to the surgery (optional, per local institutional regulation). 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 22 of 42 
CONFIDENTIAL 
 
7.2.1 Pre surgery instructions  
Subjects will be recommended to bring to the surgery; abdominal garment (for 
abdominal liposuction) and wear it for at least 2 weeks after the surgery or thigh 
garment (for thigh liposuction) and wear it for at least 1 month after the surgery. 
7.2.2 Baseline assessments 
The study investigator, and/or his designee will; 
 Monitor subject adverse events. 
 Assess the changes in medication intake since last visit. 
 Measure subject's body weight.  
 Photograph the subject, only treated area, without the face, while the subject 
is standing with hanging arms. At Assaf Harofeh site, when using a 2D camera, 
photograph the subject at frontal, back, 45 and 90 degrees positions, according 
to a standardized photography instructions (refer to section 8.4).  
 For subjects that intended to undergo facial fat grafting procedure, 
photograph the subject's face at frontal, 45 and 90 degrees positions, when 
using 2D camera (refer to section 8.4). 
 At Sanctuary Plastic Surgery site confirm and document results from the MRI, 
i.e. abdominal fat thickness and facial fat volume. 
The pictures taken in this study may be used by the Sponsor (Alma Lasers Ltd.) in 
the future for educational and marketing purposes. Subjects' identity will be 
masked to the best possible extent in these pictures. 
7.3 Surgery visit  
7.3.1 Reevaluation 
Prior to the surgery, the study investigator, and/or his designee will; 
 Evaluate any change in Inclusion/ Exclusion Criteria. 
 Confirm negative results of pregnancy urine test.  
 Assess the changes in medication intake since last visit. 
 Monitor subject adverse events. 
 Perform physical examination and vital signs. 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 23 of 42 
CONFIDENTIAL 
 
7.3.2 Surgery Procedure 
Perioperative antibiotic will be administered, per surgeon's discretion.   
During the surgery, the study investigator, and/or his designee will perform laser 
assisted liposuction using the LipoLifeTM system, including: 
1. Instilment of tumescent containing local anesthesia to the treated area 
(abdomen w/wo flanks or outer thighs (w/wo inner thighs), using the LipoFlow 
peristaltic mode. 
2. Harvest of adipose tissue (1-3 liters) from the treated are, using the Lipoflow 
suction mode and LipoDiode CW mode. 
The LipoLifeTM system is designed to be operated only by licensed medical 
practitioners properly trained in its handling and use. Personnel operating the device 
must read the operator's manual. 
For facial fat grafting procedure (if relevant) the procedure will also include;  
3. Injection of the harvested adipose tissue into the face, at least 5 cc per cheek, 
using the standard fat grafting equipment i.e. syringe, blunt cannula etc.  
For fat vitality assessment (optional), ten (10) samples of the harvested fat, from 10 
subjects at Assaf Harofeh MC, will be transported to the laboratory, within 4 hours. 
Cell viability assessment will be performed using trypan blue exclusion assay. 
7.3.3 Post-surgery instruction 
The subject will usually be discharged from the hospital at the same day or a day 
after the surgery, according to local institutional regulation, with recommendations 
to rest for two weeks, wash the surgical area with water and soap, and wear the 
abdominal/ thigh garment on a daily basis. In addition, a 1 month follow-up meeting 
will be scheduled. 
7.4 Follow-Up visits 
Follow up visits will be carried out 1 month ±7 days (1m FU), 3 months ±7 days (3m 
FU) and 6 months ±7 days (6m FU) after the surgery.  
During these visits the following procedures will be performed by the investigator, 
and/or his designee: 
 Assessment of changes in medication intake since last visit. 
 Physical examination and vital signs. 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 24 of 42 
CONFIDENTIAL 
 
 Assessment of adverse events according to subject's report and physical 
examination. 
 Obtaining subjects' satisfaction, following liposuction procedure, according to 
subject's satisfaction questionnaire (see section 8.3).   
 Body weight measurement. 
 Subjects' liposuction area photography, according to standardized photography 
instructions (see section 8.4).  
 For subjects that had fat grafting procedure: 
o 
Facial photography, according to standardized photography instructions (see 
section 8.4).  
o 
Obtaining subjects' satisfaction, following facial fat grafting procedure, 
according to subject's satisfaction questionnaire (see section 8.3).   
 At Sanctuary Plastic Surgery site, at 1m FU visit subject will be referred to 
perform MRI for abdominal fat thickness assessment and facial fat volume 
assessment, 2-3 weeks prior to the 3m FU visit. At 3m FU visit, the investigator, 
and/or his designee will confirm and document the results from the MRI 
assessments.  
7.5 Termination visit 
The termination visit occurs in parallel with the last follow up visit (6m FU visit). During 
this visit the coordinator/investigator will fill the termination CRF.  
 
 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 25 of 42 
CONFIDENTIAL 
 
7.6 Summary of study procedures 
Schedule of times and events, including required study visits, procedures and 
assessments to be performed at each visit can be found at the table below (Table 1). 
Table 1: Study Procedures- ALM-Lipo-001 
FU=follow up; m= month; W=week; d=days 
 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
 
Screening 
Pre-
Surgery 
evaluation 
Surgery 
1m FU 
3m FU 
Primary 
endpoint 
6m FU 
 
Weeks 
Up to -2m 
-1w 
0 
4W ±7d 
12W ±7d 
24W ±7d 
Informed consent 
X 
 
 
 
 
 
Demographic assessment 
X 
 
 
 
 
 
General information (previous 
smoking habits and physical 
activity) 
X 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
Concomitant Medications 
X 
 
 
 
 
 
Concomitant Medications change  
 
X 
X 
X 
X 
X 
Physical examination 
X 
X 
X 
X 
X 
X 
Vital signs  
 
 
X 
 
X 
X 
X 
X 
Pregnancy test 
X 
 
X 
 
 
 
Inclusion/Exclusion Criteria 
assessment 
X 
 
 
 
 
 
Inclusion/ Exclusion Criteria 
evaluation for change 
 
X 
X 
 
 
 
Pre/ Post-surgery instructions to 
the subjects 
 
X 
X 
 
 
 
Review pre-surgery examinations 
(optional) e.g.; Blood test, Staph 
NRSA screen test, E.K.G and chest 
X-Ray  
 
X 
 
 
 
 
Consultation with an 
anesthesiologist (optional) 
 
X 
 
 
 
 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 26 of 42 
CONFIDENTIAL 
 
 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
 
Screening 
Pre-
Surgery 
evaluation 
Surgery 
1m FU 
3m FU 
Primary 
endpoint 
6m FU 
 
Weeks 
Up to -2m 
-1w 
0 
4W ±7d 
12W ±7d 
24W ±7d 
Liposuction procedure-  
Subject's satisfaction questionnaire 
(5 point Likert scale) 
 
 
 
X 
X 
X 
Facial fat grafting procedure - 
Subject's satisfaction questionnaire 
(5 point Likert scale)* 
 
 
 
X 
X 
X 
Body weight measurement 
 
X 
 
X 
X 
X 
Subject 
photography** 
Liposuction area 
(when using 2D 
camera at Assaf 
Harofeh MC : 
Frontal, back, 45 
and 90 degrees 
positions) 
 
X 
 
X 
X 
X 
Face* 
(when using 2D 
camera at Assaf 
Harofeh MC: 
Frontal, 45 and 90 
degrees positions) 
 
X 
 
X 
X 
X 
Blinded evaluations 
 
 
 
X 
X 
X 
MRI results *** 
(abdominal fat thickness and facial 
fat volume) 
 
X 
 
 
X 
 
AE assessment 
 
X 
X 
X 
X 
X 
Termination CRF 
 
 
 
 
 
X 
* For subject that will have/had facial fat grafting procedure. 
** 3D camera at Sanctuary Plastic Surgery, US and 2D or 3D camera at Assaf Harofeh MC, Israel  
*** At Sanctuary Plastic Surgery, US 
 
 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 27 of 42 
CONFIDENTIAL 
 
 Evaluations 
8.1 Collecting demographic information, medical history and concomitant 
medications 
At the screening visit, information regarding medical history, concomitant 
medications and demographic information; i.e. age, ethnicity, BMI (calculated from 
height and weight measurements), previous smoking habits and physical activity (type 
and times/week) will be collected.  
According to this information eligibility to participate in the study will be evaluated. 
Change in concomitant medications will re-evaluated at all study's visits.  
8.2 Physical examination 
Physical examination will be performed at screening visit, in order to evaluate 
eligibility to participate in the clinical study and eligibility to the surgery.  
In addition physical examination of the surgery site will be evaluated at all studies' 
visits and will be used, inter alia, to assess AEs. 
8.3 Subject's satisfaction questionnaire 
Following laser assisted liposuction, subjects will be requested to scale their 
satisfaction from the treatment according to Subject's Satisfaction Questionnaire, 
based on 5 point Likert scale, as detailed in Table 2.  
Subjects that underwent facial fat grafting procedure will be requested to fill in 
additional form, while referring to their satisfaction from the facial fat grafting 
procedure. 
 
 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 28 of 42 
CONFIDENTIAL 
 
Table 2: Subject's Satisfaction Questionnaire- ALM-Lipo-002 
8.4 Blinded digital photography evaluations 
Standardized photography instructions  
 At Sanctuary Plastic Surgery Boca Raton FL,US  
3D digital photographs will be taken using Canfield Scientific, Inc. camera, 
including; 
Subject's Satisfaction Questionnaire 
Procedure: Lower abdomen (w/wo flanks) / Outer thighs (w/wo inner thighs) / Facial fat grafting 
(Please circle the relevant procedure) 
Subject Improvement and Satisfaction 
1. Please rate your satisfaction from the treatment results 
Subjects Improvement: 
1-  No Improvement 
2- Mild Improvement 
3- Moderate Improvement 
4- Good Improvement 
5- Excellent Improvement  
Subjects Satisfaction: 
1- Very dissatisfied 
2- Dissatisfied 
3- Somewhat satisfied 
4- Satisfied 
5- Very satisfied 
Satisfaction from skin reaction (tightening) 
2. Please rate your satisfaction from the skin reaction (tightening) after the surgery 
1- Very dissatisfied 
2- Dissatisfied 
3- Somewhat satisfied 
4- Satisfied 
5- Very satisfied 
Subject Personal Experience 
3. Will you recommend the treatment to your family/friends? 
1- Extremely unlikely   
2- Very unlikely   
3- Somewhat unlikely 
4- Very likely 
5- Extremely likely      

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 29 of 42 
CONFIDENTIAL 
 
- 
Lower abdomen w/wo flanks, without the face, for liposuction procedure 
evaluation  
- 
Subject's face for facial fat grafting procedure evaluation.  
 
 At Assaf Harofeh Medical Center, Israel 
2D and/or 3D digital photographs will be taken at Assaf Harofeh Medical Center. 
When using 2D camera (Nikon D7100), the camera will be placed at a distance of 
2 meters from the subject.  Only treated area will be photographed (i.e. lower 
abdomen w/wo flanks or thighs), without the face, at frontal, back, 45 degrees 
(left and right) and 90 degrees (left and right) positions, with arms resting on the 
side. In addition, for subjects that underwent facial fat grafting procedure, 
subject's face will be photographed at frontal, 45 and 90 degrees positions. Each 
position will be photograph 3 times. 
Photographs will be taken at baseline and at 1, 3 and 6 months FU visits. The 
photographs will be downloaded to a computer under subject's identification number 
folder, and will be compiled into a PowerPoint presentation for panel evaluation. 
Before and after photographs - Blinded evaluation 
Panel of 3 physicians, blinded to the study design will evaluate the aesthetic 
outcomes of the treated area. The physicians will be presented with two 
photographs (baseline and 1/3/6 months after the surgery) and will be requested to 
assess which photograph represent the "before" (baseline) and which one the 
"after" (1/3/6 months after the surgery). In addition they will be requested to scale 
the improvement according to Global Aesthetic Improvement Scale (GAIS), as 
detailed in table 3. 
Table 3: Global Aesthetic Improvement Scale (GAIS)- ALM-Lipo-002 
Scale 
Level of Improvement 
 
1 
Very much improved 
Optimal cosmetic results. 
2 
Much improved 
Marked improvement in appearance, but not completely 
optimal. 
3 
Improved 
Improvement in the appearance, better than initial condition, 
but re-treatment is advised. 
4 
No change 
The appearance substantially remains the same compared to 
initial condition. 
5 
Worse 
The appearance has worsened compared to the initial 
condition. 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 30 of 42 
CONFIDENTIAL 
 
8.5 Fat vitality assessment 
Fat vitality assessment will be optional. 
Ten (10) samples of the harvested fat, from 10 subjects at Assaf Harofeh MC, will be 
transported to the laboratory, within 4 hours.  
Cell viability assessment will be performed using trypan blue exclusion assay. 
 Adverse Events (AE) and Serious Adverse Events (SAE) 
The investigator is responsible for the detection and documentation of events meeting 
the criteria and definition of an adverse event (AE) or a serious adverse event (SAE) as 
provided in this protocol. During the study, when there is a safety evaluation, the 
investigator or site staff will be responsible for detecting AEs and SAEs, as detailed in 
this section of the protocol. All adverse events reported between consent and final 
follow-up will be recorded in the case report form (CRF). 
9.1 Definition of an Adverse Event (AE) 
Any untoward medical occurrence in a participant or clinical investigation participant, 
temporarily associated with the use of a medicinal product, whether or not considered 
related to the medicinal product. 
An AE can therefore be any unfavourable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease (new or exacerbated) temporally associated 
with the use of a medicinal product, whether or not considered related to the medicinal 
product. For marketed medicinal products, this also includes failure to produce benefits 
(i.e. lack of efficacy), abuse or misuse. 
9.2 Anticipated Outcome Related Adverse Events 
Anticipated related AE for liposuction procedure may include; local pain, hematoma, 
contour deformities, infection, local fibrosis of scars or systemic side effects such as 
electrolyte disorders. 
Anticipated related AE for facial fat grafting procedure may include; infection, 
ecchymosis, fat necrosis or injury of adjacent tissue. 
Any anticipated AE that occurs at any time during or after the use of the study device 
must be reported by the Investigator to Alma Lasers Ltd. If the anticipated AE, in the 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 31 of 42 
CONFIDENTIAL 
 
opinion of Alma Lasers or the Investigator, is likely to affect the safety of the subjects 
or the conduct of the study, the IRB/ Helsinki/ other ethic committee will be notified 
of the effect within 10 working days after Alma Lasers first receives notice of it.  
9.3 Unanticipated Outcome Related Adverse Events 
An unanticipated adverse device effect as defined by the Federal Regulations [21 CFR 
812.3(s)] is “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.” From a practical perspective, an unanticipated 
adverse device effect means a serious adverse event that is not listed in the device 
labelling, or the frequency or severity is greater than reported in the device labelling.  
9.4 Definition of a Serious Adverse Event (SAE) 
A serious adverse event is any untoward medical occurrence that, at any dose: 
a) Results in death 
b) Is life threatening 
c) Requires hospitalization or prolongation of an existing hospitalization. 
Hospitalization for elective treatment of a pre-existing condition that did not 
worsen from baseline is not considered an AE. 
d) Results in disability/incapacity 
e) Is a congenital abnormality / birth defect. 
f) 
Any event deemed by the investigator as being a significant medical event. 
9.5 Recording of AEs and SAEs 
When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (e.g. hospital progress notes, laboratory, and diagnostic reports) 
relative to the event. The investigator will then record all relevant information 
regarding an AE/SAE in to the CRF. It is not acceptable for the investigator to send 
photocopies of the subject’s medical records to Alma Lasers Ltd. in lieu of completion 
of the appropriate AE/SAE CRF pages. However, there may be instances when copies 
of medical records for certain cases are requested by Alma Lasers Ltd. In this instance, 
all subject identifiers will be blinded on the copies of the medical records prior to 
submission to Alma Lasers Ltd.  

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 32 of 42 
CONFIDENTIAL 
 
For each adverse event, start and stop dates, action taken, outcome, intensity and 
relationship to study product (causality) must be documented. If an AE changes in 
frequency or intensity during a study, a new entry of the event must be made in the 
CRF. 
The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. In the absence of a diagnosis, the 
individual signs/symptoms should be documented. All details of any treatments 
initiated due to the adverse event should be recorded in the subject’s notes and the 
CRF. 
9.6 Prompt Reporting of SAEs to Alma Lasers Ltd.  
Once an investigator becomes aware that an SAE has occurred in a study subject, 
he/she will immediately notify the sponsor by contacting the study monitor via 
telephone to notify him/her of the event. The SAE form must be completed as 
thoroughly as possible with all available details of the event, signed by the 
investigator, and faxed within 24 hours of first becoming aware of the event to the 
following person: 
Ronit Lipson 
Alma Lasers Ltd.  
14 Halamish Street, POB 3021 
Caesarea Industrial Park 
Caesarea, Israel 38900 
Phone: 972-52-2337768 
Fax: +972-4-627-5368 
If the investigator does not have all information regarding an SAE, he/she will not wait 
to receive additional information before notifying the study monitor of the event and 
completing the form. The form will be updated when additional information is 
received.  
The investigator must also notify the Reviewing IRB/ Helsinki/ other ethic Committee 
of any SAEs according to the guidelines of the Ethics Committee. 
9.7 Evaluating AEs and SAEs 
9.7.1 Assessment of Intensity  
The investigator will make an assessment of intensity for each AE and SAE reported 
during the study. The assessment will be based on the investigator’s clinical 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 33 of 42 
CONFIDENTIAL 
 
judgement. The intensity of each AE and SAE recorded in the CRF should be assigned 
to one of the following categories: 
Mild: An event that is easily tolerated by the subject, causing minimal discomfort and 
not interfering with everyday activities. 
Moderate: An event that is sufficiently discomforting to interfere with normal 
everyday activities. 
Severe: An event which is incapacitating and prevents normal everyday activities. 
An AE that is assessed as severe should not be confused with an SAE. Severity is a 
category utilised for rating the intensity of an event; and both AEs and SAEs can be 
assessed as severe. An event is defined as “serious” when it meets one of the pre-
defined outcomes as described in Section “Definition of an SAE”. 
9.7.2 Assessment of Causality 
The investigator is obligated to assess the relationship between investigational device 
and the occurrence of each AE/SAE. The investigator will use clinical judgment to 
determine the relationship. Alternative causes, such as natural history of the 
underlying diseases, concomitant therapy, other risk factors, and the temporal 
relationship of the event to the investigational product will be considered and 
investigated. The investigator will also consult the IB and/or device information in the 
determination of his/her assessment. 
The causal relationship to the study product assessed by the Investigator (or medically 
qualified delegate) should be assessed using the following classifications: 
Not Related 
In the Investigator’s opinion, there is not a causal relationship between 
the study product and the adverse event. 
Unlikely 
The temporal association between the adverse event and study 
product is such that the study product is not likely to have any 
reasonable association with the adverse event. 
Possible 
The adverse event could have been caused by the study participant’s 
clinical state or the study product. 
Probable 
The adverse event follows a reasonable temporal sequence from the 
time of study product administration, abates upon discontinuation of 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 34 of 42 
CONFIDENTIAL 
 
the study product and cannot be reasonably explained by the known 
characteristics of the study participant’s clinical state. 
Definitely 
The adverse event follows a reasonable temporal sequence from the 
time of study product administration or reappears when study product 
is reintroduced. 
 Statistical Analysis 
10.1 General Considerations 
When statistical tests are performed, they will be two-sided. The required significance 
level of findings will be equal to or lower than 5%. Where confidence limits are 
appropriate, the confidence level will be 95%. 
Baseline values are defined as the last valid value prior to the surgery. 
All statistical analyses of safety and performance measures will be descriptive in 
nature. Continuous variables will be summarized by a mean, standard deviation, 
minimum, median and maximum, and categorical variables by a count and 
percentage. Confidence intervals will be provided where relevant.  
10.2 Disposition of Subject 
The numbers of subjects who were enrolled and completed each visit of the study will 
be provided, as well as the reasons for all enrollment discontinuations, grouped by 
major reason (e.g., lost to follow-up, adverse event, poor compliance). A list of 
discontinued subjects, protocol deviations, and subject excluded from the efficacy 
analysis will be provided as well. 
10.3 Safety Analysis 
A detailed list of all adverse events will be presented. The adverse event rate and 
incidence will be compiled with respect to frequency, nature, seriousness of the event, 
severity of the event, and relationship to the study device. In addition, listings of all 
safety measures will be produced. 
10.4 Interim Analysis 
An interim report to analyse safety and efficacy will be performed at 3 months Follow-
Up. 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 35 of 42 
CONFIDENTIAL 
 
 Administrative Procedures 
11.1 Investigator Responsibility 
Except where the Principal Investigator’s signature is specifically required, it is 
understood that the term ‘Investigator’ as used in this Protocol and on the CRFs refers 
to the Principal Investigator or an appropriately qualified member of the staff that the 
Principal Investigator designates to perform specified duties of the Protocol.  The 
Principal Investigator is ultimately responsible for the conduct of all aspects of the 
study.  
Each Investigator will comply with the local regulations regarding clinical trials and the 
Investigator responsibilities outlined in the ICH GCP guidelines. 
11.2 Ethic committee Approval 
The Protocol will be submitted for approval to the Reviewing IRB/ Helsinki/ other ethic 
committee, and written approval obtained, before study subjects are enrolled.  The 
Investigators will receive all the documentation needed for submitting the present 
Protocol to the Ethics Committee. A copy of the respective approval letters will be 
transmitted to the Study Monitor before starting the study.  The composition of the 
Ethics Committee must also be provided to the Study Monitor.  If approval is 
suspended or terminated by the Reviewing Ethics Committee, the Investigator will 
notify the Study Monitor immediately. 
It is the responsibility of the Investigator to report study progress to the Reviewing 
Ethics Committee as required or at intervals not greater than one year. 
The Principal Investigator, or his/her nominee, will be responsible for reporting any 
serious adverse events to the Ethics Committee as soon as possible, and in accordance 
with the local guidelines.  
11.3 Informed Consent  
Before recruitment and enrollment into the study, each prospective candidate will be 
given a full explanation of the nature and purposes of the study, and a copy of the 
Informed Consent Form to review. Once the essential study information has been 
provided, and the Investigator is assured that each potential subject understands the 
implications of participating in the study, the subjects will be asked to give consent to 
participate in the study by signing the informed consent form. The consent forms shall 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 36 of 42 
CONFIDENTIAL 
 
be signed and dated by the appropriate parties.  A notation that written informed 
consent has been obtained will be made on the participant’s CRF.  The completed 
consent forms will be retained by the Investigator and a copy of these will be provided 
by the Investigator to the participant. 
11.4 Case Report Forms (CRF) 
A Case Report Form (CRF) will be completed for each study subject summarising all 
clinical screening and study data. Subjects will only be referred to in the CRF by their 
subject number and initials in order to retain their confidentiality. 
The Investigator is responsible for completely and accurately recording study data in 
the appropriate sections of the CRFs provided by Alma lasers. The CRFs must be signed 
by the Investigator or by his/her authorized person as designated in the Signature 
Authorization Log. 
The completed original CRF’s are to be sent to the Sponsor as soon as practical after 
completion and review.  A copy of each completed CRF is to be retained by the 
Investigator for a period of time as determined by local regulations. 
11.5 Monitoring and Quality Assurance 
The task of the Study Monitor is to guarantee the best conduct of the study through 
frequent contacts by phone and in person with the responsible Investigator, in 
accordance with the Monitor’s Standard Operating Procedures, with the purpose of 
facilitating the work and fulfilling the objectives of the study.  The Monitor is 
responsible for monitoring adherence to the Protocol and completion of the CRF, and 
for the relationship between the Investigator and Alma Lasers Ltd. 
The organisation, monitoring, supply of study materials and quality assurance of the 
present clinical study is the responsibility of Alma Lasers Ltd. or its designee. 
In order to ensure the accuracy of data, direct access to source documents by the 
representatives of both the Study Monitor and regulatory authorities is mandatory.  
Anonymity of the subject will be maintained at all times.  Alma Lasers Ltd. reserves 
the right to terminate the study for refusal of the Investigator/Institution to supply 
source documentation of work performed in the study. 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 37 of 42 
CONFIDENTIAL 
 
11.6 Financial Aspects 
The conduct of the study is subject to a Financial Agreement between Alma Lasers Ltd. 
and the Investigator or Institution. 
11.7 Device Use/Accountability 
Use and storage of LipoLifeTM system and accessories will be performed according to 
the Operation Manual. All received used and unused LipoLifeTM system components 
will be documented on the accountability form.  
11.8 Protocol Amendments  
Neither the Investigator nor Alma Lasers Ltd. will modify the Protocol without first 
obtaining the concurrence of the other in writing.  Protocol modifications that impact 
on participant safety or the validity of the study will be approved by the Ethics 
Committee. 
No changes (amendments) to the Protocol may be implemented without prior 
approval from the Sponsor and the Reviewing Ethics Committee.  If a Protocol 
amendment requires changes to the Informed Consent Form, the revised Informed 
Consent Form, prepared by the Investigator, must be approved by the Reviewing 
Ethics Committee. 
Once the final Protocol has been issued and signed by the Investigator and the 
authorised signatories, it shall not be informally altered.  Protocol amendments are 
alterations to a legal document and have the same legal status.  Therefore, they must 
pass through appropriate steps before being implemented.  In general, any important 
change that theoretically increases risk to participants constitutes an amendment.  
Minor changes are administrative changes and need documentation without 
approval. 
It is the responsibility of the Investigator to submit the amendment to the Reviewing 
Ethics Committee for their approval; written approval should be obtained and a copy 
provided to the Sponsor.  The Sponsor is responsible for determining whether or not 
the local regulatory authority must be notified of the Protocol change.  Completed and 
signed Protocol amendments will be circulated to all those who were on the 
circulation list for the original Protocol. 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 38 of 42 
CONFIDENTIAL 
 
The original signed copy of amendments will be kept in the Study File with the original 
Protocol.  It should be noted that where an amendment to the Protocol substantially 
alters the study design or the potential risks to the participants, each participant’s 
consent to continue participation should be obtained. 
11.9 Protocol Compliance 
The instructions and procedures specified in this Protocol require diligent attention to 
their execution.  Should there be questions or consideration of deviation from the 
Protocol, clarification will be sought from the Study Monitor. Any participant treated 
in a manner that deviates from the Protocol, or who is admitted into the study but is 
not qualified according to the Protocol as amended by Alma Lasers Ltd. and the 
Investigator, may be ineligible for analysis and thereby compromise the study. 
Only when an emergency occurs that requires a departure from the Protocol for an 
individual will there be such a departure. The nature and reasons for the Protocol 
violation/deviation shall be recorded in the CRF and the investigator should notify the 
sponsor and Ethics Committee as soon as possible. 
11.10 Archives: Retention of Study Records 
All source documents, CRFs and trial documentation will be kept by the Investigator 
for the appropriate retention period as stipulated by local regulations and ICH-GCP. 
11.11 Early Termination of the Study 
The study may be terminated prematurely by the principal investigator or his/her 
designee and the sponsor if: 
 The number and/or severity of adverse events justify discontinuation of the study 
 New data become available which raise concern about the safety of the study 
device, so that continuation might cause unacceptable risks to subjects. 
In addition, Alma Lasers Ltd. reserves the right to discontinue the trial prior to 
inclusion of the intended number of participants, but intends only to exercise this right 
for valid scientific or administrative reasons.  
After such a decision, the Investigator must contact all participating subjects, and 
written notification must be sent to the Reviewing Ethics Committee and relevant 
Regulatory Authorities.  

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 39 of 42 
CONFIDENTIAL 
 
11.12 Reporting Requirements 
The investigator must promptly report to Alma lasers any withdrawal of IRB/ 
Helsinki/other ethic committee approval at the site. Additional reporting 
requirements include: 
 Notify Alma Lasers’ designee and to the ethic committee a report of any serious 
adverse device effect, whether anticipated or unanticipated, that occurs during 
the study as soon as possible, but in no event later than 10 working days after the 
investigator first learns of the effect. This report is to include a description of the 
effect, subsequent treatments, clinical outcomes, and outcome diagnoses.  If the 
site personnel are not sure whether an event meets these criteria they should call 
the clinical monitor. 
 Notify Alma Lasers or Alma Lasers' designee and the ethic committee immediately 
(within 24 hours) if an emergency situation arises in which the subsequent 
treatment, in the best interests of the subject, requires a deviation from the 
protocol. This should be followed with written confirmation that describes the 
emergency action and outcomes, to Alma Lasers and the ethic committee within 
5 working days. 
 Report to the ethic committee and Alma Lasers, within 5 working days, the use of 
the study device without signed informed consent from the subject. 
 Report adverse events in accordance with 21 CFR 803. 
 Submit regular progress reports to the approval committee and Alma Lasers or 
Alma Lasers’ designee, as requested by the investigators or the ethic committee. 
 Submitting a final report on the study to the ethic committee and Alma Lasers or 
Alma Lasers’ designee within 3 months after termination or completion of the 
study. 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 40 of 42 
CONFIDENTIAL 
 
 References 
1. 
Plastic Surgery Statistics Report. Am. Soc. Plast. Surg. (2017). 
https://www.plasticsurgery.org/documents/News/Statistics/2017/plastic-surgery-statistics-
report-2017.pdf (Accessed on March 20, 2018). 
2. 
Atiyeh, B. et al. Functional and Therapeutic Indications of Liposuction: personal experience 
and review of the literature. Ann. Plast. Surg. 75, 231–245 (2015). 
3. 
Xie, Y. et al. An integrated fat grafting technique for cosmetic facial contouring. J. Plast. 
Reconstr. Aesthetic Surg. 63, 270–276 (2010). 
4. 
Charles-De-Sa, L. et al. Antiaging treatment of the facial skin by fat graft and adipose-derived 
stem cells. Plast. Reconstr. Surg. 135, 999–1009 (2015). 
5. 
Dasiou-Plakida, D. Fat injections for facial rejuvenation: 17 years experience in 1720 patients. 
J. Cosmet. Dermatol. 2, 119–125 (2003). 
6. 
Banyard, D.A. et al. Implications for human adipose-derived stem cells in plastic surgery. J. 
Cell. Mol. Med. 19, 21–30 (2015). 
7. 
Etzkorn, J. Autologous fat transfer: Techniques, indications, and future investigation. J. 
Cosmet. Dermatol. 24, 470–476 (2011). 
8. 
Peer, L.A. Loss of weight and volume in human fat grafts:with postulation of a &quot;cell 
survival theory&quot; Plast. Reconstr. Surg. 5, 217–230 (1950). 
9. 
Peer, L. Cell survival theory versus replacement theory. Plast. Reconstr. Surg. (1946) 16, 161–8 
(1955). 
10. 
Peer, L. The neglected free fat graft, its behavior and clinical use. Am. J. Surg. 92, 40–7 (1956). 
11. 
Sommer, B. & Sattler, G. Current Concepts of Fat Graft Survival : Histology of Aspirated 
Adipose Tissue and Review of the Literature. Dermatologic Surg. 26, 1159–1166 (2000). 
12. 
Har-Shai, Y. et al.  Large liponecrotic pseudocyst formation following cheek augmentation by 
fat injection. Aesthetic Plast. Surg. 20, 417–9 
13. 
Coleman, S. R. Facial recontouring with lipostructure. Clin. Plast. Surg. 24, 347–67 (1997). 
14. 
Pu, L.L.Q. et al.  Autologous fat grafts harvested and refined by the coleman technique: A 
comparative study. Plast. Reconstr. Surg. 122, 932–937 (2008). 
15. 
Kim, K.H. & Geronemus, R.G. Laser lipolysis using a novel 1,064 nm Nd:YAG Laser. Dermatol. 
Surg. 32, 241–48; discussion 247 (2006). 
16. 
Levi, J.R. et al. Histologic evaluation of laser lipolysis comparing continuous wave vs pulsed 
lasers in an in vivo pig model. Arch. Facial Plast. Surg. 13, 41–50 (2011). 
17. 
Katz, B. & Mcbean, J. Laser-assisted lipolysis: A report on complications. J. Cosmet. Laser Ther. 
10, 231–233 (2008). 
18. 
Levenberg, A., Scheinowitz, M. & Sharabani-yosef, O. Higher Cell Viability and Enhanced 
Sample Quality Following Laser-Assisted Liposuction versus Mechanical Liposuction. J. 
Cosmet. Dermatological Sci. Appl. 5, 238–245 (2015). 
19. 
Leclère, F.M. et al. Laser-assisted lipolysis for arm contouring in Teimourian grades I and II: a 
prospective study of 45 patients. Lasers Med. Sci. 30, 1053–1059 (2015). 
20. 
Leclère, F.M. et al. Laser-assisted lipolysis for neck and submental remodeling in Rohrich type 
IV patients: Fact or fiction? J. Cosmet. Laser Ther. 17, 31–36 (2015). 
21. 
Trelles, M.A. Laser-assisted liposuction for gynecomastia: statistical and ultrasound follow-up 
of the effects observed in skin retraction. Cir.plást. iberolatinoam 39, 425–438 (2013). 
 

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 41 of 42 
CONFIDENTIAL 
 
 Appendix 
13.1 Appendix A: Subject's satisfaction questionnaire 
 
 
Subject's Satisfaction Questionnaire 
Procedure: Lower abdomen (w/wo flanks) / Outer thighs (w/wo inner thighs) / Facial fat grafting 
(Please circle the relevant procedure) 
Subject Improvement and Satisfaction 
1. Please rate your satisfaction from the treatment results 
Subjects Improvement: 
1- No Improvement 
2- Mild Improvement 
3- Moderate Improvement 
4- Good Improvement 
5- Excellent Improvement  
Subjects Satisfaction: 
1- Very dissatisfied 
2- Dissatisfied 
3- Somewhat satisfied 
4- Satisfied 
5- Very satisfied 
Satisfaction from skin reaction (tightening) 
2. Please rate your satisfaction from the skin reaction (tightening) after the surgery 
1- Very dissatisfied 
2- Dissatisfied 
3- Somewhat satisfied 
4- Satisfied 
5- Very satisfied 
Subject Personal Experience 
3. Will you recommend the treatment to your family/friends? 
1- Extremely unlikely   
2- Very unlikely   
3- Somewhat unlikely 
4- Very likely 
5- Extremely likely      

Protocol Number: ALM-Lipo-002, V. 2.1  
________________________________________________________________________________________________________________________________________________________________________________________________________________________ 
Page 42 of 42 
CONFIDENTIAL 
 
13.2 Appendix B: Global Aesthetic Improvement Scale (GAIS)  
 
Global Aesthetic Improvement Scale (GAIS) 
Scale 
Level of Improvement 
 
1 
Very much improved 
Optimal cosmetic results. 
2 
Much improved 
Marked improvement in appearance, but not completely 
optimal. 
3 
Improved 
Improvement in the appearance, better than initial condition, 
but re-treatment is advised. 
4 
No change 
The appearance substantially remains the same compared to 
initial condition. 
5 
Worse 
The appearance has worsened compared to the initial 
condition.