A Prospective, Single Arm, Multi-center Study Evaluating the Short-term Clinical Outcomes of Ventral Hernias Treated With OviTex Reinforced Bioscaffold.
Phase: NA
Conditions: Hernia, Ventral
Sponsor: Tela Bio Inc

 
  
INVESTIGATIONAL PLAN 
 
A prospective, single arm, multi-center study evaluating the short-term clinical outcomes of 
ventral hernias treated with OviTex® reinforced bioscaffold 
 
Protocol No: 
 TB2016.01.01 
 
Type and Phase: 
 
 
 
 
 
Post-market prospective study 
Test Product: 
 
 
 
 
 
 
OviTex® Permanent 1S Reinforced Bioscaffold 
 
Sponsor:  
 TELA Bio Inc. 
Address: 
 1 Great Valley Parkway, Suite 24  
 
 Malvern, PA 19355 
 
  
Study Manager:  
 Jennifer Dugan 
Telephone No: 
 610-454-7200 
E-mail: 
 jenniferdugan@emergentclinical.com  
 
Sponsor’s Representative:  
 
Maarten Persenaire, MD 
 
 
 
 
 
 
 
 
TELA Bio Inc. 
 
 
 
 
Telephone No: 
 610-457-5275 
E-mail: 
 mpersenaire@telabio.com 
 
Principal Investigator: 
George DeNoto, MD 
 
Version and Date: 
Version 2.0 
 
15-June-2017 
 
Revision History:  
 
 
 
 
Revision 2 
 
Confidentiality Statement 
This document contains trade secrets and commercial information that are the property of, or under the control of TELA Bio, 
Inc. The information contained herein is privileged or confidential and may not be disclosed unless such disclosure is 
required by applicable law or regulations. In any event, persons to whom the information is disclosed must be informed that 
the information is privileged or confidential and may not be further disclosed by them. These restrictions on disclosure will 
apply equally to all future information supplied to you which is indicated as privileged or confidential.

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TABLE OF CONTENTS 
STUDY OVERVIEW ...................................................................................................... 12 
1 INTRODUCTION ...................................................................................................... 14 
1.1 Background ...................................................................................................... 14 
1.2 Rationale for Ventral Hernia Study ................................................................. 16 
1.3 Previous Experience (pre-clinical and clinical) ............................................... 17 
1.4 Device Description and Intended Use ............................................................. 18 
2 OBJECTIVES, 
HYPOTHESES, 
PRIMARY 
AND 
SECONDARY 
ENDPOINTS ........................................................................................................... 19 
2.1 Objectives ........................................................................................................ 19 
2.2 Primary and Secondary Endpoints .................................................................. 19 
2.2.1 Primary Endpoints ............................................................................... 19 
2.2.2 Secondary Endpoints ........................................................................... 20 
2.3 Study Design ................................................................................................... 20 
2.3.1 Rationale for the OviTex® Permanent 1S reinforced 
bioscaffold study ............................................................................... 20 
2.4 Number of Sites/Investigators ......................................................................... 21 
2.5 Number of Subjects ......................................................................................... 21 
2.6 Study Arms ...................................................................................................... 21 
2.7 Inclusion Criteria ............................................................................................. 21 
2.7.1 Inclusion Criteria at Screening: Visit 1 ............................................... 21 
2.8 Exclusion Criteria ............................................................................................ 22 
2.8.1 Exclusion Criteria at Screening: Visit 1 .............................................. 22 
2.8.2 Exclusion Criteria Intraoperative: Visit 2 ........................................... 22 
3 STUDY PROCEDURES ........................................................................................... 23 
3.1 Baseline Visit ................................................................................................... 23 
3.1.1 Surgical Date ....................................................................................... 23 
3.1.2 Shipment of Study Device .................................................................. 24 
3.2 Surgical Visit ................................................................................................... 24 
3.2.1 Admission ........................................................................................... 24 

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3.2.2 Intraoperative ...................................................................................... 24 
3.2.3 Discharge ............................................................................................ 25 
3.3 Post-operative Days 30 and 90 ........................................................................ 26 
3.4 Post-operative Months 12 and 24 .................................................................... 26 
4 CONCOMITANT 
PROCEDURES/TREATMENTS 
AND 
ADVERSE 
EVENTS .................................................................................................................. 27 
5 PATIENT WITHDRAWAL AND LOST TO FOLLOW-UP ............................... 27 
6 ADVERSE EVENTS ................................................................................................. 28 
6.1 Relationship ..................................................................................................... 29 
6.2 Serious Adverse Events ................................................................................... 30 
6.3 Anticipated and Unanticipated Adverse Device Effects ................................. 30 
6.3.1 Anticipated Adverse Events ................................................................ 30 
6.3.2 Unanticipated Adverse Device Effects (UADEs) ............................... 31 
6.4 Investigator Reporting Requirements .............................................................. 31 
6.4.1 Reporting Serious Adverse Events ..................................................... 31 
6.4.2 Reporting Unanticipated Adverse Device Effects (UADEs) .............. 31 
6.5 Serious Adverse Event and UADE Review .................................................... 32 
6.6 Complaints ....................................................................................................... 32 
7 STATISTICAL CONSIDERATIONS AND DATA MANAGEMENT ................ 32 
7.1 Sample size ...................................................................................................... 32 
7.2 Statistical Methods .......................................................................................... 32 
7.3 Planned Analysis ............................................................................................. 33 
7.4 Risk Analysis ................................................................................................... 33 
7.4.1 Potential Risks ..................................................................................... 33 
7.4.2 Potential Benefits ................................................................................ 34 
8 CLINICAL SUPPLIES ............................................................................................. 34 
8.1 Storage ............................................................................................................. 34 
8.2 Expiration ........................................................................................................ 35 
8.3 Accountability ................................................................................................. 35 

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8.4 Data Collection ................................................................................................ 35 
9 INVESTIGATOR SELECTION AND REGULATORY OBLIGATIONS ......... 35 
9.1 Investigator Selection ...................................................................................... 35 
9.2 Institutional Review Board Approval .............................................................. 36 
9.3 Investigator’s Agreement ................................................................................ 36 
9.4 Regulatory Documentation and Assessment of Site Facilities ........................ 37 
9.5 Informed Consent ............................................................................................ 38 
9.6 Confidentiality of Data .................................................................................... 38 
9.7 Protocol Amendments ..................................................................................... 39 
9.8 Protocol Adherence ......................................................................................... 40 
9.9 Change in Investigator ..................................................................................... 40 
9.10 Records Retention ........................................................................................... 40 
10 REFERENCES ......................................................................................................... 42 
11 APPENDICES .......................................................................................................... 46 
APPENDIX 1:  Quality of Life Surveys: ......................................................... 46 
APPENDIX 2:  SSI Wound Classification: ..................................................... 49 
APPENDIX 3:  Surgeon Assessment of Mesh ............................................... 50 
APPENDIX 4:  Surgeon and Subject Satisfaction Assessment: ...................... 51 
APPENDIX 5: Pain Visual Analog Scale ....................................................... 52 
APPENDIX 6: American College of Surgery; Patient Information 
Brochure for ventral hernia repair ..................................................... 53 
APPENDIX 7: STATEMENT OF INVESTIGATOR ................................... 57 
APPENDIX 8:  SUB-INVESTIGATOR AGREEMENT .............................. 59 
 

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PROTOCOL SIGNATURE PAGE 
 
The signature below constitutes the approval of this protocol entitled A 
prospective, single arm, multi-center study evaluating the short-term clinical 
outcomes of ventral hernias treated with OviTex® reinforced bioscaffold, and 
provides the necessary assurances that this trial will be conducted in compliance of 
all stipulations of the protocol, including all statements regarding confidentiality, 
and according to local legal and regulatory requirements, the Food and Drug 
Administration, International Conference on Harmonization Good Clinical Practice 
E6 (ICH-GCP), and applicable US regulatory requirements. 
 
 
 
___________________________________________________ 
Investigator’s Printed Name 
 
 
______________________________________________       _________________ 
Investigator’s Signature  
 
 
 
 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 

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STUDY SYNOPSIS 
 
Title 
A prospective, single arm, multi-center study evaluating the clinical 
outcomes of ventral hernias treated with OviTex® Permanent 1S 
reinforced bioscaffold. 
Investigational Product 
OviTex® Permanent 1S reinforced bioscaffold 
Protocol Number 
TB2016.01.01 
Study Design 
A prospective, single arm, multi-center study 
Number of Study Sites 
Up to 7 
Number of Subjects 
100 
Study Population 
Male and female subjects at least 18 years of age presenting with 
ventral hernia 
Study Treatment 
OviTex Permanent 1S reinforced bioscaffold in hernia repair  
Study Objective 
The study evaluates the post-operative complications and re-
herniations following the use of OviTex® Permanent 1S reinforced 
bioscaffold in subjects with ventral hernias. 
Study Endpoints 
Primary endpoints: 
1. 
Incidence of early post-operative surgical site 
occurrences or wound related events (e.g. - ileus, deep or 
superficial wound infection, seroma, hematoma, wound 
dehiscence, skin necrosis, fistulae) noted at the hernia repair site 
and occurring within the first three months of the ventral hernia 
repair. 
2. 
Incidence of other early post-operative 
complications (e.g. ileus, bowel obstruction, fistula) occurring 
within the first three months of the ventral hernia repair. 
 
Secondary endpoints:  

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1. 
Incidence of late post-operative surgical site 
occurrences or wound related events (e.g. ileus, deep or 
superficial wound infection, seroma, hematoma, wound 
dehiscence, skin necrosis, fistulae, bulging) noted at the 
hernia repair site and occurring > 3 months after index 
surgery. 
2. 
Incidence 
of 
other 
late 
post-operative 
complications (e.g. ileus, bowel obstruction, 
fistula) 
occurring > 3 months after index surgery. 
3. 
Patient Reported Outcomes (QoL and pain 
assessments). 
4. 
True hernia recurrence at the site of surgery at 
post-operative day 90 and months 12 and 24 months. 
 
Clinic Visits 
Baseline, hospital stay (admission, day of surgery, day of discharge), 
30 days, 90 days, 12 months, 24 months.   
 

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Time and Events Schedule 
 
 
Assessments 
Baseline 
Visit 
(BV) 
Hospital Stay 
Post-operative Visits 
Admission 
Day of 
Surgery 
(DOS) 
Day of 
Discharge 
(DOD) 
Day 30 
(±2wks) 
Day 90 
(±2wks) 
 
Month 
12 
(±4wks) 
Month 
24 
(±4wks) 
Informed 
Consent 
X 
 
 
 
 
 
 
 
I/E Criteria 
X 
 
X 
 
 
 
 
 
Medical History 
X 
 
X 
 
 
 
 
 
Physical Exam 
X 
 
X 
 
 
 
 
 
Hospitalization 
& Perioperative 
Information 
 
X 
X 
X 
 
 
 
 
Surgeon 
Assessment of 
Mesh 
 
 
X 
 
 
 
 
 
Surgical Site 
Assessment * 
 
 
 
X 
X 
X 
X 
X 
Ventral Hernia 
Assessment 
X** 
 
 
 
X 
X 
X 
X 
Pain Visual 
Analogue Scale 
 
 
 
 
X 
X 
X 
X 
QOL scales 
X 
 
 
 
X 
X 
X 
X 
Subject/Surgeon 
Satisfaction 
 
 
 
 
X 
X 
X 
X 
Adverse Events 
 
 
X 
X 
X 
X 
X 
X 
 
* Surgical site assessment is intended to document any surgical site occurrences of wound related events 
noted at the hernia repair site. 
 
** Baseline ventral hernia assessment is intended to estimate the actual hernia defect size.

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LIST OF TABLES 
Table 1: Adverse Event Severity 
 
LIST OF FIGURES 
 
Figure 
1: 
Image 
of 
OviTex 
1S 
Permanent 
RBS

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Glossary of Terms and Abbreviations 
 
AE 
Adverse Event 
ASA 
American Society of Anesthesiologists 
BV 
Baseline Visit 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulation 
Cm 
Centimeter 
COPD 
Congestive Obstructive Pulmonary Disorder CO2 Carbon Dioxide 
CRF 
Case Report Form 
CT 
Computerized Tomography 
CV 
Curriculum Vitae 
DOS 
Day of Surgery 
EBL 
Estimated Blood Loss 
ECM 
Extracellular Matrix 
EQ-5D 
EuroQol 5 Dimension 
FDA 
U.S. Food and Drug Administration 
GAGs 
Glycosaminoglycans 
GCP 
Good Clinical Practice 
HerQLes 
Hernia-Related Quality-of-Life Survey to Assess Abdominal Wall Function  
ICH 
International Conference on Harmonization 
I/E 
Inclusion/Exclusion 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
MEC 
Medical Events Committee 
Mm 
Millimeter 
OTC 
Over the Counter 
OTM 
Ovine Tissue Matrix 
OR 
Operating Room 

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PE 
Physical Exam 
POD 
Post Operative Day(s) 
PTFE 
Polytetrafluoroethylene 
QoL 
Quality of Life 
RBS 
Reinforced BioScaffold 
SAE 
Serious Adverse Event 
SSI 
Surgical Site Infection 
UADE 
Unanticipated Adverse Device Effect  
VAS 
Visual Analogue Scale 
WKS 
Weeks 
 

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STUDY OVERVIEW 
A baseline visit will be performed prior to the ventral hernia repair and will include assessment of 
the subject’s medical history, physical exam and pre-operative instructions. The subjects will 
also complete baseline Quality of Life (QOL) Surveys, one of which will be a disease specific 
assessment (HerQLes) and the other a standard measure of health outcomes (EQ-5D)  
 
On the day of surgery, repair of the ventral hernia will occur using OviTex® Permanent 1S 
reinforced bioscaffold to reinforce the repaired hernia site. Perioperative data will be collected, 
including the anatomical placement of the mesh and fixation methods.  During the course of 
hospitalization the patient will be assessed for incidence of early post-operative surgical site 
wound events and complications including the nature and severity of the complications, all 
necessary medical interventions and/or re-operations. 
 
On the day of hospital discharge, surgical site occurrences or wound related events (e.g. 
infections, hematomas, seromas, wound dehiscence) noted at the hernia repair site and the 
occurrence of other early post-operative complications (e.g. ileus, bowel obstruction, fistulae) 
will be assessed. 
 
At post-operative days 30 and 90, surgical site occurrences or wound related events (e.g. 
infections, hematomas, seromas, wound dehiscence) noted at the hernia repair site will be 
assessed. If a clinically significant hernia is suspected e.g. bulging noted at the hernia site, it will 
be confirmed via diagnostic imaging with a CT scan. The occurrence of other post-operative 
complications (e.g. ileus, bowel obstruction, fistulae) will be also assessed. Disease specific and 
general Quality of Life (QoL) surveys (HerQLes and EQ-5D), a pain scale and a subject/surgeon 
satisfaction assessment will also be administered. 
 

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At post-operative months 12 and 24, late surgical site occurrences or wound related events (e.g. 
infections, hematomas, seromas, wound dehiscence, bulging) noted at the hernia repair site will be 
assessed. If a clinically significant hernia is suspected e.g. bulging noted at the hernia site, it will 
be confirmed via diagnostic imaging with a CT scan. The occurrence of other late post-operative 
complications (e.g. ileus, bowel obstruction, fistulae) will also be assessed. Disease specific and 
general Quality of Life (QoL) surveys (HerQLes and EQ-5D), a pain scale and a subject/surgeon 
satisfaction assessment will also be administered. 
 
Concomitant treatments, surgeries and Adverse Events (AEs) will be collected throughout the 
study period. Subject safety will be monitored throughout the study period; from the Day of 
Surgery through the Month 24 visit. All AEs, UADEs and SAEs that occur from the day of 
surgery through the Month 24 visit will be reported in the CRF. In addition to notation in the 
CRF, all SAEs will also require completion of a separate reporting form for submission to the 
Sponsor through Day 90. Following the Day 90 visit, only SAEs considered by the investigator 
to be “Related or “Possibly Related” to the study product will require completion of the 
additional reporting form for submission to the Sponsor. Conversely, following the Day 90 visit, 
it will no longer be necessary to complete the separate reporting form for those SAEs that the 
investigator determines to be “Unrelated” to the OviTex mesh.   
 

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1 INTRODUCTION 
1.1 
BACKGROUND 
Meshes are indicated to reinforce absent or weakened soft tissue. Their main clinical application is 
found in hernias and abdominal wall defects. [1-3] In these diagnoses, the fascia underlying the 
abdominal muscles (rectus abdominus, transverse, internal and external obliques) exhibits a defect. 
The fascia is a layer of dense organized connective tissue that resists tension forces. It is 
comprised of closely packed bundles of organized collagen fibers, produced by the resident 
fibroblasts. [4, 5] 
 
A defect in the fascia allows abdominal contents, e.g. the viscera, to migrate or ‘herniate’ to a 
position outside the abdominal cavity, under the skin. Ventral hernias are common and are often 
the result of previous abdominal surgeries where the sutured fascia ultimately fails (incisional 
hernia). [6, 7] The term ‘abdominal wall defect’ is reserved for situations where a substantial 
section of the fascia is missing, and surgical repair is challenging. This can be caused by failed 
previous surgeries, infections, trauma and other causes. Many subjects with ventral hernias or 
abdominal wall defects suffer from co-morbid conditions that can have a negative impact on 
healing, such as obesity, diabetes, COPD, steroid use, or the presence of a stoma, [8] which may 
add to the complexity of the surgical repair and recovery.  Reported recurrence rates after ventral 
hernia repair range from 2.7% to 62%.  [2] [9-13] 
 
The goal for surgical repair of these ventral hernias is to obtain a tension-free primary closure of 
the defect in [1-3] the fascia, although this is not always possible. Techniques used to create 
more ‘real estate’ to achieve this goal, such as component separation, result in an increased 
surface area, but an overall thinner, and thus potentially weaker, abdominal wall. [1, 14] To 
reinforce the abdominal wall, many hernia surgeries include the use of a mesh. In cases where 
primary closure has been achieved, the mesh is used to reinforce the fascia and is placed either on 
top or below the newly constructed abdominal wall. e.g. ‘onlay’ or ‘underlay’.[15] In cases 

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where primary closure cannot be achieved meshes are used to bridge the remaining defect, e.g. 
‘inlay’.[16] 
 
There exist two main classes of meshes, synthetics made of materials such as polyester, 
polypropylene, polytetrafluoroethylene (PTFE); and biologic ones that consist of decellularized 
extracellular matrix from different organs and species. Within these classes many different 
implants exist. [17, 18] Some synthetic meshes include a resorbable coating on one or both sides 
to prevent or reduce the incidence and severity of adhesions. The advantages of synthetic meshes 
are that they are strong, provide a permanent repair without developing laxity, can be designed in 
different shapes and are relatively low cost. [19] Disadvantages of synthetics include that they 
may need to be removed in the presence of infection, are prone to adhesions, promote scar 
formation instead of de novo fascia, become brittle over time, shrink, and can cause ‘meshomas’ 
or migrate and erode through organs. [20-22] 
 
Biological meshes are made from connective tissue known as ‘extracellular matrix’. These meshes 
are made from dermis, small intestine, bladder, pericardium and other organs rich in connective 
tissue. In the manufacturing process the extracellular matrix is separated from associated layers 
and decellularized via mechanical and chemical processes. The structure of the matrix is preserved 
as much as possible. The composition of the extracellular matrix is virtually identical among all 
mammals. Its main constituent is fibrillar type I and III collagen; it also contains adhesion 
molecules such as proteoglycans, glycosaminoglycans (GAGs), and other glycoproteins. These 
molecules play numerous structural and functional roles, including binding and presenting growth 
factors to cell surface receptors, interacting directly with cells via specific receptors including 
integrins, and forming complex extracellular structures. Many of these functions are crucial to 
remodeling the implanted matrix into functional native tissue. [23] 
 
The collagenous matrix however is sensitive to damage caused by manufacturing processes, 
including terminal sterilization.  The damage inflicted can take the form of fragmentation, cross-
linking, or denaturation. The resulting matrix may no longer be completely natural and may be 

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perceived as a foreign body by the host, and cause inflammation or become encapsulated. Each 
manufacturer uses different source materials and proprietary protocols to decellularize and 
sterilize their product, leading to marked differences in their mechanical and biological 
performance. [24, 25] 
 
The advantages of effective biologic meshes include that they recreate a natural fascia, allow the 
surgeon to treat local infections while leaving the implant in-situ, cause minimal or no adhesions 
to the viscera and other tissues, do not shrink and do not lead to long-term complications such as 
‘meshomas’ or erosion of organs. 
 
None of the biological meshes on the market today meet all the criteria of an ideal implant. [26] 
The degree to which they fall short of the mark varies; disadvantages that are mentioned 
frequently are the development of laxity (‘bulging’) over time, true recurrences and the costs of 
the implants. [27, 28] 
 
1.2 
RATIONALE FOR VENTRAL HERNIA STUDY 
 
In today’s surgical practice, synthetic meshes are typically indicated for patients with low to 
moderate risk of post-operative complications, with expectations that the mesh will become 
integrated into a fascia like layer.  Biologic meshes, on the other hand, tend to be reserved for use 
in patients with a high risk of post-operative complications, with the expectation that the product 
will remodel into de-novo native fascia. [8] In reality, neither product fully succeeds in achieving 
either of these goals. Poor outcomes associated with use of both types of product have prompted 
the development of a unique new product category of Reinforced BioScaffolds (RBS). It is 
hypothesized that RBS have all the characteristics and benefits of a biologic, e.g. avoiding 
complications of fibrosis, bowel erosion and infection, while retaining the strength of a synthetic 
material and providing adequate reinforcement to a poor/damaged fascia and as such are not 
prone to bulging and form an improved alternative in the repair of ventral hernias. 

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OviTex® Permanent 1S reinforced bioscaffold consists of an extracellular matrix with a light 
internal polymer skeleton. The biologic component of OviTex® Permanent 1S reinforced 
bioscaffold is derived from ovine rumen and available in several thicknesses (strengths) and 
reinforced using a monofilament polypropylene thread. The processing has been optimized to 
ensure preservation of the natural characteristics of the matrix, after which the material is freeze 
dried. Layers are subsequently sewn together and sterilized. The sewing pattern yields a 6 x 6 
mm square open pattern. OviTex Permanent 1S includes one outer layer with a reduced 25 x 25 
mm pattern on one side to reduce the risk of adhesions when placed in contact with the viscera. 
 
It is hypothesized that the use of OviTex® Permanent 1S reinforced bioscaffold in abdominal 
hernia repair (in comparable subjects) will result in less seroma formation, the same percentage 
or fewer infections and fewer surgical repair related secondary procedures such as fluid 
aspirations or wound debridement. In addition, the use of OviTex® Permanent 1S reinforced 
bioscaffold is expected to result in a similar or lower rate of true recurrent herniations as reported 
for comparable prospectively studied subjects in the literature treated with other implants. [30-
33] Surgical procedure related outcomes tend to occur within the first three months after surgery, 
and the recurrence of a hernia may occur at any point in time after treatment. This study focuses 
on the surgical outcomes over the first 3 months and continues for a total of 24 months to capture 
the longer-term incidence of hernia recurrences.  
 
1.3 
PREVIOUS EXPERIENCE (PRE-CLINICAL AND CLINICAL) 
OviTex® Permanent 1S reinforced bioscaffold has been (and is being) evaluated in several 
animal models. A rat study comparing a previous version of the OviTex reinforced bioscaffold to 
Surgisis, a porcine small intestine derived biologic, has been completed.   A non-human primate 
study was performed and the results were compared to other mesh products used in ventral hernia 
repair, both synthetics and biologics studied in the same model. The results of the primate 
studies show OviTex® Permanent 1S reinforced bioscaffold to perform equivalent or superior to 
the most widely biologic and synthetic meshes used in this field with regards to inflammation, 

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kinetics of cell repopulation, absence of seroma formation and handling. The study reports are 
currently being prepared. 
 
A study in rabbits evaluating the formation of adhesions was recently completed, initial results 
show that Ovitex Permanent 1S implants are less prone to adhesion formation than the positive 
control (Prolene).  
 
A previous embodiment of the Reinforced BioScaffold also constructed from layers of ovine rumen 
and monofilament polypropylene has been implanted in 19 patients. Seventeen were treated for 
inguinal hernia and two for ventral hernia.  To date, no adverse events or recurrences have been 
reported in these patients. 
 
1.4 
DEVICE DESCRIPTION AND INTENDED USE 
OviTex® Permanent 1S reinforced bioscaffold is a six-layer construct of ovine derived 
extracellular matrix (ECM) and are assembled by stitching together multiple sheets of ECM with 
monofilament polypropylene. An example of an OviTex device is shown in Figure 1 below. The 
device is individually packaged and supplied sterile in various sizes up to 400 cm2. The device is 
supplied freeze dried and sterile in a “ready to use” in a peel pouch, and requires up to 5 minutes 
of rehydration time prior to implantation. 
 

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Figure 1:  Image of OviTex 1S Permanent RBS 
 
 
 
 
 
 
 
 
 
 
OviTex® Permanent 1S reinforced bioscaffold is intended for use as a surgical mesh to reinforce 
and/or repair soft tissue where weakness exists.  Indications for use include the repair of hernias 
and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain 
the desired surgical outcome. 
 
2 OBJECTIVES, HYPOTHESES, PRIMARY AND SECONDARY ENDPOINTS 
2.1 
OBJECTIVES 
The study is designed to demonstrate that, in subjects with comparable characteristics, the use of 
OviTex® Permanent 1S reinforced bioscaffold in ventral hernias leads to the same or lower 
percentage of early post-operative complications and true hernia occurrences as compared to 
prospective reports in the literature for either synthetic or biological meshes. 
 
2.2 
PRIMARY AND SECONDARY ENDPOINTS 
2.2.1 Primary Endpoints 
1. Incidence of early post-operative surgical site occurrences or wound related events (e.g. - 
ileus, deep or superficial wound infection, seroma, hematoma, wound dehiscence, skin 
necrosis, fistulae) noted at the hernia repair site and occurring within the first three months 

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of the ventral hernia repair. 
2. Incidence of other early post-operative complications (e.g. ileus, bowel obstruction, fistula) 
occurring within the first three months of the ventral hernia repair. 
 
2.2.2 Secondary Endpoints 
1. Incidence of late post-operative surgical site occurrences or wound related events (e.g. ileus, 
deep or superficial wound infection, seroma, hematoma, wound dehiscence, skin necrosis, 
fistulae, bulging) noted at the hernia repair site and occurring > 3 months after index 
surgery. 
2. Incidence of other late post-operative complications (e.g. ileus, bowel obstruction, fistula) 
occurring > 3 months after index surgery. 
3. Patient Reported Outcomes (QoL and pain assessments). 
4. True hernia recurrence at the site of surgery at post-operative day 90 and 12 and 24 months. 
 
2.3 
STUDY DESIGN 
This is a prospective, single arm, multi center, study evaluating the early post-operative clinical 
course and the true hernia recurrence rate of ventral hernias treated with the OviTex® Permanent 
1S reinforced bioscaffold device. The study will be conducted at up to 7 sites and uses a 
prospective, observational design.  Refer to Section 5 below for the Statistical Considerations of 
the study. 
 
2.3.1 Rationale for the OviTex® Permanent 1S reinforced bioscaffold study 
The purpose of the OviTex® Permanent 1S reinforced bioscaffold Study is to provide prospective 
data on the early post- operative clinical course and the true hernia recurrence rates in the repair of 
ventral hernias. Data relating to subjects with similar baseline characteristics will be correlated 
and compared to (prospective) published data where applicable. 
 

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2.4 
NUMBER OF SITES/INVESTIGATORS 
This study will be conducted at up to 7 investigational sites with George DeNoto, M.D. serving as 
the Lead Principal Investigator. 
 
2.5 
NUMBER OF SUBJECTS 
The study will enroll at least 100 subjects who complete the screening visit (see Section 5). 
Interim analyses will be performed to assess whether sufficient subjects exhibiting similar 
baseline characteristic have been included to allow statistical comparison to the literature. 
Based on the interim analyses enrollment may continue beyond 100 subjects. 
 
2.6 
STUDY ARMS 
The study will include a single arm design with all subjects receiving the OviTex® Permanent 1S 
reinforced bioscaffold device. 
 
2.7 
INCLUSION CRITERIA 
2.7.1 Inclusion Criteria at Screening: Visit 1 
1. Subject suffers from an uncomplicated ventral hernia that requires surgical repair 
(open, laparoscopic or robotic) with the use of an implant to reinforce or replace 
weakened or missing tissue.  
2. The size of the implant needed for repair is expected to be 18 x 22 cm,  20 x 20 cm 
or less. 
3. Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-
Contaminated) or Class III (Contaminated) criteria.  
4. Subject is willing and able to sign an informed consent for the study and has 
signed the IRB approved Informed Consent form for this study. 

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5. Subject is able to complete Quality of Life (QoL) and pain Questionnaires. 
6. Subject is at least 18 years old, (or considered an adult per state law). 
7. Subject is able to participate fully in, and for the full duration of, the study. 
 
2.8 
EXCLUSION CRITERIA  
2.8.1 Exclusion Criteria at Screening: Visit 1 
1. Subject has a BMI of > 40 
2. Subject meets CDC/SSI Wound Classification Class IV (Dirty-Infected) criteria 
3. Subject is female and is pregnant. 
4. Subject has a life expectancy of < 2 years making it unlikely that the 
subject will successfully achieve two-year follow-up. 
5. Subject has recent history of drug or alcohol abuse (in last 3 years). 
6. Subject has an allergy to ovine-derived products. 
7. Subject has participated in another clinical trial within the past 30 days or is 
currently involved in another clinical trial. 
8. Subject unable to receive OviTex® Permanent 1S reinforced bioscaffold at time of 
surgery 
 
2.8.2 Exclusion Criteria Intraoperative: Visit 2 
1. Subject requires implant that exceeds 18 x 22 cm or 20 x 20 cm. 
2. Subject unable to receive OviTex® Permanent 1S reinforced bioscaffold at time of 
surgery. 
 

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3 STUDY PROCEDURES 
3.1 
BASELINE VISIT 
The baseline visit will be performed in the 30 days prior to, including the day of, ventral hernia 
repair.  Subjects will provide written consent, using the Institutional Review Board (IRB) 
approved informed consent form, before any study procedures are performed.  After informed 
consent is obtained screening on all potential subjects will consist of the following: 
• Assessment of subject’s study eligibility according to study inclusion/exclusion 
criteria. Subjects who meet all of the inclusion and none of the exclusion criteria will 
be assigned a sequential subject number.  
• A relevant physical examination including review of systems and collection of height, 
weight, BMI, blood pressure, temperature, as well as an abdominal examination to 
evaluate the ventral hernia and to estimate the defect size, (length, width, area cm2 ). 
• A review of relevant medical history, including previous abdominal surgeries and 
any co-morbidities. A review of subject demographics including age, gender, race 
and ethnicity. 
• Assessment of disease specific and general Quality of Life (QoL) surveys 
(HerQLes and EQ-5D), (See Appendix 1). 
• A clinical evaluation to determine surgical approach (open, laparoscopic or robotic), a 
brief review of the surgical procedure and device to be used, in addition to pre- 
operative instructions. 
 
3.1.1 Surgical Date 
Sites will notify TELA Bio of scheduled surgeries within 5 days of the actual surgery date to 
ensure that study product is on-site for the day of surgery. 
 

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3.1.2 Shipment of Study Device 
The study will be performed using product that is provided at no cost by the Sponsor to all sites 
participating in the study.  
 
3.2 
SURGICAL VISIT 
The surgical visit is split into three phases: admission, intraoperative and discharge. 
3.2.1 Admission 
During the admission visit, the following components will be collected/reviewed: 
 
• A brief review of inclusion/exclusion criteria. 
• 
An abbreviated review of subject’s medical history to document any changes since the 
baseline visit. 
• 
An abbreviated physical examination to evaluate hernia and document any changes since 
the baseline visit. 
• 
Assessment of Surgical Site Infection (SSI) classification (See Appendix 2) 
 
• 
For female subjects, a pregnancy test will be performed 
 
 
3.2.2 Intraoperative 
On the day of surgery, definitive repair of the ventral hernia site will be performed with an 
OviTex® Permanent 1S reinforced bioscaffold implant. The Investigator will use the study 
product on a first-to-expire basis. Investigators will follow their individual Institutional guidelines 
for their standard surgical preparation regimen. During the index surgery, the following 
perioperative components will be collected: 
 
• 
Type of approach (Laparoscopic versus Open) 
• 
Actual size of defect (length, width, cm2 ) 
• 
Product item and lot-serial number used 

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• 
Size of implant used in surgery (final mesh dimensions after any trimming) 
• 
Location of implant (onlay, retrorectus, extraperitoneal, intraperitoneal or 
inlay/bridging) 
• 
Operative data 
o Component separation (anterior or posterior) 
o Fixation method (suture type and size) 
o Number of drain(s) placed, drain volume and duration 
o Rectus muscle condition 
o Presence or absence of adhesions 
o Any concomitant procedures 
o Iatrogenic injury 
o Blood loss 
o Skin closure (complete restoration of abdominal wall and primary skin closure) 
o Operative time (time of first cut to last suture) 
• 
All subjects will be assessed for intraoperative complications. 
• 
Using a Likert scale, surgeons will be asked to provide their subjective assessment on 
the mesh handling characteristics as defined by ease of placement and ease of 
securing OviTex® Permanent 1S reinforced bioscaffold implant (See Appendix 3). 
 
3.2.3 Discharge 
On the day of hospital discharge, the following will be collected: 
• 
Length of Stay, including number of days hospitalized prior to repair and following 
surgery, the number of days in ICU, step down and regular ward. 
• 
Number of drains still in place, drain volume and duration. 
• 
Any early surgical site occurrences (infections, seroma, hematoma, wound dehiscence) 
or wound related events noted at the hernia repair site. 
• 
Any other early post-operative complications (ileus, fistulae).  
 

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3.3 
POST-OPERATIVE DAYS 30 AND 90 
At post-operative days 30 and 90, the following procedures will be completed: 
• 
Number of drains still in place, drain volume and duration. 
• 
Assessment of any surgical site occurrences or wound related events (infections, seromas, 
hematoma, wound dehiscence) noted at the hernia repair site. 
• 
A relevant physical examination to evaluate hernia repair.  If there is any suspicion of a 
recurrent hernia e.g. bulging noted at the repair site, an abdominal CT scan will be performed to 
confirm the clinical diagnosis. If it is determined that it is clinically necessary to repair the 
hernia recurrence during the study period, those subjects will complete their participation in the 
study at the time of that repair 
• 
Assessment of any other post-operative complications (ileus, fistulae). 
• 
Assessment of disease specific and general Quality of Life (QoL) surveys e.g. EQ-5D and 
HerQLes, (See Appendix 1). 
• 
Subject and Surgeon satisfaction assessment of hernia repair (See Appendix 5). 
• 
Subject assessment of post-operative pain as measured by the Pain Visual Analog Scale 
((VAS) See Appendix 5). 
 
3.4 
POST-OPERATIVE MONTHS 12 AND 24 
 
The following activities will be performed at months 12 and 24 of Study period visit: 
• 
Assessment of any late surgical site occurrences or wound related events (e.g. infections, 
seromas, hematoma, wound dehiscence, bulging) noted at the hernia repair site. 
• 
A relevant physical examination to evaluate hernia repair. If there is any suspicion of a 
recurrent hernia e.g. bulging noted at the repair site, an abdominal CT scan will be performed to 
confirm the clinical diagnosis. If it is determined that it is clinically necessary to repair the 
hernia recurrence during the study period, those subjects will complete their participation in the 
study at the time of that repair. 

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• 
Assessment of any other late post-operative complications (e.g. ileus, fistulae). Assessment 
of disease specific and general Quality of Life (QoL) surveys e.g. EQ-5D and HerQLes, (See 
Appendix 1). 
• 
Subject and Surgeon satisfaction assessment of hernia repair (See Appendix 4). 
• 
Subject assessment of post-operative pain as measured by the Pain Visual Analog Scale 
((VAS) See Appendix 5). 
 
4 CONCOMITANT PROCEDURES/TREATMENTS AND ADVERSE EVENTS 
All treatments, surgeries, procedures and Adverse Events will be recorded for the duration of the 
study. All AEs, UADEs and SAEs that occur from the day of surgery through the Month 24 
visit will be reported in the CRF. In addition to notation in the CRF, all SAEs will also require 
completion of a separate reporting form for submission to the Sponsor through Day 90. Any 
Serious Adverse Events (SAEs) or Unanticipated Adverse Device Effects (UADEs) will be 
reported to TELA Bio (or their designee) within 24 hours of the investigator’s first awareness of 
their occurrence. Following the Day 90 visit, only SAEs considered by the investigator to be 
“Related or “Possibly Related” to the study product will require completion of the additional 
reporting form for submission to the Sponsor. Conversely, following the Day 90 visit, it will no 
longer be necessary to complete the separate reporting form for those SAEs that the investigator 
determines to be “Unrelated” to the OviTex mesh.   
 
 
5 PATIENT WITHDRAWAL AND LOST TO FOLLOW-UP 
Subjects have the right to withdraw from the study at any time for any reason. Subjects who wish 
to withdraw from the study should be instructed to notify the investigator in writing. The 
Investigator, acting in the best interests of the patient, also has the right to withdraw subjects 
from the study. 
 

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If the reason for removal of a subject from the study is an adverse event, the event will be 
recorded on the Adverse Event Case Report Form. In the case of any Serious Adverse Event (SAE) 
or Unanticipated Device Effect (UADE) the Investigator is also required to report the event using 
the required reporting forms. All efforts will be made to follow-up the patient until the condition 
resolves or Investigator determines that the patient's health has returned to an acceptable state. 
 
In the event that a patient is lost to follow-up (LTFU), the Investigators should document due 
diligence efforts to maintain contact with any subjects with at least 3 attempts by email or 
telephone with the final attempt being made by certified mail. 
 
6 ADVERSE EVENTS 
An adverse event is any unfavorable, unintended sign, symptom, condition or disease in a study 
subject, where the experience occurs during the course of the study, regardless of its relationship 
to the test product or surgical procedure. Follow-up of an AE, even after the completion of the 
study is required until the event or its sequelae resolve or stabilize at a level acceptable to the 
Investigator and TELA Bio. 
 
All AEs will be recorded in the Electronic Case Report Form and source documents.  The 
Investigator will assess each event in terms of severity and relationship to study product, as 
follows: 
TABLE 1 
Intensity 
Definition 
 
Mild 
Experiences that are transient, requiring no special treatment, or do not interfere 
with the subject’s daily activities 
 
 
Moderate 
Experiences that introduce some level of inconvenience or concern to the subject 
and may somewhat interfere with daily activities but are usually ameliorated by 
simple therapeutic measures, such as over the counter (OTC) medications. 

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Severe 
Experiences that are unacceptable or intolerable, significantly interrupt the 
subject’s usual daily activity, and/or require systemic drug therapy or other 
treatment, including other medical or surgical intervention or hospitalization. 
 
6.1 
RELATIONSHIP 
The relationship or association of the AE to study product will be characterized by the 
following categories:  
 
Not related:   
• There is no temporal relationship between the study product/treatment and the 
event, which makes a causal relationship clearly and incontrovertibly due to 
extraneous causes, e.g. not related to study product. 
• Other factors, such as concurrent illness, progression or expression of a disease, or a 
reaction to a concomitant medication are a more likely the cause of the event.  It is 
improbable that the study product caused the AE. 
 
Possibly related: 
• 
The AE cannot be fully explained by other causes, and it is possible that the study 
product caused the event. 
 
Related: 
• 
A reasonable temporal association exists between the AE and the study product, and 
based upon the investigators clinical experience, the association of the AE with the study 
product treatment seems probable. 
• 
A definite or certain temporal association exists between the AE and study product, and 
based upon the Investigator’s clinical experience, the association of the AE with study 
product seems definite or certain. 

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6.2 
SERIOUS ADVERSE EVENTS 
Serious Adverse Events are those Adverse Events that are: 
• Are life-threatening, 
• Are fatal, 
• Result in inpatient hospitalization or prolongation of a hospitalization, 
• Result in persistent or significant disability/incapacity, or 
• Result in congenital anomaly or birth defect. 
 
6.3 
ANTICIPATED AND UNANTICIPATED ADVERSE DEVICE EFFECTS 
6.3.1 Anticipated Adverse Events 
Anticipated adverse events related to ventral hernia repair include post- operative surgical site 
events such as ileus, deep or superficial wound infection, seroma, hematoma, wound dehiscence, 
skin necrosis, fistulae and recurrent hernia. A comprehensive list of these events can be found in a 
patient 
information 
brochure 
at 
the 
American 
College 
of 
surgery 
website; 
(http://www.facs.org/public_info/operation/brochures/ventral_hernia.pdf), 
see 
Appendix 
7).  
Although anticipated, should these events occur in subjects enrolled in this study, they are 
considered Adverse Events and should be noted in the eCRF. 
 
In addition to those events listed above, there are other anticipated adverse device effects that 
include failure of the product to incorporate, rupture of the OviTex® Permanent 1S reinforced 
bioscaffold sheet or dehiscence of the product, mesh infection, bowel obstructions from 
adhesions or other mesh complications. These events, although possible and therefore defined as 
anticipated, are considered to be rare occurrences. 
 

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6.3.2 Unanticipated Adverse Device Effects (UADEs)  
As per 21 CFR 812.3, Unanticipated adverse device effects are those effects, which have a 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 this study all SAEs as defined in Section 6.2 above and adverse events which occur that are not 
identified will be considered Unanticipated Device Effects and will be reported to the Sponsor as 
described in Section 6.4.  
 
6.4 
INVESTIGATOR REPORTING REQUIREMENTS 
6.4.1 Reporting Serious Adverse Events 
In addition to notation in the CRF, all SAEs will also require completion of a separate reporting 
form for submission to the Sponsor through Day 90. All Serious Adverse Events will be reported 
to TELA Bio within 24 hours of the Investigator’s first awareness of their occurrence. Following 
the Day 90 visit, only SAEs considered by the Investigator to be “Related or “Possibly Related” 
to the study product will require completion of the additional reporting form for submission to 
the Sponsor. Conversely, following the Day 90 visit, it will no longer be necessary to complete 
the separate reporting form for those SAEs that the Investigator determines to be “Unrelated” to 
the OviTex mesh.   
 
6.4.2 Reporting Unanticipated Adverse Device Effects (UADEs) 
Unanticipated adverse device effects (UADEs) are those that in nature, severity or degree of 
incidence differ from the list of anticipated adverse events above.  UADEs will be reported to the 
Sponsor within 24 hours of the Investigator’s first awareness of their occurrence. 
 

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6.5 
SERIOUS ADVERSE EVENT AND UADE REVIEW 
Reported SAEs and UADEs will be reviewed and investigated per TELA Bio Operating 
Procedures. When considered appropriate, TELA Bio will notify pertinent regulatory bodies and 
all Investigators within 10 working days of TELA Bio’s receipt of notification of the event.    It 
is the Investigators responsibility to notify their respective IRBs. 
 
6.6 
COMPLAINTS 
Any deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or 
performance of OviTex® Permanent 1S reinforced bioscaffold, but which are not Adverse 
Events, will be promptly reported to the Sponsor’s Customer Service Department.  
 
7 STATISTICAL CONSIDERATIONS AND DATA MANAGEMENT 
7.1 
SAMPLE SIZE 
A sample size of up to 100 subjects is planned for this study.  This is a sample of convenience 
and is estimated to be sufficient to allow assessment of clinical performance in this patient 
population. 
 
7.2 
STATISTICAL METHODS 
Statistical methods will be carried out in accordance with the Statistical Analysis Plan (SAP) 
developed for this study. 
 
The majority of data will be expressed as descriptive statistics. A p-value of less than or equal to 
0.05 will be considered statistically significant. Any confidence bounds will show two-sided 95% 
confidence interval limits. Categorical variables will be summarized by number and percent. 
Continuous variables will be summarized by total number (N), mean, standard deviation, median, 
min and max.  It is anticipated that the data will be evaluated using standard parametric and non-
parametric procedures. Analyses of particular interest will be: 

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1. Correlation of rate of surgical site wound infection to SSI wound classification, number of 
previous repairs and pre-morbid conditions. 
2. Correlation of surgical site occurrences or wound related events to re-herniation, BMI, 
number of previous abdominal. 
3. Correlation of number of previous repairs with true hernia recurrence 
4. Correlation of a visible bulge at hernia repair site with true hernia recurrence 
5. Correlation of subject abdominal wall function and QoL with bulging at the hernia repair site 
and hernia recurrence rates. 
 
The primary and secondary endpoints of this study will be also be compared to the clinical 
outcomes reported for other prospective studies in the literature. The results will be compared for 
the group as a whole, and, if the numbers will allow this, for subgroups of subjects exhibiting 
similar baseline characteristics, such as size of the hernia, co-morbid conditions, number of 
previous abdominal procedures etc. 
 
7.3 
PLANNED ANALYSIS 
Interim analyses will be performed to assess the short-term outcomes when the first 25, 50 and 75 
active subjects reach 90 days. The final analysis for the primary endpoint will be performed when 
all active subjects have completed their 90-day follow-up, and when all subjects have completed 
their Month 12 visit.  Additional analyses will be done when subjects have completed their 12 and 
24 months visits. 
 
7.4 
RISK ANALYSIS 
7.4.1 Potential Risks 
Potential risks of surgery with the OviTex® Permanent 1S reinforced bioscaffold device are 
similar to those that are encountered with other surgical meshes used to reinforce and/or repair 

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soft tissue where weakness exists. The associated risks will also be noted in the Informed Consent 
Form that all study subjects are required to sign prior to participation in the investigation. 
 
As per the patient information brochure of the American College of Surgery, the risks of ventral 
hernia repair include, but are not limited to: 
• 
Recurrence 
• 
Seroma 
• 
Intestines / bowel injury or temporary decrease in motility 
• 
Urinary retention 
• 
Wound infection 
• 
Pain 
• 
Hernia at port site 
• 
Hematoma or bleeding into the abdomen 
• 
Heart and breathing problems 
• 
Death 
http://www.facs.org/public_info/operation/brochures/ventral_hernia.pdf (See Appendix 7) 
 
7.4.2 Potential Benefits 
Subjects receiving the OviTex® Permanent 1S reinforced bioscaffold device may not experience 
any direct benefit as a result of the study. However, there is the potential that the use of the product 
may lead to lower incidence of seroma, infection and re-herniations than reported in the literature 
for synthetic and biologic meshes, as well as an overall lower cost of treatment. 
 
8 CLINICAL SUPPLIES 
8.1 
STORAGE 
The OviTex® Permanent 1S reinforced bioscaffold device should be stored in a clean, dry location 
at room temperature (25°C). The device should not be frozen. 
 

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8.2 
EXPIRATION 
The expiry date is displayed in the product labeling as the year (4 digits) and month (2 digits) next 
to an hourglass symbol. The product expires after the last day of the month indicated on the 
labeling.  
 
8.3 
ACCOUNTABILITY 
The study will be performed using commercially available product and will not be subject to 
investigational device regulations. However, the lot number of implants used in the study will be 
recorded in the subject medical records and also on a product accountability log. Accountability 
of product used in this study is the responsibility of the Investigator and appropriate records of 
receipt of the product and implantation should be maintained. 
 
8.4 
DATA COLLECTION 
Data submitted in support of the safety and efficacy of the study must be accurate and complete. 
The most effective way to accomplish this is to have accurate completion of the electronic Case 
Report Forms (eCRFs) and appropriate supporting source documentation maintained at the site. 
For this study, electronic CRFs will be maintained. The system, iMedNet, is certified as 21 CFR 
Part 11 compliant. Instructions on the use of the system and on completion of the specific CRFs 
will be provided to the site and reviewed by the study monitor as part of the Site Initiation 
Visit. Instruction/training will be repeated as necessary throughout the duration of the study. 
 
9 INVESTIGATOR SELECTION AND REGULATORY OBLIGATIONS 
9.1 
INVESTIGATOR SELECTION 
Investigators will be identified based on their qualifications to conduct the investigation. TELA Bio 
or their designee will further assess the qualifications of each Investigator and their staff by 

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conducting a review of their CV, checking the status of the Investigator within the FDA Debarment 
List, discussing the availability of the correct patient population at the institution and through a 
review of the clinical space to ensure that the facility has adequate amenities to conduct the study 
according to the protocol. The final determination on an Investigator’s participation will be made 
following review of the above criterion and completion of the Site Qualification/Pre-Study Visit. 
 
9.2 
INSTITUTIONAL REVIEW BOARD APPROVAL 
Investigators will be responsible for obtaining the initial and continuing review approvals from the 
governing IRB for the institution at which the proposed clinical investigation is to be conducted. 
Written certification of approval, and any conditions of approval imposed by the IRB, will be 
submitted to TELA Bio or their designee prior to the site’s participation in this investigation. 
Investigational supplies will not be shipped to participating sites until documentation of IRB 
approval has been provided to TELA Bio or their designee. The Investigator and/or his staff is 
responsible for knowing and complying with any reporting requirements stipulated by their 
governing IRB. 
 
9.3 
INVESTIGATOR’S AGREEMENT 
Investigators will be advised of their responsibilities as Investigators in a clinical study. 
Investigators will also be advised regarding FDA regulations governing clinical studies, and must 
abide by record keeping and reporting requirements. This information will be provided to the 
Investigators via the Clinical Trial Agreement, which must be signed by the Investigator and 
returned to TELA Bio or their designee prior to study participation. The Investigator will also be 
required to read and sign a Statement of the Investigator (See Appendix 8) and Sub-Investigators 
will be required to read, understand and sign the Sub-Investigator agreement (See Appendix 9). 
 

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9.4 
REGULATORY DOCUMENTATION AND ASSESSMENT OF SITE FACILITIES 
As part of the study start-up process, the Investigator and his staff will be required to supply 
documentation of their qualifications to participate in the study as well as a Financial Disclosure 
Form. Prior to participation in the study, each Investigator is required to submit the following 
documentation to TELA Bio or their designee: 
• 
A signed Clinical Trial Agreement 
• 
A current signed and dated curriculum vitae (current within 2 years) 
• 
A completed Financial Disclosure questionnaire 
• 
Written approval of the study protocol and associated Informed Consent Form from their 
governing IRB, (This must be provided prior to Investigational product being sent to the 
site or any subjects being enrolled). 
 
The Investigator/site is also required to submit any information required as part of the 
approval/renewal process for their governing IRB. Reports of any protocol deviations, AEs and 
Lost-to-Follow-Up subjects should also be provided to the IRB according to their stated 
requirements. 
 
The Site Qualification Visit or Pre-Study Visit enables the Monitor to review the following with the 
Investigator and his staff: clinical protocol, Investigator responsibilities, data collection and 
reporting requirements. 
 
Another purpose of this visit is for the Monitor to assure that the Investigator: 
• 
Has appropriate training, facilities, patient load, staff, time and willingness to comply with 
study requirements; 
• 
Understands the requirement to submit the clinical protocol to the IRB for review and 
approval; 
• 
Understands the requirement to maintain all study correspondence, study binders, case 

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report forms and patient records on file; and 
• 
Assumes responsibility for oversight of the investigation at his / her center 
 
The Monitor will complete a Qualification Visit Report to document all activities and topics 
reviewed during the visit as well as the site personnel present for the meeting. The report 
will also document any open action items identified as a result of the visit. 
 
9.5 
INFORMED CONSENT 
Subjects expressing an interest in participating in the study will be provided a copy of the IRB 
approved Informed Consent Form for review. The Investigator or a qualified member of his study 
staff should answer any study related questions posed by the potential subject.  
 
Potential subjects willing to participate in the study will be required to sign and date the Informed 
Consent Form. Only those who meet all inclusion and exclusion criteria for the study may be 
enrolled. Execution of the Informed Consent Form must be completed prior to initiating any study 
specific procedures. The signed original informed consent is to be maintained in the site records 
and the subject should be provided with a copy for their records. 
 
9.6 
CONFIDENTIALITY OF DATA 
Access to subject’s records is restricted to the Investigators, site support staff, and to TELA Bio’s 
(or their designee’s) clinical research personnel. Investigators are to instruct their staff in the 
methods and importance of maintaining subject confidentiality. On all study related documents, 
paperwork and reporting forms, study subjects should be identified only by their assigned subject 
number and initials. 
 
Study results reported by TELA Bio will be in aggregate form and individual identities will not 
be publicly disclosed. It is possible that regulatory authorities (e.g., FDA) may request detailed 

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clinical information regarding specific subjects. In these situations, information will be 
provided to regulatory authorities by the assigned subject number and subject initials. 
 
The investigator agrees that complete source documents for this study will need to be available to 
appropriately qualified personnel from TELA Bio (or their designee) or to country specific health 
authority inspectors after appropriate notification. The verification of Electronic Case Report 
Form data will be done by direct inspection of source documents (where permitted by law). 
Record review will be done in adherence with HIPAA and in a manner that protects subject 
confidentiality. 
 
During the conduct of the study, Investigators must agree not to publicly disclose any study 
related information including the study design, results or conclusions of the investigation without 
prior consent of TELA Bio. 
 
9.7 
PROTOCOL AMENDMENTS 
While not expected, it is possible that TELA Bio may need to amend the clinical protocol (for 
example, at the request of the FDA, due to emergence of new information etc.). In the event that 
this is needed, the protocol amendment will be reviewed and approved internally by the 
appropriate TELA Bio staff. Once finalized, the amendment will be distributed to the participating 
Investigator sites. Protocol amendments must undergo IRB review and approval at each clinical 
site, but may undergo expedited review if minor changes are made in the protocol that does not 
alter subject risk. The written approval from the IRB for the amendment should specifically refer 
to the Investigator, the protocol number and title, and reference any amendment numbers that are 
applicable. 
 

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9.8 
PROTOCOL ADHERENCE 
It is the responsibility of each Investigator and TELA Bio to conduct this study in accordance with 
all aspects of the protocol, Institutional Review Board requirements, the Declaration of Helsinki, 
the Code of Federal Regulations 21 CFR Part 50- Protection of Human Subjects, 21 CFR Part 
54- Financial Disclosure, and 21 CFR Part 56- Institutional Review Boards, International 
Organization for Standardization (ISO) 14155:2011 and general Good Clinical Practice (GCP). 
 
In the event of protocol deviations, both TELA Bio and the IRB should be notified of the event via 
the Protocol Deviation Log as soon as possible. If necessary, corrective actions will be taken to 
ensure the patient’s safety and the integrity of the clinical investigation including, but not limited 
to site or study termination. 
 
9.9 
CHANGE IN INVESTIGATOR 
Should the Investigator, during the conduct of the study, resign, relocate or retire, he / she must 
immediately inform TELA Bio and provide an orderly process for study continuation. Should the 
Investigator, after completion of the study, resign, relocate or retire, he / she must immediately 
inform TELA Bio and provide an orderly process for record retention. 
 
9.10 RECORDS RETENTION 
The types of records to be created and maintained for the clinical trial are dictated by the study 
protocol, Institutional Review Boards, and Federal regulations. Maintenance of records of device 
disposition, signed consent forms, study data forms (CRFs), adverse event reports, all 
correspondence, dates of monitoring visits, and supporting information for a period of two years 
following the completion of the study. The Investigator has the responsibility to retain all study 

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records, including the protocol, case report forms, IRB correspondence, letters to and from TELA 
Bio and any other applicable study documentation for the applicable period. 
 
At the completion of the required retention period, it is requested that the Investigator contact 
TELA Bio and allow TELA Bio the option of permanently retaining the Investigator's study 
records. 
 
If the Investigator retires or relocates, he/she must identify an individual at their site who will 
hold responsibility for maintaining the study records. The name and title of this individual should 
be provided to TELA Bio. Under no circumstances will anyone remove study records from the 
original study site without prior notification of, and approval by TELA Bio. 
 
Investigators may release responsibility to maintain records and transfer custody to any other 
person who accepts such responsibility. A notice of transfer must be given to the sponsor no later 
than ten working days after the transfer occurs. 
 

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10 REFERENCES 
1. Luijendijk RW, Hop WC, van den Tol MP, et al. (2000) A comparison of suture repair 
with mesh repair for 
incisional hernia. N Engl J Med 343:392–398. doi: 
10.1056/NEJM200008103430603 
 
2. Burger JWA, Luijendijk RW, Hop WCJ, et al. (2004) Long-term Follow-up of a 
Randomized Controlled Trial of Suture Versus Mesh Repair of Incisional Hernia. 
Transactions of the Meeting of the American Surgical Association CXXII:176–183. 
doi: 10.1097/01.sla.0000141193.08524.e7 
 
3. Butler CE, Baumann DP, Janis JE, Rosen MJ (2013) Abdominal wall reconstruction. Curr 
Probl Surg 50:557–586. doi: 10.1067/j.cpsurg.2013.08.003 
 
4. Peeters E, Hertogh G, Junge K, et al. (2013) Skin as marker for collagen type I/III ratio in 
abdominal wall fascia. Hernia. doi: 10.1007/s10029-013-1128-1 
 
5. Franz MG (2006) The biology of hernias and the abdominal wall. Hernia 10:462–471. doi: 
10.1007/s10029-006- 0144-9 
 
6. Poulose BK, Shelton J, Phillips S, et al. (2011) Epidemiology and cost of ventral hernia repair: 
making the case for hernia research. Hernia 16:179–183. doi: 10.1007/s10029-011-0879-9 
 
7. Muysoms FE, Miserez M, Berrevoet F, et al. (2009) Classification of primary and 
incisional abdominal wall hernias. Hernia 13:407–414. doi: 10.1007/s10029-009-
0518-x 
 
8. Breuing, K, Butler, CE, Ferzoco, S, Franz, M, et al. (2010) Incisional ventral hernias: review 
of the literature and recommendations regarding the grading and technique of repair. 
Surgery 148:544–558. doi: 10.1016/j.surg.2010.01.008 
 
9. Nockolds CL, Hodde JP, Rooney PS (2014) Abdominal wall reconstruction with components 
separation and mesh reinforcement in complex hernia repair. BMC Surgery 14:1–7. doi: 
10.1186/1471-2482-14-25 
 
10. Petro CC, Nahabet EH, Criss CN, et al. (2014) Central failures of lightweight 
monofilament polyester mesh causing hernia recurrence: a cautionary note. Hernia. doi: 
10.1007/s10029-014-1237-5 
 

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11. Nguyen MT, Berger RL, Hicks SC, et al. (2014) Comparison of Outcomes of Synthetic 
Mesh vs Suture Repair of Elective Primary Ventral Herniorrhaphy: A Systematic Review 
and Meta-analysis. JAMA Surg 149:415. doi: 10.1001/jamasurg.2013.5014 
 
12. Carter SA, Hicks SC, Brahmbhatt R, Liang MK (2014) Recurrence and 
pseudorecurrence after laparoscopic ventral hernia repair: predictors and patient-
focused outcomes. Am Surg 80:138–148. 
 
13. Liang MK, Berger RL, Li LT, et al. (2013) Outcomes of laparoscopic vs open repair of 
primary ventral hernias. JAMA Surg 148:1043–1048. doi: 10.1001/jamasurg.2013.3587 
 
14. Lipman J, Medalie D, Rosen MJ (2008) Staged repair of massive incisional hernias with loss 
of 
abdominal 
domain: 
a 
novel 
approach. 
Am 
J 
Surg 
195:84–88. 
doi: 
10.1016/j.amjsurg.2007.02.017 
 
15. Hawn MT, Snyder CW, Graham LA, et al. (2010) Long-term follow-up of technical outcomes 
for 
incisional 
hernia 
repair. 
ACS 
210:648–55– 
655–7. 
doi: 
10.1016/j.jamcollsurg.2009.12.038 
 
16. Jin J, Rosen MJ, Blatnik J, et al. (2007) Use of acellular dermal matrix for complicated ventral 
hernia repair: does technique affect outcomes? J Am Coll Surg 205:654–660. doi: 
10.1016/j.jamcollsurg.2007.06.012 
 
17. Bringman S, Conze J, Cuccurullo D, et al. (2009) Hernia repair: the search for ideal 
meshes. Hernia 14:81–87. doi: 10.1007/s10029-009-0587-x 
 
18. Brown CN, Finch JG (2010) Which mesh for hernia repair? Ann R Coll Surg 
Engl 92:272–278. doi: 10.1308/003588410X12664192076296 
 
19. Pott PP, Schwarz MLR, Gundling R, et al. (2012) Mechanical properties of mesh materials 
used for hernia repair and soft tissue augmentation. PLoS ONE 7:e46978. doi: 
10.1371/journal.pone.0046978.t005 
 
20. Klosterhalfen B, Junge K, Klinge U (2005) The lightweight and large porous mesh 
concept 
for 
hernia 
repair. 
Expert 
Rev 
Med 
Devices 
2:103–117. 
doi: 
10.1586/17434440.2.1.103 
 
21. Amid PK (2004) Radiologic images of meshoma: a new phenomenon causing chronic 
pain after prosthetic repair of abdominal wall hernias. Arch Surg 139:1297–1298. doi: 
10.1001/archsurg.139.12.1297 

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22. Millas SG, Mesar T, Patel RJ (2013) Chronic abdominal pain after ventral hernia due to 
mesh migration and erosion into the sigmoid colon from a distant site: a case report and 
review of literature. Hernia. doi: 10.1007/s10029-013-1182-8 
 
23. Badylak SF, Freytes DO, Gilbert TW (2009) Extracellular matrix as a biological scaffold 
material: 
Structure 
and 
function. 
Acta 
biomaterialia 
5:1–13. 
doi: 
10.1016/j.actbio.2008.09.013 
 
24. Zhang J, Wang GY, Xiao YP, et al. (2011) The biomechanical behavior and host response 
to porcine-derived small intestine submucosa, pericardium and dermal matrix acellular 
grafts in a rat abdominal defect model. 
Biomaterials 32:7086–7095. doi: 
10.1016/j.biomaterials.2011.06.016 
 
25. Kulig KM, Luo X, Finkelstein EB, et al. (2013) Biologic properties of surgical scaffold 
materials 
derived 
from 
dermal 
ECM. 
Biomaterials 
34:5776–5784. 
doi: 
10.1016/j.biomaterials.2013.02.055 
 
26. Shankaran V, Weber DJ, Reed RL II, Luchette FA (2011) A Review of Available 
Prosthetics 
for 
Ventral 
Hernia 
Repair. 
Ann 
Surg 
253:16–26. 
doi: 
10.1097/SLA.0b013e3181f9b6e6 
 
27. Patel KM, Bhanot P (2012) Complications of Acellular Dermal Matrices in Abdominal 
Wall Reconstruction. Plastic and Reconstructive Surgery 130:216S–224S. doi: 
10.1097/PRS.0b013e318262e186 
 
28. Bower, C and Roth, J Scott (2013) Economics of Abdominal Wall Reconstruction. Surgical 
Clinics of NA 93:1241– 1253. doi: 10.1016/j.suc.2013.06.007 
 
29. White A, Burns D, Christensen TW (2006) Effective terminal sterilization using 
supercritical 
carbon 
dioxide. 
Journal 
of 
Biotechnology 
123:504–515. 
doi: 
10.1016/j.jbiotec.2005.12.033 
 
30. Bellows CF, Shadduck P, Helton WS, et al. (2013) Early report of a randomized comparative 
clinical trial of Strattice™ reconstructive tissue matrix to lightweight synthetic mesh in the 
repair of inguinal hernias. Hernia. doi: 10.1007/s10029-013-1076-9 
 
 
31. Ruiz-Jasbon F, Norrby J, Ivarsson ML, Björck S (2014) Inguinal hernia repair using a synthetic 
long-term 

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resorbable mesh: results from a 3-year prospective safety and performance 
study. Hernia. doi: 10.1007/s10029-014-1249-1 
 
32. Itani KMF, MD et al. (2012) Prospective study of single-stage repair of contaminated 
hernias using a biologic porcine tissue matrix: the RICH Study. Surgery 152:498–505. 
doi: 10.1016/j.surg.2012.04.008 
 
33. Zerbib P, Caiazzo R, Piessen G, et al. (2013) Outcome in porcine acellular dermal matrix 
reinforcement of infected abdominal wall defects: a prospective study. Hernia. doi: 
10.1007/s10029-013-1153-0 
 
 
 
 
 
 
 

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11 APPENDICES 
APPENDIX 1:  Quality of Life Surveys: 
HerQLes Questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Reference: Krpata DM1, Schmotzer BJ, Flocke S, Jin J, Blatnik JA, Ermlich B, Novitsky YW., Rosen  MJ.  
Design and initial implementation of HerQLes: a hernia-related quality-of-life survey to assess 
abdominal 
wall 
function. 
 
J 
Am 
Coll 
Surg. 
2012 
Nov;215(5):635-42. 
doi: 
10.1016/j.jamcollsurg.2012.06.412. Epub 2012 Aug 4. 

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EQ-5D 
Under each heading, please tick the ONE box that best describes your health TODAY 
 
MOBILITY  
I have no problems in walking about □ 
I have slight problems in walking about □ 
I have moderate problems in walking about □ 
I have severe problems in walking about □ 
I am unable to walk about □ 
 
SELF-CARE   
I have no problems washing or dressing myself □ 
I have slight problems washing or dressing myself 
□ 
I have moderate problems washing or dressing myself □ 
I have severe problems washing or dressing myself □ 
I am unable to wash or dress myself □ 
 
USUAL ACTIVITIES  
(e.g. work, study, housework, family or leisure activities)   
I have no problems doing my usual activities □ 
I have slight problems doing my usual activities □ 
I have moderate problems doing my usual activities □ 
I have severe problems doing my usual activities □ 
I am unable to do my usual activities □ 
 
PAIN / DISCOMFORT   
I have no pain or discomfort □ 
I have slight pain or discomfort □ 
I have moderate pain or discomfort □ 
I have severe pain or discomfort □ 
I have extreme pain or discomfort □ 
 
ANXIETY / DEPRESSION   
I am not anxious or depressed □ 
I am slightly anxious or depressed □ 
I am moderately anxious or depressed □ 
I am severely anxious or depressed □ 
I am extremely anxious or depressed  □ 
 
 

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We would like to know how good or bad your health is today.  This scale is numbered from 0 to 
100: 
➢   100 means the best health you can imagine.  
➢   0 means the worst health you can imagine.  
➢   Mark an X on the scale to indicate how your health is TODAY.  
 
Now, please write the number you marked on the scale in the box below.  
YOUR HEALTH TODAY = □ 

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APPENDIX 2:  SSI Wound Classification: 
 
Classification 
Criteria 
Class I  
 
Clean 
Elective, not emergency, non-traumatic, primarily closed; no acute 
inflammation, no break in technique; respiratory, gastrointestinal, biliary and 
genitourinary tracts not entered. 
Class II 
 
Clean- 
contaminated 
Urgent or emergency case that is otherwise clean; elective opening of 
respiratory, gastrointestinal, biliary or genitourinary tract with minimal spillage 
(e.g. appendectomy) not encountering infected urine or bile; minor technique 
break. 
Class III 
 
Contaminated 
Non-purulent inflammation; gross spillage from gastrointestinal tract; entry 
into biliary or genitourinary tract in the presence of infected bile or urine; 
major break in technique; penetrating trauma <4 hours old; chronic open 
wounds to be grafted or covered. 
Class IV 
 
Dirty 
Purulent inflammation (e.g. abscess); preoperative perforation of respiratory, 
gastrointestinal, biliary, or genitourinary tract; penetrating trauma >4 hours 
 

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APPENDIX 3:  Surgeon Assessment of Mesh 
 
Very 
Easy 
Easy 
OK 
A little 
difficult 
Very 
difficult 
Rate the ease of placement 
Rate ease of securing mesh 
 

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APPENDIX 4:  Surgeon and Subject Satisfaction Assessment: 
 
1. Subject Satisfaction with ventral hernia repair: 
 
        Worst  
 
 
 
 
 
 
 
 
________OK  
 
 
 
 
 
 
 
 
 
    ________Best 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Mark an "x" at the number that corresponds with the subject's 
assessment.  
Subject initials 
Date   
 
 
2. Surgeon Satisfaction with ventral hernia repair: 
 
        Worst  
 
 
 
 
 
 
 
 
________OK  
 
 
 
 
 
 
 
 
 
    ________Best 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Mark an "x" at the number that corresponds with the surgeon's 
assessment.  
Surgeon initials 
Date   
 
 

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APPENDIX 5: Pain Visual Analog Scale 
 
 
Please circle the number that most closely represents the level of pain you are experiencing at 
your ventral hernia repair site: 
 
 
 
 
 
 

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APPENDIX 6: American College of Surgery; Patient Information Brochure for ventral 
hernia repair 
 

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APPENDIX 7: STATEMENT OF INVESTIGATOR 
 
STUDY: 
TB2016.01.01 
FORM: 
STATEMENT OF THE INVESTIGATOR 
PROTOCOL TITLE: A prospective, single arm, multi-center study evaluating 
the short-term clinical outcomes of ventral hernias treated with OviTex® 
reinforced bioscaffold. 
 
• 
I agree to conduct the study in accordance with this protocol and to make 
no changes except when necessary to protect the safety, rights or welfare 
of subjects. If such a change occurs, I will promptly inform the Sponsor of 
this event. 
 
• 
I agree to personally conduct or supervise the study, and that all 
associates, colleagues and employees assisting me in the conduct of this 
study are informed of their obligations in meeting study commitments. 
 
• 
I have read and understand the information in the Investigator’s Brochure 
and/or the Instructions for Use, including the potential risks, expected 
adverse events and potential side effects of the study itself and the 
product being studied. 
 
• 
I agree to protect the rights of my patients and obtain informed consent 
from those who may participate in this study, in accordance with 21CFR 
Part 56 and the requirements of my Institutional Review Board/Ethics 
Committee. 
 
• 
I agree to report to the Sponsor adverse experiences that occur in the 
course of this study, in accordance with the study protocol requirements. 
 
• 
I agree to maintain adequate and accurate records in accordance with study 
requirements and those records will be made available for inspection by 
the Sponsor, IRB or regulatory bodies such as the U.S. Food 
& Drug Administration. 
 
• 
I agree to control the distribution of study product provided to me in the 
course of this study and provide accurate accounting of the disposition of 
those products. 
 
• 
I agree to provide my Institutional Review Board/Ethics Committee with 

 
 
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all the information required to support both the initial and continuing 
review and approval of this study and I will not implement this study until 
such approval has been obtained. I agree to promptly report to the 
Institutional Review Board/Ethics Committee all changes in research 
activity and all unanticipated problems involving risk to subjects or others. 
 
• 
Finally, I agree to comply with all other requirements regarding the 
obligations of clinical investigators, as outlined in 21 CFR Part 
812.100-150. A copy of those regulations has been provided to me. 
 
INVESTIGATOR NAME: ____________________________________________ 
 
INVESTIGATOR SIGNATURE:_______________________________________ 
 
DATE: ____________________________________________________________ 
 
INSTITUTION: _____________________________________________________ 
 
 

 
 
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APPENDIX 8:  SUB-INVESTIGATOR AGREEMENT 
 
STUDY: 
TB2016.01.01 
 
FORM: 
SUB-INVESTIGATOR AGREEMENT 
 
PROTOCOL TITLE: A prospective, single arm, multi-center study evaluating 
the short-term clinical outcomes of ventral hernias treated 
with OviTex® reinforced bioscaffold. 
 
 
Each of the undersigned collaborating physicians (“Sub-Investigators”) shall be 
primarily responsible together with the Principal Investigator, for performing the 
obligations of the Principal Investigator in accordance with the Clinical Trial 
Agreement among TELA Bio, the Research Institution and Principal Investigator. 
Each Sub-Investigator certifies by signing below that he/she has all rights and 
privileges necessary to perform obligations of the Agreement under Protocol 
number TB2016.01.01 at the Research Institution.  Each undersigned Sub-
Investigator hereby expressly: 
 
a. Acknowledges that he/she has received copies of, read and 
understands this Agreement and the TB2016.01.01 Protocol 
b. Agrees to perform the obligations of the Investigator under the 
Agreement, and 
c. Agrees that his/her participation in the study shall at all 
times be under the direct supervision of the Principal 
Investigator. 
 
 
Principal Investigator Signature: _________________________________________ 
Printed Name: ________________________________________________________ 
 
Date: _______________________________________________________________