Complications and 1-Year Outcomes Following Hiatal Hernia Repair With MIROMESH a Novel, Highly Vascular, Porcine Derived, Biologic Matrix
Conditions: Hiatal Hernia With Gastroesophageal Reflux Disease, Gastroesophageal Reflux, GERD
Sponsor: Miromatrix Medical Inc.

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CONFIDENTIAL
Exhibit A: Study Services and Compensation 
Title 
Complications and 1-Year Outcomes following hiatal hernia repair with 
MIROMESH a novel, highly vascular, porcine derived, biologic matrix 
Miromatrix 
Product 
MIROMESH® Biologic Matrix 
Sponsor 
Miromatrix Medical Inc 
10399 W. 70th Street 
Eden Prairie, MN 55344 
Protocol Number 
2017001  Version 2 
Sponsor Contact 
M. Mason Macenski, Ph.D. 
952.942-6000 X112 
612.378-2612 
Principal 
Investigator 
G. Kevin Gillian, MD 
Study Center 
Virginia Heartburn and Hernia Institute 
8988 Lorton Station Blvd 
Suite 202 
Lorton, VA 22079 
Planned Sample 
Size 
70 consecutive subjects at least 1-year post-index procedure 
Study Population 
Consecutive cohort of patients who have undergone a hiatal hernia repair 
between 1 Jul 2015 and 1 June 2016 
•
A minimum of three attempts to reach each subject in the cohort shall
be made 
Study Objectives 
Primary Objective 
Characterize the procedural and early post-operative safety profile of 
MIROMESH when used as reinforcement in hiatal hernia repair.   
Secondary Objectives 
Identify a consecutive cohort who may be tracked long term to identify survival 
of repair. 
Identify a consecutive cohort who may be tracked long term to characterize 
mid- and long-term clinical outcomes. 
Identify a consecutive cohort who may be tracked long term to further 
characterize the safety profile over time. 
Study Design 
This will be a retrospective chart review to identify the appropriate cohort with 
a prospective follow-up survey to acquire safety and outcome information.  
Study Assessments 
and Time Points 
Preoperative – Chart Review 
A retrospective chart review of appropriate subjects. 
Data to be acquired will be: 
•
Gender
•
Date of birth
•
Weight
•
BMI
July 24, 2017
WIRB 20171474
APPROVED 
 
WIRB® 
 
 
 
 
 

 
 
 
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• 
Specific diagnosis 
• 
DeMeester Score 
• 
24 hour pH test (% acid exposure in 24 hours) 
• 
GERD-HRQL Score 
Peri-operative Preoperative – Chart Review 
• 
Date of surgery 
• 
Number of stitches used to close wound 
• 
Paraesophageal hernia type 
• 
Mesh shape 
• 
Mesh size used 
• 
Attachment technique 
• 
Length of stay 
• 
Complications 
Post-Operative (With-in 1 month of surgery) Preoperative – Chart Review 
• 
Complications (Mesh related) 
• 
Complications (procedure related) 
• 
Prolonged dysphagia (Y/N) 
• 
Stenosis (Y/N) 
• 
Dilations (Y/N) 
• 
EGD/UGL documented hernia recurrence 
• 
GERD-HRQL Score 
Minimum 1-year Follow-Up Telephone Interview 
• 
Have you had a revision surgery? 
• 
GERD-HRQL Score 
• 
How satisfied are you with the procedure? 
• 
How likely are you to recommend this procedure to a loved one? 
 
Timeline 
Data collection will be complete 3-months after approval and funding 
Assessment Tools 
Patient Charts 
DeMeester Score 
24 hour pH test (% acid exposure in 24 hours) 
GERD-HRQL Score 
Project Budget 
$15,000 and IRB fees as invoiced (or directly paid) 
• 
25% upon full execution of agreement 
• 
25% Upon receipt of spreadsheet showing 50% (35 subjects) 
completion 
• 
25% upon receipt of spreadsheet with all subject data (70 subjects) 
• 
25% upon receipt of study report – narrative style 
Privacy 
Considerations 
Principle Investigator and Sponsor will enter into a Limited-Data Set Data Use 
Agreement consistent with 45 CFR 164.514.  Data listed above will be 
transferred and no protected health information not specifically covered by the 
data use agreement will be delivered to the sponsor.   
Informed Consent 
All subjects will be required to give verbal consent, via the telephone interview, 
for participation in this study.  Subjects will be informed that they were chosen 

 
 
 
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based on the procedure and mesh they received. They will be informed that 
historical data regarding their pathology and procedure will be gathered and 
that they will be asked several questions about their current health.  They will 
be informed that, except for, information used to determine age and date of 
surgery, no protected health information will be used.  Subjects that elect to 
participate will be informed that they will receive a copy of the verbal informed 
consent. 
 
Investigator will mail a copy of the consent script to all subjects who elect to 
participate in this study. 
Ethical 
Considerations 
This Study Proposal Summary will be reviewed by an accredited institutional 
review board and will not be initiated until written approval has been received. 
Statistical Analysis 
Descriptive statistics including but not limited to mean, standard deviation, 
frequency and percentages will be used to describe demographics, medical 
history, and characterize baseline variable as appropriate. 
Inferential statistics will be used to describe changes in variable over time. 
Deliverable(s) 
Excel spreadsheet with all data as outlined above 
Narrative study report outlining results and drawing conclusions.