Measuring Renuvion Soft Tissue Contraction Using Ultrasound
Phase: NA
Conditions: Skin Laxity
Sponsor: Apyx Medical

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 1 of 45 
  
 
 
CLINICAL TRIAL PROTOCOL NUMBER: APX-23-02 
 
MEASURING RENUVION SOFT TISSUE CONTRACTION USING 
ULTRASOUND 
 
SPONSOR: APYX MEDICAL 
FUNDED BY: APYX MEDICAL 
 
DATE: MAY 23, 2023 
DRAFT OR VERSION: 1.1 
 
CONFIDENTIAL – PROPRIETARY INFORMATION 
 
 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 2 of 45 
SPONSOR STATEMENT AND SIGNATURE PAGE 
Company Name:  
 
Apyx Medical 
Address: 
 
 
5115 Ulmerton Rd. 
 
 
 
 
Clearwater, FL 33760 
Telephone: 
 
 
800.537.2790 
Study Device: 
 
 
Apyx Plasma RF 
Protocol Title: 
 
 
Measuring Renuvion Soft Tissue Contraction Using Ultrasound 
Protocol Number: 
 
APX-23-02 
 
The investigation will be conducted in compliance with the clinical investigation plan (CIP), GCP, EN ISO 14155, the 
Declaration of Helsinki, and regulatory authority requirements. 
 
Apyx Medical (hereinafter “Study Sponsor”) maintains responsibility for the ongoing safety of this clinical trial 
involving the evaluation of the Renuvion system.  Study Sponsor will promptly notify all investigators, the responsible 
IRB(s), and the regulatory authorities of any findings from ongoing trial monitoring activities that could adversely 
affect the safety of subjects, impact the conduct of the clinical study, or alter the IRB’s approval to continue the 
study, specifically within 5 working days of making an Unanticipated Adverse Device Effect (UADE) determination or 
15 working days after first receiving notice of the UADE, within 10 days for Serious Adverse Event reports, and at 
least annually for routine reports.  In the event that participant safety could be directly affected by study results 
after the study has ended, Study Sponsor will notify all investigators of these results to enable investigators to 
consider informing participants as soon as possible or at least within one year of study closure.   
The following individuals are responsible for the content of the CIP: 
 
 
______________________________________________ 
 
_____________________________ 
Emily Hughes 
 
 
 
 
 
 
 
Date 
Sr. Manager, Clinical Affairs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Kari Larson 
 
 
 
 
 
 
 
Date 
Sr. Director, Clinical Affairs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Shawn Roman 
 
 
 
 
 
 
 
Date 
Vice-President, R&D 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Lisa Graney 
 
 
 
 
 
 
 
Date 
Vice-President, Quality Assurance & Regulatory Affairs 
 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 3 of 45 
INVESTIGATOR AGREEMENT/STATEMENT OF COMPLIANCE 
I have thoroughly read and reviewed this clinical investigation plan (CIP) and hereby agree to participate in this 
clinical trial sponsored by Study Sponsor. I agree to conduct this investigation according to the requirements of the 
CIP provided by the Study Sponsor and in accordance with Good Clinical Practice (GCP) as required by EN ISO 14155, 
the Declaration of Helsinki, Investigational Device Exemption (21 CFR Part 812), Protection of Human Subjects (45 
CFR Part 46), and other applicable FDA regulations, and regulations of other relevant regulatory authorities and 
conditions imposed by the reviewing Institutional Review Board (IRB) or Ethics Committee (EC). I agree that no 
deviation from, or changes to the CIP will take place without prior agreement from the sponsor and documented 
approval from the IRB, except where necessary to eliminate an immediate hazard(s) to the trial participants. I agree 
to ensure that appropriate informed consent is obtained from all subjects prior to inclusion in this study.  I also agree 
to supervise all testing of the device involving human subjects, and to report to the Study Sponsor, within 24 hours, 
any adverse event that is serious, whether considered treatment-related or not.  I am aware that the Study Sponsor 
reserves the right to discontinue this investigation at any time. 
 
I understand that this investigation will be monitored by the Study Sponsor and/or a designee employed by the Study 
Sponsor. This monitoring will involve periodic inspection of my investigational site and ongoing review of the data 
that is submitted by me to the Study Sponsor.  
 
All study data will be entered into the EDC and a PDF of the paper CRF will be uploaded to the EDC within 3 days 
after the study visit.  
 
I am also aware that I may be inspected by a representative of the relevant regulatory authorities, including the 
United States Food and Drug Administration, to verify compliance with applicable regulations related to clinical 
research on human subjects. 
 
My current curriculum vitae and the curriculum vitae of physicians/licensed practitioners at this institution who will 
participate as co-investigators/sub-investigators in this study will be provided to the Study Sponsor. The curriculum 
vitae will include the extent and type of our relevant experience with pertinent dates and locations. All personnel 
involved in the conduct of this study have completed Human Subjects Protection Training. 
 
I certify that I have not been involved in an investigation that was terminated for non-compliance at the insistence 
of the Study Sponsor, the IRB or EC, or other regulatory authorities. I agree to provide the Study Sponsor sufficient, 
accurate financial disclosure information.  I also agree to update financial disclosure information if any relevant 
changes occur during the investigation and for one year following the completion of the study. 
 
I understand that this CIP and the trial results are confidential, and I agree not to disclose any such information to 
any person other than a representative of the Study Sponsor or the relevant competent authorities without the prior 
written consent of the Study Sponsor. 
 
Accepted by: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Co-Principal Investigator Signature  
Principal Investigator Name 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Co-Principal-Investigator Signature  
Co-Investigator Name 
 
 
 
Date 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 4 of 45 
LIST OF ABBREVIATIONS 
AE 
Adverse Event 
CRF 
Case Report Form 
CRO 
Clinical Research Organization  
DCF 
Data Clarification Form 
DRM 
Data Review Meeting  
ESU 
Electrosurgical Generator Unit 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
GAIS 
Global Aesthetic Improvement Scale 
GCP 
Good Clinical Practice 
ICH  
International Conference for Harmonization of Technical Requirements of Pharmaceuticals 
for Human Use  
IFU 
Instructions for Use 
IPR 
Independent Photographic Reviewer 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
NRS 
Numeric Rating Scale 
NSAID 
Non-steroidal Anti-Inflammatory Drug 
PP 
Per Protocol 
PPS 
Per Protocol Set 
RF 
Radiofrequency 
SAE 
Serious Adverse Event 
SAL 
Suction-Assisted Liposuction 
UADE 
Unanticipated Adverse Device Effect 
 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 5 of 45 
PROTOCOL SYNOPSIS 
Protocol Title: 
Measuring Renuvion Soft Tissue Contraction Using Ultrasound 
Investigational Device: 
The Renuvion Generator (K192867) is indicated for delivery of radiofrequency energy 
and/or helium plasma to cut, coagulate and ablate soft tissue during open and 
laparoscopic surgical procedures. The Renuvion APR Handpiece (K223262) is intended for 
the 
delivery 
of 
radiofrequency 
energy 
and/or 
helium 
plasma 
where 
coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue. 
The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological and 
aesthetic procedures to improve the appearance of lax (loose) skin in the neck and 
submental region. The Renuvion® APR Handpiece is intended to be used with compatible 
electrosurgical generators owned by Apyx Medical. 
 
The Apyx One Console (K221830) is indicated for delivery of radiofrequency energy and/or 
helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic 
surgical procedures. The helium plasma portion of the generator can be used only with 
dedicated Renuvion/J-Plasma handpieces. 
 
Together, the Renuvion Generator and Handpiece are referred to as the Renuvion APR 
System. 
Development Phase: 
Post-Marketing  
Study Purpose: 
The purpose of this study is to quantitatively measure the amount of soft tissue 
contraction produced by the delivery of Renuvion helium plasma energy to the 
subcutaneous connective tissue. 
Brief Study Overview: 
This is a prospective, single-center, non-randomized study of up to 5 subjects who are 
receiving treatment with the Renuvion APR system following power-assisted liposuction 
in the abdomen per investigator standard of care. Subjects may also have other body areas 
treated at the same time. Demographic information, medical history, and procedure 
details will be documented. Pre- and post-procedure care are per investigator standard of 
care and documented. Video may be taken during the procedure. 
 
Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during 
the procedure. Measurements of contraction will be calculated from the ultrasound 
images by an ultrasonographer. At baseline, photographs will be taken of the treatment 
areas. Surface area measurements will be taken of each treatment area prior to study 
treatment.  
 
Post-procedure care will be as per investigator standard of care and documented. All 
adverse events and expected treatment effects will be documented. 
 
Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, 
D180, D270, & D365.  
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
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Title: Clinical Trial Protocol 
Revision: 03 
 
Page 6 of 45 
An interim analysis of data will be completed following study treatments and following 
each follow-up visit (D30, D45, D60, D90, D180, D270); a final report will provide 
comprehensive study results through D365.  
Number of Sites Enrolling 
Participants: 
Subjects will be recruited from a single (1) US site. 
Sample Size:  
Up to 5 treated subjects; subjects enrolled may be greater than subjects treated. 
Subject Population: 
Healthy, female and male adult subjects, ages 18 – 65 years old who meet the 
inclusion/exclusion criteria.  
Inclusion Criteria: 
• 
Patients who are scheduled for a procedure involving the use of Renuvion for the 
contraction of subcutaneous soft tissue.  Patients undergoing procedures involving 
Renuvion alone and/or Renuvion following liposuction will be included. 
• 
Patients who have acceptable cardiopulmonary health for outpatient surgery. 
• 
Willing and able to comply with protocol requirements, including obtaining study-
required images/photos and assessments, and returning for follow-up visits. 
• 
Willing to release rights for the use of study photos, including in potential publication. 
• 
Able to communicate with the site via video and/or photographs, in the event of a 
virtual follow-up visit. 
• 
Able to read, understand, sign and date the informed consent document (English 
only). 
Exclusion Criteria: 
• 
BMI of greater than 35. 
• 
Diabetes mellitus with A1C score >7. 
• 
Active cigarette smokers or nicotine vape users. 
• 
History of connective tissue disease (Ehlers Danlos, Cutis Laxa, Pseudoxanthoma 
Elasticum, Marfan's, etc.) 
• 
Patients who, in the opinion of the investigator, is not an appropriate candidate for 
the study. 
• 
Patients requiring a concomitant procedure in the Renuvion treatment area that 
could impact the ultrasound measurements or the effectiveness results. 
Primary Outcome 
Measures: 
Analysis of contraction measured by an ultrasonographer and then analyzed as follows: 
• 
Quantify the amount of intra-operative contraction produced by liposuction. 
• 
Quantify the amount of intra-operative contraction produced by each pass of 
Renuvion.  
• 
Determine if amount of intra-operative contraction produced by Renuvion begins 
to level off (reach a point of diminishing return).  
• 
Determine how the amount of intra-operative contraction varies based on the 
initial length at baseline.  
• 
Correlate the amount of intra-operative contraction to energy delivered. 
• 
Determine how the amount of contraction changes over time. 
• 
Correlate the amount of contraction to GAIS and PSQ.  
• 
Correlate the amount of contraction or energy delivered to AEs. 
• 
Correlate the amount of contraction to IPR review. 
Additional Outcome 
Measures: 
1. Improvement in appearance of skin laxity in the treatment area assessed by selection 
of the correct post-treatment image as determined by a masked, qualitative 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
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Title: Clinical Trial Protocol 
Revision: 03 
 
Page 7 of 45 
assessment of photographs by blinded independent reviewers at 90-days, 180-days, 
270-days, and 365-days post-treatment compared to baseline.  
2. The Principal Investigator, sub-investigator or qualified clinician delegated by the 
principal investigator, will complete a PGAIS assessing overall aesthetic improvement 
in the treatment area at day 60, 90, 180, 270, and 365 post-treatment. 
3. The subject will complete a SGAIS assessing overall aesthetic improvement in the 
treatment area at day 60, 90, 180, 270, and 365 post-treatment. 
4. The subject will complete a Patient Satisfaction Questionnaire (PSQ) at the 180-, 270- 
and 365-day follow-up visits. 
5. Analysis of energy delivered per surface area and per volume of tissue. 
Safety Variables: 
• 
Prior to treatment, the subject’s medical history will be reviewed, a urine pregnancy 
test will be performed (if applicable), and a physical examination will be conducted.  
• 
Following study treatment and at each subsequent visit, the subject will be queried 
about adverse events, expected treatment effects, and changes in concomitant 
medications, and the treatment area will be visually examined.  
• 
Analysis of adverse events through the D365 post-treatment visit. 
Study Duration: 
The duration from when the study opens to enrollment until completion of data analyses 
is anticipated to be 16 months. 
 
 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 8 of 45 
TABLE OF CONTENTS 
Sponsor Statement and Signature Page ................................................................................... 2 
Investigator Agreement/Statement of Compliance ................................................................. 3 
List of Abbreviations ................................................................................................................ 4 
Protocol Synopsis ..................................................................................................................... 5 
1. 
KEY ROLES .................................................................................................................... 12 
1.1 
Internal Responsibilities ..................................................................................................................... 12 
1.2 
External Responsibilities .................................................................................................................... 12 
2. 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ............... 13 
2.1 
Background Information & Rationale ................................................................................................. 13 
2.1.1 
Renuvion System Device and Indications for Use ................................................................................ 14 
2.1.1 
Ultrasound System and Indications for Use ......................................................................................... 16 
2.2 
Potential Risks and Benefits ............................................................................................................... 17 
2.2.1 
Potential Risks ...................................................................................................................................... 17 
2.2.2 
Potential Benefits ................................................................................................................................ 18 
3. 
STUDY PURPOSE .......................................................................................................... 19 
4. 
STUDY DESIGN AND ENDPOINTS .................................................................................. 19 
4.1 
Description of the Study Design .......................................................................................................... 19 
4.2 
Duration of Study ............................................................................................................................... 19 
4.3 
Study Endpoints ................................................................................................................................. 19 
4.3.1 
Primary Effectiveness Endpoint ........................................................................................................... 19 
4.3.2 
Safety Variables ................................................................................................................................... 20 
4.3.3 
Additional Outcome Measures ............................................................................................................ 20 
4.3.4 
Evaluation Tools ................................................................................................................................... 20 
5. 
SUBJECT ENROLLMENT AND WITHDRAWAL ................................................................. 22 
5.1 
Study Population ................................................................................................................................ 22 
5.1.1  
Informed Consent ................................................................................................................................ 22 
5.1.2  
Pre-treatment Recruiting/Screening ................................................................................................... 23 
5.2 
Inclusion Criteria ................................................................................................................................ 23 
5.3 
Exclusion Criteria ............................................................................................................................... 24 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 9 of 45 
5.4 
Strategies for Recruitment and Retention ........................................................................................... 24 
5.5  
Participant Withdrawal or Termination .............................................................................................. 24 
5.5.1 
Reasons for Withdrawal or Termination ............................................................................................. 24 
5.5.2 
Handling of Withdrawals or Termination ............................................................................................ 24 
5.6 
Premature Termination or Suspension of the Study or a Study Site ..................................................... 25 
6. 
STUDY DEVICE .............................................................................................................. 25 
6.1 
Packaging & Storage ........................................................................................................................... 25 
6.2 
Accountability .................................................................................................................................... 26 
6.3 
Device Malfunction/Observation ........................................................................................................ 26 
7. 
STUDY PROCEDURES AND SCHEDULE ........................................................................... 26 
7.1 
Pre-Procedure .................................................................................................................................... 26 
7.2 
Study Procedure ................................................................................................................................. 26 
7.3 
Follow-up Procedures ........................................................................................................................ 27 
7.3.1 Immediately Post-Procedure ...................................................................................................................... 27 
7.3.2 Follow-up Visits & Subject Contact outside of Follow-up Visits ................................................................. 27 
7.4 
Subject Randomization and Treatment Group Assignment ................................................................. 28 
7.5 
Study Schedule................................................................................................................................... 28 
7.5.1 
Screening ............................................................................................................................................. 28 
7.5.2 
Baseline Assessment ............................................................................................................................ 28 
7.5.3 
Treatment Visit .................................................................................................................................... 29 
7.5.4 
Follow-up ............................................................................................................................................. 29 
7.5.5 
Safety Assessments .............................................................................................................................. 30 
7.5.6 
Unscheduled Visit ................................................................................................................................ 30 
7.5.7 
End of Study (Completion) ................................................................................................................... 30 
8. 
ASSESSMENT OF SAFETY .............................................................................................. 30 
8.1 
Specifications of Safety Parameters .................................................................................................... 30 
8.1.1 
Definition of an Expected Treatment Effect (ETE) and an Adverse Event (AE) .................................... 30 
8.1.2 
Definition of Serious Adverse Event (SAE) ........................................................................................... 31 
8.1.3 
Definition of Unanticipated Adverse Device Effects (Events) .............................................................. 31 
8.2 
Classification of an Event .................................................................................................................... 32 
8.2.1 
Severity of Event .................................................................................................................................. 32 
8.2.2 
Relationship to the Investigational Device .......................................................................................... 32 
8.3 
Time Period and Frequency for Event Assessment and Follow-up ....................................................... 32 
8.4 
Reporting Procedures ......................................................................................................................... 33 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 10 of 45 
8.4.1 
Adverse Event Reporting ..................................................................................................................... 33 
8.4.2 
Serious Adverse Event Reporting ......................................................................................................... 33 
8.4.3 
Unanticipated Adverse Device Effect Reporting .................................................................................. 34 
8.4.4 
Reporting of Pregnancy ....................................................................................................................... 34 
8.4.5 Reporting of Deaths .................................................................................................................................... 34 
8.5 
Study Halting Rules ............................................................................................................................ 34 
9. 
CLINICAL MONITORING ................................................................................................ 35 
10. 
Statistical Methodology ............................................................................................... 35 
10.1 
Statistical and Analytical Plans ........................................................................................................... 35 
10.2 
Sample Size ........................................................................................................................................ 35 
11. 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/ DOCUMENTS .......................... 35 
12. 
QUALITY ASSURANCE AND QUALITY CONTROL ............................................................ 35 
13. 
ETHICS/PROTECTION OF HUMAN SUBJECTS ................................................................. 36 
13.1 
Ethical Standard ................................................................................................................................. 36 
13.2 
Institutional Review Board ................................................................................................................. 36 
13.3 
Participant and Data Confidentiality ................................................................................................... 36 
14. 
DATA HANDLING AND RECORD KEEPING ..................................................................... 37 
14.1 
Data Collection and Management Responsibilities .............................................................................. 37 
14.2 
Investigator Records and Reports ....................................................................................................... 38 
14.2.1 
Investigator Records ............................................................................................................................ 38 
14.2.2 
Investigator Reports ............................................................................................................................ 39 
14.3 
Study Records Retention .................................................................................................................... 39 
14.4 
Protocol Deviations ............................................................................................................................ 40 
14.5 
Publication and Data Sharing Policy .................................................................................................... 40 
15. 
STUDY ADMINISTRATION ............................................................................................. 40 
15.1 
 Study Investigators ............................................................................................................................ 40 
15.2 
Amendment Policy ............................................................................................................................. 41 
16. 
CONFLICT OF INTEREST POLICY ..................................................................................... 41 
17. 
LITERATURE REFERENCES ............................................................................................. 42 
ATTACHMENT A: PATIENT SATISFACTION QUESTIONNAIRE ................................................... 44 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 11 of 45 
PROTOCOL REVISION LOG ...................................................................................................... 45 
 
 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 12 of 45 
1. 
KEY ROLES 
Persons, companies, and/or groups serving in key roles in the conduct or oversight of this clinical trial are listed in 
Table 1 and Table 2, including sponsor, clinical project manager for the trial, investigator responsible for conducting 
the trial. Additional details are available in the study specific Project Plan. 
1.1 
INTERNAL RESPONSIBILITIES 
 
TABLE 1: INTERNAL RESPONSIBILITIES 
Name 
Function 
Address 
Apyx Medical 
Sponsor 
5115 Ulmerton Road 
Clearwater, FL 
Emily Hughes 
Sr. Manager, Clinical Affairs 
Phone: 731.414.2603 
Email: Emily.Hughes@apyxmedical.com 
Kari Larson 
Sr. Director, Clinical Affairs 
Phone: 801.244.0058 
Email: Kari.Larson@apyxmedical.com 
Shawn Roman 
VP, R&D and Clinical Affairs 
Phone: 904.382.4857 
Email: Shawn.Roman@apyxmedical.com 
 
1.2 
EXTERNAL RESPONSIBILITIES 
The administrative structure for external responsibilities includes, but is not limited to, the participants in Table 2: 
TABLE 2: EXTERNAL RESPONSIBILITIES 
Name 
Function 
Address 
Chris Nichols, MD 
Co-Principal Investigator 
Pearl Plastic Surgery & Medical Spa 
145 Lilly Road NE 
Olympia, WA 98501 
Phone: 360-878-9300 
Email: cnichols@pearlplasticsurgery.com 
Dan Albershardt, MD 
Co-Principal Investigator & 
Ultrasonographer 
Pearl Plastic Surgery & Medical Spa 
145 Lilly Road NE 
Olympia, WA 98501 
Phone: 360-878-9300 
Email: doctordan@pearlplasticsurgery.com 
Castor 
EDC 
Phone: 628-239-3493 
Email: ted.mehalic@castoredc.com 
Dropbox 
Secure cloud-based document 
repository for CRF and images 
upload 
N/A 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 13 of 45 
2. 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE 
2.1 
BACKGROUND INFORMATION & RATIONALE 
Energy has been applied in some form to tissue since the beginning of recorded history.  The practice of applying 
heat to tissue through the use of cauteries was used for thousands of years as an invaluable method of controlling 
hemorrhage.  Continuous improvement of methods for utilizing the beneficial effects of heat on tissue eventually 
led to the development of the basic concepts of electrosurgery we know today.  In October of 1926, Dr. Harvey 
Cushing used an electrosurgical unit developed by Dr. William T. Bovie to successfully remove a highly vascularized 
brain tumor from a patient after previous failed attempts.  Today, electrosurgical instruments are used in almost 
every surgical procedure performed worldwide.1 
Through this long history, the heat effects of the radiofrequency (RF) alternating current used in electrosurgery on 
cells and tissue have been well established.  Normal body temperature is 37°C and, with normal illness, can increase 
to 40°C without permanent impact or damage to the cells of our body.  However, when the temperature of cells in 
tissue reaches 50°C, cell death occurs in approximately 6 minutes.2  When the temperature of cells in tissue reaches 
60°C, cell death occurs instantaneously.3  Between the temperatures of 60°C and just below 100°C, two simultaneous 
processes occur.1  The first is protein denaturation leading to coagulation which will be discussed in more detail 
below.  The second is desiccation or dehydration as the cells lose water through the thermally damaged cellular wall.  
As temperatures rise above 100°C, intracellular water turns to steam and tissue cells begin to vaporize as a result of 
the massive intracellular expansion that occurs.  Finally, at temperatures of 200°C or more, organic molecules are 
broken down into a process called carbonization.  This leaves behind carbon molecules that give a black and/or 
brown appearance to the tissue. 
 
Understanding these heat effects of RF energy on cells and tissue can allow the predictable changes to be used to 
accomplish beneficial therapeutic results.  Protein denaturation leading to soft tissue coagulation is one of the most 
versatile and widely utilized tissue effects.  Protein denaturation is the process in which hydrothermal bonds 
(crosslinks) between protein molecules, such as collagen, are instantaneously broken and then quickly reformed as 
tissue cools.  This process leads to the formation of uniform clumps of protein typically called coagulum through a 
subsequent process known as coagulation.  In the process of coagulation, cellular proteins are altered but not 
destroyed and form protein bonds that create homogenous, gelatinous structures.  The resulting tissue effect of 
coagulation is extremely useful and most commonly used for occluding blood vessels and causing hemostasis. 
 
In addition to causing hemostasis, coagulation results in predictable contraction of soft tissue.  Collagen is one of the 
main proteins found in human skin and connective tissue.  The coagulation/denaturation temperature of collagen is 
conventionally stated to be 66.8°C, although this can vary for different tissue types.4  Once denatured, collagen 
rapidly contracts as fibers shrink to one-third of their overall length.5  This principal of thermally-induced contraction 
of collagen through denaturation and coagulation of soft tissue is well known in medicine and is used to achieve 
beneficial results in ophthalmology, orthopedic applications, and the treatment of varicose veins.  Once tissue is 
heated to the appropriate temperature, protein denaturation and collagen contraction occur resulting in a reduction 
of volume and surface area of the heated tissue.  Noninvasive use of RF devices, lasers, and plasma devices have 
been used for the reduction of facial wrinkles and rhytides caused by thermal-induced collagen/tissue contraction 
since the mid-1990s.6-11 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 14 of 45 
Minimally invasive devices that deliver thermal energy in the same subcutaneous tissue planes in which liposuction 
is performed have achieved the appropriate balance between excisional and non-invasive procedures.  Laser-
assisted liposuction (LAL) has shown to be effective at producing more skin tightening than suction-assisted 
liposuction (SAL) alone18,19.  DiBernardo showed an average skin surface area reduction of 22% and 17% at one- and 
three-month follow-up visits, respectively, and an average of 26% skin tightening at three months when utilizing LAL 
to address abdominal skin laxity20.  In 2008, radiofrequency (RF) devices were introduced and have demonstrated 
efficacy in multiple body areas including the abdomen21,22, the arms23,24, and the face and neck25,26.  The efficacy 
results in all of these publications are based on contraction measurements taken on the surface of the skin.  Although 
skin surface contraction measurements are useful, they are limited for the following reasons: 
• 
The mechanism of action (especially of Renuvion) is to treat and contract the fibro septal connective tissue.  
This contraction of the connective tissue draws the skin closer to the underlying muscle, and this, in turn, 
improves the appearance of the skin by reducing the laxity.  When addressing skin laxity through the three-
dimensional contraction of the connective tissue, the overall magnitude of improvement may not always 
be reflected in surface area changes on the skin surface.  To date, no studies have measured the amount of 
contraction of the connective tissue itself. 
• 
Using camera-based measurements of skin surface area changes do not allow for quantification of intra-
operative (on the table) changes. 
• 
Using camera-based measurements of skin surface area changes requires split-body treatments to 
differentiate between the results produced by liposuction and the energy device. 
 
Due to these limitations, having another way to quantify and visualize contraction will be helpful. This study will use 
ultrasound images to visualize the contraction throughout the procedure and during follow-up. Utilizing those 
ultrasound images, this study will provide the ability to quantitatively measure the amount of soft tissue contraction 
produced by the delivery of Renuvion helium plasma energy to the subcutaneous connective tissue. 
 
2.1.1 RENUVION SYSTEM DEVICE AND INDICATIONS FOR USE 
The Renuvion APR system consists of a handpiece (Figure 1), an electrosurgical unit (ESU, Figure 2), and a supply of 
helium gas (Figure 2).  RF energy is delivered to the handpiece by the ESU and used to energize an electrode.  When 
helium gas is passed over the energized electrode, a helium plasma is generated which allows for conduction of the 
RF energy from the electrode to the subject in the form of a precise helium plasma beam.   

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 15 of 45 
 
FIGURE 1: RENUVION APR HANDPIECE 
 
 
FIGURE 2: ELECTROSURGICAL UNIT AND HELIUM TANK 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 16 of 45 
The Renuvion system has received FDA clearance under 510(k) numbers K223262 and K170188. The Renuvion® APR 
Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where 
coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue. The Renuvion® APR 
Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance 
of lax (loose) skin in the neck and submental region. The Renuvion® APR Handpiece is intended to be used with 
compatible electrosurgical generators owned by Apyx Medical.  
 
The Apyx One Console (K221830) is indicated for delivery of radiofrequency energy and/or helium plasma to cut, 
coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The helium plasma portion of the 
generator can be used only with dedicated Renuvion/J-Plasma handpieces.  
    
2.1.1 ULTRASOUND SYSTEM AND INDICATIONS FOR USE 
The GE Versana Active 1.5 (K200998) is a general-purpose diagnostic ultrasound system intended for use by qualified 
and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body 
and fluid. Versana Active clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, 
Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and 
Pediatric), Vascular/ Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/ 
Pleural, Transcranial, Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, 
vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color 
M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D, 4D and Combined modes: B/M, B/ Color M, B/PWD 
or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD. The device is intended for use in an indoor hospital 
environment, in medical offices/clinics and other Healthcare facilities. 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 17 of 45 
 
2.2 
POTENTIAL RISKS AND BENEFITS 
2.2.1 POTENTIAL RISKS 
This treatment modality was designed to inherently minimize the risk to the subject. However, treatment with 
energy-based modalities (laser, radiofrequency, and plasma devices) produce subsequent heating of the soft tissue 
that could involve the following commonly Expected Treatment Effects (ETEs): discomfort/pain, edema, erythema, 
ecchymosis, hypoesthesia, temporary sensory nerve injury (touch sensitivity, itching, temporary numbness/tingling), 
transient migratory firmness, and temporary and/or transient crepitus. 
 
In addition to commonly expected treatment effects, treatment with the Renuvion system could involve the 
following risks: helium embolism into the surgical site due to inadvertent introduction into the venous or arterial 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 18 of 45 
blood supply system, unintended burns (deep or superficial), pneumothorax, temporary or permanent motor nerve 
injury, ischemia, fibrosis, infection, gas buildup, bleeding, hematoma, seroma, subcutaneous induration, 
pigmentation changes, increased healing time, unsatisfactory scarring, asymmetry and/or unacceptable cosmetic 
result. 
 
Risks associated with tumescent anesthesia (lidocaine and epinephrine) include blurred vision, mental/mood 
changes, drowsiness, dizziness, unusually slow heartbeat, rash, itching, swelling, anxiety, apprehensiveness, 
restlessness, tremor, weakness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory 
difficulties. 
 
Subjects using drugs that reduce coagulation (aspirin or NSAIDs) may experience increased bruising or bleeding at 
the treatment site. Any other medication prescribed for the procedure or after-procedure by the investigator have 
their own risks; these risks should be discussed with the subject. 
 
A grounding pad is used to ground/neutralize the electrical current. Subjects undergoing radiofrequency treatment 
will be kept away from contact with metal parts which are grounded, or which have appreciable capacitance to 
earth. 
 
Any unexpected or unforeseen complications will be managed by the investigator throughout the conduct of the 
study. Unforeseen or unexpected side effects not listed above will be reported to the sponsor and regulatory 
representatives (IRB/EC) as they occur. 
 
2.2.1.1  MINIMIZATION OF POTENTIAL RISKS 
These risks are mitigated by utilizing qualified clinical Investigators who have training and are experienced in 
procedures delivering radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is 
needed and in the use of ultrasound systems.  In addition, risks are mitigated by including only those subjects that 
meet the study eligibility criteria. This study also includes evaluation of study subject satisfaction with this procedure. 
Given the anticipated acceptable risk, the risk-benefit assessment of the use of the Renuvion APR device to deliver 
radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed appears to 
offer a substantial clinical benefit at a reasonable risk. 
2.2.2 POTENTIAL BENEFITS 
The benefit of this study is to add to the industry knowledge base a better understanding of the 
coagulation/contraction of soft tissue produced by the Renuvion APR system. Subjects enrolled in this study will 
receive the benefit of using the Renuvion APR device for the coagulation/contraction of soft tissue.    
 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 19 of 45 
3. 
STUDY PURPOSE 
The purpose of this study is to quantitatively measure the amount of soft tissue contraction produced by the delivery 
of Renuvion helium plasma energy to the subcutaneous connective tissue. 
4. 
STUDY DESIGN AND ENDPOINTS 
4.1 
DESCRIPTION OF THE STUDY DESIGN 
This is a prospective, single-center, non-randomized study of up to 5 subjects who are receiving treatment with the 
Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. 
Subjects may also have other body areas treated at the same time. Demographic information, medical history, and 
procedure details will be documented. Pre- and post-procedure care are per investigator standard of care and 
documented. Video may be taken during the procedure. 
 
Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during the procedure. 
Measurements of contraction will be calculated from the ultrasound images by an ultrasonographer. At baseline, 
photographs will be taken of the treatment areas. Surface area measurements will be taken of each treatment area 
prior to study treatment.  
 
Post-procedure care will be as per investigator standard of care and documented. All adverse events and expected 
treatment effects will be documented. 
 
Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180, D270, & D365.  
 
An interim analysis of data will be completed following study treatments and following each follow-up visit (D30, 
D45, D60, D90, D180, D270); a final report will provide comprehensive study results through D365.  
4.2 
DURATION OF STUDY 
Recruitment for this study may take approximately three (3) months. Following the treatment visit, subjects will be 
followed for a total duration of 365-days. Therefore, the anticipated total duration of the study is approximately 
sixteen (16) months. 
4.3 
STUDY ENDPOINTS 
4.3.1 PRIMARY EFFECTIVENESS ENDPOINT 
The primary effectiveness endpoint is an analysis of contraction measured by an ultrasonographer and then analyzed 
as follows: 
• 
Quantify the amount of intra-operative contraction produced by liposuction. 
• 
Quantify the amount of intra-operative contraction produced by each pass of Renuvion.  
• 
Determine if amount of intra-operative contraction produced by Renuvion begins to level off (reach a point 
of diminishing return).  
• 
Determine how the amount of intra-operative contraction varies based on the initial length at baseline.  
• 
Correlate amount of intra-operative contraction to energy delivered.  
• 
Determine how amount of contraction changes over time. 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 20 of 45 
• 
Correlate the amount of contraction to GAIS and PSQ.  
• 
Correlate the amount of contraction or energy delivered to AEs.  
• 
Correlate the amount of contraction to IPR review. 
4.3.2 SAFETY VARIABLES 
The safety variables included in this study are as follows: 
• 
Prior to treatment, the subject’s medical history will be reviewed, a urine pregnancy test will be performed 
(if applicable), and a physical examination will be conducted.  
• 
Following study treatment and at each subsequent visit, the subject will be queried about adverse events, 
expected treatment effects, and changes in concomitant medications, and the treatment area will be 
visually examined.  
• 
Analysis of adverse events through the D365 post-treatment visit. 
4.3.3 ADDITIONAL OUTCOME MEASURES 
1. Improvement in appearance of skin laxity in the treatment area assessed by selection of the correct post-
treatment image as determined by a masked, qualitative assessment of photographs by blinded 
independent reviewers at 90-days, 180-days, 270-days, and 365-days post-treatment compared to baseline.  
2. The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will 
complete a PGAIS assessing overall aesthetic improvement in the treatment area at day 60, 90, 180, 270, 
and 365 post-treatment. 
3. The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area at day 60,  
90, 180, 270, and 365 post-treatment. 
4. The subject will complete a Patient Satisfaction Questionnaire (PSQ) at the 180-, 270- and 365-day follow-
up visits. 
5. Analysis of energy delivered per surface area and per volume of tissue. 
 
4.3.4 EVALUATION TOOLS 
The following evaluation tools will be used in this study: 
4.3.4.1 ANALYSIS OF CONTRACTION (PRIMARY OUTCOME MEASURE) 
Ultrasound images will be taken of the abdomen prior to and during the procedure, and at all follow-up visits. An 
experienced ultrasonographer will calculate the measurement of contraction. The measurements will be recorded 
on a study-specific Case Report Form (CRF). Measurements will be calculated as follows: 
• 
Reproducible landmarks will be established on the ultrasound prior to beginning any treatment.  
• 
The measurements will be taken from the underside of dermis to top of the muscle fascia. 
 
Measurements will be calculated by the ultrasonographer at the following timepoints: 
• 
At baseline (prior to any treatment – before infiltration). 
• 
Following liposuction. 
• 
Following each Renuvion treatment pass. 
• 
At all follow-up visits. 
 
Utilizing the measurements calculated by the ultrasonographer, Apyx Medical or a contracted statistician will 
calculate the following contraction analyses: 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 21 of 45 
• 
Quantification of the amount of intra-operative contraction produced by liposuction. 
• 
Quantification of the amount of intra-operative contraction produced by each pass of Renuvion. 
• 
 Determine if amount of intra-operative contraction produced by Renuvion begins to level off (reach a point 
of diminishing return).  
• 
Determine how the amount of intra-operative contraction varies based on the initial length at baseline.  
• 
Correlate amount of intra-operative contraction to energy delivered.  
• 
Determine how amount of contraction changes over time. 
• 
Correlate the amount of contraction to GAIS and PSQ.  
• 
Correlate the amount of contraction or energy delivered to AEs.  
• 
Correlate the amount of contraction to IPR review. 
4.3.4.2 2-DIMENTIONAL PHOTOGRAPHY  
Two-dimensional (2D) photographic images will be captured utilizing the study site’s camera system.  The same 
standardized views will be used throughout the study.  Images will be taken at baseline, 30-day, 45-day, 60-day, 90-
day, 180-day, 270-day, and 365-day visits. 
4.3.4.3 INDEPENDENT PHOTOGRAPHIC ASSESSMENTS 
Three experienced, independent blinded photographic reviewers will perform a qualitative analysis/review of pre-
treatment and post-treatment sets of images for each subject.  Images will be provided in a blinded and randomized 
order.  Each blinded reviewer will choose which is the before image and which is the after.  Success will be correct 
identification of before and after by at least 2 of the 3 reviewers. 
4.3.4.4 MODIFIED GLOBAL AESTHETIC IMPROVEMENT SCALE (GAIS) 
The Modified Global Aesthetic Improvement Scale (GAIS) is a subjective rating of improvement in treatment results 
compared to pre-treatment.  The Investigator will grade the overall improvement of abdominal treatment area as 
indicated in Table 2 by comparing the subject’s appearance at follow-up visits against a photograph taken prior to 
procedure.  Likewise, the subject will also rate their improvement compared to pre-treatment as shown in Table 3.   
The modified GAIS results will be collected at the 60-day, 90-day, 180-day, 270-day, and 365-day follow-up visits.   
TABLE 3: MODIFIED GLOBAL AESTHETIC IMPROVEMENT SCALE EVALUATION - INVESTIGATOR 
Rating 
Description  
Very much improved 
Optimal cosmetic result from this procedure in this subject 
Much improved 
Marked improvement in appearance from the initial condition, but not 
completely optimal for this subject 
Improved 
Obvious improvement in appearance from the initial condition 
No change 
The appearance is essentially the same as the original condition 
Worse  
The appearance is worse than the original condition 
Much worse 
The appearance is much worse than the original condition 
Very much worse 
The appearance is very much worse than the original condition 
 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 22 of 45 
TABLE 4: MODIFIED GLOBAL AESTHETIC IMPROVEMENT SCALE EVALUATION - SUBJECT 
Rating 
Very much improved 
□ 
Much improved 
□ 
Improved 
□ 
No change 
□ 
Worse  
□ 
Much worse 
□ 
Very much worse 
□ 
Both scales should be completed in two steps: 
• 
Based on a live assessment of the subject while referring to the subject’s pre-treatment photographs 
(subjects should utilize a mirror for assessment); and  
• 
Based on a comparison of the subject’s pre-treatment photographs to the current post-treatment 
photographs. 
4.3.4.5 PATIENT SATISFACTION QUESTIONNAIRE (PSQ) 
Patient Satisfaction Questionnaires (Attachment B) will be completed at the 180-day, 270-day, and 365-day follow-
up visits. The subject should complete this assessment while referring to baseline photos, current photos, and a 
hand mirror. 
4.3.4.6 ADVERSE EVENT REPORTING 
The definitions of Adverse Events (AEs) and the subtypes are provided in Section 8 of the study protocol.  Adverse 
events will be classified by the investigator as to: 
• 
Serios vs not serious 
• 
Expected Treatment Effect (ETE) vs Adverse Event (AE) 
• 
Severity: mild, moderate, severe 
• 
Device/procedure causality: not related, related, undetermined. 
 
5. 
SUBJECT ENROLLMENT AND WITHDRAWAL 
5.1 
STUDY POPULATION 
The study population will consist of males and females between 18 and 65 years of age who have chosen to 
participate in this clinical trial as evidenced by execution of the informed consent document and meet eligibility 
criteria defined in this protocol are eligible for participation in this clinical trial. Subjects will be considered enrolled 
into the study when they have signed an approved informed consent form. Subjects who are enrolled and do not 
meet eligibility criteria will be exited as a screen fail without study treatment. A study exit Case Report Form will be 
completed for all enrolled subjects. 
5.1.1  INFORMED CONSENT 
Informed consent will be obtained from all subjects prior to study participation. 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 each participant.  

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 23 of 45 
 
Investigators have ethical and legal responsibilities to ensure that the protocol is clearly explained to each subject 
considered for enrollment in the study. Compliance with this requirement should be documented on a written 
Informed Consent Form approved by the reviewing IRB. Each Informed Consent Form will include the elements 
required by FDA regulations in 21 CFR Part 50. 
 
Consent forms will be IRB-approved, and the participant will be asked to read and review the document. The investigator, 
or investigator-delegated study personnel, 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 IRB-approved Informed Consent Form will be signed by the study personnel obtaining consent. A copy of the 
informed consent document will be given to the participants for their records. The investigative site will keep the 
original on file. 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. 
 
The participants may withdraw consent at any time throughout the course of the trial without any penalty or loss of 
benefits to which the subject is otherwise entitled. An Investigator may also discontinue a subject from the study without the 
subject’s consent, if the Investigator feels it is in the best medical interest of the subject.  The date and the reason for study 
withdrawal will be indicated on the Study Exit CRF.   
5.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO PARTICIPANTS 
Consent forms describing in detail the study device, study procedures, and risks are given to the participant and 
written documentation of informed consent is required prior to starting intervention/administering study product.  
5.1.2  PRE-TREATMENT RECRUITING/SCREENING 
Subjects will be recruited from the study site’s patient database and social media and screened.  Study site personnel 
will explain the design and purpose of the study to potential study subjects.  Subjects interested in participating and 
who qualify will visit the study site where informed consent will be obtained.  The site may utilize a pre-screening 
questionnaire that has been approved by the IRB. 
5.1.2.1 SCREEN FAILURES 
A screen failure subject is one from whom informed consent is obtained and is documented in writing (i.e., subject 
signs an Informed Consent Form), but who does not receive a study treatment because of failure to meet all of the 
eligibility criteria. Screen failure subjects will be included in the total number of subjects enrolled (i.e., all subjects 
consented), but not counted towards the total subjects treated. 
5.2 INCLUSION CRITERIA 
Subjects must meet all of the following criteria for study enrollment: 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 24 of 45 
• 
Patients who are scheduled for a procedure involving the use of Renuvion for the contraction of 
subcutaneous soft tissue.  Patients undergoing procedures involving Renuvion following liposuction in the 
abdomen will be included. 
• 
Patients who have acceptable cardiopulmonary health for outpatient surgery. 
• 
Willing and able to comply with protocol requirements, including obtaining study-required images/photos 
and assessments, and returning for follow-up visits. 
• 
Willing to release rights for the use of study photos, including in potential publication. 
• 
Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit. 
• 
Able to read, understand, sign and date the informed consent document (English only). 
 
5.3 
EXCLUSION CRITERIA 
Subjects will be excluded if they meet any of the following criteria: 
• 
BMI of greater than 35. 
• 
Diabetes mellitus with A1C score >7. 
• 
Active cigarette smokers or nicotine vape users. 
• 
History of connective tissue disease (Ehlers Danlos, Cutis Laxa, Pseudoxanthoma Elasticum, Marfan's, etc.). 
• 
Patients who, in the opinion of the investigator, are not an appropriate candidate for the study. 
• 
Patients with a history of or requiring a concomitant procedure in the Renuvion treatment area that could 
impact the ultrasound measurements or the effectiveness results. 
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Subjects will receive compensation for completion of the 30, 45, 90, 180, 270, and 365-day visits.  This small stipend 
will be outlined in the site specific ICF and approved by the IRB prior to subject enrollment.  The reason for the 
subject’s withdrawal should be documented on the appropriate study specific CRF. 
 
5.5  
PARTICIPANT WITHDRAWAL OR TERMINATION 
5.5.1 REASONS FOR WITHDRAWAL OR TERMINATION 
All subjects have the right to withdraw at any point during the study without prejudice. The investigator can 
discontinue any subject, at any time, if medically necessary. Subjects must be discontinued from the investigation 
by the investigator at any time for any of the following reasons: 
• 
Withdrawal of informed consent. 
• 
Pregnancy (no further study-related procedures will be performed). 
• 
Any AEs for which treatment continuation would constitute an unacceptably high risk for the subject. 
 
The reason for subject’s withdrawal should be documented on the appropriate study specific CRF.  
5.5.2 HANDLING OF WITHDRAWALS OR TERMINATION 
The subject must undergo the recommended follow-up assessments specified for the last study visit unless 
contraindicated due to a medical condition. Withdrawn subjects will not be replaced. 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 25 of 45 
Subjects who are discontinued from the study due to an AE(s) will be treated according to standard clinical practice 
and will be followed-up until the final study visit/safety visit.  All pertinent information concerning the AE will be 
documented on the appropriate study specific CRF. 
 
A subject may discontinue from the study at any time without any penalty or loss of benefits to which the subject is 
otherwise entitled. An Investigator may also discontinue a subject from the study without the subject’s consent, if 
the Investigator feels it is in the best medical interest of the subject.  The date and the reason for study withdrawal 
will be indicated on the Study Exit CRF.   
5.6 
PREMATURE TERMINATION OR SUSPENSION OF THE STUDY OR A STUDY SITE 
The study or a study site can be prematurely terminated or suspended by the sponsor. Reasons for termination of 
the study or a study site may include, but are not limited to, the following: 
• 
Subject enrollment is unsatisfactory. 
• 
The risks and benefits of continuing the study have been reassessed, and the risks outweigh any potential 
benefits. 
• 
The incidence of AEs constitutes a potential health hazard to the subjects. 
• 
New scientific data do not justify a continuation of the study. 
• 
The investigator or study site exhibit serious and/or persistent non-adherence to the protocol, the 
Declaration of Helsinki, EN ISO 14155, and/or applicable regulatory requirements. 
• 
The sponsor decides to terminate the study at any time for any other reason. 
Furthermore, the study may be prematurely ended if the regulatory authority or the IRB has decided to terminate 
or suspend approval for the study, the study site, or the investigator. 
 
If the study is prematurely terminated or suspended for any reason, the investigator must inform the subjects and 
assure appropriate follow-up treatment. Within the timeframes noted in applicable regulations, the sponsor will 
promptly inform the investigators, study sites, the IRB, and regulatory authorities of the termination or suspension 
of the study, as well as provide reasons for the action. 
6. 
STUDY DEVICE 
Cleared Renuvion handpieces shipped for use in clinical investigations conform to the applicable general safety and 
performance requirements (GSPR) apart from the aspects covered by the clinical investigation and that, with regard 
to those aspects, every precaution is taken to protect the health and safety of the subjects. This includes, where 
appropriate, technical, and biological safety testing and pre-clinical evaluation as well as provisions in the field of 
occupational safety and accident prevention and taking into consideration the state of the art. Apyx Medical will 
provide Renuvion handpieces for use in this clinical investigation. The site will utilize their own Renuvion generator 
and ultrasound system. 
6.1 
PACKAGING & STORAGE 
The sponsor will provide appropriate packaging and storage instructions of the Renuvion handpieces to the study 
sites. 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 26 of 45 
6.2 
ACCOUNTABILITY 
The investigator, or designee, must maintain an inventory record using the site-specific Device Disposition Form of 
study devices received, used for treatment, and returned to the Sponsor to ensure that the investigational device 
will not be dispensed to any person who is not a subject under the terms and conditions set forth in this protocol. 
There will be 100% accountability for all study devices. The clinical study site shall maintain all devices received for 
clinical trial use in a locked, limited access cabinet or room until the end of the study unless they are returned to 
Apyx while the study is being conducted, such as at the end of study treatments. 
6.3 
DEVICE MALFUNCTION/OBSERVATION 
All malfunctions of, or defects of the delivery system will be reported to the Sponsor by the study sites.  This will 
include situations where the delivery system did not perform as intended; user errors; study device/component 
being physically defective, including out of the box failure. 
7. 
STUDY PROCEDURES AND SCHEDULE 
7.1 
PRE-PROCEDURE 
Study subjects will have verification of eligibility criteria, a brief general examination including medical history, and 
pre-procedure assessments as detailed below completed within 30 days prior to undergoing the study procedure. 
In response to the ongoing coronavirus disease (COVID-19) pandemic, preoperative testing can be completed at the 
Investigator’s discretion.  Pre-operative testing should be performed as close to the scheduled study procedure as 
feasible, but in time to get the results. Up to two urine pregnancy tests must be obtained prior to study procedure 
for females with child-bearing potential (one at pre-procedure screening and one on the day of the procedure prior 
to the procedure if pre-procedure screening and procedure are not performed on the same day).  
The following pre-treatment assessments will be performed:  
• 
2D photographic images will be captured. The same standardized photography views will be used 
throughout the study.  
• 
Urine pregnancy test (for females of childbearing potential). 
• 
General physical exam including medical history, vital signs, collection of patient demographic information, 
and BMI. 
 
Medications subject is taking upon entry into the study should also be documented in the Case Report Forms (CRF). 
All concomitant prescription medications taken during study participation will be recorded on the appropriate study 
specific CRF. For this protocol, a prescription medication is defined as a medication that can be prescribed only by a 
properly authorized/licensed clinician. Medications to be reported on the CRF and entered on the eCRF are 
concomitant prescription medications, over-the-counter medications, and non-prescription medications. 
Medication used for analgesia and/or anesthesia should be recorded as concomitant medication as well. To ensure 
the capture of the foregoing information on pre-existing conditions, sites should also be attentive to the need to 
document without limitation and whenever discovered: (1) all chronic, episodic or ‘as needed’ medications used 
before study enrollment; (2) prior episodic or ‘as needed’ therapeutic interventions, procedures or hospitalizations; 
and, (3) recent or planned surgical procedures.  
7.2 
STUDY PROCEDURE 
On the day of the procedure and prior to the study procedure, female subjects with child-bearing potential must 
complete a urine pregnancy test (result must be obtained prior to the procedure), see Table 4.   

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 27 of 45 
Medications at investigator discretion may be provided. 
The abdominal procedure utilizing the Renuvion APR system will be performed per the investigator’s standard 
clinical practice. Subjects may also have other body areas treated at the same time. Procedure data and adverse 
events will be captured. 
Ultrasound Measurements of the abdomen will be collected intra-operatively (pre-treatment, post-liposuction, post 
each Renuvion pass). Video may be taken during the procedure. 
7.3 
FOLLOW-UP PROCEDURES  
7.3.1 IMMEDIATELY POST-PROCEDURE  
Following the procedure, the research staff and the subject will care for the treated areas using the Post-Procedure 
Care Instructions per the Investigator’s standard clinical practice.  
7.3.2 FOLLOW-UP VISITS & SUBJECT CONTACT OUTSIDE OF FOLLOW-UP VISITS 
The Investigator will follow-up with the study subjects per their Standard of Care (SOC), at the following time-points: 
• 
30 (±4) days 
• 
45 (±10) days 
• 
60 (±10) days 
• 
90 (±10) days 
• 
180 (±15) days 
• 
270 (±15) days 
• 
365 (±15) days 
 
Post-procedure assessments, ultrasound imaging, and 2D photographic imaging will be performed during the follow-
up visits, see Table 4. The same standardized photography views and ultrasound imaging will be used throughout 
the study as documented in the image capture document developed for the study.  
Due to the challenges of COVID-19, if a subject is unable to return to the office for an in-person visit, follow-up visits 
will be conducted virtually. If a visit is completed virtually, missing assessments such as photographs will be 
documented as a protocol deviation specifically noting COVID-19. Outside of photographs, study investigators and 
study staff will ensure all other assessments related to each follow-up visit are completed virtually if the visit is done 
virtually. For virtual visits, the investigator and/or study staff completing the visit and assessments will be identified 
on the case report form; as well, the manner in which the visit was completed will also be recorded (i.e., video call, 
phone call, etc.). Virtual visits should be done via video call, if possible, to ensure subject identity. If a telephone call 
must be done, the investigator and/or study staff must positively identify the subject prior to conducting the virtual 
visit by requesting the subject to state their address and date of birth. Subjects will be strongly encouraged to come 
in (albeit safely) for their D365 visit; this visit is vitally important as this is the primary endpoint and photographic 
images are needed for many of the assessments. Only investigators and study staff who have been trained and 
delegated to conduct virtual visits as indicated on the delegation log may conduct virtual study visits. 
Subjects may be seen for an unscheduled appointment at any time at investigator’s discretion. 
Study staff will contact (phone, text, email, video call at subject’s preference) all subjects with ongoing Adverse 
Events at regular intervals. If the subject is unreachable by the preferred method of contact, another method of 
contact may be attempted. 
 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 28 of 45 
TABLE 4: STUDY REQUIRED PROCEDURES 
 
 
Baseline/ Pre-
Procedure 
Screening1 
Procedure 
(Day 0) 
30 Day 
45 Day 
60 Day 
 90 Days 
 180 Days 
 270 Days 
 365  Days 
26-34 
days 
35-55 
days 
50-70 
days 
80-100  
days 
165-195  
days 
255-285 
days 
350-380 
days 
Informed Consent 
X 
 
 
 
 
 
 
 
 
Assess 
Inclusion/Exclusion 
Criteria 
X 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Urine Pregnancy Test2 
X 
X 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
General Physical Exam 
X 
 
 
 
 
 
 
 
 
Review Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Photographic Imaging3 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Study Procedure 
 
X 
 
 
 
 
 
 
 
Ultrasound 
Imaging/Measurements4 
 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Event Assessment  
 
X 
X 
X 
X 
X 
X 
X 
X 
Modified 
Global 
Aesthetic 
Improvement Scale (GAIS) 5  
 
 
 
 
X 
X 
X 
X 
X 
Patient 
Satisfaction 
Questionnaire6  
 
 
 
 
 
 
X 
X 
X 
1 Pre-procedure Screening assessments to take place within 30 days prior to undergoing the procedure. 
2 Up to two urine pregnancy tests must be obtained prior to study procedure for females with child-bearing potential (one at pre-procedure 
screening and one on the day of the procedure prior to the procedure if screening and procedure are not performed on the same day). 
3Digital photographs will be taken and labeled according to Photography Instructions.  Standard positioning and lighting will be used for all 
photographs.  
4To be taken intraoperatively (pre-treatment, post-liposuction, and post each Renuvion pass) and at each follow-up visit  
 5 To be completed by Investigator and study subject at day 60, day 90, day 180, day 270, and day 365 follow-up visits. 
6To be completed by study subject at day 180, day 270, and day 365 follow-up visits. 
7.4 
SUBJECT RANDOMIZATION AND TREATMENT GROUP ASSIGNMENT  
Subjects are not randomized in this study.  
7.5 
STUDY SCHEDULE 
7.5.1 SCREENING 
• 
Obtain informed consent of potential participant verified by signature on study informed 
consent form. 
• 
Verify all preliminary/screening inclusion/exclusion criteria are met. 
7.5.2 BASELINE ASSESSMENT  
• 
Document medical history. 
• 
Obtain pregnancy screen (if applicable). 
• 
Perform baseline photography.  
• 
Document concurrent medications. 
• 
Obtain height and weight. 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 29 of 45 
7.5.3 TREATMENT VISIT  
• 
Greater than 30 days between baseline and treatment visits will require that the subject be re-screened to 
confirm enrollment eligibility.  
• 
Obtain pregnancy screen (if applicable) prior to study treatment. 
• 
Perform study treatment. 
• 
Provide post-treatment instructions. 
7.5.4 FOLLOW-UP 
Subjects will be asked to return to the clinic for follow-up visits at 30-, 45-, 60-, 90-, 180-, 270-, and 365-days post-
treatment. At all visits, subjects will be assessed for safety and efficacy, standardized images will be taken, ultrasound 
images will be taken for the independent ultrasonographer measurements, adverse events and protocol deviations 
will be assessed, and study outcome measures (GAIS, as applicable) will be completed. At the 180-day, 270-day, and 
365-day follow-up appointment in addition to the above referenced assessments, the subject will complete a Patient 
Satisfaction Questionnaire.   
7.5.4.1 FOLLOW-UP ASSESSMENT AT 30+4 DAYS 
• 
Obtain Images. 
• 
Obtain ultrasound images for measurements. 
• 
Assess/collect any adverse events. 
7.5.4.2 FOLLOW-UP ASSESSMENT AT 45+10 DAYS 
• 
Obtain Images. 
• 
Obtain ultrasound images for measurements. 
• 
Assess/collect any adverse events 
7.5.4.3 FOLLOW-UP ASSESSMENT AT 60+10 DAYS 
• 
Obtain Images. 
• 
Obtain ultrasound images for measurements. 
• 
Obtain aesthetic improvement scores. 
• 
Assess/collect any adverse events 
7.5.4.3 FOLLOW-UP ASSESSMENT AT 90+10 DAYS 
• 
Obtain Images. 
• 
Obtain ultrasound images for measurements. 
• 
Obtain aesthetic improvement scores. 
• 
Assess/collect any adverse events. 
7.5.4.4 FOLLOW-UP ASSESSMENT AT 180+15 DAYS 
• 
Obtain Images. 
• 
Obtain ultrasound images for measurements. 
• 
Obtain aesthetic improvement scores. 
• 
Obtain patient satisfaction scores.  
• 
Assess/collect any adverse events. 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 30 of 45 
7.5.4.5 FOLLOW-UP ASSESSMENT AT 270 +15 DAYS 
• 
Obtain Images. 
• 
Obtain ultrasound images for measurements. 
• 
Obtain aesthetic improvement scores. 
• 
Obtain patient satisfaction scores.  
• 
Assess/collect any adverse events. 
7.5.4.6 FINAL VISIT AT 365 +15 DAYS 
• 
Obtain Images. 
• 
Obtain ultrasound measurements. 
• 
Obtain aesthetic improvement scores. 
• 
Obtain patient satisfaction scores.  
• 
Assess/collect any adverse events. 
7.5.5 SAFETY ASSESSMENTS 
Assess for adverse events immediately post-treatment and at all follow-up visits. 
7.5.6 UNSCHEDULED VISIT 
Any unscheduled visit or examine should be documented in the subject’s medical record and adverse event form 
(if applicable) stating the reason for the visit and any actions taken. The Sponsor should be notified of the 
unscheduled visit. 
 
7.5.7 END OF STUDY (COMPLETION) 
All subjects who have signed an Informed Consent Form will be considered enrolled in the study. Subjects who 
complete the study duration will be considered to have completed the study. The end of study will be defined as 
completion of all study visits by all enrolled subjects. If a device-related AE, SAE, or unanticipated serious device-
related effect is ongoing at the final study visit, the subject will be followed until resolution, until the condition 
stabilizes, until the event is otherwise explained, or the subject is lost to follow-up.  
 
A study closure visit may be conducted at the study site in order to review record retention requirements, device 
disposition requirements, etc., with site personnel.  The Sponsor may choose to conduct the closure visit via 
telephone contact if appropriate. 
8. 
ASSESSMENT OF SAFETY 
8.1 
SPECIFICATIONS OF SAFETY PARAMETERS 
8.1.1 DEFINITION OF AN EXPECTED TREATMENT EFFECT (ETE) AND AN ADVERSE EVENT (AE) 
An expected treatment effect (ETE) is defined as any typical treatment side-effect of Renuvion APR of mild to 
moderate severity and lasting up to a typical maximum duration.  An adverse event (AE) is defined as any new 
medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, 
whether or not it is considered device-related by the investigator.   
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 31 of 45 
A preexisting condition (one that is present at the start of the study) will be recorded as an AE only if the frequency, 
intensity, or the character of the condition worsens during the study period. Neither the condition, hospitalization, 
prolonged hospitalization, nor surgery are reported as an AE in the following circumstances: hospitalization or 
prolonged hospitalization for diagnostic or elective surgical procedures for a preexisting condition. Surgery should 
not be reported as an outcome of an AE if the purpose of the surgery was elective or diagnostic and the outcome 
was uneventful. 
 
All ETEs and AEs will be collected during the conduct of this trial.   
8.1.2 DEFINITION OF SERIOUS ADVERSE EVENT (SAE) 
Each adverse event should be assessed for its seriousness. The definition below should be used for this assessment. 
Please note that the term serious adverse event is not synonymous with a “severe” adverse event, which may be 
used to describe the intensity of an event experienced by the subject.  
 
An adverse event should be classified as serious if it meets any of the following criteria: 
a. Death 
Death was an outcome of the adverse event.  
b. Life-threatening 
The subject was at substantial risk of dying at the time of the adverse event or use or continued use of 
the device. 
c. 
Hospitalization (initial or prolonged) 
Admission to the hospital or prolongation of hospitalization was a result of the adverse event. 
d. Disability or Permanent Damage 
The adverse event resulted in a substantial disruption of a person's ability to conduct normal life 
functions, i.e., the adverse event resulted in a significant, persistent or permanent change, impairment, 
damage or disruption in the patient's body function/structure, physical activities and/or quality of life. 
e. Congenital Anomaly/Birth Defect 
Exposure to a medical product prior to conception or during pregnancy may have resulted in an adverse 
outcome in the child. 
f. 
Required Intervention to Prevent Permanent Impairment or Damage (Devices) 
Medical or surgical intervention was necessary to preclude permanent impairment of a body function, 
or prevent permanent damage to a body structure, either situation suspected to be due to the use of 
a medical product. 
g. Other Serious (Important Medical Events) 
The event does not fit the other outcomes, but the event may jeopardize the subject and may require 
medical or surgical intervention (treatment) to prevent one of the other outcomes. 
 
Non-serious adverse events are all events that do not meet the criteria for a “serious” adverse event. 
8.1.3 DEFINITION OF UNANTICIPATED ADVERSE DEVICE EFFECTS (EVENTS) 
An unanticipated adverse device effect is defined as “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 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 32 of 45 
supplementary application), or any other unanticipated serious problem associated with a device that relates to the 
rights, safety, or welfare of subjects.” 
8.2 
CLASSIFICATION OF AN EVENT 
8.2.1 SEVERITY OF EVENT 
Each adverse event should be assessed for its severity, or the intensity of an event experienced by the subject, using 
the following classifications: 
 
• 
Mild: easily tolerated by the subject, causing minimal discomfort and not interfering with everyday 
activities. These events generally do not require treatment.  
• 
Moderate: sufficiently discomforting to interfere with normal everyday activities.  These events are 
usually relieved by simple therapeutic measures.  
• 
Severe:  prevents normal, everyday activities.  These events may require systemic drug therapy or other 
medical treatment. 
8.2.2 RELATIONSHIP TO THE INVESTIGATIONAL DEVICE 
The relationship to the study device and/or procedure will be determined by the investigator utilizing the following 
categories: 
• 
Not Related: An event for which an alternative explanation is conclusively identified – e.g., concomitant 
drug(s), concomitant disease(s), and/or the relationship in time suggests that a causal relationship is highly 
unlikely. 
• 
Related: The adverse event follows a reasonable temporal sequence related to treatment by the device 
and/or study procedure, follows a known or suspected response pattern and a plausible alternative etiology 
cannot be identified. 
• 
Undetermined: The relation of the adverse event has some temporal relationship to the device and/or 
study procedure, is not clearly due to another condition and the involvement of the study device is 
unknown.  
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 a study visit or upon review by 
a study monitor. All ETEs and AEs will be captured on the appropriate CRF. Information to be collected includes event 
description, date of onset, clinician’s assessment of seriousness and severity, relationship to study device/treatment 
(assessed only by those with the training and authority to make a determination), actions taken, and date of event 
resolution. All AEs occurring while on study must be documented appropriately regardless of relationship. All device 
related ETEs/AEs assessed as “not yet resolved” must continue to be followed via telephone contact, email or clinic 
visit as per the physician’s direction until event resolution or stabilization.   
 
A pre-existing condition should not be reported as an adverse event unless there has been a substantial increase in 
severity or frequency of the problem that has not been attributed to natural history. Changes in the severity of an 
event will be documented to allow for a determination if the event should be re-categorized from an ETE to AE.   
Safety evaluations for this study include an interview with the study subject at each follow-up visit by the Investigator 
or delegated study staff to elicit information about any medical occurrence that meets the definition of Adverse 
Event. This information will be documented in CRF without regard for cause or relation to device and/or procedure. 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 33 of 45 
Subjects may be asked by the study investigator to come into the site at any time to assess adverse events.  
Study investigators are provided liberty to mitigate adverse events as deemed necessary per IHC GCP Guidelines 
E6(R2)4.3.2 which states “During and following a subject’s participation in a trial, the investigator/institution should 
ensure that adequate medical care is provided to a subject for any adverse events related to the trial”. 
Adverse event resolution dates will be determined by investigator using either in-person or remote (phone, video 
call, text, email, etc.) examinations or communication with the subject.  To ensure the most accurate reporting of 
adverse event durations, investigators are instructed not to wait until scheduled office follow-up visits to assess 
resolution. 
It is the Investigator’s responsibility to determine seriousness, severity, and relatedness of the Adverse Event to the 
device and procedure using the definitions in this protocol. 
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 ETEs/AEs/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 Adverse Events (AEs) and Expected Treatment Effects (ETEs) observed by study subjects, investigators, or other 
study staff from first exposure to the study product through last study follow-up visit will be recorded. If a device-
related AE, ETE, SAE, or unanticipated serious device related effect is ongoing at the final study visit, the subject will 
be followed until resolution, until the condition stabilizes, until the event is otherwise explained, or the subject is 
lost to follow-up. The investigator should make every effort to ensure that follow-up includes any supplemental 
investigations as may be indicated to elucidate, as completely as practical, the nature and/or causality of the AE or 
SAE. This may include unscheduled follow up visits for AE assessment. 
 
Study subjects will be instructed in the ICF, post-treatment take home instructions, and verbally by study staff to 
report all AEs to the clinical study staff.  AE information will be collected throughout the duration of the study and 
recorded on CRFs. Subjects experiencing ongoing adverse events will be contacted as per Section 8.3.                                                         
 
Any new medical problem, or an exacerbation of an existing condition, reported from the time the informed consent 
form is signed must be followed until the last study visit after the last study treatment or until event resolution.   
AEs will not be followed up after the final study visit, which is scheduled <add time period in days, weeks or months> 
after the last study treatment. 
8.4.2 SERIOUS ADVERSE EVENT REPORTING 
Serious adverse events must be reported to the Sponsor as soon as possible, preferably within 24 hours but in no 
event later than 72 hours. Any AE considered serious by the PI or Sub-investigator, or which meets the definition 
of an SAE included in Definition of Serious Adverse Event must be documented on an SAE CRF.   
 
The Sponsor will conduct an investigation. If the Sponsor determines that the investigation presents an unreasonable 
risk to subjects, all investigations or parts of the investigation presenting that risk will be terminated as soon as 
possible. The investigator must report serious adverse events to the reviewing IRB/FDA according to the IRB/FDA 
regulations. 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 34 of 45 
8.4.3 UNANTICIPATED ADVERSE DEVICE EFFECT REPORTING 
If an unanticipated adverse device effect occurs, the study investigator shall complete the appropriate study specific 
CRF 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 
Apyx Medical Study Contact List. The study sponsor is responsible for conducting an evaluation of an unanticipated 
adverse device effect and shall report the results of such evaluation to FDA 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 FDA requests. 
8.4.4 REPORTING OF PREGNANCY 
Each pregnancy that starts during the subject’s study participation must be reported by the investigator to the 
Sponsor within 24 hours of learning of its occurrence. Pregnancies and pregnancy follow-up should be reported on 
an Adverse Event form. Pregnancy follow-up should describe the outcome of the pregnancy, including any voluntary 
or spontaneous discontinuation; details of the birth; the presence or absence of any congenital abnormalities, birth 
defects, maternal or newborn complications, and their relation to the device or treatment. Each pregnancy must be 
reported as a non-serious AE if the subject has received at least one study treatment.  The following criteria should 
be followed: 
• 
If a subject becomes pregnant after the Baseline visit and all study treatments have been completed, the 
subject should continue to be followed for the duration of the pregnancy. 
• 
If a subject becomes pregnant after the Baseline visit but before any study treatments, the subject should 
be exited from the study. 
• 
If a subject becomes pregnant after the Baseline visit but before all study treatments have been completed, 
additional study treatments should be discontinued, and the subject should continue to be followed for the 
duration of the pregnancy. 
8.4.5 REPORTING OF DEATHS 
The investigator must notify the Sponsor as soon as possible, preferably within 24 hours but in no event later than 
48 hours, of learning of a subject’s death, regardless of whether the death is related or unrelated to the 
investigational device. The investigator should attempt to determine, as conclusively as possible, whether the death 
is related to the device. The cause of death and the investigator’s discussion regarding whether or not the death was 
device-related should be described in a written report. The investigator mush report death to the reviewing IRB 
according to the IRB regulations at the study site. 
8.5 
STUDY HALTING RULES 
This clinical trial will be halted if subjects’ safety is questioned based on a reporting of severe, device-related AEs at 
an excessive frequency.  The Sponsor and/or investigator may recommend termination or modification of the study 
if there is an occurrence of any device- or treatment-related Serious Adverse Event, using the clinical protocol 
definitions of Serious Adverse Event. In addition, termination or modification may be recommended for any other 
perceived safety concern based on clinical judgment, including but not limited to a severe burn (anticipated or 
unanticipated), a higher than anticipated rate for any component of the safety measures, device failures resulting in 
Adverse Events, or unexpected SAEs. The study sponsor will notify all investigators to immediately halt any 
continuing enrollment activities and not enroll any additional study participants.  The study sponsor will inform the 
IRB/FDA of the temporary halt and the disposition of the study. 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 35 of 45 
The Sponsor and/or investigator may recommend termination or modification of the study if there is an occurrence 
of any device- or treatment-related Serious Adverse Event, using the clinical protocol definitions of Serious Adverse 
Event in Section 8.3 of this protocol. In addition, termination or modification may be recommended for any other 
perceived safety concern based on clinical judgment, including but not limited to a severe burn (anticipated or 
unanticipated), a higher than anticipated rate for any component of the safety measures, device failures resulting in 
Adverse Events, or unexpected SAEs. Enrollment and treatment would be suspended during root cause investigation 
to determine the cause of the respective AE. 
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).  Details 
of clinical site monitoring are documented in the Study-specific Monitoring Plan (SMP), a separate document which 
documents in detail who will conduct the monitoring, at what frequency monitoring will be done, at what level 
ofdetail monitoring will be performed, and the distribution of monitoring reports. 
10. STATISTICAL METHODOLOGY 
10.1 STATISTICAL AND ANALYTICAL PLANS 
As this trial is exploratory in nature, not statistically powered, and has a very small sample size, only descriptive 
statistics will be used to summarize these data. Summarizes will include mean, standard deviation and median for 
continuous data and counts and frequencies for categorical data. 95% confidence intervals may be constructed, 
but it is recognized that they will be quite wide with such a small sample size.  
10.2 SAMPLE SIZE 
The study will include up to 5 treated subjects from a single US site. 
11. SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/ 
DOCUMENTS 
Source documents are defined as the results of original observations and activities of a clinical investigation. Source 
documents will include, but are not limited to, study specific CRFs, progress notes, electronic data, computer 
printouts, screening logs, and recorded data from automated instruments. All source documents pertaining to this 
study will be maintained by the investigators and made available for inspection by authorized persons. 
12. QUALITY ASSURANCE AND QUALITY CONTROL 
Quality Assurance and Quality Control 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 via data queries. 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 36 of 45 
Following written SOPs, the clinical study 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 
This clinical study will be conducted in accordance with the Protection of Human Subjects Regulations, including 
Subpart B Informed Consent of Human Subjects (21 CFR Part 50); the Institutional Review Board Regulations (21 CFR 
Part 56); the Financial Disclosure by Clinical Investigators Regulations (21 CFR Part 54); and the Investigational Device 
Exemptions Regulations (21 CRF Part 812), and the ICH E6 and in compliance with the Declaration of Helsinki, Council 
for International Organizations of Medical Science (CIOMS), International Ethical Guidelines for Biomedical Research 
Involving Human Subjects (2002), and EU MDR for protection of human subjects.  
13.2 INSTITUTIONAL REVIEW BOARD 
Prior to initiation of any study procedures, the protocol, informed consent, and recruitment materials, and all 
participant materials will be submitted to a duly constituted IRB for view and approval. In addition, any amendments 
to the protocol or Informed Consent Form will be reviewed and approved by the IRB. The Sponsor must receive a 
letter documenting IRB approval at the clinical site prior to the initiation of the study. 
 
The investigator is responsible for providing the appropriate reports to its reviewing IRB during the course of the 
clinical study. These reports will include: 
• 
Informing the IRB of the study progress periodically as required, but at least annually; 
• 
Reporting any unanticipated adverse device effects within 10 working days of first learning of the event; 
• 
Reporting any deviations from the clinical protocol to protect the life or well-being of a subject in the case 
of an emergency within five working days after the emergency occurred; 
• 
Reporting the use of the device without obtaining informed consent from a subject within five working days 
of the event; and  
• 
Providing any other reports requested by the IRB. 
The IRB must be notified of study completion within 30 days of the final visit of the last subject and should be 
provided with a summary of the results of the study by the investigator. 
13.3 PARTICIPANT AND DATA CONFIDENTIALITY 
All information generated in this study must be considered highly confidential and must not be disclosed to any 
persons not directly concerned with the study without prior written permission from the Sponsor. Authorized 
regulatory officials and Sponsor personnel (or its representatives) will be allowed full access to inspect the records. 
Data disclosed outside the study team will be de-identified or will only include general group demographic 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 37 of 45 
information. Protected Health Information and/or identifiable study data will not be shared with anyone outside the 
study team or Health System, with the exception of the study sponsor, and federal regulators/ institutional officials 
for the purposes of auditing. 
 
All study devices and/or other materials collected will be used solely in accordance with this protocol, unless 
otherwise agreed to in writing by the Sponsor.  
 
Subjects should be identified only by initials and unique subject numbers on study specific CRFs. If necessary, their 
full names may be made known to a regulatory agency or other authorized officials. Information to be stored on the 
computer will be identified by subject ID and will be password protected. 
14. DATA HANDLING AND RECORD KEEPING 
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.  
 
During each subject’s visit to the clinic, study data will be documented by study personnel on study-specific Case 
Report Forms (CRFs) prior to entry into an Electronic Data Capture (EDC) system. Subject demographic information, 
procedural data, adverse events, device observations, and study required assessments will be documented on the 
CRFs by delegated site personnel.  Study subjects will complete Modified Global Aesthetic Improvement Scale (GAIS) 
Evaluations at protocol specified follow-up visits. Subjects will complete a Satisfaction Survey at the 60-day, 90-day, 
180-day, 270-day, and 365-day follow-up visits. In addition, study personnel will record progress notes to document 
all significant observations, and any contact with a subject by telephone or other means that provides significant 
clinical information will also be documented in the progress notes as described above. In this clinical trial, study 
specific CRFs may serve as source documents. 
 
For transmission to the Sponsor, information from the study progress notes and other source documents will be 
promptly transcribed to study specific CRF to the EDC with the CRF attached for remote monitoring of the data. 
Transcription of study data onto study specific CRFs and entry into the EDC should be completed within 3 days of 
the study visit. 
 
Copies of the electronic CRF (eCRF) serving as source documents must be maintained for each participant enrolled in 
the study. Data reported in the eCRF 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 
electronic study record. 
 
Any changes to information in the study progress notes, other source documents, and CRFs will be initialed and 
dated in ink on the day the change is made by a site study staff member authorized to make the change. Changes 
will be made by striking a single line through erroneous data, and clearly entering the correct data. If the reason for 
the change is not apparent, a brief explanation for the change will be written in the source documentation by the 
investigator and/or delegated staff. 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 38 of 45 
Photographic images will be captured utilizing the investigator’s private practice camera system. Images will be 
uploaded to a secure site, Dropbox.com, for transfer to the study sponsor. 
 
Data management and oversight is the responsibility of the Sponsor.  A study specific Data Management Plan 
provides additional details.  
 
Responsibilities may be delegated to applicable vendors. 
14.2 INVESTIGATOR RECORDS AND REPORTS 
14.2.1 INVESTIGATOR RECORDS 
Prior to participation in the investigation, the investigator must provide the following documentation to the Sponsor:  
• 
Investigator Agreement, signed by the investigator, which lists any physicians who will be involved in 
conducting the investigation under the direction of the primary investigator. 
• 
A copy of the principal investigator’s, sub-investigator’s, other delegated study clinicians’ curriculum vitae. 
• 
A letter signed by the chairperson of the IRB overseeing the conduct of this study indicating that the IRB 
has reviewed and approved this investigational plan. 
• 
A copy of the IRB-approved Informed Consent Form. 
During the study, investigators are required to maintain on file the following accurate, complete, and current records 
relating to this study as described in 21 CFR §812.140. A summary of these records is listed below: 
• 
Executed Clinical Trial Agreement. 
• 
Signed Financial Disclosure. 
• 
All correspondence and required reports, which pertain to the study, including IRB approvals and 
correspondence. 
• 
Shipping documents and Device Disposition Log which records of receipt, use, or disposition of study 
devices, including the type and quantity of devices; the dates of receipt; the identifying product numbers; 
the names of all persons who received, used or disposed of each device; and why and how many units of 
the device have been returned to the Sponsor, repaired, or otherwise disposed. 
• 
Records of each subject’s case history and exposure to the device. 
• 
Signed and dated consent forms. 
• 
Relevant observations, including records concerning adverse events, condition of each subject upon 
entering and results of diagnostic tests. 
• 
Study-specific CRFs and corrections to the forms. 
• 
Protocol and amendments with signed Investigator Agreement/Statement of Compliance. 
• 
IRB-approved subject recruiting materials. 
• 
Investigator curriculum vitae and medical license. 
• 
Monitoring reports and correspondence. 
• 
Study logs including: Site Training Log, Site Visit Log, Site Delegation Log, and Subject Enrollment Log. 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 39 of 45 
14.2.2 INVESTIGATOR REPORTS 
Investigators are required to prepare and submit to the Sponsor the following complete, accurate, and timely reports 
on this investigation when are required. These reports, which are listed below, are required by 21 CFR §812.150; 
additional reports may be requested by the Sponsor: 
• 
The investigator will notify the Sponsor of a subject death occurring during the investigation, as soon as 
possible, preferably within 24 hours of learning of the subject’s death, but in no event later than 48 hours. 
The investigator will notify the reviewing IRB of a subject death as specified by the IRB. 
• 
The investigator will notify the Sponsor of any unanticipated adverse device effects within 48 hours after 
learning of the effect. The investigator will notify its reviewing IRB of any unanticipated adverse device 
effects, as soon as possible, but no later than 10 working days after learning of the effect. 
• 
The investigator will notify the Sponsor of the withdrawal of IRB approval, as soon as possible, but no later 
than five working days after learning of the withdrawal. 
• 
The investigator will provide current progress reports to the Sponsor and reviewing IRB at regular intervals 
and at least on an annual basis. 
• 
The investigator will notify the Sponsor and reviewing IRB of any deviation from the investigational plan to 
protect the life and physical well-being of a subject in an emergency, as soon as possible, but no later than 
five working days after the emergency occurred. 
• 
The investigator will notify the Sponsor and reviewing IRB that an informed consent was not obtained from 
a subject, as soon as possible, but no later than five working days after such an occurrence. 
• 
The investigator will provide a final summary report to the Sponsor and reviewing IRB within three months 
after termination or completion of the study. 
• 
The investigator will provide any other information upon the request of an IRB, FDA, or the Sponsor. 
14.3 STUDY RECORDS RETENTION 
The investigator is responsible for retaining the necessary records, including a copy of the protocol, device labeling, 
study-specific CRFs, medical records, original reports of test results, all study-related correspondence, a record of 
written informed consent, and any other documents pertaining to the conduct of this study. 
 
FDA regulations require all investigators participating in investigational device studies to maintain detailed clinical 
records during the investigation and for a period of at least two years after the latter of the following two dates: 
1. The date on which the investigation is terminated or complete; or 
2. The date the records are no longer required for purposes of supporting a premarket approval application. 
The investigator must not dispose of any records relevant to this study without either: 
1. Obtaining written permission from the Sponsor; or 
2. Providing an opportunity for the Sponsor to collect such records. 
The investigator shall take responsibility for maintaining adequate and accurate electronic or hard copy source 
documents of all observations and data generated during this study. Such documentation is subject to inspection by 
the Sponsor and the FDA. 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 40 of 45 
14.4 PROTOCOL DEVIATIONS 
A protocol deviation is an event in which the investigator or site personnel did not conduct the study in accordance 
with the protocol or the Clinical Trial Agreement. This study should be conducted as described in this protocol, except 
for an emergency situation in which the protection, safety, and well-being of a subject requires a protocol deviation, 
based on the judgment of the investigator (or a responsible, appropriately trained professional designated by the 
investigator). If the deviation from the protocol is necessary to protect the physical well-being of a subject in an 
emergency, such protocol deviations must be reported to the Sponsor and the reviewing IRB as soon as possible, 
but no later than five working days after the emergency occurred.  
 
In the event of a significant deviation from the protocol due to an accident or mistake, the investigator or designee 
must contact the Sponsor at the earliest possible time to discuss the deviation and its impact on the study and 
subject continuation in the study. All protocol deviations and justification for the deviation will be documented on 
the applicable Case Report Form. 
14.5 PUBLICATION AND DATA SHARING POLICY 
The data produced by this Apyx Medical‐sponsored study is the sole property of Apyx Medical.  Thereby, 
abstracts, publications and presentations of this data must be pre‐approved by Apyx in writing (e‐mail approval 
is acceptable).  The Sponsor must also be provided with the opportunity to review all investigator‐prepared 
abstracts, publications or presentations.  A period of thirty (30) days for presentational materials and abstracts 
and forty‐five (45) days for manuscripts will be required for review and comment by Sponsor’s Clinical Affairs 
Department. These requirements acknowledge Sponsor's responsibility to evaluate such publications for their 
accuracy, to ascertain whether Confidential Information is being inappropriately released, to provide the 
Principal Investigator with information which may not yet have been available to him/her, and to provide input 
from co‐authors regarding content and conclusions of the publication or presentation. If requested in writing by 
the Sponsor, the Institution will withhold publication to protect the potential patentability of any invention 
described therein and/or made available to fulfill regulatory requirements. 
 
Notwithstanding the foregoing, Institution agrees that if the Study is part of a multi‐center study, the first 
publication of the results of the Study shall be made in conjunction with the results from the investigators at the 
other study centers as a multi‐center publication. 
 
The sponsor ensures that the study is registered, and study results are disclosed in at least one public clinical study 
registry, in accordance with national regulations and other requirements. Study registration may include a list of the 
study sites, as applicable. 
15. STUDY ADMINISTRATION  
15.1 
 STUDY INVESTIGATORS 
Participating Investigators will be qualified based on professionals experienced in treatment delivering 
radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed, such as plastic 
or cosmetic surgeons and the use of ultrasound systems.  Investigators will be selected based on interest and 
availability for participation in the study; ability to provide qualified subjects; adequate support staff; experience 
conducting clinical research; and willingness to comply with the protocol, IRB requirements, regulatory requirements 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 41 of 45 
(including the signed investigator agreement and statements disclosing any financial relationship investigators might 
have with Apyx Medical Corporation), and applicable regulations. 
15.2 AMENDMENT POLICY 
The investigator will not make any changes to this protocol without prior written consent from the Sponsor and 
subsequent approval by the IRB, except if the deviation from the protocol is necessary to protect the life and physical 
well-being of a subject in an emergency. Such protocol deviations must be reported to the Sponsor and the reviewing 
IRB as soon as possible, but no later than five working days after the emergency occurred. 
 
 Any permanent change to the protocol, whether it is an overall change or a change for specific study center(s), must 
be handled as a protocol amendment. Any amendment to the protocol that appears indicated as the study 
progresses will be fully discussed by the investigator(s) and the Sponsor. If agreement is reached regarding the need 
for an amendment, the Sponsor will write it. The written amendment must be submitted to the chairman of the IRB 
identified with this responsibility. Except for “administrative amendments”, investigators must await IRB approval 
of protocol amendments before implementing the change(s). Administrative amendments are defined to have no 
effect on the validity of the data or information resulting from the completion of the approved protocol, or the 
relationship of likely patient risk to benefit relied upon to approve the protocol; the scientific soundness of the 
investigational plan or protocol; and the right, safety or welfare of the human subjects involved in the investigation. 
When, in judgment of the chairman of the IRB, the investigators and/or the Sponsor, the amendment to the protocol 
substantially alters the study design and/or increases the potential risk to the subject, the currently approved written 
Informed Consent Form will require similar modification. In such cases, repeat informed consent will be obtained 
from subjects enrolled in the study before continued participation. 
16. CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence 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 study leadership has established policies and procedures 
for all study group members to disclose all conflicts of interest and will establish a mechanism for the management of all 
reported dualities of interest. 
 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 42 of 45 
17. LITERATURE REFERENCES 
1. Feldman LS, Fuchshuber PR, Jones DB. The SAGES Manual on the Fundamental Use of Surgical Energy 
(FUSE).  Springer Science+Business Media, LLC.  2012. 
2. Goldberg SN, Gazelle GS, Halpern EF, Rittman WJ, Mueller PR, Rosenthal DI. Radiofrequency tissue 
ablation: importance of local temperature along the electrode tip exposure in determining lesion shape 
and size.  Acad Radiol. 1996;3:212-8. 
3. Thomsen S. Pathologic analysis of photothermal and photomechanical effects of laser-tissue interactions.  
Photochem Photobiol.  1991;53:825-35. 
4. Ross EV, McKinlay JR, Anderson RR.  Why does carbon dioxide resurfacing work?  A review.  Arch 
Dermatol 1999;135(4):444-454. 
5. Gardner ES, Reinisch L, Stricklin GP, Ellis DL.  In vitro changes in non-facial human skin following CO2 laser 
resurfacing: a comparison study.  Lasers Surg Med 1996;19(4):379-387. 
6. Doshi SN, Alster TS.  Combination radiofrequency and diode laser for treatment of facial rhytides and skin 
laxity.  Cosmet Laser Ther 2005;7:11-15. 
7. Fatemi A, Weiss MA, Weiss RA.  Short-term histologic effects of nonablative resurfacing: results with a 
dynamically cooled millisecond-domain 1320nm Nd:YAG laser.  Dermatol Surg 2002;28(2):172-176. 
8. Mayoral FA.  Skin tightening with a combined unipolar and bipolar radiofrequency device.  J Drugs 
Dermatol 2007;6(2):212-215. 
9. Alster TS, Doshi SN, Hpping SB.  Combination surgical lifting with ablative laser skin resurfacing of facial 
skin: a retrospective analysis.  Dermatol Surg 2004;30(9):1191-1195. 
10. Zelickson B, Kist D, Bernstein E, Brown DB, Ksenzenko S, Burns J, Kilmer S, Mehregan D, Pope K.  
Histological and ultrastructural evaluation of the effects of a radiofrequency-based nonablative dermal 
remodeling device: a pilot study.  Arch Dermatol 2004;140:204-209. 
11. Hsu T, Kaminer M.  The use of nonablative radiofrequency technology to tighten the lower face and neck.  
Semin Cutan Med Surg 2003;22:115-123. 
12. Paul M, Blugerman G, Kreindel M, Muholland RS.  Three-dimensional radiofrequency tissue tightening:  a 
proposed mechanism and applications for body contouring.  Aesthetic Plast Surg.  2011;35(1):87-95. 
13. Hurwitz D, Smith D.  Treatment of overweight patients by radiofrequency-assisted liposuction (RFAL) for 
aesthetic reshaping and skin tightening.  Aesthetic Plast Surg.  2012;36(1):62-71. 
14. Duncan DI.  Nonexcisional Tissue Tightening:  Creating Skin Surface Area Reduction During Abdominal 
Liposuction by Adding Radiofrequency Heating.  Aesthetic Surgery Journal.  2013;33(8):1154-1166. 
15. Ulthera White Paper.  Lower Face, Submentum, and Neck.  Publicly available on www.ultherapy.com by 
Ulthera Inc.  
16. Boeni, R. Safety of Tumescent Liposuction under Local Anesthetsia in a Series of 4,380 Patients. 
Dermatology. 2011;222:278-281. 
17. O'Brien Jr WD, O'Brien Jr WD. Assessing the risks for modern diagnostic ultrasound imaging. Japanese 
journal of applied physics. 1998 May 1;37(5S):2781. 
18. Goldman A, Gotkin RH. (2009). Laser assisted lipolysis. Clin Plast Surg; 36(2):241-253. 
19. Mordon S, Plot E. (2009). Laser lipolysis versus traditional liposuction for fat removal. Expert Rev Med 
Devices; 6(6):677-688. 
20. DiBernardo BE, Reyes J. (2009). Evaluation of skin tightening after laser-assisted liposuction. Aesthet Surg 
J; 29(5):400–407. https://doi.org/10.1016/j.asj.2009.08.006. 
21. Duncan DI. (2013). Nonexcisional Tissue Tightening: Creating Skin Surface Area Reduction During 
Abdominal Liposuction by Adding Radiofrequency Heating. Aesthet Surg J; 33(8):1154-1166.  
22.  Paul M, Blugerman G, Kreindel M, Mulholland RS. (2011). Three-Dimensional Radiofrequency Tissue 
Tightening: A Proposed Mechanism and Applications for Body Contouring. Aesth Plast Surg; 35:87-95, 
doi:10.1007/s00266-010-9564-0 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 43 of 45 
23. Duncan DI. (2012) Improving outcomes in upper arm liposuction: adding radiofrequency-assisted 
liposuction to induce skin contraction. Aesthet Surg J; 32(1):84-95, doi:10.1177/1090820X11429549. 
PMID: 22231416. 
24. Chia CT, Theodorou SJ, Hoyos AE, Pitman GH. (2015). Radiofrequency-Assisted Liposuction Compared with 
Aggressive Superficial, Subdermal Liposuction of the Arms: A Bilateral Quantitative Comparison. Plast 
Reconstr Surg Glob Open; 3(7):e459. doi:10.1097/GOX.0000000000000429. PMID: 26301148; PMCID: 
PMC4527633. 
25. Key DJ. (2014). Integration of thermal imaging with subsurface radiofrequency thermistor heating for the 
purpose of skin tightening and contour improvement: a retrospective review of clinical efficacy. J Drugs 
Dermatol; 13(12):1485-9. PMID: 25607794. 
26. Han X, Yang M, Yin B, Cai L, Jin S, Zhang X, Li F. (2021). The Efficacy and Safety of Subcutaneous 
Radiofrequency After Liposuction: A New Application for Face and Neck Skin Tightening. Aesthet Surg J; 
41(3):NP94-NP100, doi:10.1093/asj/sjz364. PMID: 32004377. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 44 of 45 
ATTACHMENT A: PATIENT SATISFACTION QUESTIONNAIRE 
Please have the subject complete this assessment while referring to their image in the mirror and current post-
treatment photos compared to baseline photos. Provide the subject with a mirror.  
 
Using a mirror and reviewing your post-treatment photos, compare how your treatment area currently 
looks compared to your pre-treatment photos.  
 
1. Do you notice any improvement in how your abdomen looks? 
 YES → 
 Improvement in wrinkles 
 
 Less sagging skin 
 
 Smoother skin texture 
 
 More even skin tone (color) 
 
 Other:  
 
 
 
 
 
 NO 
 
2. How would you characterize your satisfaction with your procedure? 
 Very Satisfied  
 
 Satisfied 
        
 Slightly Satisfied  
 Neither Satisfied or Dissatisfied  
 Slightly Dissatisfied 
 Dissatisfied 
 Very Dissatisfied 
 
3. Would you recommend this procedure to your friends and family members (check one)? 
 YES  
 
 NO 
 
 
4. On a scale from 1-10 (1 is the worst, 10 is the best), what is your overall satisfaction with the procedure and 
the results of the procedure performed (circle ONE number)? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Worst                      
 
 
 
 
 
 
Best 
 
Thank you for completing this questionnaire. 
 
Subject Initials: ______________ 
 
Date: _____________________ (DD/MON/YYYY) 

Apyx Medical Corporation 
 
Protocol Number:  APX-23-02 
Effective Date: May 23, 2023 
Revision No: 1.1 
Title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound Clinical Trial Protocol 
 
Form-CLA-003-001                                                
 
Title: Clinical Trial Protocol 
Revision: 03 
 
Page 45 of 45 
PROTOCOL REVISION LOG 
TABLE 5: PROTOCOL REVISION LOG 
VERSION 
DATE 
SIGNIFICANT REVISIONS 
1.0 
4/21/23 
Initial Release 
1.2 
5/23/2023 
Addition of Day 60 Follow-Up Visit