Post-market Study of the Biodesign® Hernia Graft
Conditions: Ventral Hernia
Sponsor: Cook Biotech Incorporated

Cook Biotech Incorporated   
Version: 19-004-01 
Post-market study of the Biodesign® Hernia Graft 
05 November 2019 
 
COMPANY CONFIDENTIAL 
 
 
Page 1 of 29 
 
 
 
POST-MARKET STUDY PLAN 
 
Post-market study of the Biodesign® Hernia Graft 
 
 
Clinical Study Number 19-004-CBI 
 
Version: 19-004-01 
Version Date: 05 November 2019 
 
Global Sponsor: 
 
Cook Biotech Incorporated 
 
 
 
 
1425 Innovation Place 
 
 
 
 
West Lafayette, IN 47906 
 
 
 
 
USA 
 
Manufacturer: 
 
Cook Biotech Incorporated 
 
 
 
 
1425 Innovation Place 
 
 
 
 
West Lafayette, IN 47906 
 
 
 
 
USA 
 
 
 
 
 

Cook Biotech Incorporated   
Version: 19-004-01 
Post-market study of the Biodesign® Hernia Graft 
05 November 2019 
 
COMPANY CONFIDENTIAL 
 
 
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POST-MARKET STUDY PLAN SIGNATURE PAGE 
 
 
Global Sponsor Contact: 
 
I hereby acknowledge that the content presented in this Post-Market Study Plan has been 
reviewed and agreed upon. 
 
 
 
X 
 
 
 
Signature 
Date (DD Mon YYYY) 
 
 
 
Printed Name 
 
 
Jason Hodde
13 October 2020

Cook Biotech Incorporated   
Version: 19-004-01 
Post-market study of the Biodesign® Hernia Graft 
05 November 2019 
 
COMPANY CONFIDENTIAL 
 
 
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POST-MARKET STUDY PLAN SIGNATURE PAGE 
 
 
Principal Investigator: 
 
I hereby acknowledge that I have read and understand this Post-Market Study Plan and 
agree to comply with its content and requirements. 
 
 
X 
 
 
 
Signature 
Date (DD Mon YYYY) 
 
 
 
Printed Name 
 
 
 

Cook Biotech Incorporated   
Version: 19-004-01 
Post-market study of the Biodesign® Hernia Graft 
05 November 2019 
 
COMPANY CONFIDENTIAL 
 
 
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CONFIDENTIALITY STATEMENT 
 
 
 
This document shall be treated as a confidential document for the sole information 
and use of the clinical site personnel and the Institutional Review Board (IRB) 
 
 
 

Cook Biotech Incorporated   
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Post-market study of the Biodesign® Hernia Graft 
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Table of Contents  
1.0 
Clinical Study Plan Overview ..................................................................................7 
2.0 
Ethical Considerations and Regulatory Compliance ...............................................8 
3.0 
Objectives of the Clinical Study ..............................................................................8 
4.0 
Device Description...................................................................................................8 
4.1 
Intended Use .................................................................................................8 
4.2 
General Device Description ..........................................................................9 
4.3 
Device Identification and Tracking ..............................................................9 
5.0 
Background Information ..........................................................................................9 
6.0 
Risk Analysis and Risk Assessment ......................................................................10 
6.1 
Risks and Possible Adverse Reactions .......................................................10 
6.2 
Methods to Minimize Risks ........................................................................10 
6.3 
Anticipated Clinical Benefits ......................................................................10 
7.0 
Design of the Clinical Study ..................................................................................11 
7.1 
Design of the Clinical Study .......................................................................11 
7.2 
Study Design Rationale ..............................................................................11 
7.3 
Duration of the Study and Patient Participation .........................................11 
7.4 
Measures to be Taken to Avoid or Minimize Bias .....................................11 
7.5 
Endpoints ....................................................................................................12 
7.5.1 Primary Endpoint ............................................................................12 
7.5.2 Additional Measures .......................................................................12 
7.5.3 Rationale for Endpoints ..................................................................12 
7.6 
Variables to be Measured to Demonstrate Achievement of Endpoints ......12 
8.0 
Eligibility Criteria ..................................................................................................14 
8.1 
Patient Consent ...........................................................................................14 
9.0 
Methods..................................................................................................................15 
9.1 
Pre-procedure Evaluation ...........................................................................15 
9.2 
Point of Enrollment ....................................................................................15 
9.3 
Study Procedure ..........................................................................................15 
9.4 
Follow-up....................................................................................................16 
9.5 
Adverse Events ...........................................................................................17 
10.0 
Participation Endpoints of the Study .....................................................................18 
10.1 
Patient Withdrawal .....................................................................................18 
10.2 
Patient Loss to Follow-up ...........................................................................18 
10.3 
Early Termination or Suspension of the Clinical Study .............................18 

Cook Biotech Incorporated   
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Post-market study of the Biodesign® Hernia Graft 
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11.0 
Statistical Considerations .......................................................................................19 
11.1 
Sample Size ................................................................................................19 
11.2  Analyses......................................................................................................20 
11.3 
Hypothesis to be Tested ..............................................................................20 
11.4 
Planned Subgroups and Covariates ............................................................20 
11.5 
Missing Data ...............................................................................................20 
11.6 
Site-level Poolability ..................................................................................21 
11.7 
Limitations of the Study .............................................................................22 
12.0 
Deviations from Clinical Study Plan .....................................................................22 
13.0 
Data Collection and Management ..........................................................................23 
14.0 
Monitoring .............................................................................................................23 
15.0 
Clinical Study Administration ...............................................................................24 
15.1 
Approvals....................................................................................................24 
15.2 
Clinical Study Reporting ............................................................................24 
15.3 
Contact Information ....................................................................................25 
15.4 
Insurance .....................................................................................................25 
16.0 
Publication Policy ..................................................................................................25 
17.0 
References ..............................................................................................................25 
 
Appendices  
Contact Information ........................................................................................... Appendix A 
Study Event Schedule ........................................................................................ Appendix B 
Definitions.......................................................................................................... Appendix C 

Cook Biotech Incorporated   
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1.0 
Clinical Study Plan Overview 
Objective: 
 
To collect data on the performance of the Biodesign® 
Hernia Graft when used to reinforce soft tissues during 
ventral hernia repair.  
 
Design: 
 
Multicenter, open-label, prospective clinical study. 
Primary performance 
endpoint: 
 
Hernia recurrence through 1-year follow-up (hernia 
recurrence as defined in Appendix C). 
 
Additional measures: 
 
 
 
 
 
 
 
 
 
The additional measures include summaries of the 
following: 
• Device-, procedure-, and hernia-related adverse 
event rates through the 2-year follow-up period 
• Hernia recurrence rate through 2-year follow-up 
• Operative times 
• Duration of hospital stay 
• Hospitalization times for related Serious Adverse 
Events (SAEs) 
• Patient-reported quality of life 
 
Number of patients: 
 
95 patients 
Number of clinical 
sites: 
 
 
5 clinical sites initially, with the possibility to add up to 5 
more sites (for up to 10 clinical sites in total) as needed to 
mitigate enrollment difficulties or other unforeseen 
challenges. 
Patient participation 
duration: 
 
Patients will be followed at a minimum of 30 days, 6 
months, 1 year, and 2 years post-procedure.  
Expected study 
duration: 
 
 
 
 
 
It is expected that enrollment will begin within 1 month of 
the first site being eligible to enroll. Individual patient 
enrollment will last through procedure and 2-year follow-
up. Total study duration (from study initiation through 
patient enrollment and follow-up) is expected to be 5-6 
years. 

Cook Biotech Incorporated   
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2.0 
Ethical Considerations and Regulatory Compliance 
This clinical study will be conducted in accordance with the Clinical Study Plan, the 
ethical principles that have their origin in the Declaration of Helsinki, ISO 14155, and 
other applicable local regulations as appropriate. 
3.0 
Objectives of the Clinical Study 
The primary objective of this study is to collect data on the performance of the Biodesign 
Hernia Graft when used to reinforce soft tissues during ventral hernia repair. 
The primary performance endpoint is the rate of hernia recurrence as defined in 
Appendix C through 1-year follow-up.  
Additional objectives of this clinical study are to: 
• Summarize the adverse event rates for normal commercial use of the device (e.g., 
seroma and infection rates) 
• Assess the long-term success of the device in the reinforcement of hernia repairs 
through 2-year follow-up 
Additional measures to address these objectives include summaries of the following: 
• Device-, procedure-, and hernia-related adverse event rates through the 2-year 
follow-up period  
• Hernia recurrence rate through 2-year follow-up  
• Operative times 
• Duration of hospital stay 
• Patient-reported quality of life  
 
4.0 
Device Description  
4.1 
Intended Use (Europe) 
The Biodesign® Hernia Graft is intended for implantation to reinforce soft tissues where 
weakness exists during ventral hernia repair. 
4.2  
Intended Use (rest of world)  
The Biodesign® Hernia Graft is intended for implantation for to reinforce soft tissues 
where weakness exists. Indications for use include the repair of a hernia or body wall 
defect. 

Cook Biotech Incorporated   
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4.3 
General Device Description 
The Biodesign Hernia Graft is a graft composed of porcine small intestine submucosa 
(SIS). The device is CE-marked (G7 039164 0116) and cleared by the United States Food 
and Drug Administration (FDA) (K133306) for clinical use. The device will be used 
according to the labeled indication and in accordance with the Manufacturer’s 
Instructions for Use (IFU).  
The device IFU contains the following information: 
• Instructions for storage and handling requirements 
• Precautions and preparation for use of the device 
• Description of the procedures involved in the use of the device including 
recommendations for device placement 
4.4 
Device Identification and Tracking  
The Biodesign Hernia Graft is commercially available and will be obtained by each 
institution through normal commercial channels. Tracking of individual devices within 
the study will not be performed; however, information such as the size of each device 
used in a patient will be documented and recorded on electronic case report forms 
(eCRFs).    
5.0 
Background Information 
The Biodesign Hernia Graft is comprised of 8 layers of decellularized porcine small 
intestinal submucosa (SIS) that has been pressed-lyophilized (i.e., freeze-dried under 
vacuum pressure) to laminate the component sheets (i.e., layers) together. In addition, it 
is perforated and sewn with 4-0 Trisorb suture (polyglycolic acid (PGA); Samyang 
Corporation, Seoul, South Korea). The suture is distributed in a diamond pattern across 
the graft and along the periphery and is intended to mitigate delamination of the layers 
upon rehydration and/or manipulation during implantation. Being a completely biologic 
device, the Biodesign Hernia Graft is considered MR safe. 
The Biodesign Hernia Graft is available in eight (8) sizes: 8 cm x 10 cm, 8 cm x 20 cm, 8 
cm x 30 cm 10 cm x 10 cm, 13 cm x 15 cm, 13 cm x 22 cm, 20 cm x 20 cm, and 20 cm x 
30 cm. The graft is terminally sterilized using an established ethylene oxide (EtO) 
sterilization cycle that has been validated to a sterility assurance level of 10-6. 
Sterilization is routinely monitored, calibrated, and operated in adherence with 
standardized procedures. The Biodesign Hernia Graft may be stored at room temperature 

Cook Biotech Incorporated   
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in a clean, dry location for up to 18 months. 
The Biodesign Hernia Graft is a technology that has been used in the treatment of hernias 
and abdominal wall defects for nearly 10 years. This post-market clinical follow-up study 
is being performed to confirm the continued safety and performance of the Biodesign 
Hernia Graft when used in accordance with its approved labeling. 
6.0 
Risk Analysis and Risk Assessment 
6.1 
Risks and Possible Adverse Reactions 
Foreseeable adverse events associated with the use of the Biodesign Hernia Graft and 
other biologic graft prostheses are described in the IFU and will be collected in this study 
and reported as an additional measure.  
 
Please reference the IFU for the following: 
• Contraindications 
• Warnings 
• Precautions 
The use of this FDA cleared device does not introduce any new or additional risk to 
standard ventral hernia procedures using biologic mesh materials. 
Because the Biodesign Hernia Graft is cleared for general use in this patient population, 
the only additional patient risk associated with participation in this study is accidental 
release of protected health information. 
6.2 
Methods to Minimize Risks  
In order to minimize the risks noted in the IFU, the procedure for proper use of the 
Biodesign Hernia Graft described in the IFU will be followed. In addition, only qualified 
surgeons with surgical training and experience in ventral hernia repairs will be involved 
in the study. Finally, the capture, handling, and storage of the study data are done in 
compliance with applicable regulations to minimize the risk of release of any personal 
health information. 
 
6.3 
Anticipated Clinical Benefits 
There is no direct benefit for the patient regarding participation in this study, other than 
the benefit of having scheduled follow-up visits for two years to follow their general 
health status and outcome. However, it is important to gain more knowledge of the 

Cook Biotech Incorporated   
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performance of the Biodesign Hernia Graft in normal clinical use. The increased 
knowledge of the use of the product in this patient population will be beneficial for future 
patients and society as a whole.    
 
7.0 
Design of the Clinical Study 
7.1 
Design of the Clinical Study 
This multicenter, open-label, prospective clinical study will evaluate the performance of 
the Biodesign Hernia Graft to reinforce soft tissues during ventral hernia repair. 
This post-market study will enroll up to 95 patients at up to 10 clinical sites. Each clinical 
site will be limited to a maximum of 50 patients to ensure a variety of patients and 
surgical techniques are represented. There is no minimum enrollment number per site.  
7.2 
Study Design Rationale 
This study has been designed as a multicenter, open-label, prospective study to collect 
data on the performance of the Biodesign Hernia Graft. The inclusion and exclusion 
criteria for this study have been selected based on the instructions outlined in the IFU so 
that the results from this study can provide data on the real world use of the device. 
7.3 
Duration of the Study and Patient Participation 
Patient enrollment is expected to be completed within 3-4 years of study initiation. Total 
study duration (from study initiation through patient enrollment and follow-up) is 
expected to be 5-6 years. 
 
Patients are expected to participate in this study for 2 years (± 90 days) after the study 
procedure. 
7.4 
Measures to be Taken to Avoid or Minimize Bias 
This multi-center, open-label, prospective study is intended to collect information 
regarding the performance of the study device. Patients will be selected and included in 
accordance with the eligibility criteria and the need for a biologic graft to treat their 
hernia. In addition, the study will utilize uniform definitions for study endpoints. Study 
results will be analyzed in accordance with the prospectively defined analysis plan 
outlined in Section 11. 

Cook Biotech Incorporated   
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7.5 
Endpoints 
7.5.1 Primary Endpoint 
The primary performance endpoint is the rate of hernia recurrence as defined in 
Appendix C through 1-year follow-up.  
7.5.2 Additional Measures 
Additional measures will include the following: 
• Device-, procedure-, and hernia-related adverse event rates through the 2-year 
follow-up period  
• Hernia recurrence rate through 2-year follow-up  
• Operative times 
• Duration of hospital stay 
• Hospitalization times for related SAEs  
• Patient-reported quality of life 
7.5.3 Rationale for Endpoints 
The endpoints and measures were chosen since hernia recurrence and adverse events 
related to the use of surgical grafts have been identified as issues of clinical interest; 
many of these events often result in additional surgical procedures. Furthermore, patient 
quality of life has been chosen as an additional measure to capture the outcome of the 
intervention from the patient’s perspective. Using patient-reported outcomes measures, 
we will be able to evaluate abdominal wall function and patient’s perception of pain 
independently of hernia recurrence. 
7.6 
Variables to be Measured to Demonstrate Achievement of Endpoints 
The endpoints and measures will be assessed as described in Table 7.6-1. 
Table 7.6-1. Assessment of Endpoints and Measures 
Endpoint / Measure 
Assessment1 
Hernia recurrence 
Clinical examination 
Rate of adverse events 
Evaluation based upon reports of events 
submitted by the study sites 
Rate of Surgical Site Occurrences 
(SSO) 
Evaluation based upon reports of 
occurrences submitted by the study sites 
Rate of Surgical Site Occurrences 
needing Intervention (SSOPI) 
Evaluation based upon reports of 
occurrences submitted by the study sites 

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Patient quality of life 
Postoperative assessment (patient 
questionnaire) 
 
1For the 1 and 2-year follow-up visits: Every attempt should be made to have the patient return for a 
physical exam at the 1-year and 2-year timepoints in order to determine hernia recurrence. Results 
from a physical exam made by a non-study physician (e.g. primary care physician) can be included if 
assessment at the clinical site is not possible. 
 
If the patient refuses or is unable to return in person for the 1-year or 2-year physical  exam, patient 
self-assessment of the presence of recurrence symptoms, patient responses regarding adverse events, 
and patient questionnaires may be obtained via telephone or email. If the patient self-assessment of the 
presence of recurrence symptoms suggests that a hernia is present, the patient should be contacted and 
requested to return for a physical exam for confirmation.  
 
Patient reported outcomes will be tabulated and reported. The primary endpoint will be analysed as 
noted in Section 11.0.   
 
Patient data will be documented by trained personnel at the clinical site and recorded onto 
eCRFs through an electronic data capturing (EDC) system. The assessment schedule is 
summarized in Table 7.6-2 and in Appendix B:  
Table 7.6-2. Assessment schedule 
Pre- 
Procedure 
Procedure 
Follow-up 
30 days 
(± 15 
days) 
6 month 
(± 30 
days) 
1 year 
(± 90 
days) 
2 
years 
(± 90 
days) 
Consent 
X 
 
 
 
 
 
Medical 
history 
X 
 
 
 
 
 
Procedure 
Information 
 
X 
 
 
 
 
Physical exam 
X 
X 
X 
X 
X 
X 
Patient 
Reported 
Outcomes 
measures 
 
 
X 
X 
Xa 
Xa 
Adverse events 
 
X 
X 
X 
Xa 
Xa 
 
a Every attempt should be made to have the patient return for a physical exam at the 1-year and 2-year 
timepoints in order to determine hernia recurrence. Results from a physical exam made by a non-study 
physician (e.g. primary care physician) can be included if assessment at the clinical site is not possible. 
If the patient refuses or is unable to return in person for the 1-year or 2-year physical  exam, patient 

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self-assessment of the presence of recurrence symptoms, patient responses regarding adverse events, 
and patient questionnaires may be obtained via telephone or email. 
8.0 
Eligibility Criteria 
Patients will be selected in accordance with the device’s labeled indication and according 
to the Manufacturer’s Instructions for Use. 
Inclusion Criteria 
Patients who meet the following criterion are suitable for receiving a Biodesign Hernia 
Graft, and are therefore suitable for inclusion in this study: 
1. Primary or recurrent ventral hernia in need of surgical repair 
Exclusion Criteria 
According to the IFU, the Biodesign Hernia Graft should not be used in patients with 
known sensitivity to porcine material. Therefore, the following patients will be excluded 
from the study: 
1. Known sensitivity to porcine material 
For the purpose of the study, the following patients will also be excluded:  
2. Age < 18 years  
3. Unable or unwilling to provide informed consent 
4. Life expectancy of less than one year from the date of the index procedure  
Patients will be excluded from the study if they never receive a Biodesign Hernia Graft 
during their index procedure. 
8.1 
Patient Consent 
Patients who meet all of the inclusion criteria and none of the exclusion criteria will be 
invited to participate in this study. Patients eligible for enrollment will have the clinical 
study explained to them, as well as the potential risks and benefits of their participation in 
the study, at a time point sufficiently prior to study participation to allow the patient 
adequate time to fully consider their participation in the study. All information pertinent 
to the study will be provided in writing in a language understandable to the patient. Each 
patient who decides to participate will sign and date an informed consent document prior 
to the procedure or any study-specific assessments. If new information is obtained, 
patients who have not exited the study will be informed about the new information, and 
will be re-consented if required by the clinical site’s IRB. 

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9.0 
Methods 
9.1 
Pre-procedure Evaluation 
Prior to patient enrollment, patients will undergo a baseline evaluation. Assessments will 
be completed as described in Table 9.1-1. All pre-procedure assessments are considered 
standard of care. 
Table 9.1-1. Pre-procedure requirements 
Pre-procedure  
Timing  
Prior to the study procedure 
Type  
In-person 
Assessment 
Review study with patient and obtain written informed consent 
Clinical assessment including hernia assessment and 
symptomology  
Record patient demographics and pre-op evaluation 
9.2 
Point of Enrollment 
Patients are considered enrolled in the study when the device implant procedure is 
completed.  
9.3 
Study Procedure  
The patient will undergo repair of a ventral hernia with the implantation of the Biodesign 
Hernia Graft, and any other concomitant procedures that are clinically indicated. 
Presence of hernia will be confirmed intra-operatively and classified using the European 
Hernia Classification System. 
The device will be implanted according to the IFU.  
Peri- and post-operative patient treatment will be conducted in accordance with surgeon 
discretion and institutional standard of care. All peri- and post-operative details will be 
documented and recorded on the eCRFs within the EDC system.  
Discharge following the procedure will be in accordance with surgeon discretion and 
institutional standard of care. Patients should be given instructions to refrain from activity 
that may complicate recovery. 

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9.4 
Follow-up 
Patients are expected to participate in this study for 2 years after the procedure. The 
follow-up visits will occur within the time frames listed below. Following the study 
procedure, assessments will be completed as described in Table 9.4-1. 
Table 9.4-1. Follow-up requirements 
30-day Follow-up (± 15 days) 
Timing 
15-45 days following the study procedure 
Type  
In person 
Assessments  
Physical exam of the incision and abdominal wall 
Record specific data points within the EDC system 
Administer a postoperative assessment (patient questionnaire) 
6- month Follow-up (± 30 days) 
Timing 
153-213 days following the study procedure 
Type 
In person 
Assessments 
Physical exam of the incision and abdominal wall 
Record specific data points within the EDC system 
Administer postoperative assessment (patient questionnaire) 
1-Year Follow-up (± 90 days) 
Timing 
275 – 455 days following the study procedure 
Type 
In person1 
Assessments  
Physical exam of the incision and abdominal wall 
Record specific data points within the EDC system 
Administer postoperative assessment (patient questionnaire) 
2-Year Follow-up (± 90 days) 
Timing 
640 – 820 days following the study procedure 
Type 
In person1 
Assessments  
Physical exam of the incision and abdominal wall 
Record specific data points within the EDC system 
Administer postoperative assessment (patient questionnaire) 
1For the 1 and 2-year follow-up visits: Every attempt should be made to have the patient return for a 
physical exam at the 1-year and 2-year timepoints in order to determine hernia recurrence. Results 
from a physical exam made by a non-study physician (e.g. primary care physician) can be included if 
assessment at the clinical site is not possible. 
 
If the patient refuses or is unable to return in person for the 1-year or 2-year physical  exam, patient 
self-assessment of the presence of recurrence symptoms, patient responses regarding adverse events, 

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and patient questionnaires may be obtained from the patient via telephone or email. If the patient self-
assessment of the presence of recurrence symptoms suggests that a hernia is present, the patient should 
be contacted and requested to return for a physical exam for confirmation.  
 
Patient reported outcomes will be tabulated and reported. The primary endpoint will be analysed as 
noted in Section 11.0.   
9.5 
Adverse Events  
An adverse event is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects (patients), 
users, or other persons, whether or not related to the medical device. 
A Serious Adverse Event is an adverse event that: 
• Led to death, 
• Led to serious deterioration in the health of the subject (patient), that either 
resulted in: 
• 
A life-threatening illness or injury, or 
• 
A permanent impairment of a body structure or a body function, or 
• 
In-patient or prolonged hospitalization, or 
• 
Medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function, 
• Led to fetal distress, fetal death, or a congenital abnormality or birth defect. 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required 
by the study plan, without serious deterioration in health, is not considered a serious 
adverse event. 
The EDC system allows for recording of adverse events and should therefore be used as 
the typical method of adverse event reporting. The study sponsor will periodically review 
adverse events that have been added to the EDC system and will process these events 
according to standard operating procedures. If an adverse event meets the criteria for 
reporting to a regulatory agency, the sponsor will contact the principal investigator and 
will perform a thorough investigation of the adverse event as required under applicable 
regulations. The sponsor is responsible for reporting events to the regulatory authorities, 
the reviewing IRB(s), and the principal investigator(s), as required according to 
applicable regulations/standards/policies. 
Serious Adverse Events should be added to the EDC system and reported to the study 
sponsor within 3 calendar days of the study site becoming aware of the event. 

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The principal investigator will notify their IRB of applicable adverse events occurring for 
the duration of the study according to institutional guidelines.  
10.0 
Participation Endpoints of the Study 
A patient’s participation in the study will end after any of the following: 
• Completion of all scheduled clinical evaluations through 2 years  
• Subsequent procedure due to recurrence of the original hernia defect 
• Any subsequent surgical procedure resulting in removal of the study device 
• Patient withdrawal  
• Principal investigator withdrawal of patient 
• Patient loss to follow-up 
• Patient death 
After a patient exits the study for any reason, there are no study-specific requirements for 
follow-up and no additional data will be collected. Any data collected up to the point of 
patient exit may be used in the study. 
10.1 
Patient Withdrawal  
A patient may decide to withdraw from the study at any time either before or after 
undergoing the study procedure without prejudice or loss of care. The principal 
investigator may also decide to withdraw the patient from the study at any time based on 
medical judgment. The principal investigator will ensure that the sponsor is notified of 
any patient withdrawal. In all instances of withdrawal, data collected up to the time of 
patient withdrawal, will be submitted and will include the reason why the patient has 
been withdrawn from the study (e.g. patient request).   
10.2 
Patient Loss to Follow-up 
In the event a patient cannot be reached for post-procedure assessments, at least three 
attempts will be made to contact the patient; efforts (and methods) to contact the patient 
will be documented. If the patient cannot be located and is determined to be unreachable, 
data collected up to the time of patient loss to follow-up will be submitted.  
10.3 
Early Termination or Suspension of the Clinical Study 
Any decision to suspend enrollment or terminate the clinical study, either completely or 
at one or more clinical sites, will be made by the sponsor or the IRB. Reasons for early 
termination or suspension of a study (at one or more sites) may be due to ethical 
concerns, clinical site performance, or organizational issues. In the event of clinical site 

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or study closure, all patients who have received the study treatment will be followed until 
their primary endpoint is met.     
 
The sponsor is responsible for reporting early termination or suspension of the study to 
the IRB(s) and principal investigators as required according to applicable regulations and 
standards.  
11.0 
Statistical Considerations 
11.1 
Sample Size 
A sample size of 86 patients was determined using a confidence interval-based approach 
with the following assumptions: 
• 80.1% success (freedom from hernia recurrence) at 1 year, based on recurrence 
rates for biologic meshes from literature review (Table 11.1-1). 
• α = 0.05, power = 0.8, margin = 10% 
• 2-sided confidence interval 
To account for patients lost to follow-up, this study intends to enroll 95 patients. 
 
Table 11.1-1. Summary of Review Data on the Use of Biologic Graft for Ventral 
Hernia Repair 
Paper 
Mesh 
Length of Follow 
up 
Recurrence -  
pooled rate (n) 
Infection 
Complications 
- pooled rate (n) 
Clean/Clean Contaminated 
Darehzereshki A, et 
al., World J Surg. 
2014  
Biologic 
14.7-66 mo 
18.6% (311) 
10.9% (155) 
Synthetic 
13-66 mo 
15.7% (533) 
36.5% (85) 
Lee L, et al., Surg 
Endosc. 2014  
Biologic 
Most > 1yr 
12.5% (214) 
31.6% (214) 
Synthetic 
Most > 1yr 
8.2% (434) 
6.4% (434) 
Fischer J et al., 
Plast Reconstr 
Surg. 2016  
Biologic 
12-32.9 mo 
14.6% (159) 
32.1% (159) 
Synthetic 
12-39 mo 
17.6% (135) 
19.1% (135) 
Clean Contaminated or Potentially Contaminated# 
Atema J et al., Am 
J Surg. 2016  
Biologic 
12-26.4 mo 
9% (807) 
21% (807) 
Synthetic 
13.1-36 mo 
9% (204) 
12% (204) 
Contaminated, Dirty or Infected 
Cross W et al., Am 
Surg. 2014 
Biologic 
5.8-52 mo 
20% (554) 
24% (554) 
Lee L, et al., Surg 
Endosc. 2014  
Biologic 
Most > 1 yr 
27.2% (549) 
35.5% (582) 
Synthetic 
Most > 1yr 
3.2% (74) 
42.6% (74) 
Atema J et al., Am 
J Surg. 2016  
Biologic 
14-26 mo 
30% (527) 
38% (527) 
Synthetic* 
10.8 mo 
7% (100) 
11% (100) 
Biologic 
4.5 –29 mo 
25.8% (357) 
Not Provided 

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Hodgkinson J et al., 
Colorectal Dis. 
2017 
Synthetic 
14 – 74 mo 
29% (131) 
Not Provided 
# Atema et al. grouped clean contaminated and potentially contaminated cases together in the review 
paper 
* Results from a single study (review was only able to identify one study on use of synthetics in 
contaminated fields) 
 
11.2  Analyses 
Patients’ baseline medical characteristics will be summarized. For continuous baseline 
characteristic variables, descriptive statistics will be provided; for categorical baseline 
characteristic variables, contingency tables will be tabulated to display the distribution. 
The primary endpoint is the rate of hernia recurrence as defined in Appendix C through 
1-year follow-up. Patients whose device is damaged in a subsequent procedure prior to 
reaching the primary efficacy endpoint will not be included in the primary endpoint 
analysis. The point estimate and the 95% confidence interval will be summarized. 
11.3 
Hypothesis to be Tested 
The primary hypothesis for effectiveness is the rate of hernia recurrence through  
1-year follow-up (𝜋𝜋𝑔𝑔𝑔𝑔𝑔𝑔𝑔𝑔𝑔𝑔). The null (H0) and alternative (HA) hypotheses for the primary 
effectiveness are expressed as follows: 
 
𝐻𝐻𝑜𝑜  ∶ 𝜋𝜋𝑔𝑔𝑔𝑔𝑔𝑔𝑔𝑔𝑔𝑔≥ 22% 
              𝐻𝐻𝐴𝐴  ∶ 𝜋𝜋𝑔𝑔𝑔𝑔𝑔𝑔𝑔𝑔𝑔𝑔< 22% 
11.4 
Planned Subgroups and Covariates 
All patients enrolled in the study, except patients whose device is damaged in a 
subsequent procedure prior to reaching the primary efficacy endpoint, will be included 
for the primary analyses. If warranted, baseline characteristics (including but not limited 
to: patient demographics and hernia type) and procedural details (including but not 
limited to: procedure type (laparoscopic or open), surgical repair technique, fascial 
closure, and location of device placement) will be analyzed to determine their impact on 
the hernia recurrence rate. 
 
11.5 
Missing Data 
The total study enrollment is augmented to achieve sufficient data to analyze the study 
outcome in the presence of missing data due to lost to follow-up or withdrawn patients. 
However, it is also recognized that patients may refuse or be unable to return to the study 

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site for a physical exam at the 1-year and 2-year timepoints, leading to missing physical 
exam information. 
The primary endpoint will be analyzed using per-protocol and analyzable patient 
populations to assess the robustness of the efficacy results. Three imputation methods 
will be implemented for missing physical exam data to evaluate the impact of missing 
data on the conclusions of treatment effect: (1) complete case analysis, (2) estimating 
missing data with the best available data, (3) multiple imputation. All three methods for 
missing data will be used to assess the robustness of the primary endpoint. 
 
Analyses will account for missing data in the following manner: if missing data can be 
determined from a subset of best available data, these data will be documented and 
analyzed. Multiple imputation will be considered, and appropriate methods to impute 
data based on the analysis population will be documented and presented in the analysis 
results.  
 
Specifically, when dealing with missing physical exam information for the primary 
recurrence endpoint, the following analysis is planned: 
1. Patients self-reporting the absence of recurrence symptoms will be deemed to 
not have experienced a hernia recurrence in the absence of physical 
exam/imaging information. 
2. Data from patients with both physical exam/imaging information and positive 
recurrence symptoms on the self-assessment will be utilized to assess the 
accuracy of patient self-reporting of hernia recurrence. 
3. This level of accuracy will be applied to the patient subset with only positive 
recurrence symptoms on the self-assessment as a means of estimating the true 
recurrence rate. 
 
11.6 
Site-level Poolability 
Poolability of data from multiple clinical sites will be verified by examining the primary 
endpoint across sites. Site-level poolability will be considered appropriate provided that 
the endpoint is similar across clinical sites. 
 
It is expected that some clinical sites may have too few patients to provide reasonable 
site-level estimates of the primary measure. Pooling of this information will be explored 
based on relevant covariates such as: hospital size (e.g. number of beds, number of 
annual discharges), clinical site enrollment, type of hospital (community versus 
teaching), and geographic region.   

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It is recognized that patient baseline characteristics may differ across clinical sites, with 
some clinical sites routinely treating patients with more severe disease progression. It is 
anticipated that the primary endpoint measure may be related to covariates that reflect 
this disease progression, which are in turn related to outcome. Thus, observed site-
specific differences among the primary endpoint may be checked for confounding with 
other measured covariates (e.g., age, sex). This can be accomplished using regression 
models (linear and logistic where appropriate) that include clinical site and other 
measured covariates as independent variables. 
Should one or more clinical site(s) be found to differ significantly from the rest, then 
subsequent analyses may include the discriminating covariate or a covariate to 
distinguish between the unusual clinical site(s) and those clinical sites that are considered 
poolable. 
11.7 
Limitations of the Study 
A limitation of this study is that it includes patients regardless of concomitant diseases 
and medications. This can introduce a potential heterogeneity that potentially can 
compromise the outcome of the study. Another limitation of this study is that it allows for 
the hernia repair procedure to be conducted using open, laparoscopic and/or robotic 
techniques, and allows for both acute and elective repairs. The rates of adverse events and 
hernia recurrences may differ across repair types and techniques, which introduces a 
possible bias. On the other hand, the inclusion of patients regardless of concomitant 
diseases and medications and regardless of type of repair or technique reflects a more 
diverse population and provides more real-world data.   
 
12.0 
Deviations from Clinical Study Plan 
Except under emergency situations when necessary to preserve the rights, safety, or well-
being of study patients, principal investigators are not allowed to deviate from this 
protocol without documented prior approval by the sponsor and the IRB. Clinical study 
noncompliances (i.e., deviations from the protocol, investigator agreement, IRB policy, 
and/or any applicable regulations) will be documented, along with an explanation. 
Deviations or non-compliances that impact the rights, welfare, or safety of patients will 
be reported to the sponsor and IRB as required and as soon as possible. If appropriate, 
corrective and preventive actions will be discussed by the sponsor, investigator, and/or 
the IRB to determine a suitable course of action.  
The sponsor is responsible for reporting clinical study noncompliances to the reviewing 
IRB(s) and investigator(s) as required according to applicable regulations and standards.  

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In accordance with applicable regulations/standards, the sponsor will review all clinical 
study noncompliances and take suitable action(s) to secure compliance. If appropriate, 
based on the number and nature of noncompliances, actions may include termination of a 
principal investigator’s participation in this clinical study.   
13.0 
Data Collection and Management  
Patient data will be documented and recorded by trained personnel at the clinical site onto 
eCRFs through an EDC system. This is a secure, validated, web-based system, allowing 
those with permission to access data from any location at any time. Source data will be 
retained for all data entered into the EDC system. In cases where patient responses 
regarding hernia symptoms, adverse events, and/or questionnaires are obtained by 
telephone, the data provided from the telephone interview may be entered directly into 
the EDC system and will be considered source data.  
Clinical site personnel are required to undergo training and will have unique login names 
and passwords in order to enter patient data. The EDC system creates a secure, computer-
generated, time stamped audit trail to record the date and time of operator entries and 
actions that create, modify, or delete electronic records. Principal investigators shall 
review and electronically sign the eCRFs to confirm that the data recorded are accurate 
and complete. 
Principal investigators will input all applicable clinical data and documentation into the 
EDC system in a timely manner. All clinical study documents (including patient data) 
will be retained at the study sites as required by the applicable regulations and standards. 
The principal investigator or clinical site personnel should contact the sponsor before 
removing any documents pertaining to the clinical study (i.e., patient consent forms).  
The Sponsor is responsible for data management, data verification, data archiving, and 
data retention.   
As needed to assist the sponsor in its research (e.g., during evaluation of an adverse 
event), data will be accessible to the sponsor, the participating principal investigators, the 
manufacturer, and companies or individuals the sponsor authorizes. 
14.0 
Monitoring  
The conduct of the clinical study will be supervised through a process of centralized and 
on-site monitoring.  

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For the first 2 patients at each study site, the electronic data entries in the EDC system 
will be checked for accuracy to the medical record. If the data accuracy check 
demonstrates that the site is accurately (90% compliance with data fields) entering the 
data into the EDC system, no additional monitoring of the site will be required. If the data 
accuracy check reveals deficiencies that call into question the inputted data, the sponsor 
will arrange for more formal on-site monitoring to occur. 
A formal query process in the EDC system will be utilized to resolve data discrepancies. 
Queries may arise from automated processes or from manual review of eCRFs, 
procedural reports, or correspondence received. Principal investigators will ensure timely 
resolution of queries.   
On-site monitoring will be implemented as necessary throughout the course of the study 
to ensure the principal investigators are fulfilling the obligations set forth in the CIP, 
agreement(s), IRB policies, and applicable regulations and standards. Source data 
verification will be performed during these on-site visits. The principal investigator and 
clinical site will provide direct access to source data and documents for study-related 
monitoring, audits and IRB review.  
15.0 
Clinical Study Administration  
15.1 
Approvals  
The principal investigator is responsible for obtaining approval of this clinical study 
(including the CIP, informed consent form, and all patient materials) from the relevant 
IRB at their associated clinical site. The clinical study will not begin at a particular 
clinical site until a favorable opinion of the IRB has been obtained. The protocol and 
other clinical study documents may be revised by the sponsor, as appropriate, based on 
new or changes to important information. Changes or modifications to the protocol, 
informed consent form, or patient materials will not be initiated without IRB approval. 
The principal investigator is responsible for keeping their IRB informed as to the 
progress of the study and complying with requirements imposed by their IRB and/or 
regulatory authority. Furthermore, the sponsor and the principal investigator will ensure 
that local regulations concerning data protection are followed. 
15.2 
Clinical Study Reporting 
Principal investigators will provide notifications to the sponsor within 5 working days of 
withdrawal of IRB approval. The sponsor is responsible for providing progress reports 
and final reports, notification of study completion or termination to IRB(s) and principal 

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investigator(s) as required according to applicable regulations and standards. 
Furthermore, the sponsor is responsible to report any changes significantly affecting the 
conduct of the clinical study and/or increasing risk to the patient to the IRB(s).  
15.3 
Contact Information 
Refer to Appendix A for a list of the sponsor, monitor, and the manufacturer. 
 
Contact information and qualifications for the clinical site(s), principal investigator(s), 
co-investigators or other institutions involved, will be maintained by the sponsor. The 
sponsor will also maintain contact information for each IRB. 
15.4 
Insurance 
The device is covered by the sponsor’s product liability insurance. A clinical study 
insurance policy will be taken out according to local requirements. 
16.0 
Publication Policy 
This clinical study will be registered on www.ClinicalTrials.gov and the intent is to make 
study results public. Publication policy, rights, and obligations for this study will be 
negotiated, detailed and defined in the clinical study’s contractual documents with the 
clinical site and principal investigator.   
 
17.0 
References 
1. Poussier M, Deneve E, Blanc P, et al. A review of available prosthetic 
material for abdominal wall repair. J Visc Surg. 2013; 150(1):52-59. 
 
2. Bellows CF, Smith A, Malsbury J, et.al. Repair of incisional hernias with 
biological prosthesis: a systematic review of current evidence. Am J 
Surg.2013; 205(1):85-101. 
 
3. Beale EW, Hoxworth RE, Livingston EH, et.al. The role of biologic mesh in 
abdominal wall reconstruction: a systematic review of the current literature. 
Am J Surg. 2012;204(4):510-517. 
 
4. Lee L, Mata J, Landry T, et al. A systematic review of synthetic and biologic 
materials for abdominal wall reinforcement in contaminated fields. Surg 
Endosc. 2014;28(9):2531-2546. 
 
5. El-Hayek K, Yoo J, Phillips M, et.al. Zenapro™ Hybrid Hernia Repair Device 
for Ventral Hernia Repair. Abstract presented at: 1st World Conference on 
Abdominal Wall Hernia Surgery; April 2015; in Milan; Italy. 

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6. El-Hayek K, Yoo J, Phillips M, et.al. First Human Experience with a Hybrid 
Biologic and Synthetic Mesh: Zenapro™ Hernia Repair Device for Ventral 
Hernia Repair. Abstract presented at: Society of American Gastrointestinal 
and Endoscopic Surgeons (SAGES) Annual Meeting; March 2016; Boston, 
MA; US. 
 
7. Muysoms FE, Miserez M, Berrevoet F, et.al. Classification of primary and 
incisional abdominal wall hernias; Hernia. 2009; 13(4):407-14. 
 
8. The Ventral Hernia Working Group: Breuing K, Butler CE, Ferzoco S, et.al. 
Incisional ventral hernias: Review of the literature and recommendations 
regarding the grading and technique of repair; Surgery 2010;148:544-58. 
 
 
 

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APPENDIX A: Contact Information 
 
Global Sponsor and Monitor  
Cook Biotech Incorporated 
1425 Innovation Place 
West Lafayette, IN 47906 
USA  
 
Contact: 
 
Samantha Stevenson 
 
 
Clinical Project Manager  
Telephone: 
 
+1-765-497-3355 
E-mail:  
 
SStevenson@Cookbiotech.com 
 
 
Manufacturer 
Cook Biotech Incorporated 
1425 Innovation Place 
West Lafayette, IN 47906 
USA  
 
Contact: 
 
Jason Hodde 
 
 
 
Director of Medical Sciences 
Telephone: 
 
+1-765-497-3355 
E-mail  
 
Jason.Hodde@Cookbiotech.com 

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007-13 03.01T 
APPENDIX B: Study Event Schedule 
 
Pre- 
Procedure 
Procedure 
Follow-up 
30 days  
(± 15 days) 
6 months 
(± 30 days) 
12 months 
(± 90 days) 
2 years 
(± 90 days) 
Informed consent 
X 
 
 
 
 
Medical history 
X 
 
 
 
 
Procedure Information 
 
x 
 
 
 
Physical exam 
X 
X 
X 
X 
X1 
X1 
 Patient Reported 
Outcomes measures  
 
 
X 
X 
X1 
X1 
Adverse events 
 
x 
X 
X 
X1 
X1 
 
1Every attempt should be made to have the patient return for a physical exam at the 1-year and 2-year timepoints in order to determine hernia 
recurrence. Results from a physical exam made by a non-study physician (e.g. primary care physician) can be included if assessment at the 
clinical site is not possible. If the patient refuses or is unable to return in person for the 1-year or 2-year physical  exam, patient self-assessment 
of the presence of recurrence symptoms, patient responses regarding adverse events, and patient questionnaires may be obtained via telephone 
or email.

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007-13 03.01T 
APPENDIX C: Definitions 
Center of Disease Control (CDC) Wound Classification:  
 
Classification 
Description 
Clean  
(Class I) 
An uninfected operative wound in which no inflammation is encountered and the 
respiratory, alimentary, genital, or uninfected urinary tract is not entered. In addition, 
clean wounds are primarily closed and, if necessary, drained with closed drainage. 
Operative incisional wounds that follow non-penetrating (blunt) trauma should be 
included in this category if they meet the criteria. 
Clean-
contaminated  
(Class II) 
An operative wound in which the respiratory, alimentary, genital, or urinary tract are 
entered under controlled conditions and without unusual contamination. Specifically, 
operations including the biliary tract, appendix, vagina, and oropharynx are included in 
this category provided no evidence of infection or major break in sterile technique is 
encountered.  
Contaminated  
(Class III) 
Open, fresh, accidental wounds. In addition, operations with a major break in sterile 
technique (e.g., open cardiac massage) or gross spillage from the gastrointestinal tract, 
and incisions in which acute nonpurulent inflammation is encountered are included in 
this category. 
Dirty-infected 
(Class IV) 
Old traumatic wounds with retained devitalized tissue and those that involve existing 
clinical infection or perforated viscera. This definition suggests that the organisms 
causing post-operative infection were present in the operative field before the 
operation. 
 
Hernia Recurrence (recurrence of tissue defect): 
Any of the following post-operative findings at the site of the hernia defect repaired at the index 
procedure will be categorized as a hernia recurrence:  
• A symptomatic, palpable or visible protrusion of underlying tissue through a defect in the 
abdominal wall, possibly with a palpable fascial defect 
Any patient who presents asymptomatically, but additional imaging indicates presence of a 
hernia.