A Pilot, Open-Label Study to Evaluate the Safety, Tolerability, and Performance of the FAST PV Technology™ in Chronic Dialysis Patients With Extremely Reduced or No Kidney Function
Phase: NA
Conditions: End Stage Renal Disease
Sponsor: FAST BioMedical

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Clinical Study Protocol 
 
A Pilot, Open-Label Study to Evaluate the Safety, Tolerability, and Performance of 
the FAST PV Technology™ in Chronic Dialysis Patients with Extremely Reduced 
or No Kidney Function 
 
Protocol Number: 2008193898 
 
IDE Number: G130164 
Version 1.2  
Date: 17 December 2020 
 
Sponsor: 
FAST BioMedical, Inc. 
9075 N. Meridian Street, Suite 200 
Indianapolis, IN 46260 USA 
Telephone: (866) 700-7310 
Principle Investigator: 
Arjun D. Sinha, MD, MS 
Renal Section Chief 
Richard L. Roudebush VA Medical Center 
1481 W. 10th St. 111N 
Indianapolis, IN 46202 
 
Confidentiality Statement 
This document and the information contained herein or attached hereto ("Confidential Material") are 
confidential and proprietary to FAST BioMedical.  This Confidential Material should be viewed only by 
those individuals or companies that have been given prior authorization to do so by FAST BioMedical 
("Authorized Users").  This Confidential Material should not be made available in any form to any person 
or company, other than the Authorized Users and their respective employees or associates on a 
need-to-know basis, without the prior written consent from FAST BioMedical. 
 

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2020 
 
 
 
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Table of Contents 
Description 
Page 
1. 
SYNOPSIS ..........................................................................................................6 
2. 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS.................11 
3. 
STUDY ADMINISTRATIVE STRUCTURE ...............................................13 
4. 
INTRODUCTION AND BACKGROUND ...................................................14 
4.1. 
Introduction ......................................................................................................14 
4.2. 
Investigational Device Background ................................................................14 
4.3. 
Study Product Background.............................................................................15 
4.4. 
Summary of Findings to Date .........................................................................15 
4.4.1. 
Nonclinical Studies ...........................................................................................15 
4.4.2. 
Effects in Humans ............................................................................................16 
4.4.2.1. 
Summary of Clinical Findings ........................................................................16 
4.4.2.2. 
Pharmacokinetics and Pharmacodynamics in Human Subjects .................18 
4.5. 
Iohexol Background .........................................................................................18 
4.6. 
Study Rationale ................................................................................................19 
4.6.1. 
Rationale for Dose Selection ...........................................................................19 
4.6.2. 
Rationale for Study Design .............................................................................20 
5. 
OBJECTIVES ..................................................................................................21 
5.1. 
Primary Objectives ..........................................................................................21 
6. 
STUDY DESIGN ..............................................................................................22 
6.1. 
Study Design and Overview ............................................................................22 
6.1.1. 
Duration of Study .............................................................................................22 
6.1.2. 
Definition of Study Completion ......................................................................22 
6.1.3. 
End of Study .....................................................................................................23 
7. 
SELECTION AND WITHDRAWAL OF SUBJECTS ................................24 
7.1. 
Inclusion Criteria .............................................................................................24 
7.2. 
Exclusion Criteria ............................................................................................24 
7.3. 
Subject Withdrawal .........................................................................................26 
7.4. 
Early Termination of Study ............................................................................26 
8. 
TREATMENT OF SUBJECTS ......................................................................27 
8.1. 
Identity of Study Product and Comparator ..................................................27 

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8.2. 
Treatments Administered ...............................................................................27 
8.3. 
Method of Assigning Subjects to Cohorts......................................................28 
8.4. 
Measurements of Compliance .........................................................................28 
8.5. 
Storage, Accountability, and Preparation .....................................................29 
8.5.1. 
Storage Conditions ...........................................................................................29 
8.5.2. 
Preparation .......................................................................................................29 
8.6. 
Packaging and Labeling ..................................................................................29 
8.6.1. 
Study Product ...................................................................................................29 
8.6.2. 
Blinding of Treatment Assignment ................................................................29 
8.7. 
Concomitant Medications and Other Restrictions .......................................29 
8.7.1. 
Concomitant Medications ...............................................................................29 
8.7.2. 
Other Restrictions ............................................................................................30 
9. 
STUDY ASSESSMENTS AND PROCEDURES ..........................................31 
9.1. 
Medical and Surgical History .........................................................................31 
9.2. 
Demographic Characteristics .........................................................................31 
9.3. 
Physical Measurements ...................................................................................31 
9.4. 
Performance Assessments ...............................................................................31 
9.5. 
Safety Assessments ...........................................................................................31 
9.5.1. 
Adverse Events .................................................................................................31 
9.5.2. 
Clinical Laboratory Tests ...............................................................................31 
9.5.2.1. 
Kidney Function ...............................................................................................32 
9.5.2.2. 
Other Tests .......................................................................................................32 
9.5.3. 
Vital Signs .........................................................................................................33 
9.5.4. 
Physical Examination ......................................................................................33 
9.5.5. 
Appropriateness of Safety Assessments .........................................................33 
10. 
ADVERSE EVENTS .......................................................................................34 
10.1. 
Recording Adverse Events ..............................................................................34 
10.2. 
Assessment of Adverse Events ........................................................................34 
10.2.1. 
Serious Adverse Events ...................................................................................35 
10.2.2. 
Intensity ............................................................................................................35 
10.2.3. 
Relationship to Study Product ........................................................................36 
10.3. 
Discontinuation due to Adverse Events .........................................................36 

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10.4. 
Reporting Serious Adverse Events .................................................................36 
10.5. 
Documentation and Reporting of Immediately Reportable 
Adverse Events .................................................................................................36 
10.6. 
Pregnancy .........................................................................................................37 
10.7. 
Drug-induced Liver Injury .............................................................................38 
11. 
STATISTICAL CONSIDERATIONS ...........................................................39 
11.1. 
Sample Size Calculation ..................................................................................39 
11.2. 
Analysis Populations ........................................................................................39 
11.3. 
Endpoints ..........................................................................................................39 
11.3.1. 
Primary Endpoints ..........................................................................................39 
11.4. 
Safety Analysis .................................................................................................39 
11.5. 
Performance Analysis ......................................................................................39 
11.5.1. 
Plasma Volume .................................................................................................39 
11.5.2. 
Interstitial Volume ...........................................................................................39 
12. 
ACCESS TO SOURCE DATA/DOCUMENTS ............................................40 
13. 
QUALITY CONTROL AND QUALITY ASSURANCE .............................41 
13.1. 
Conduct of Study .............................................................................................41 
13.1.1. 
Protocol Deviations ..........................................................................................41 
13.2. 
Protocol Amendments .....................................................................................41 
13.3. 
Monitoring of Study .........................................................................................41 
14. 
ETHICS ............................................................................................................43 
14.1. 
Institutional Review Board/Independent Ethics Committee 
Approval ...........................................................................................................43 
14.1.1. 
Ethics Review Prior to Study ..........................................................................43 
14.1.2. 
Ethics Review of Other Documents ................................................................43 
14.2. 
Written Informed Consent ..............................................................................43 
15. 
DATA HANDLING AND RECORD KEEPING ..........................................44 
15.1. 
Data Reporting and Case Report Forms .......................................................44 
15.1.1. 
Case Report Forms ..........................................................................................44 
15.1.2. 
Laboratory Data ..............................................................................................44 
15.1.3. 
Retention of Source Documents......................................................................44 
15.2. 
Retention of Essential Documents ..................................................................44 
15.3. 
Sample Retention .............................................................................................45 

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15.4. 
Privacy ..............................................................................................................45 
16. 
ADMINISTRATIVE INFORMATION .........................................................46 
16.1. 
Financing and Insurance .................................................................................46 
16.2. 
Publication Policy ............................................................................................46 
17. 
REFERENCES .................................................................................................47 
APPENDIX A PREPARATION OF FAST VISIBLE FLUORESCENT 
INJECTATE .....................................................................................................49 
 
List of Tables 
Description 
Page 
Table 1. 
Schedule of Assessments and Procedures ................................................8 
Table 2. 
Performance Sampling Schedule – (Two Performance 
Periods) .....................................................................................................10 
Table 3. 
Planned Dose Cohorts..............................................................................22 
Table 4. 
Study Product and Comparator .............................................................27 
Table 5. 
Visible Fluorescent Injectate Doses ........................................................28 
Table 6. 
Clinical Laboratory Tests........................................................................32 
 

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1. SYNOPSIS 
Protocol Title: 
A Pilot, Open-Label Study to Evaluate the Safety, Tolerability, and Performance of the FAST 
PV Technology in Chronic Dialysis Patients with Extremely reduced or no Kidney Function 
Indication: 
Quantitative determination of plasma volume (PV) and interstitial volume (ISV) 
Investigators and 
Clinical Research 
Units: 
Patients will be recruited and evaluated at a single site located in the United States. 
Objectives: 
Primary: 
• 
To evaluate PV and ISV using the FAST PV Technology and iohexol in patients on 
chronic dialysis predialysis. 
• 
To evaluate the interaction between PV and ISV measured after a dialysis with a repeat 
injection of VFI using the FAST PV Technology. 
• 
To assess the safety and tolerability of visible fluorescent injectate (VFI)™ (employing 
the FAST PV Technology) in chronic dialysis patients with extremely reduced or 
no renal function. 
Endpoints: 
Primary: 
• 
To measure quantitatively the ISV and PV of patients pre and post dialysis using the 
FAST PV Technology and Iohexol measurement. 
• 
Directly compare quantitative difference of ISV and PV measured by the FAST PV 
Technology and Iohexol measurement to the volume removed during dialysis. 
• 
To assess safety through adverse events (AEs) and serious adverse events (SAEs), 
clinical laboratory tests, physical examination findings and vital signs. 
Study Design: 
This is a pilot, single-center, open-label study designed to evaluate the safety, tolerability, 
and performance of the FAST PV Technology in patients on chronic dialysis. 
The planned dose cohorts are presented in the table below: 
 
Cohort 
Population 
eGFRa 
Base 
VFI 
Doseb 
Number 
of Doses 
Comparator 
Dose 
Number 
of Doses 
Number 
of 
Subjects 
1 
Dialysis 
Patients 
≤ 2 
mL/min/ 
1.73 m2 
3 mL 
2 
Iohexol 5 mL 
2 
10 
Abbreviations: eGFR = estimated glomerular filtration rate; N/A = not applicable. 
a  Patients must be on chronic hemodialysis for  3 months and oliguric defined as 2 urinary voids 
per day. 
b  3 mL for subjects/patients  40 and  100 kg + 1 mL for every 40 kg increase in body weight 
Administration of VFI will occur within 28 days of screening. 
Patients will receive 1 dose of VFI and 1 dose of iohexol approximately 4 hours prior to 
undergoing dialysis followed by a second dose of VFI and second dose of iohexol 
approximately 1 hour after completing dialysis.  Patients will be discharged following 
completion of Day 1 activities.  A follow-up visit will occur at the patient’s next 2 dialysis 
appointments (approximately 2-3 days after Day 1) and 1 week after Day 1.  A follow-up 
phone call will be performed on Day 31 (± 1 day). 
Subject Selection 
Criteria: 
Males and females  18 will be enrolled in the study.  Patients must be oliguric (have an 
estimated glomerular filtration rate (eGFR)  2 mL/min/1.73 m2) and must be receiving 
maintenance chronic dialysis. 
Investigational 
Product, Dose, and 
Route of 
VFI, 3 mL for subjects/patients  40 and  100 kg + 1 mL for every 40 kg increase in body 
weight, bolus injection 

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Administration: 
Comparator, 
Dose, and Route of 
Administration: 
Omnipaque™ 300 (iohexol), 647 mg of iohexol equivalent to 300 mg of organic iodine/1 mL 
(each mL of iohexol solution contains 1.21 mg tromethamine and 0.1 mg edetate calcium 
disodium), 5 mL, bolus injection 
Criteria for 
Evaluation: 
Safety: 
Adverse events will be collected and evaluated as they occur throughout the study. Safety 
assessments, including physical examinations, vital signs, and clinical laboratory tests, will 
be performed at specified time points. 
Performance: 
Measurements of PV and ISV will be determined using the FAST BioMedical Fluorescent 
Instrument (FBFI) and iohexol. 
Plasma Volume: Plasma volume will be determined using FAST PV Technology. 
Interstitial Volume: Interstitial Volume will be determined using the FAST PV Technology 
based on both FAST VFI and Iohexol plasma concentrations. 
Planned Sample 
Size: 
The anticipated sample size of approximately 10 is appropriate for pilot studies of similar 
design. 
Statistical 
Analysis: 
Analysis Populations: 
Safety Population: All subjects who receive any amount of study product. 
Performance Population: All subjects who have either a PV or ISV measurement using any of 
the techniques under study. 
Safety Analysis: 
The number and percentage of subjects reporting any treatment-emergent AE will be 
tabulated by system organ class, preferred term (coded using Medical Dictionary for 
Regulatory Activities), and cohort.  Treatment-emergent AEs will be further classified by 
severity and relationship to study product. 
Vital signs and clinical laboratory test data (observed and change from baseline) will be 
summarized by cohort and time point using appropriate descriptive statistics.  Physical 
examination findings results will only be listed. 
Performance Analysis: 
PV and ISV Measurements determined by FAST PV Technology will be compared to 
measurements determined by iohexol for both Dose 1 and Dose 2.  Basic statistical analyses 
including correlations and Bland-Altman plots will be performed. 
Changes in PV and ISV measurements between Dose 1 and Dose 2 determined by the FAST 
PV Technology and iohexol will be compared to the known volume of fluid removed during 
dialysis treatment.  Basic statistical analyses including correlations and Bland-Altman plots 
will be performed. 
Residual amounts of FAST VFI will be assayed on the Day 3 and Day 8 follow-up visits to 
assess the continued removal of the FAST VFI in this patient population. 
 

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Table 1. 
Schedule of Assessments and Procedures 
Study Procedure 
Screeninga 
Day 1 
Follow-Up 
Dischargeb 
Days -28 to -2 
Dose 1 
Dose 2 
Day 3 
Day 8 
Day 31 
Informed consent 
X 
 
 
 
 
 
Inclusion/exclusion criteriaa 
X 
X 
 
 
 
Demographics 
X 
 
 
 
Height 
X 
 
 
 
Body weight 
X 
X 
X 
 
 
 
BMIc 
X 
X 
 
 
 
Medical and surgical history 
X 
Xd 
 
 
 
Physical examination 
X 
X 
 
 
 
Vital signse 
X 
Xf 
Xf 
 
 
 
Clinical laboratory testsg 
Xgh 
Xh 
 
 
 
Hematocrit 
 
Xi 
Xi 
 
 
 
nT pro-BNP 
X 
 
 
 
Creatinine phosphokinase 
 
Xh 
 
X 
X 
 
Liver function tests 
 
X 
 
X 
X 
 
Timed Urine Collectionj 
 
X 
X 
 
 
 
Pregnancy test (nonmenopausal 
females only) 
X 
X 
 
 
 
Outpatient visit 
X 
X 
X 
X 
X 
X 
FAST VFI administration 
 
X 
Xk 
 
 
 
Iohexol administration 
 
X 
X 
 
 
 
FD001 and FD003 plasma 
samples 
Refer to Table 2 
Xl 
Xl 
 
Iohexol plasma samples 
 
Refer to Table 2 
 
 
 
Adverse events 
X 
X 
X 
X 
X 
Serious adverse events 
 
X 
X 
X 
X 
X 
Concomitant medications 
X 
X 
X 
 
 
 
Abbreviations: BMI = body mass index; FD001 = 5 kD carboxymethyl dextran; FD003 = 150 kD carboxymethyl 
dextran; FSH = follicle-stimulating hormone; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human 
immunodeficiency virus; VFI = visible fluorescent injectate. 
a. Assessments conducted upon enrollment will be used to reconfirm a subject’s eligibility for enrollment into the 
study. 
b. Discharge procedures will be performed following completion of all Day 31 assessments.  Subjects who 
terminate from the study early will have discharge procedures performed at the time of discontinuation. 
c. BMI will be calculated using the height obtained at screening. 
d. Medical and surgical history will be collected and documented to determine if any changes have occurred since 
screening. 
e. Vital signs will be measured after the subject has been resting quietly in a supine position or in the most 
recumbent position possible for at least 5 minutes. 
f. Vital signs will be measured within approximately 30 minutes prior to VFI and iohexol administrations and 
approximately 60-, 120- and 180-minutes post VFI and iohexol administrations. 
g. Refer to Table 6 for a detailed list of clinical laboratory test parameters, which will be collected from the medical 

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2020 
 
 
 
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Table 1. 
Schedule of Assessments and Procedures 
Study Procedure 
Screeninga 
Day 1 
Follow-Up 
Dischargeb 
Days -28 to -2 
Dose 1 
Dose 2 
Day 3 
Day 8 
Day 31 
record. 
h. BUN and serum creatinine will be drawn pre-dose dose 1 and post the dose 2 180 min VFI blood draw.  
i. Predose 
j. Pooled urine collection (from patient arrival to departure) to measure total volume, creatinine and urea nitrogen. 
No catheter.  
k. VFI administration of Dose 2 will occur approximately 8 hours following VFI administration of Dose 1 
l. Blood samples to be drawn after dialysis session to allow for determination of any remaining FAST VFI. 
NOTE: In the event multiple postdose procedures are required to be conducted at the same nominal time point, the 
timing of performance blood sample collections will take priority over all other scheduled activities.  In practice, the 
following order is recommended: (1) vital signs assessments; (2) performance blood sampling; (3) clinical 
laboratory tests sampling; (4) physical examination.  Vital signs may be conducted up to 10 minutes prior to the 
nominal time to minimize the potential autonomic effects of blood draws on these measurements. 
 

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Table 2. 
Performance Sampling Schedule – (Two Performance Periods) 
Nominal Time Relative to 
Start of VFI Bolus 
Injection 
FD001 and FD003 
Plasma Sample 
Iohexol Plasma 
Sample 
Volume of Blood 
drawnb 
Timed Urine 
Collection 
Predose (within 30 minutes) 
X 
X 
6 mL 
Pool urine from 
patient arrival to 
departure. 
0 minutes 
VFI and Iohexol Administration 
 
15 minutes 
X 
X 
7 mL 
60 minutes 
X 
X 
7 mL 
80 minutes 
X 
4 mL 
120 minutes 
X 
X 
7 mL 
180 minutes 
X 
X 
7 mL 
Dialysis Treatment (4 hours) 
 
Pre- Rinseback 
X 
 
4 mL 
Equilibrium time Post-Dialysis (1 hour) 
 
Predose (within 5 minutes of 
drug administration) 
X 
X 
7 mL 
0 minutes 
VFI and Iohexol Administrationa 
 
15 minutes 
X 
X 
7 mL 
60 minutes 
X 
X 
7 mL 
80 minutes 
X 
4 mL 
120 minutes 
X 
X 
7mL 
180 minutes 
X 
X 
7 mL 
Blood Samples will be drawn at approximately the times listed in Table 2.2; however due to the nature of the 
study some variation in timing may occur. Regardless of the time and number of blood draws, no subject will 
have more than 80 mLs blood drawn for this study within a 24-hour period. 
Abbreviations: FD001 = 5 kD carboxymethyl dextran; FD003 = 150 kD carboxymethyl dextran; VFI = visible 
fluorescent injectate. 
a. Second VFI and iohexol administration will occur approximately 8 hours after the initial administrations. 
b. Each blood draw will be taken as follows: 1 mL waste draw, 3mL FAST blood sample, 3 mL Iohexol Sample 
Note: Blood samples will be collected from the venous side of the arteriovenous fistula/graft. Performance blood 
samples will be collected as close to the nominal time point as possible. The allowable window for postdose blood 
sample collection relative to the start of VFI/iohexol bolus injection will be ±5 minute. 
 

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2. LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
Abbreviation 
Definition 
ADL 
activities of daily living 
AE 
adverse event 
Ae0-24 
amount of FD001 excreted in urine from time 0 to 24 hours 
AIDS 
acquired immunodeficiency syndrome 
AKI 
acute kidney injury 
BP 
blood pressure 
bpm 
beats per minute 
BUN 
blood urea nitrogen 
CI 
confidence interval 
CKD 
chronic kidney disease 
CKD-EPI 
Chronic Kidney Disease Epidemiology Collaboration 
CLr 
renal clearance 
CLr0-24 
renal clearance from time 0 to 24 hours 
CRU 
clinical research unit 
CYP 
cytochrome P450 
DILI 
drug-induced liver injury 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
eGFR 
estimated glomerular filtration rate 
EOS 
end-of-study 
FD001 
5 kD carboxymethyl dextran 
FD003 
150 kD carboxymethyl dextran 
FDA 
Food and Drug Administration 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
GFR 
glomerular filtration rate 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
HPLC 
high performance liquid chromatography 
HR 
heart rate 
ICH 
International Council for Harmonisation 
IEC 
independent ethics committee 
INR 
international normalized ratio 
IRB 
institutional review board 

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Abbreviation 
Definition 
IV 
intravenous(ly) 
ISV 
interstitial volume 
IVV 
intravascular volume 
LOQ 
limit of quantitation 
MDRD 
Modification of Diet in Renal Disease 
mGFR 
measured glomerular filtration rate 
OTC 
over-the-counter 
PD 
pharmacodynamic(s) 
PK 
pharmacokinetic(s) 
PR (interval) 
interval measured from the beginning of the P wave to the beginning of the QRS 
complex in the heart’s electrical cycle as measured by electrocardiogram 
PV 
plasma volume 
QRS (interval) 
the interval between the Q wave and the S wave in the heart’s electrical cycle as 
measured by electrocardiogram; principal deflection in the electrocardiogram 
QT (interval) 
a measure of the time between the start of the Q wave and the end of the T wave in the 
heart’s electrical cycle as measured by electrocardiogram 
QTc (interval) 
QT interval corrected for heart rate 
QTcF (interval) 
QT interval corrected for heart rate using Fridericia’s formula 
RR (interval) 
the time elapsed between 2 consecutive R waves as measured by electrocardiogram 
SAE 
serious adverse event 
Scr 
serum creatinine 
SRC 
safety review committee 
SRM 
study reference manual 
TEAE 
treatment-emergent AEs 
UADE 
unanticipated adverse device effect 
ULN 
upper limit of normal 
VFI 
visible fluorescent injectate 
 

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3. STUDY ADMINISTRATIVE STRUCTURE 
Sponsor: 
FAST BioMedical 
9075 N Meridian Street, Suite 200 
Indianapolis, IN 46260, USA 
Telephone: (866) 700-7310 ext. 701 
Sponsor’s Responsible Medical 
Officer: 
Bruce Molitoris, MD 
Chief Medical Officer 
FAST BioMedical 
Principle Investigator: 
Arjun D. Sinha, MD, MS 
Renal Section Chief 
Richard L. Roudebush VA Medical Center 
1481 W. 10th St. 111N 
Indianapolis, IN 46202 
Sponsor’s Contact: 
James Strickland 
President 
FAST BioMedical 
Analytical Laboratories: 
Iohexol Plasma Concentration Determination: 
Jesse Seegmiller, PhD 
Assistant Professor Dept. Lab. Med. and Pathology 
University of Minnesota 
Advanced Research & Diagnostic Laboratory 
Room D185 Mayo Bldg. 
420 Delaware St. SE 
Minneapolis, MN 55455, USA 
Telephone: (612) 625-6198 
 
FD001 and FD003 Concentration Determination and  
PV and ISV Determinations: 
Dan Meier, PhD 
Vice President of Product Development 
FAST BioMedical 
Telephone: (866) 700-7310 
VA Central Lab 
1481 W. 10th Street 
Indianapolis, IN 46202 
Telephone: 317 554 0000 
 
Patients will be recruited and evaluated at a single site located in the United States. 

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4. INTRODUCTION AND BACKGROUND 
4.1. 
Introduction 
The mortality of patients on chronic hemodialysis (HD) remains high at 17% per year and 
similarly the 5-year survival rate is low at only 42% (United Stated Renal Data System, 2018), 
which is worse than for advanced colon cancer (O’Connell et al, 2004). Cardiovascular events 
are the leading cause of death (United Stated Renal Data System, 2018), and an important but 
often unrecognized cause for excess cardiovascular mortality on HD is volume overload. 
Volume overload contributes to hypertension (Agarwal et al, 2009) and left ventricular 
hypertrophy (Hur et al, 2013), both of which are associated with cardiovascular events and 
mortality (Sarnak et al, 2003). Experimental objective measures of volume status have directly 
associated volume overload with mortality (Agarwal 2010; Wizemann et al, 2009). 
Despite classical recognition for the importance of removing adequate volume with HD, volume 
overload remains common in the HD population. HD patients are hospitalized frequently, with 
an average of 1.7 hospitalizations per year with rehospitalization within 30 days of discharge 
occurring in 38% of discharges (United Stated Renal Data System, 2018), which is far in excess 
of the general population. Volume overload conservatively contributes to over 10% of both 
initial hospitalizations and readmissions within 30 days(United Stated Renal Data System, 2018), 
with 1 analysis finding a 14% yearly rate for acute dialysis performed for volume overload at a 
cost to Medicare of $266 million in 2010 dollars (Arneson et al, 2010). 
The persistent morbidity and mortality attributable to volume overload is in part due to the lack 
of a validated objective measure of volume status for the dialysis population (Sinha 2011). In the 
absence of an objective method, the subjective dry weight method is used to manage volume 
status on HD. The dry weight method remains essentially unchanged since it was first described 
over 60 years ago and it relies on the clinical interview and exam to detect volume overload 
(Thompson et al, 1967). Unfortunately, the clinical exam is not sensitive for detecting small but 
clinically relevant volume overload (Sinha and Agarwal, 2009), and changes in dry weight of 
only 0.6 to 1 kilogram have been shown to be clinically significant (Agarwal et al 2009; 
Hur et al, 2013). 
There is a clear and longstanding need for a reliable objective measure of volume status for use 
in guiding volume removal in the chronic HD population. 
4.2. 
Investigational Device Background 
The FAST PV and mGFR Technology is a direct measurement of PV and GFR that relies on 
reading the intensity of fluorescent markers attached to different sized dextran molecules 
introduced into the bloodstream. The test is intended as an adjunct to current methods utilized to 
assess kidney function, intravascular volume and interstitial volume. 
The FAST PV and mGFR Technology includes intravenously (IV) administered fluorescent 
markers, timed blood draws, a validated fluorometric assay, and a computed algorithm to 
integrate the results and calculate the PV and GFR. 

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In cases where there near zero or zero kidney function, the FAST PV and mGFR Technology can 
be used to determine the interstitial volume of a patient. The distribution of the FD001, measured 
by timed blood samples, combined with the measured PV, allows for the ISV determination. 
The FAST PV and mGFR Technology will aid in identifying and determining the extent of renal 
dysfunction, therefore promoting early treatment, including dialysis initiation, as well as 
enrollment and stratification for clinical studies. This technology could also be used to determine 
the effect of a clinical maneuver on GFR such as volume resuscitation. 
4.3. 
Study Product Background 
The bolus IV administered visible fluorescent injectate (VFI) agent is comprised of a mixture of 
2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different 
fluorescent dye molecules attached. The 5 kD carboxymethyl dextran (FD001) is labeled with 
5-aminofluorescein and the 150 kD carboxymethyl dextran (FD003) is labeled with 
2-sulfohexamine rhodamine. These fluorescent labels are covalently attached to the dextran 
through the carboxymethyl moiety. When combined in a 3:1 (mass) ratio of small to large 
molecules, these dextrans make up the VFI. 
The high molecular weight labeled carboxymethyl dextran, FD003, is not rapidly cleared from 
the vasculature and is not rapidly cleared by passive filtration in the kidneys; therefore, its 
concentration in the blood stream after injection provides a direct measurement of the total PV. 
The low molecular weight labeled carboxymethyl dextran, FD001, is also not subject to rapid 
metabolism but is freely filtered by the kidneys. The decline in the concentration of FD001 
combined with the PV measured by FD003 provides a rapid and accurate assessment of GFR. 
In previous studies, the FD001 component of the FAST VFI was used to determine mGFR. In 
this study, the FD001 marker will be used to measure the volume of distribution or interstitial 
volume (ISV). Its distribution into the interstitial space, combined with the measurement of PV 
by FD003 will allow for the calculation of a true measured volume of distribution. 
While the VFI is a substantially modified dextran-based compound, other dextran products have, 
on rare occasions, been associated with mild to severe, acute anaphylactic reactions including 
death. As a precaution, subjects will be closely monitored for signs of allergy and anaphylaxis, 
and an emergency resuscitation kit and team will be available throughout the performance 
period. 
4.4. 
Summary of Findings to Date 
4.4.1. Nonclinical Studies 
Nonclinical studies are summarized in Section 3 of the current FAST PV and mGFR Technology 
Investigator’s Brochure. 

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4.4.2. Effects in Humans 
4.4.2.1. 
Summary of Clinical Findings 
FAST BioMedical has conducted 4 clinical studies evaluating the FAST PV and mGFR 
Technology in healthy subjects (Study FAST_GFR-01.1), in healthy subjects and subjects with 
compromised renal function (Study Pilot B/Phase 2a), in healthy subjects and patients with 
varying degrees of renal impairment (Study Phase 2b) and in hospitalized ADHF patients (Study 
Phase 2c). 
The Phase 1 single-dose, dose-ranging clinical study was conducted in Germany with the FAST 
PV and mGFR Technology (Study FAST_GFR-01.1). In this study, 32 subjects divided into 
4 cohorts of 8 subjects (6 subjects receiving the VFI and 2 subjects receiving placebo) between 
the ages of 21 and 45 years completed the study. Doses of the VFI evaluated in this study were 5, 
15, 75, and 150 mg administered by slow bolus injection. The placebo subjects received 0.9% 
normal saline for injection. The components of the device used in the study included a catheter- 
-based fiber optic probe placed in the subject’s peripheral vein to allow the concentration of 
fluorescent markers to be monitored and an optical device to excite and detect the markers. 
Single-dose administration of VFI in a range of 5 to 150 mg was safe and well tolerated. Overall, 
9 subjects (28.1%) experienced 15 treatment-emergent adverse events (TEAEs), which were 
considered reasonably related to the VFI administration or study procedures by the investigator. 
Most related TEAEs were observed after administration of 15 mg VFI (9 TEAEs reported by 
3 subjects). Two subjects (both receiving 15 mg VFI) reported 6 TEAEs (pruritus and 
gastrointestinal disorders), which were considered related to VFI (mainly injection site pain and 
hematoma at the blood sampling site). The most frequently reported TEAEs were nervous 
system disorders (10 subjects [31.3%], 10 TEAEs), which mainly included headache considered 
unrelated to the VFI or study procedures. All TEAEs were of mild to moderate intensity and 
there were no serious adverse events (SAEs); no subject discontinued the study due to an adverse 
event (AE). No treatment-related TEAEs were observed after the highest dose. There were no 
adverse device effects. Safety laboratory parameters, vital signs, and electrocardiogram (ECG) 
parameters showed no clinically relevant time- or treatment-related differences. 
The Phase 2a clinical study was a prospective study evaluating the FAST PV and mGFR 
Technology in subjects with preserved and impaired kidney function. In this study, 4 cohorts of 
8 subjects and 1 cohort of 6 subjects were planned to receive 75 mg of the VFI (50 mg FD001 
and 25 mg FD003). A total of 33 subjects were enrolled with 1 of 6 planned subjects enrolled in 
the AKI group. Cohorts 1 and 5 had normal kidney function with GFR of ≥ 60 mL/min, Cohort 2 
GFR was estimated at 30 to 59 mL/min, Cohort 3 GFR was 15 to 29 mL/min, and Cohort 4 was 
planned to be AKI subjects with Scr  2-fold increase or eGFR > 50% decrease compared to 
baseline. Of the 33 subjects enrolled, 19 (57.6%) subjects experienced 37 TEAEs during the 
study. There were no treatment-emergent SAEs during the study. The majority of laboratory 
parameters were within normal ranges or considered not clinically significant. No clinically 
significant changes in vital signs were noted during the study. The majority of subjects had 
ECGs that were normal or had abnormalities that were considered not clinically significant. 
Two subjects, both with medical histories significant for cardiac disorders, had abnormalities that 
were considered to be clinically significant AEs. 

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The Phase 2b study was a prospective, open-label study designed to evaluate the safety, 
tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of FAST PV and mGFR 
Technology in healthy subjects and patients with varying degrees of renal impairment. A total of 
32 subjects were planned to be enrolled in 4 cohorts of up to 8 subjects/patients each. Healthy 
subjects in Cohorts 1 and 2 had an eGFR ≥ 60 mL/min/1.73 m2; patients with impaired renal 
function in Cohort 3 had an eGFR  30 and < 60 mL/min/1.73 m2; and patients with impaired 
renal function in Cohort 4 had an eGFR  15 and < 30 mL/min/1.73 m2. Subjects in Cohort 1 
received a single dose of VFI followed 130 minutes later by a 350-mL infusion of 5% albumin in 
normal saline over 30 minutes on Day 1. Subjects in Cohort 2 received a dose of VFI followed 
160 minutes later by a single dose of iohexol (refer to Section 4.5 for additional information on 
iohexol) on Day 1 and a second dose of VFI 24 hours following the initial dose of VFI. Patients 
in Cohorts 3 and 4 received a single dose of VFI followed 160 minutes later by a single dose of 
iohexol on Day 1. 
The FAST VFI was safe and well tolerated in healthy subjects in Cohorts 1 and 2 and in patients 
with impaired renal function in Cohorts 3 and 4. No severe or serious TEAEs, TEAEs leading to 
study drug discontinuation, or deaths were reported during the study. Overall, the majority of 
TEAEs reported were mild in severity. Three patients in Cohort 4 had a TEAE of blood creatine 
phosphokinase increased related to clinically significant abnormal creatine kinase levels. All 
3 TEAEs of blood creatine phosphokinase increased were mild in severity and considered by the 
investigator to be possibly related to study drug. There were no other clinically significant 
abnormal clinical laboratory values. There were no clinically significant abnormal ECG or vital 
signs measurements, nor were there clinically meaningful trends identified in observed values or 
changes from baseline. There were no clinically significant abnormal physical examination 
findings. 
The Phase 2c study was an investigator-initiated, human clinical trial designed to evaluate the 
safety and functionality of the FAST PV and mGFR Technology in hospitalized CHF patients. 
Patients enrolled in the study were administered VFI (Day 1) with a second dose occurring 48h 
(+/- 5h) after the initial dose (Day 3). A total of 37/50 (74%) patients had a treatment-emergent 
AE (TEAE) while 21/30 (42%) had a treatment-emergent SAE (TESAE). One patient died 
during the study, but the death was deemed to be not related to the intervention. Further, there 
were no treatment related SAEs and 10/50 (20%) patients had a treatment related AE with 
maximal mild severity. In total, 4 patients (4/50, 8%) suffered from treatment related diarrhoea 
including 1 with a moderate severity while for all other related TEAES only 1 patient was 
affected each time (1/50, 2%). Of all 50 patients, 3 patients (6%) were affected by pneumonia, 
cardiac failure, and acute kidney injury each while 2 patients had endocarditis. All other SAEs 
occurred only in 1 patient each (1/50, 2%). 

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4.4.2.2. 
Pharmacokinetics and Pharmacodynamics in Human Subjects 
In the first-in-human clinical study (Study FAST_GFR-01.1), mean plasma concentrations of 
FD001 increased dose dependently with peak concentrations observed at 0.25 hours after 
administration (first blood sample). Thereafter, mean concentration decreased rapidly with no 
concentration above the limit of quantitation (LOQ) observed at 48 hours postdose. Mean plasma 
concentrations of FD003 increased dose dependently with peak concentrations observed at 
0.25 (5 mg VFI) to 2 hours (75 and 150 mg VFI) after injection. Thereafter, mean concentrations 
decreased with a constant rate until 312 hours postdose. A slower elimination rate was observed 
until 480 hours after administration (end of the observation period). At 480 hours, all subjects in 
the 75- and 150-mg groups had concentrations of FD003 above the LOQ. 
In the Phase 2a clinical study, following IV bolus injection of the VFI to patients with varying 
degrees of kidney function, FD001 generally reached maximum observed concentration 
following the end of the infusion and decreased in a multiexponential, first order elimination 
manner with early-phase distribution apparently complete at 8 to 12 hours. The mean time at 
which the maximum plasma concentration was observed was approximately 0.25 hours. Mean 
plasma elimination half-life estimates increased with decreasing renal function (5.64 hours in 
Cohort 5, 9.48 hours in Cohort 2, and 18.3 hours in Cohort 3). In contrast, mean plasma FD003 
elimination half-life estimates were generally similar regardless of renal function (90.9 hours in 
Cohort 5, 123 hours in Cohort 2, and 125 hours in Cohort 3). Mean FD003 volume estimates 
indicated that FD003 appeared to occupy a volume space that corresponds to PV. Mean FD003 
clearance did not change with decreasing renal function. 
The Phase 2b clinical study showed that FD001 does not appear to accumulate in most healthy 
subjects with normal renal function when dosed at a 24-hour interval. The PK of the FAST VFI 
in patients with varying degrees of kidney function indicated the renal clearance of FD001 from 
0 to 3 hours after dosing is indicative of GFR. The exposure to and elimination of FD003 was 
independent of renal function. FD003 distributed in a manner consistent with vascular volume. 
Additionally, FD003 remained stable in the vasculature for a period of at least 6 hours, allowing 
repeat measurements of PV during that time period without redosing. 
The PV data showed good correlation and no bias when compared to Nadler’s estimate 
(Nadler et al, 1962). A comparison of iohexol GFR to the FAST VFI mGFR showed excellent 
correlation through the entire range of GFRs measured. The FAST VFI method was able to 
accurately measure the change in PV within subjects due to the administration of 350 mL of 5% 
albumin. The FAST mGFR technology delivered clinically meaningful results as demonstrated 
by its ability to stratify patients by kidney function. 
Pharmacokinetics were not studied in the Phase 2c study. 
4.5. 
Iohexol Background 
OMNIPAQUE 300 (hereafter referred to as iohexol) is indicated in adults for aortography 
including studies of the aortic arch, abdominal aorta and its branches, contrast enhancement for 
computed tomographic head and body imaging, cerebral arteriography, peripheral venography 
(phlebography), and excretory urography. 

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Following intravascular injection, iohexol is distributed in the extracellular fluid compartment 
and is excreted unchanged by glomerular filtration. It will opacify those vessels in the path of 
flow of the contrast medium permitting radiographic visualization of the internal structures until 
significant hemodilution occurs. 
Approximately 90% or more of the injected dose is excreted within the first 24 hours, with the 
peak urine concentrations occurring in the first hour after administration. Plasma and urine 
iohexol levels indicate that the iohexol body clearance is due primarily to renal clearance (CLr). 
An increase in the dose from 500 to 1500 mgI/kg does not significantly alter the clearance of the 
drug. The following PK values were observed following the IV administration of iohexol 
(between 500 to 1500 mgI/kg) to 16 adult human subjects: CLr = 120 (86 to 162) mL/min; total 
body clearance = 131 (98 to 165) mL/min; and volume of distribution = 165 (108 to 219) mL/kg. 
Renal accumulation is sufficiently rapid that the period of maximal opacification of the renal 
passages may begin as early as 1 minute after IV injection. Urograms become apparent in about 
1 to 3 minutes with optimal contrast occurring between 5 to 15 minutes. In nephropathic 
conditions, particularly when excretory capacity has been altered, the rate of excretion may vary 
unpredictably, and opacification may be delayed after injection. Severe renal impairment may 
result in a lack of diagnostic opacification of the collecting system and, depending on the degree 
of renal impairment, prolonged plasma iohexol levels may be anticipated. In these patients, the 
route of excretion through the gallbladder and into the small intestine may increase. 
Iohexol displays a low affinity for serum or plasma proteins and is poorly bound to serum 
albumin. 
No significant metabolism, deiodination, or biotransformation occurs. 
Iohexol enhances computed tomographic imaging through augmentation of radiographic 
efficiency. The degree of density enhancement is directly related to the iodine content in an 
administered dose; peak iodine blood levels occur immediately following rapid IV injection. 
Blood levels fall rapidly within 5 to 10 minutes and the vascular compartment half-life is 
approximately 20 minutes. This can be accounted for by the dilution in the vascular and 
extravascular fluid compartments which causes an initial sharp fall in plasma concentration. 
Equilibration with the extracellular compartments is reached in about 10 minutes; thereafter, the 
fall becomes exponential. 
Refer to the OMNIPAQUE (iohexol) injection prescribing information (2010) for additional 
details. 
4.6. 
Study Rationale 
4.6.1. Rationale for Dose Selection 
Each anticipated single dose for a 70-kg human will consist of 35 mg of FD001 and 12 mg of 
FD003, diluted at 15.7 mg/mL, for a total injection of 3.0 mL VFI, equivalent to 0.78 mg/kg or 
28.9 mg/m2 for a 60-kg human. 

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4.6.2. Rationale for Study Design 
This is a pilot, single-center, open-label study designed to evaluate the safety, tolerability, and 
performance of the FAST PV Technology in chronic dialysis patients. The dosing schedule was 
determined based on anticipated clinical use. 
Male and female subjects will be enrolled in the study. As no sufficient data are available on a 
potential influence of the VFI on embryo-fetal development, female subjects must be of 
non-childbearing potential or must provide confirmation of a known and medically acceptable 
contraception method. Reproductively active men must agree to either practice abstinence or 
utilize adequate contraception. 
Subject safety will determine the progression or discontinuation of the study. In rare cases, 
dextran products have been documented to produce anaphylactic reactions in humans, and the 
onset of symptoms is documented to be acute. The VFI is a substituted dextran product that has 
shown little evidence of antigenicity in nonclinical studies. 
The duration of confinement and medical surveillance are considered adequate to ensure safety 
of the subjects. 
The FAST VFI has not been given to dialysis patients before. In the Phase 2c study, a patient 
with a measured GFR of 16.7 mL/min/1.73m2 was dosed with VFI with no AE or SAEs related 
to the study drug observed. Although the patients in this study will receive 2 doses of FAST VFI, 
the initial doses of VFI and iohexol will be removed during the patient’s dialysis session. The 
second dose of VFI and Iohexol will be removed between 36 and 48 hours later at the first 
follow-up dialysis session. The concentration the patients in this study will be exposed to is 
higher for longer than previous studies due to the lack of kidney function; however, the FD001 
and iohexol, will continue to distribute into the extracellular fluid of the patient. The FD003 
exposure is unchanged from prior studies. 

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5. OBJECTIVES 
5.1. 
Primary Objectives 
• To evaluate PV and ISV using the FAST PV Technology and iohexol in patients on chronic 
dialysis predialysis. 
• To evaluate the interaction between PV and ISV measured after a dialysis with a repeat 
injection of VFI using the FAST PV Technology. 
• To assess the safety and tolerability of visible fluorescent injectate (VFI) (employing the 
FAST PV Technology) in chronic dialysis patients with extremely reduced or no renal 
function.  

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6. STUDY DESIGN 
6.1. 
Study Design and Overview 
This is a pilot, single site, open-label study designed to evaluate the safety, tolerability, and 
performance of the FAST PV Technology in dialysis patients. 
The planned dose cohorts are presented in Table 3. 
Table 3. 
Planned Dose Cohorts 
Cohort 
Population 
eGFRa 
Base 
VFI 
Doseb 
Number 
of Doses 
Comparator 
Dose 
Number 
of Doses 
Number 
of 
Subjects 
1 
Dialysis 
Subjects 
≤ 2 mL/min/1.73m2 
3 mL 
2 
Iohexol 5 mL 
2 
Up to 10 
Abbreviation: N/A = not applicable 
a. Patients must be on chronic hemodialysis for  3 months and oliguric defined as  2 urinary voids per day. 
b. 3 mL for subjects/patients  40 and  100 kg + 1 mL for every 40 kg increase in body weight 
 
Administration of VFI will occur within 28 days of screening. 
Patients will receive 1 dose of VFI and 1 dose of iohexol approximately 4 hours prior to 
undergoing dialysis followed by a second dose of VFI and iohexol approximately 1 hour after 
completing dialysis. Patients will be discharged following completion of Day 1 activities. 
Patients will be seen and evaluated on their next 2 dialysis sessions for any adverse reaction by 
answering questions about their health, approximately on Day 3 and Day 8. A follow-up phone 
call will be performed on Day 31 (± 1 day). 
Refer to Table 1 for the Schedules of Assessments and Procedures. 
6.1.1. Duration of Study 
Participation is expected to last up to 59 days, including a screening period of up to 28 days and 
an on-study period of up to 31 days (consisting of a single performance period and a follow-up 
phone call). 
6.1.2. Definition of Study Completion 
Discharge/EOS procedures will be performed as specified in the Schedules of Assessments and 
Procedures (Table 1); subjects/patients who terminate from the study early will have 
discharge/EOS procedures performed at the time of discontinuation. Subjects/patients with 
ongoing clinically significant clinical or laboratory findings will be followed until the finding is 
resolved or medically stable; reasonable attempts will be made to follow-up with 
subjects/patients. The subject’s/patient’s participation in the study will end once all study 
assessments and follow-up have been completed. 

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6.1.3. End of Study 
The end of the study is defined as the date when the last subject/patient has completed all study 
procedures up to and including the follow-up phone call/EOS visit as outlined in the Schedules 
of Assessments and Procedures (Table 1). 

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7. SELECTION AND WITHDRAWAL OF SUBJECTS 
Subjects/patients must meet all the following criteria in order to be enrolled in the study. 
7.1. 
Inclusion Criteria 
Subjects/patients must meet all inclusion criteria to be eligible for study participation. 
1. Males or females  18 years of age. 
2. Females must be of non-childbearing potential (eg, postmenopausal [defined cessation of 
regular menstrual periods for at least 1 year confirmed by age  60 or surgically sterile by 
hysterectomy, bilateral oophorectomy, or bilateral tubal ligation [documentation required]) or 
be using a medically acceptable form of birth control (a barrier method, intrauterine device, 
or hormonal contraception) from screening through 30 days after administration of the last 
dose of VFI. 
3. Males who are sexually active and whose partners are females of childbearing potential must 
agree to practice abstinence or use condoms from screening through 90 days after 
administration of the last dose of VFI, and their partners must be willing to use a medically 
acceptable method of contraception (a barrier method, intrauterine device, or hormonal 
contraception) from screening through 90 days after administration of the last dose of VFI. 
4. Males must agree to not donate sperm from screening through 90 days after administration of 
the last dose of VFI. 
5. Subjects/patients must be able to communicate effectively with the study personnel. 
6. Patients must be on chronic hemodialysis for  3 months and oliguric defined as  2 urinary 
voids per day. 
7. Patients must have an average interdialytic weight gain of at least 2 kg. 
8. Patients must have an A-V dialysis shunt. 
9. Patients must have a functioning A-V dialysis shunt, either fistula or graft. 
7.2. 
Exclusion Criteria 
Subjects/patients will not be eligible for study participation if they meet any of the exclusion 
criteria, or will be discontinued at the discretion of the investigator if they develop any of the 
exclusion criteria during the study. 
1. Subject is a pregnant or nursing (lactating) woman, where pregnancy is defined as the state of 
a female after conception and until the termination of gestation, confirmed by a positive 
human chorionic gonadotropin (hCG) laboratory test. 
2. History or presence of conditions which, in the judgment of the investigator, are known to 
interfere with the distribution, metabolism, or excretion of drugs. 
3. History or presence of conditions that may place the subject/patient at increased risk as 
determined by the investigator. 

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4. History of surgery or major trauma within 12 weeks of screening or surgery planned within  
4 weeks of the study including during study participation. 
5. Has taken other investigational drugs within 30 days or 5 half-lives of the investigational 
drug’s PK, PD, or biological activity, whichever is longer, prior to first dose of VFI in this 
study. 
6. Prior exposure to VFI or known allergy or hypersensitivity to dextran, 5-aminofluorescein 
dye, or 2-sulfohexamine rhodamine dye. 
7. History of any clinically significant allergic or negative reactions, side effects, or anaphylaxis 
to iodine, dyes, shellfish, isotopes, or dextran molecules. 
8. Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma within 
4 weeks prior to study participation. 
9. Presence of significant hemodynamic instabilities defined as systolic BP <100 on dialysis 
requiring saline infusion in the past 4 weeks. 
10. Presence of ascites and/or 4+ anasarca. 
11. Any other condition or prior therapy that, in the investigator’s opinion, would make the 
subject unsuitable for the study, or unable or unwilling to comply with the study procedures. 
12. Involved in the planning or conduct of this study. 
13. Unwilling or unlikely to comply with the requirements of the study. 
14. Clinically significant ongoing bleeding, changing hemoglobin, or experienced significant 
blood loss within last 4 weeks. 
15. Had a PRBC transfusion in the prior 2 weeks 
16. Use of midodrine. 
17. Any other condition or prior therapy that, in the investigator’s opinion, is likely to deteriorate 
during study participation 
18. Subjects suffering from significant non-cardiac diseases of other organ systems (eg, 
malignancies, significant neurological diseases). 
19. Subject has a psychiatric disease or a history of illicit drug use that would prohibit them from 
complying with study requirements. 
20. Use of hemodialysis catheter as primary vascular access for hemodialysis 

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7.3. 
Subject Withdrawal 
Subjects/patients are free to discontinue the study at any time, for any reason, and without 
prejudice to further treatment. The investigator may remove a subject/patient if, in the 
investigator’s judgment, continued participation would pose unacceptable risk to the 
subject/patient or to the integrity of the study data. All procedures for early termination must be 
completed. Reasons for removal or withdrawal may include: 
• Withdrawal of consent 
• Administrative decision by the investigator or sponsor 
• Ineligibility 
• Significant protocol deviation 
• Subject/patient noncompliance 
• Safety concern by the investigator or sponsor 
• Lost to follow-up 
Subjects/patients who are withdrawn for reasons other than safety issues may be replaced at the 
discretion of the sponsor and investigator. 
In the event of a subject’s/patient’s withdrawal, the investigator will promptly notify the sponsor 
and will make every effort to complete discharge procedures. All withdrawn subjects/patients 
with ongoing clinically significant clinical or laboratory findings will be followed until the 
finding is resolved or medically stable; reasonable attempts will be made to follow-up with 
subjects/patients. 
7.4. 
Early Termination of Study 
The study may be terminated at any time by the sponsor if serious side effects occur, if potential 
risks to study participants are identified, if the investigator does not adhere to the protocol, or if, 
in the sponsor’s judgment, there are no further benefits to be achieved from the study. In the 
event that the clinical development of the study product is discontinued, the sponsor shall inform 
all investigators/institutions and regulatory authorities. 

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8. TREATMENT OF SUBJECTS 
8.1. 
Identity of Study Product and Comparator 
The identity of the study product and comparator are presented in Table 4. 
Table 4. 
Study Product and Comparator 
Study Product 
Dosage Form 
Strength 
Dose 
Visible Fluorescent 
Injectate 
Solution for injection 
35 mg FD001/12 mg 
FD003 
3 mL + 1 mL for every 40 kg increase 
in body weight (refer to Table 7.2) 
Comparator 
Omnipaque 300 
(iohexol) 
Solution for injection 
647 mg of iohexol 
equivalent to 300 mg of 
organic iodine/1 mL 
5 mL 
 
VFI will be sourced by FAST BioMedical. The VFI is packaged in a 10-mL, 20-mm clear glass 
vial with a 20-mm gray stopper and blue cap, and the product is a deeply colored lyophilized 
cake. 
Iohexol will be sourced by the VA. Iohexol is packaged in a clear 10 mL bottle with a brown 
cap, and the product is a colorless to pale-yellow liquid. Each mL of iohexol solution contains 
1.21 mg tromethamine and 0.1 mg edetate calcium disodium. 
8.2. 
Treatments Administered 
Each subject/patient will receive 2 doses of VFI and 2 doses of iohexol, which will be 
administered IV through a bolus injection. An IV catheter will be inserted into the subject’s 
arteriovenous fistula or graft by an experienced dialysis nurse. 
Patients will receive 1 dose of VFI and 1 dose of iohexol approximately 4 hours prior to 
undergoing dialysis followed by a second dose of VFI and second dose of iohexol approximately 
1 hour after completing dialysis. 
The dose of VFI will be 3 mL for subjects/patients  40 and  100 kg and will increase by 1 mL 
for every 40 kg increase in body weight as outlined in Table 5. 

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Table 5. 
Visible Fluorescent Injectate Doses 
Body weight 
Dose 
VFI 
FD001 
FD003 
VFI 
FD001 
FD003 
(lbs) 
(kg) 
(mL) 
(mg) 
(mg) 
(mg) 
(mg/kg) 
(mg/kg) 
(mg/kg) 
88 
40 
3 
47.01 
35.01 
12 
1.18 
0.88 
0.300 
154 
70 
3 
47.01 
35.01 
12 
0.67 
0.50 
0.171 
220 
100 
3 
47.01 
35.01 
12 
0.47 
0.35 
0.120 
223 
101 
4 
62.68 
46.68 
16 
0.62 
0.46 
0.158 
309 
140 
4 
62.68 
46.68 
16 
0.45 
0.33 
0.114 
311 
141 
5 
78.35 
58.35 
20 
0.56 
0.41 
0.142 
397 
180 
5 
78.35 
58.35 
20 
0.44 
0.32 
0.111 
399 
181 
6 
94.02 
70.02 
24 
0.52 
0.39 
0.133 
485 
220 
6 
94.02 
70.02 
24 
0.43 
0.32 
0.109 
487 
221 
7 
109.69 
81.69 
28 
0.50 
0.37 
0.127 
573 
260 
7 
109.69 
81.69 
28 
0.42 
0.31 
0.108 
575 
261 
8 
125.36 
93.36 
32 
0.48 
0.36 
0.123 
661 
300 
8 
125.36 
93.36 
32 
0.42 
0.31 
0.107 
664 
301 
9 
141.03 
105.03 
36 
0.47 
0.35 
0.120 
750 
340 
9 
141.03 
105.03 
36 
0.41 
0.31 
0.106 
 
A low-protein snack will be served prior to administration of VFI (eg, toast, bagel, Graham 
crackers, or primarily carbohydrate-based small portion). Water will be allowed as desired up to 
1.5 liters, but must be tracked on the CRF. Meals appropriate for the patient’s medical condition 
will be served. 
8.3. 
Method of Assigning Subjects to Cohorts 
Eligible subjects/patients will be enrolled in a single cohort. 
8.4. 
Measurements of Compliance 
Study product and comparator will be administered by qualified healthcare professionals at the 
study site as designated by the investigator. Details regarding dosing, including the dose 
administered and the date and time of dosing, will be recorded. 

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8.5. 
Storage, Accountability, and Preparation 
8.5.1. Storage Conditions 
The VFI will be stored in a refrigerator set to maintain 2°C to 8°C (36°F to 46°F). Vials and 
glass or polymer bottles of iohexol will be protected from strong daylight and direct exposure to 
sunlight and will be stored at controlled room temperature at 20°C to 25°C (68°F to 77°F); 
excursions are permitted to 15°C to 30°C (59°F to 86°F). 
The VFI will be prepared within 60 minutes prior to dosing, and the prepared product will be 
stored at room temperature (approximately 20°C to 25°C). The product will be protected from 
sunlight and ultraviolet light until dosing. 
Iohexol will be drawn into a syringe for administration and stored at room temperature 
(approximately 20°C to 25°C). 
8.5.2. Preparation 
The procedure for reconstitution of the FAST VFI is located in Appendix A. 
8.6. 
Packaging and Labeling 
8.6.1. Study Product 
The study product will be provided with appropriate labeling, including: sponsor name, address, 
and phone number, product name, active constituents, content by volume and number of units, 
batch number, expiry date, storage instructions, and the term “Caution: Investigational Device. 
Limited by US Federal Law for Investigational Use Only.” 
8.6.2. Blinding of Treatment Assignment 
Not applicable. This is an open-label study. 
8.7. 
Concomitant Medications and Other Restrictions 
8.7.1. Concomitant Medications 
Maintenance medications as prescribed by their physicians are permitted. All medications 
(prescription and OTC), vitamin and mineral supplements, and herbs taken during the study will 
be documented on the concomitant medication case report form (CRF). Information recorded 
will include: start and stop dates and times, dose and route of administration, and indication. 
Medications taken for a procedure should also be included. 

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8.7.2. Other Restrictions 
Subjects/patients will be instructed to adhere to the following restrictions: 
• Strenuous activity (as assessed by the investigator) is prohibited from 72 hours prior to 
admission until completion of dosing. 
• Subjects/patients are not permitted to consume alcohol from 24 hours prior to admission until 
completion of dosing. 
• Subjects/patients are not permitted to consume any food and drink from outside of the VA 
during the testing period. 
• Subjects/patients must comply with the VA smoking policy, if applicable. 
• Subjects/patients are not permitted to participate in any other clinical trial or donate blood or 
plasma while participating in this clinical trial. 

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9. STUDY ASSESSMENTS AND PROCEDURES 
Subjects/patients will undergo study procedures and assessments at time points specified in the 
Schedules of Assessments and Procedures (Table 1) 
9.1. 
Medical and Surgical History 
The investigator or designee will collect and document a complete medical and surgical history 
at screening. Medical and surgical history will be collected and documented at test day 
admission to determine if any changes have occurred since screening. The medical history 
should include all active medical problems regardless of time of onset. 
9.2. 
Demographic Characteristics 
Demographic characteristics including sex, age, race, and ethnicity will be recorded. 
9.3. 
Physical Measurements 
Height (cm) and body weight (kg) without shoes will be recorded. Body mass index will be 
calculated using the height obtained at screening. 
9.4. 
Performance Assessments 
Plasma performance samples for determination of PV and GFR will be collected at time points 
specified in the Performance Sampling Schedules (Table 2). Concentration of FAST VFI will be 
determined on the FAST BioMedical Fluorescent Instrument (FBFI). Concentrations of iohexol 
will be determined via the validated University of Minnesota LC-MS/MS method. 
Measurements of PV and ISV will be determined using the FAST BioMedical Technology and 
mathematical equations. 
9.5. 
Safety Assessments 
9.5.1. Adverse Events 
Subjects will be monitored for AEs from administration of the first dose of VFI through the 
follow-up phone call/EOS visit. Refer to Section 10 for additional details. 
9.5.2. Clinical Laboratory Tests 
The electronic medical record will be used to find the most recent values for the clinical 
laboratory tests listed in Table 6, all of which are checked with a frequency ranging from twice a 
month to once a quarter during the routine course of hemodialysis. The baseline laboratory test 
results for clinical assessment for a particular test will be defined as the last measurement prior to 
the first dose of VFI. 

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During the screening period, if a subject/patient has an out-of-range value for a clinical 
laboratory parameter which the investigator believes is not clinically significant, but the 
investigator wants to confirm with a repeat laboratory test, a single repeat is allowed to confirm 
the initial result. 
Table 6. 
Clinical Laboratory Tests 
Hematology 
Serum Chemistry 
Hematocrit 
Hemoglobin 
Red blood cell count 
Mean corpuscular volume 
White blood cell count 
Platelet count (estimate not acceptable) 
Sodium 
Potassium 
Chloride 
Albumin 
Alkaline phosphatase 
Glucose 
Total cholesterol 
BUN 
Creatinine 
Total bilirubin 
Calcium 
Total protein 
Phosphorous 
 
For any laboratory test value outside the reference range that the investigator considers clinically 
significant during the on-study period (ie, following dose administration), the investigator will: 
• Repeat the test to verify the out-of-range value and clinical significance. 
• Follow the out-of-range value to a satisfactory clinical resolution. 
• Record as an AE any laboratory test value that (1) is confirmed by repeat and the investigator 
considers clinically significant, (2) requires a subject/patient to be discontinued from the 
study, (3) requires a subject/patient to receive treatment, or (4) requires a change or 
discontinuation of the study product (if applicable). 
9.5.2.1. 
Kidney Function 
• Patients must be on chronic hemodialysis for  3 months and oliguric defined as  2 
urinary voids per day. 
9.5.2.2. 
Other Tests 
A certified laboratory will be utilized to process and provide results for the additional lab tests 
listed below, to be drawn prospectively for the study unlike the baseline tests listed in Table 6. 
• Pregnancy test (nonmenopausal females only) 
• nT Pro-BNP 

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• Creatinine phosphokinase 
• Liver function tests: Alanine aminotransferase (ALT), aspartate aminotransferase 
(AST), and total bilirubin 
• Timed Urine Collection (patient arrival to departure on visit 2) for: 
 
Total Volume 
 
Creatinine 
 
Urea Nitrogen 
9.5.3. Vital Signs 
Vital signs assessments will include oral temperature (°C), respiratory rate (breaths per minute), 
systolic and diastolic BP (mmHg), and pulse rate (bpm). Blood pressure and pulse rate will be 
measured after the subject/patient has been resting quietly in a supine position or in the most 
recumbent position possible for at least 5 minutes. 
Vital signs abnormalities that (1) are considered clinically significant initially and on 
confirmation, (2) require a subject/patient to be discontinued from the study, (3) require a 
subject/patient to receive treatment, or (4) require a change or discontinuation from the study 
product (if applicable) will be recorded as AEs. 
9.5.4. Physical Examination 
Complete physical examinations (including eyes, ears, nose and throat, cardiac, peripheral 
vascular, pulmonary, musculoskeletal, neurologic, abdominal, lymphatic, and dermatologic 
systems) will be performed, and abnormal findings will be documented in the subject’s/patient’s 
CRF. 
An abnormal physical examination finding that is considered clinically significant and 
(1) requires the subject/patient to be discontinued from the study, (2) requires the subject/patient 
to receive treatment, or (3) requires a change or discontinuation of the study product (if 
applicable) will be recorded as an AE. 
9.5.5. Appropriateness of Safety Assessments 
Safety evaluations selected for this study are typical of those for this subject/patient population 
and utilize widely accepted measures. 

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10. ADVERSE EVENTS 
An AE is defined as any untoward medical occurrence in a subject administered a 
pharmaceutical product during the course of a clinical investigation. An AE can therefore be any 
unfavorable and unintended sign, symptom, or disease temporally associated with the use of an 
investigational product, whether or not thought to be related to the investigational product. Any 
worsening of the patient’s disease under study or other medical conditions will also be 
considered to be an adverse event, unless it is within the normal range of disease fluctuation for 
that patient. 
An unanticipated adverse device effect (UADE) is any serious adverse effect on health or safety 
or any life-threatening problem or death caused by, or associated with, a device, if that effect 
problem, or death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan, or any other unanticipated serious problem associated with a device that 
relates to the rights, safety, or welfare of subjects. 
Subjects will be monitored throughout the study for AEs, from administration of the first dose of 
VFI through the follow-up phone call/EOS visit. Adverse events that are identified at the last 
assessment visit (or the early termination visit) as specified in the protocol must be recorded on 
the AE CRF with the status of the AE noted. All events that are ongoing at this time will be 
recorded as ongoing on the CRF. All (both serious and nonserious) AEs must be followed until 
they are resolved or stabilized, or until attempts to determine resolution of the event are 
exhausted. The investigator should use his/her discretion in ordering additional tests as necessary 
to monitor the resolution of such events. 
The procedures specified in Section 10.4 are to be followed for reporting SAEs. 
10.1. Recording Adverse Events 
Adverse events are to be recorded on the AE page of the CRF. The following information will be 
recorded: 
• Assessment of whether or not the AE is an SAE (Section 10.2.1) 
• Assessment of AE intensity (Section 10.2.2) 
• Assessment of AE relationship to study product (Section 10.2.3) 
• Action taken - categorized as none, study drug discontinued, dose modified, required 
concomitant medication, required procedure, or other. 
• Outcome - recorded as event resolved, resolved with sequelae, ongoing, or death. 
10.2. Assessment of Adverse Events 
The investigator will assess each AE for seriousness, intensity, and relationship to study product. 

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10.2.1. Serious Adverse Events 
The investigator is responsible for determining whether an AE meets the definition of an SAE. 
An SAE is any AE occurring from ICF signing through the follow-up phone call/EOS visit that 
results in any of the following outcomes: 
• Death 
• A life-threatening adverse drug experience 
• Inpatient hospitalization or prolongation of existing hospitalization 
• A persistent or significant disability/incapacity 
• A congenital anomaly/birth defect 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical judgment, they 
may jeopardize the subject and may require medical or surgical intervention to prevent any of the 
outcomes listed in this definition. Examples of such medical events include allergic 
bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias 
or convulsions that do not result in inpatient hospitalization, or the development of drug 
dependency or drug abuse. 
Note: SAEs require immediate reporting to the sponsor. Refer to “Reporting Serious Adverse 
Events” (Section 10.4) for details. 
10.2.2. Intensity 
The intensity of an AE will be graded according to the following definitions: 
• Mild: Any symptom of which the subject is aware, but which is easily tolerated; 
asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not 
indicated. 
• Moderate: Any symptom which is discomforting enough to cause interference with a 
subject's usual activity; minimal, local, or noninvasive intervention indicated; limiting 
age-appropriate instrumental activities of daily living (ADL). 
• Severe: Any symptom which causes a subject's inability to perform usual activity; severe or 
medically significant but not immediately life-threatening; hospitalization or prolongation of 
hospitalization indicated; disabling; limiting self-care ADL. 
It should be noted that a severe adverse event need not be serious in nature and that an SAE need 
not, by definition, be severe. 

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10.2.3. Relationship to Study Product 
The relationship of an AE to the study product should be determined by the investigator 
according to the following criteria: 
• Not related: The event is most likely produced by other factors such as the subject’s clinical 
condition, intercurrent illness, or concomitant drugs, and does not follow a known response 
pattern to the study product, or the temporal relationship of the event to study product 
administration makes a causal relationship unlikely 
• Possibly related: The event follows a reasonable temporal sequence from the time of drug 
administration, and/or follows a known response pattern to the study product, but could have 
been produced by other factors such as the subject's clinical condition, intercurrent illness, or 
concomitant drugs 
• Related: The event follows a reasonable temporal sequence from the time of drug 
administration, and/or follows a known response pattern to the study product, and cannot be 
reasonably explained by other factors such as the subject's clinical condition, intercurrent 
illness, or concomitant drugs 
10.3. Discontinuation due to Adverse Events 
Any subject who experiences an AE may be withdrawn at any time from the study at the 
discretion of the investigator. Subjects withdrawn from the study due to an AE, whether serious 
or nonserious, may be followed by the investigator until the clinical outcome of the AE is 
determined. The AE(s) should be noted on the appropriate CRFs and the subject’s progress 
should be followed until the AE is resolved or stabilized as determined by the investigator. The 
sponsor must be notified. If the AE relates to overdose of study treatment, the Investigator’s 
Brochure should be consulted for details of any specific actions to be taken. 
10.4. Reporting Serious Adverse Events 
In the event of any SAE reported or observed during the study, whether or not attributable to the 
study drug, site personnel will report it immediately by telephone to the medical monitor. Any 
SAE attributable to study participation will be reported promptly to the IRB as required by the 
Richard L. Roudebush Veterans Affairs Medical Center. 
10.5. Documentation and Reporting of Immediately Reportable Adverse Events  
Any unexpected adverse event that could adversely affect the safety of the subjects or the 
conduct of the study and any serious adverse event, which occurs during the course of this study, 
will be reported to the sponsor immediately (ie, within 24 hours). 

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The information will comprise at least the following data: 
• Name, address, and telephone number of the reporting investigator 
• Investigational product(s) 
• Study code 
• Subject identification number, initials, sex, and date of birth 
• Description of the adverse event, measures taken and outcome (if resolved) 
• Likelihood of drug causation of the adverse event assessed by the investigator 
 
The sponsor ensures that all relevant information about suspected serious unexpected adverse 
reactions that are fatal or life threatening is recorded and reported as soon as possible to the 
FDA, and in any case no later than 7 days after knowledge by the sponsor of such a case, and 
that relevant follow up information is subsequently communicated within additional 7 days. The 
study team will be responsible for informing the IRB of any promptly reportable events within 5 
days of discovery, in accordance with IU policy. 
All other suspected serious unexpected adverse reactions will be reported to the FDA as soon as 
possible but with a maximum of 15 days of first knowledge by the sponsor.  The sponsor will 
inform all investigators. In accordance with IU policy, the study team will be responsible for 
informing the IRB of any promptly reportable events within 5 days of discovery including those 
listed below. 
The sponsor will inform as soon as possible, but no later than 15 days after knowledge, the FDA 
and the IRB about any event which necessitates reconsideration of the benefit-risk-ratio of the 
investigational drug.  These events are in particular:  
• Single cases of expected serious adverse reactions with an unexpected outcome. 
• An increased incidence of expected serious adverse reactions which is considered clinically 
relevant. 
• Suspected serious unexpected adverse reactions occurring after a concerned person has 
completed the study. 
• Events related to the conduct of the study or the development of the drugs possibly affecting 
the safety of the concerned persons. 
All additional measures deemed necessary through new findings and taken by the sponsor or the 
investigator to protect the safety of the persons concerned and their triggering circumstances will 
be reported as soon as possible to the FDA and the IRB. 
10.6. Pregnancy 
The investigator must report any pregnancy to the medical monitor and to the Richard 
L. Roudebush Veterans Affairs Medical Center within 1 business day of becoming aware of the 
pregnancy. An uncomplicated pregnancy will not be considered an AE or SAE; however, all 
pregnancies will be followed through birth and 3 months postdelivery. 

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Pregnancies in the sexual partners of male subjects will be captured from the time the subject is 
first exposed to the investigational product until 90 days after last exposure to the investigational 
product. 
Any congenital abnormalities in the offspring of a subject who received study drug will be 
reported as a SAE. The outcome of any pregnancy and the presence or absence of any congenital 
abnormality will be recorded in the source documentation and reported to the medical monitor 
and sponsor. 
10.7. Drug-induced Liver Injury 
Subjects will be monitored for signs of drug-induced liver injury (DILI). Study product will be 
withheld in the event of potential DILI. 
Potential events of DILI will be defined as meeting all of the following criteria (as specified in 
the FDA Guidance for Industry Drug-induced Liver Injury: Premarketing Clinical Evaluation, 
2009): 
• Alanine aminotransferase or aspartate aminotransferase > 3 × ULN 
• Total bilirubin > 2 × ULN without initial findings of cholestasis (elevated serum alkaline 
phosphatase) 
• No other reason can be found to explain the combination of laboratory value increases 
(eg, acute viral hepatitis; alcoholic and autoimmune hepatitis; hepatobiliary disorders; 
nonalcoholic steatohepatitis; cardiovascular causes; concomitant treatments) 
Potential events of DILI will be reported as SAEs (Section 10.4). All subjects with potential 
DILI will be closely followed until abnormalities return to normal or baseline or until all 
attempts to determine resolution of the event are exhausted. 

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11. STATISTICAL CONSIDERATIONS 
11.1. Sample Size Calculation 
The anticipated sample size of approximately 10 subjects is not powered. 
11.2. Analysis Populations 
Safety Population: All subjects who receive any amount of study product. 
Performance Population: All subjects who have either a PV or GFR measurement using any of 
the techniques under study. 
11.3. Endpoints 
11.3.1. Primary Endpoints 
• To measure quantitatively the ISV and PV of patients pre and post dialysis using the FAST 
PV Technology and Iohexol measurement. 
• Directly compare quantitative difference of ISV and PV measured by FAST PV Technology 
and Iohexol measurement to the volume removed during dialysis. 
• To assess safety through adverse events (AEs) and serious adverse events (SAEs), clinical 
laboratory tests, physical examination findings and vital signs. 
11.4. Safety Analysis 
The number and percentage of subjects reporting any TEAE will be tabulated by system organ 
class, preferred term (coded using Medical Dictionary for Regulatory Activities), and cohort. 
Treatment-emergent AEs will be further classified by severity and relationship to study product. 
Vital signs and clinical laboratory test data (observed and change from baseline) will be 
summarized by cohort and time point using appropriate descriptive statistics. Physical 
examination findings will only be listed. 
11.5. Performance Analysis 
11.5.1. Plasma Volume 
Plasma volume will be determined using the FBFI measured plasma concentrations of FD003 
and the FAST PV Technology. 
11.5.2. Interstitial Volume 
Interstitial volume will be determined using the FBFI measured plasma concentrations of FD001 
and the FAST PV Technology as well as by HPLC analysis of iohexol concentrations. 

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12. ACCESS TO SOURCE DATA/DOCUMENTS 
The investigator will provide direct access to source data and documents for individuals 
conducting study-related monitoring, audits, Institutional Review Board/Independent Ethics 
Committee (IRB/IEC) review, and regulatory review. The investigator must inform the study 
subject that his/her study-related records may be reviewed by the above individuals without 
violating the subject’s privacy of personal health information in compliance with Health 
Insurance Portability and Accountability Act of 1996 (HIPAA) regulations. 
Attention is drawn to the regulations promulgated by the FDA under the Freedom of Information 
Act providing, in part, that information furnished to clinical investigators and IRBs will be kept 
confidential by the FDA only if maintained in confidence by the clinical investigator and IRB. 
By signing this protocol, the investigator affirms to the sponsor that the investigator will 
maintain, in confidence, information furnished to him or her by the sponsor and will divulge 
such information to the IRB under an appropriate understanding of confidentiality with such 
board. 

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13. QUALITY CONTROL AND QUALITY ASSURANCE 
FAST BioMedical will implement and maintain quality control and quality assurance procedures 
with written standard operating procedures to ensure the study is conducted and data are 
generated, documented, and reported in compliance with the protocol, GCP, and applicable 
regulatory requirements. 
13.1. Conduct of Study 
This study will be conducted in accordance with the ICH E6 Guidelines on good clinical practice 
(CPMP/ICH/135/95). Specifically, this study is based on adequately performed laboratory and 
animal experimentation; the study will be conducted under a protocol reviewed by an IRB or 
IEC; the study will be conducted by scientifically and medically qualified persons; the benefits 
of the study are in proportion to the risks; the rights and welfare of the subjects will be respected; 
the physicians conducting the study do not find the hazards to outweigh the potential benefits; 
and each subject will give his or her written, informed consent before any protocol-driven tests 
or evaluations are performed. 
The investigator may not deviate from the protocol without a formal protocol amendment having 
been established and approved by an appropriate IRB/IEC, except when necessary to eliminate 
immediate hazards to the subject or when the change(s) involve only logistical or administrative 
aspects of the study and are approved by FAST BioMedical. Any deviation may result in the 
subject having to be withdrawn from the study, and may render that subject non-evaluable. 
13.1.1. Protocol Deviations 
A protocol deviation is defined as any intentional or unintentional change to, or noncompliance 
with, the approved protocol procedures or requirements. Deviations may result from the action or 
inaction of the subject, investigator, or site staff. 
At the outset of the study, a process for defining and handling protocol deviations will be 
established. This will include determining which violations will be designated “key,” requiring 
immediate notification to FAST BioMedical. The investigator is responsible for seeing that any 
known protocol deviations are recorded and handled as agreed. 
13.2. Protocol Amendments 
Only the sponsor may modify the protocol. Amendments to the protocol will be made only after 
consultation and agreement between the sponsor and the investigator. All amendments that have 
an impact on subject risk or the study objectives, or require revision of the ICF, must receive 
approval from the IRB/IEC prior to their implementation. 
13.3. Monitoring of Study 
The investigator will permit the site monitor to review study data as frequently as is deemed 
necessary to ensure data are being recorded in an adequate manner and protocol adherence is 
satisfactory. 

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The investigator will provide supervised access to medical records for the monitor to verify CRF 
entries. Only de-identified data will leave the Richard L. Roudebush Veterans Administration 
Medical Center. The investigator is expected to cooperate with FAST BioMedical or a designee 
in ensuring the study adheres to GCP requirements. Only de-identified data will leave the 
Richard L. Roudebush Veterans Administration Medical Center. 
The investigator may not recruit subjects into the study until FAST BioMedical or a designee has 
conducted a site initiation visit (in-person or via telephone) to review the protocol and CRF in 
detail. 

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14. ETHICS 
14.1. Institutional Review Board/Independent Ethics Committee Approval 
14.1.1. Ethics Review Prior to Study 
The investigator will ensure that the protocol and consent form are reviewed and approved by the 
appropriate IRB/IEC prior to the start of any study procedures. The IRB/IEC will be 
appropriately constituted and will perform its functions in accordance with FDA regulations, 
ICH GCP guidelines, and local requirements as applicable. 
14.1.2. Ethics Review of Other Documents 
The IRB will approve all protocol amendments (except for sponsor-approved logistical or 
administrative changes), written informed consent documents and document updates, subject 
recruitment procedures, written information to be provided to the subjects, available safety 
information, information about payment and compensation available to subjects, the 
investigator’s curriculum vitae and/or other evidence of qualifications, and any other documents 
requested by the IRB/IEC and regulatory authority as applicable. 
14.2. Written Informed Consent 
The nature and purpose of the study will be fully explained to each subject. The subjects must be 
given ample time and opportunity to inquire about details of the study, to have questions 
answered to their satisfaction, and to decide whether to participate. Written informed consent 
must be obtained from each subject prior to any study procedures being performed. 

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15. DATA HANDLING AND RECORD KEEPING 
15.1. Data Reporting and Case Report Forms 
15.1.1. Case Report Forms 
The investigator will be provided with CRFs and will ensure all data from subject visits are 
promptly entered into the CRFs in accordance with the specific instructions given. The 
investigator must sign the CRFs to verify the integrity of the data recorded. 
15.1.2. Laboratory Data 
A list of the normal ranges for all laboratory tests to be undertaken forms part of the 
documentation to be collated prior to study start. If a central laboratory has been selected to 
conduct any or all tests, it is essential all samples be analyzed at that laboratory. The investigator 
must maintain source documents such as laboratory reports and complete history and physical 
examination reports. 
15.1.3. Retention of Source Documents 
The investigator must maintain source documents such as laboratory reports, x-rays, ECGs, 
consultation reports, and complete history and physical examination reports. 
15.2. Retention of Essential Documents 
The study essential documents must be maintained as specified in the ICH guidelines for GCP 
and the applicable regulatory requirements. The investigator/institution should take measures to 
prevent accidental or premature destruction of these documents. 
Essential documents should be retained until at least 2 years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated marketing 
applications in an ICH region or until at least 2 years have elapsed since the formal 
discontinuation of clinical development of the investigational device. These documents should be 
retained for a longer period, however, if required by the applicable regulatory requirements or by 
an agreement with sponsor. It is the responsibility of FAST BioMedical to inform the 
investigator/institution as to when these documents no longer need to be retained. 
VA research records will be maintained by the investigator for 6 (six) years following the federal 
fiscal year end (September 30) after the study has been closed by the VA in accordance with the 
VHA Records Control Schedule or longer if required by other Federal regulations. 
As described in the Informed Consent and HIPAA authorization, data collected during the study 
may be used and analyzed after study expiration, however data will be de-identified prior to 
sharing outside the VA study team. 
 

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15.3. Sample Retention 
Samples will be labeled with a unique code study identifier, the collection date, and collection 
time; there will be no protected health information (PHI) on the samples. 
Unless otherwise required by the U.S. Food and Drug Administration or other laws or 
regulations, samples will be stored for a maximum of 18 months after collection and then 
destroyed. 
15.4. Privacy 
Access to all VA files will be made by study staff who are required to complete and maintain 
training on privacy, HIPAA, and human subjects’ protection. All data files will be maintained on 
a secure drive on the research server at RLR VAMC and will be accessible only to the PI, project 
coordinator, and data manager. Any identifiable data will be kept in restricted folders on the 
research secured server at RLR VAMC with access restricted to authorized members of the study 
team. Paper documents will be kept in a locked cabinet in PI’s locked office inside a locked 
office suite on the 7th floor of the RLR VAMC. 
Study numbers will be assigned to each subject such that lab samples will be labeled with a 
unique code study identifier, the collection date, and collection time; there will be no protected 
health information (PHI) on the samples. 
Any publications will not have subject names or identifying information. 
Additionally, all PHI will be de-identified prior to leaving the VA and will be checked by the 
privacy officer before release. 

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16. ADMINISTRATIVE INFORMATION 
16.1. Financing and Insurance 
Financing and insurance will be addressed in a separate agreement between FAST BioMedical 
and the clinical study site. 
16.2. Publication Policy 
FAST BioMedical will retain ownership of all data. All proposed publications based on this 
study will be subject to sponsor’s approval requirements. 

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17. REFERENCES 
Agarwal R, Alborzi P, Satyan S, Light RP. Dry-weight reduction in hypertensive hemodialysis 
patients (DRIP): a randomized, controlled trial. Hypertension. 2009;53:500-507. 
Agarwal R. Hypervolemia is associated with increased mortality among hemodialysis patients. 
Hypertension. 2010;56:512-517. 
Arneson TJ, Liu J, Qiu Y, Gilbertson DT, Foley RN, Collins AJ. Hospital Treatment for Fluid 
Overload in the Medicare Hemodialysis Population. Clin J Am Soc Nephrol. 2010;5 (6) 1054-
1063. 
Food and Drug Administration. Guidance for Industry: Drug-Induced Liver Injury: Premarketing 
Clinical Evaluation. July 2009. 
Hur E, Usta M, Toz H et al. Effect of fluid management guided by bioimpedance spectroscopy 
on cardiovascular parameters in hemodialysis patients: a randomized controlled trial. Am J 
Kidney Dis. 2013;61:957-965. 
Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 
1962;51(2):224-32. 
O'Connell JB, Maggard MA, Ko CY. Colon cancer survival rates with the new American Joint 
Committee on Cancer sixth edition staging. J Natl Cancer Inst 2004; 96: 1420-1425. 
OMNIPAQUE (iohexol) injection (prescribing information). GE Healthcare Inc; Princeton, NJ. 
2010. 
Sarnak MJ, Levey AS, Schoolwerth AC, et al. Kidney disease as a risk factor for development of 
cardiovascular disease: a statement from the American Heart Association Councils on Kidney in 
Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology 
and Prevention. Circulation. 2003;108:2154-2169. 
Sinha AD, Agarwal R. Can Chronic Volume Overload Be Recognized and Prevented in 
Hemodialysis Patients? Semin Dial. 2009;22:480-482. 
Sinha AD. Why assistive technology is needed for probing of dry weight. Blood Purif. 
2011;31:197-202. 
Thomson GE, Waterhouse K, McDonald HP, Jr., Friedman EA. Hemodialysis for chronic renal 
failure. Clinical observations. Arch Intern Med. 1967;120:153-167. 
United States Renal Data System. 2018 USRDS annual data report: Epidemiology of kidney 
disease in the United States. National Institutes of Health, National Institute of Diabetes and 
Digestive and Kidney Diseases, Bethesda, MD, 2018. 

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Wizemann V, Wabel P, Chamney P et al. The mortality risk of overhydration in haemodialysis 
patients. Nephrol Dial Transplant. 2009;24:1574-1579. 

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APPENDIX A 
PREPARATION OF FAST VISIBLE FLUORESCENT 
INJECTATE 
1. Add 4 mL of sterile water to the vial of VFI over 4 seconds. 
2. Gently swirl the vial for 3 minutes; avoid allowing the liquid to reach the rubber stopper. 
3. Place vial on a roller/rocker table to mix for 30 minutes. 
4. Product is ready for drawing up of dose. 

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SIGNATURES 
Protocol Title: A Pilot Open-Label Study to Evaluate the Safety, Tolerability, and 
Performance of FAST PV Technology in Chronic Dialysis Patients with Extremely 
Reduced or No Kidney Function 
FAST BioMedical Signature 
This clinical study protocol has been reviewed and approved by FAST BioMedical. 
 
 
 
 
James Strickland 
President 
 
Date 
 

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Protocol Title: A Pilot Open-Label Study to Evaluate the Safety, Tolerability, and 
Performance of FAST PV Technology in Chronic Dialysis Patients with Extremely 
Reduced or No Kidney Function 
FAST BioMedical Signature 
This clinical study protocol has been reviewed and approved by FAST BioMedical. 
 
 
 
 
Bruce Molitoris, MD 
Medical Director 
 
Date 
 

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Protocol Title: A Pilot Open-Label Study to Evaluate the Safety, Tolerability, and 
Performance of FAST PV Technology in Chronic Dialysis Patients with Extremely 
Reduced or No Kidney Function 
Investigator Signature 
I agree to conduct the aforementioned study according to the terms and conditions of the 
protocol, Good Clinical Practice (GCP) guidelines, and all other applicable local and regulatory 
requirements. All information pertaining to the study will be treated in a confidential manner. 
 
Site Name 
 
 
Print Name 
 
 
 
 
Signature 
 
Date