A Phase I Open-label, First-in-Man Acute Safety, Tolerability and Device Acceptability Study of Experimental Device RD19 for Protection From Human Respiratory Tract Pathogens
Phase: NA
Conditions: Respiratory Tract Infections
Sponsor: EmitBio Inc.

EmitBio Inc. 
RD19-01-3Q20 
Version 2.0 
14 August 2020 
 
CONFIDENTIAL 
 CLINICAL TRIAL PROTOCOL 
 
A Phase I Open Label, First-in-Man Acute Safety, 
Tolerability and Acceptability Study of the EmitBio™ 
RD19 Device 
Protocol Number: RD19-01-3Q20 
 
Investigational Device: EmitBio™ RD19 
 
Indication: Respiratory Infectious Diseases, Multiple, Prevention - including 
SARS-CoV-2 
 
Phase: I 
 
Clinical Trial Site: Carolina Phase I Clinical Trial Unit, Raleigh, NC 
 
Principle Investigator:  
 
 
Sub-Investigator: 
 
Lisa Cohen, DO  
 
 
 
Lynn Eckert, PA 
Family Practice  
 
 
 
Suite 304, 3100 Duraleigh Road 
Suite 304, 3100 Duraleigh Road 
 
Raleigh, NC 27612 
Raleigh, NC 27612 
 
 
 
Tel: +1 (919) 781-2514 
Tel: +1 (919) 781-2514  
 
 
leckert@wakeresearch.com 
 
Name and Address of Sponsor: 
 
John G. McNeil, MD MPH PHD 
Lynn A. Baglyos, MSN 
EmitBio Inc. 
EmitBio Inc. 
Chief Medical Officer 
Senior Clinical Project Manager 
Suite 470, 4222 Emperor Blvd 
Suite 470, 4222 Emperor Blvd 
Durham, NC 27703 
Durham, NC 27703 
Tel: + 1 (843) 540-3569 
Tel: +1 (610) 570-7425 
 
GCP Statement: This trial will be performed in compliance with (c)GCP. 
The information in this document is confidential and is proprietary to EmitBio Inc 
and/or KnowBio LLC. It is understood that information in this document shall not 
be used other than for the direct purpose of executing this protocol without the 
expressed written permission of EmitBio Inc or KnowBio LLC. 

EmitBio Inc. 
RD19-01-3Q20 
Version 2.0 
14 August 2020 
 
CONFIDENTIAL 
 
INSTITUTIONAL STATEMENT OF COMPLIANCE 
 
Each institution engaged in this research will hold a current Federal Wide Assurance (FWA) 
issued by the Office of Human Research Protection (OHRP), and/or will be guided by the 
review and deliberations of an Institutional Review Board (IRB)/Independent or Institutional 
Ethics Committee (IEC) that must be registered with OHRP as applicable to the research. 
 
The study will be carried out in accordance with the following as applicable: 
• United States (US) Code of Federal Regulations (CFR) 45 CFR Part 46: Protection of 
Human Subjects 
• Food and Drug Administration (FDA) Regulations: 21 CFR Part 50 (Protection of 
Human Subjects), 21 CFR Part 54 (Financial Disclosure by Clinical Investigators), 21 
CFR Part 56 (IRBs), 21 CFR Part 11, and 21 CFR 812 (Investigational Device 
Exemptions) 
• The International Council for Harmonization (ICH) of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH) E6(R2) Good Clinical Practice 
(GCP), and the Belmont Report: Ethical Principles and Guidelines for the Protection of 
Human Subjects of Research, Report of the National Commission for the Protection of 
Human Subjects of Biomedical and Behavioral Research 
• Any additional applicable Federal, State, and Local Regulations and Guidance 
 
 
. 

EmitBio Inc. 
RD19-01-3Q20 
Version 2.0 
14 August 2020 
 
CONFIDENTIAL 
 
 
 
This signature provides the necessary assurance that this study will be conducted according to all 
stipulations of the protocol, including statements regarding confidentiality, and according to local 
legal and regulatory requirements, US federal regulations, and ICH E6(R2) GCP guidelines. 
 
 
Principle Investigator Signature: 
 
 
Signed: _____________________________ Date: _________________                                   
Lisa Cohen, DO 
Suite 304  
3100 Duraleigh Road 
Raleigh, NC 27612 
Tel: +1 (919) 781-2514 
 
 
 
 
 
 
1. 
PROTOCOL SUMMARY 
1.1 
Executive Synopsis 
1.1.1 
Claim(s) and Indication 
1.1.2 
Objectives and Endpoints 
1.1.3 
Inclusion & Exclusion Criteria 
1.1.4 
Study Key Characteristics 
1.2 
Schedule of Activities (Study Recipe) 
2. 
INTRODUCTION 
2.1 
Background and Study Rationale 
2.1.1 
RD19 Device Characteristics 
2.2 
Risk/Benefit Assessment 
2.2.1 
Known Potential Risks 
2.2.2 
Known Potential Benefits 
3. 
STUDY DESIGN 
3.1 
Overall Design 
3.2 
Objectives and Endpoints 
3.3 
Scientific Rationale for Study Design 
3.4 
Justification for Dose & Schedule 
4. 
STUDY POPULATION 
4.1 
4.2 
Inclusion Criteria 
Exclusion Criteria 

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CONFIDENTIAL 
4.3 
Strategies for Recruitment and Retention 
4.3.1 
Recruitment 
4.3.2 
Retention 
4.4.3 
Compensation Plan for Subjects 
4.5.4 
Cost 
4.4 
Informed Consent 
5. 
STUDY DEVICE 
5.1 
Regulatory Considerations 
5.1.1 
Preliminary Regulatory Pathway for EmitBio™ RD19 device 
5.1.2 
Proposed Label Claim / Indication for Use 
5.1.3 
Medical Device Quality System  
5.2 
Study Device and Use 
5.2.1 
Device Description 
5.2.2 
Dosing and Administration 
5.3 
Use / Storage & Maintenance /Accountability 
5.3.1 
Acquisition, Labeling, Packaging and Accountability 
5.3.2 
Device Appearance 
5.3.3 
Device Storage and Maintenance 
5.3.4 
Preparation for Use and Use 
5.4 
Measures to Maximize Study Subject Compliance 
5.4.1 
Study Subject Instruction Handout 
5.4.2 
Study Subject Training & Compliance Re-training 
5.5 
Device Discontinuation 
5.5.1 
Study Subject Pausing Criteria 
5.5.2 
Study Pausing Criteria 
5.5.3 
Subject Elects to Discontinue 
5.5.4 
Investigator Decision to Discontinue Study Subject Device Use 
5.5.5 
Follow-up of Subjects who Discontinue Use of Device 
6. 
STUDY ASSESSMENTS AND PROCEDURES 
6.1 
Screening Assessments 
6.1.1 
Screening Procedures 
6.1.2 
Procedures to follow for abnormal clinical and laboratory findings 
6.1.3 
Informed Consent 
 
6.2 
Safety and Other Assessments 
6.2.1 
Definition of Adverse Event (AE) 
6.2.2 
Solicited Adverse Events 
6.2.3 
Unsolicited Adverse Events 
6.2.4 
Reporting of Adverse Events 
6.2.5 
Definition of Serious Adverse Event (SAE) 
6.2.6 
Reporting of SAEs 
6.2.7 
Classification of an Adverse Event 
6.2.8 
Severity of Adverse Events 
6.2.9 
Adverse Event Attribution 

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6.2.10 
Time Period and Frequency for Event Assessment and Follow-Up 
6.2.11 
Adverse and Serious Adverse Event Reporting to Subjects 
6.2.12 
Pregnancy Reporting 
6.2.13 
Device Acceptability 
6.3 
Unanticipated Problems 
6.3.1 
Definition of Unanticipated Problems (UPs) 
6.3.2 
Unanticipated Problem Reporting 
6.3.3 
Reporting Unanticipated Problems to Subjects 
7. STATISTICAL CONSIDERATIONS 
7.1 
Statistical Hypotheses 
7.2 
Sample Size Determination 
7.3 
Populations for Analyses 
7.4 
Statistical Analyses 
7.4.1 
Primary Safety Analyses 
7.4.2 
Analysis of the Secondary Endpoints 
8. OPERATIONAL CONSIDERATIONS AND SUPPORTING DOCUMENTATION 
8.1 
Ethical Considerations 
8.1.1 
Informed Consent Agreement 
8.1.2 
Confidentiality and Privacy 
8.1.3 
Clinical Study Monitoring 
8.1.4 
Quality Control (QC) and Quality Assurance (QA) 
8.1.5 
Data Collection and Management Responsibilities 
8.1.6 
Study Documents 
8.1.7 
Study Document Retention 
8.1.8 
Protocol Deviations 
8.1.9 
Publication and Data Sharing 
8.1.10 
Conflict of Interest Policy 
8.1.11 
Research-related Injuries 
9. 
REFERENCES 
10. USER INSTRUCTIONS (APPENDIX 1) 
11. TOXICITY GRADING TABLES (APPENDIX 2) 

EmitBio Inc 
RD19-01-3Q20 
Version 2.0 
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CONFIDENTIAL 
 
1. PROTOCOL SUMMARY 
1.1 Executive Synopsis 
Rationale for Proposed Clinical Study 
In December 2019 the Wuhan Municipal Health Committee identified an outbreak of viral 
pneumonia cases of unknown cause. Coronavirus ribonucleic acid (RNA) was quickly identified 
in some of these patients. As of July, 2020 there were 15.5 million confirmed cases (>4 million 
in the US) and over 600,000 deaths (~145,000 in the US). There are currently no FDA approved 
prophylactic interventions against SARS-CoV-2 while social distancing and personal protective 
equipment constitute our only viable countermeasures to help reduce the incidence of 
community transmission. While vaccine candidates are being developed at unprecedented 
speeds, their efficacy is completely unknown and will not be known for many months. 
 
Therefore, there is an urgent public health need for rapid development of novel protective 
measures, as well as improved therapeutic interventions. The EmitBio™ RD19 device emits 
visible blue light to stimulate host defenses (as explained below) to eliminate invading 
pathogens in the oropharynx and surrounding tissues. The RD19 device does this without 
additional photosensitizers or chemical reagents that are typically employed with traditional 
photodynamic therapeutics. Specifically, selected wavelengths of light have been evaluated 
across the visible spectrum, and it was discovered that safe, visible blue light emitted from 
non-coherent LED sources could perform both of the following functions: 
(1) 
upregulate the sustained production of nitric oxide in epithelial tissue through 
increase of nitric oxide synthases (NOSs); 
 
 
(2) 
stimulate the instantaneous release of the body’s bound stores of nitric oxide. 
 
Nitric oxide produced naturally in epithelial tissues also induces and recruits effector cells of 
the innate immune system, including natural killer (NK) cells, neutrophils and macrophages 
to phagocytize virus-infected cells at the site of primary infection. 
 
 

EmitBio Inc 
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1.1.1 Claims and Indication: 
The EmitBio™ RD19 device uses blue light to boost the body’s natural immune response, 
which when combined with social distancing and proper mask use as part of healthy living, may 
help to reduce the risk of infection by respiratory viruses like influenza and SARS-CoV-2. 
This first-in-man (FIM) phase I study will evaluate the acute safety, tolerability, device 
acceptability for use among 25 healthy volunteers between the age of 18 and 45. Based on the 
results of extensive in-house research, a single dose (9 Joules/cm2) and schedule (twice a day for 3 
minutes, separated by at least 4 hours, ideally 8 to 12 hours apart) will be evaluated. 
Safety and tolerability (local reactogenicity) will be assessed actively at study day screening 
(baseline set), 1, 7 and 14, and on non-clinic visit days by collection of these data by history 
during clinic visits via a memory aid (diary cards). Volunteers will be encouraged to contact 
designated clinical trial staff for AEs of a medically-urgent nature as soon as is practically 
possible and to seek immediate medical care, if needed. 
Metabolic, liver and kidney safety laboratory evaluations, as well as urinalysis, will be performed 
at screening and at Day 14 or early termination (and potentially during unscheduled) clinic visits. 
Hematological safety assessments will be performed at all visits. 
 
1.1.2 Objectives and Endpoints 
Table 1: Objectives and Endpoints (Outcome Measures) 
 
OBJECTIVES 
ENDPOINTS 
(OUTCOME MEASURES) 
Primary 
• Evaluation of the safety and 
reactogenicity of the RD19 device. 
• Frequency, grade and attribution of each 
incident local and systemic AE during the 
14 day study period. 
• Frequency and attribution of any 
incident SAEs during the 14 day 
study period. 
Secondary 
• Evaluation of  the acceptability 
of the EmitBio™ RD19 device. 
• Ease of use, clarity of user instructions, 
& compliance with per protocol 
schedule and, if out of compliance, 
reason(s) for non-compliance. 

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1.1.3 Inclusion Criteria (abbreviated) 
See full inclusion criteria in Section 4.1  
A subject must meet all the following criteria to be eligible to participate in this study: 
1. Provides written informed consent prior to initiation of any study procedures. 
2. Be able to understand and agrees to comply with planned study procedures and be 
available for all study visits. 
3. Agrees to the collection of venous blood per protocol. 
4. Male or non-pregnant female, 18 to 45 years of age, inclusive, at time of enrollment. 
5. Body Mass Index 18-35 kg/m2, inclusive, at screening. 
6. No active disease process (chronic or acute) or physical or mental conditions or attributes at the 
time of screening, which in the opinion of the PI, will prevent full use and assessment of RD19. 
7. Oral temperature is less than 100.0°F (37.8°C). 
8. Pulse no greater than 90 beats per minute. 
9. Systolic blood pressure (BP) is 85 to 150 mmHg, Diastolic blood pressure (BP) is ≤ 90, inclusive. 
10. Clinical screening laboratory evaluations are within acceptable normal reference ranges at the 
clinical laboratory being used in the study 
 
 
Exclusion Criteria (abbreviated) 
See full exclusion criteria in Section 4.2  
A subject who meets any of the following criteria will be excluded from participation in this 
study: 
1. Positive urine pregnancy test at screening. 
2. Has any medical disease or condition that, in the opinion of the site Principal Investigator 
(PI) or appropriate sub-investigator, precludes study participation. 
3. Presence of self-reported or medically documented significant medical or psychiatric 
condition(s). 
4. Has an acute illness, as determined by the site PI or appropriate sub-investigator, with or 
without fever [oral temperature >37.8°C (100.00F)] within 72 hours prior to screening. 
5. Has participated in another investigational study involving any SARS-CoV-2/COVID-19 
interventional investigational product within 30 days of screening. 
6. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized 
urticaria, angioedema, other significant reaction) to nitrites, nitrates or sun exposure. 

EmitBio Inc 
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1.1.4 Study Key Characteristics 
Study Phase 
• I 
Study Population 
• Twenty-five (25) males and non-pregnant females, 18 to 45 years of age, 
inclusive, who are in good health and meet all eligibility criteria will be enrolled. 
Sites 
• Carolina Phase I, Raleigh, NC 

EmitBio Inc 
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RD19 Device 
• The EmitBio™ RD19 device emits visible blue light to stimulate host defenses (as 
explained below) and eliminate invading pathogens in the oropharynx and 
surrounding tissues. The RD19 device does this without additional photosensitizers or 
chemical reagents that are typically employed with traditional photodynamic 
therapies. Specifically, selected wavelengths of light have been evaluated across the 
visible spectrum, and it was discovered that a narrow wavelength band blue light 
emitted from non-coherent LED sources could perform both of the following 
functions: upregulate the sustained production of nitric oxide in epithelial tissue 
through the increase of NO synthases (NOSs); and stimulate the instantaneous release 
of the body’s bound stores of nitric oxide. Nitric oxide also induces and recruits 
effector cells of the innate immune system, including natural killer (NK) cells, 
neutrophils and macrophages to phagocytize virus-infected cells at the site of primary 
infection. 
 
Table 2: Treatment Group 
 
Group 
RD19 
Duration 
OL 
25 
3' x 2/day 
 
 
  
  
  
  
 
Study Duration 
• The duration of the entire study is anticipated to be ≤ 18 days (from start of screening 
to last subject last visit). 
Subject Duration 
• The duration on trial for each individual subject is ≤ 18 days (from start of screening 
to last visit). 
Safety 
• The study will use study pausing rules 
• This study will involve the Sponsor’s Chief Medical Officer as medical monitor, 
who along with the study PI(s) will assess severe AEs and SAEs, and together 
will constitute the attribution team. 

 
CONFIDENTIAL 
EmitBio Inc. 
EB19-01-3Q20 
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1.2 Schedule of Activities (SOA) - Table 3 
Study Procedures 
Screening Visit 
Preliminary Observation 
Full Assessment Period 
Study Day 
≤ -7 to 0 
1 
7 
Day 14/ Early 
Term 
Study Procedures 
  
  
  
Informed Consent 
X 
  
  
  
Inclusion/Exclusion Criteria 
X 
X 
  
  
Demographics Questionnaire 
X 
  
  
  
Medical History  
X 
* Changes since last visit 
only 
*Changes since 
last visit only  
*Changes since 
last visit only  
Physical Examination 
X 
*Targeted only 
*Targeted only 
*Targeted only 
BMI 
X 
 
 
 
 
Vital Signs 
X 
X 
X 
X 
Methemoglobin 
X 
*Before and 60 minutes 
after device use 
*Before and 60 
minutes after 
device use 
*Before and 60 
minutes after 
device use 
Lab Sample Collection & Processing 
X 
  
 
X 
CBC and differential 
X 
  
 
X 
CMP 
X 
  
  
X 
Urinalysis 
X 
  
  
X 
Urine Pregnancy Test 
X 
  
  
X 
Concomitant Medication History/New 
X 
X 
X 
X 
Device Illumination 
 
X 
X 
X 
 
Acceptability Assessment of Device 
  
X 
X 
X 
Distribution and train diary card 
  
X 
  
  

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2. INTRODUCTION 
2.1 
Background and Study Rationale 
In December 2019 the Wuhan Municipal Health Committee identified an outbreak of viral 
pneumonia cases of unknown cause. Coronavirus RNA was quickly identified in some of these 
patients. This novel Coronavirus (nCoV) has been abbreviated as 2019-nCoV and is now named 
SARS-CoV-2 (due to its similarity to the Severe Acute Respiratory Syndrome [SARS] 
Coronavirus [CoV; SARS-CoV]). It has 89% nucleotide identity with bat SARS-like- 
CoVZXC21 and 82% with that of human SARS-CoV (Chan JF et al., 2020). The disease caused 
by SARS-CoV-2 is called Coronavirus disease 2019 (COVID-19). As of July, 2020 there were 
15.5 million confirmed cases (> 4 million in the US) and over 600,000 deaths (~145,000 in 
the US). There are currently no FDA approved prophylactic interventions against SARS-CoV-
2 while social distancing and personal protective equipment constitute our only viable 
countermeasures to help reduce the incidence of community transmission. While vaccine 
candidates are being developed at unprecedented speeds, their efficacy is completely unknown 
and will not be known for many months. Outbreak forecasting and modeling suggest that 
these numbers will continue to rise. Global efforts to evaluate novel antivirals and therapeutic 
strategies to treat 2019-nCoV severe infections have intensified.  
Therefore, there is an urgent public health need for rapid development of novel protective 
measures, as well as improved therapeutic interventions. The EmitBio™ RD19 device emits 
visible blue light to stimulate host defenses and eliminate invading pathogens in the 
oropharynx and surrounding tissues. The RD19 device does this without the additional 
photosensitizers or chemical reagents that are typically employed with traditional 
photodynamic therapy approaches. Specifically, selected wavelengths of light have been 
evaluated across the visible spectrum, and it was discovered that a narrow wavelength band 
blue light emitted from non-coherent LED sources could perform both of the following 
functions: upregulate the sustained production of nitric oxide in epithelial tissue through the 
increase of NO synthases (NOSs); and stimulate the instantaneous release of the body’s 
bound stores of nitric oxide. Nitric oxide also induces and recruits effector cells of the innate 
immune system, including natural killer (NK) cells, Neutrophils and Macrophages to 
phagocytize virus-infected cells at the site of primary infection. 

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2.1.1 EmitBio™ RD19 Device Characteristics: 
 
Characteristic 
Target 
Route of Administration 
Oral Illumination 
Device Configuration 
Hand-held, rechargeable 
Blue Light Source 
Non-coherent, light emitting diode (LED) array 
UVA Content (315 nm – 400 nm) 
<1% 
UVB Content (280 nm - 315 nm) 
not detectable* 
UVC Content (100 nm - 280 nm) 
not detectable* 
Target Exposure Area 
Oropharynx and surrounding tissues 
Exposure Time 
3 min per treatment, 2X/day at least 4 hrs apart 
Single Light Dose (@ 90 mm) 
~ 9 J/cm2 
Joules = Watts x seconds 
Total Daily Dose (@ 90 mm) 
~ 18 J/cm2 
Depth of Tissue Penetration 
< 0.5 mm 
Temperature (IEC 60601-1) 
< 48 °C (for durations <10 min) 
*UVA/UVB not detectable in Labsphere 1M Integrating Sphere equipped with CDS-610 Mini CCD Array Spectrometer 

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2.2 Risk/Benefit Assessment 
2.2.1 
Known Potential Risks 
The potential risks of participating in this trial are those associated with having blood drawn and 
unlikely, but possible, mild local reactions to the EmitBio™ RD19, entirely unknown adverse 
events, and inadvertent breach of confidentiality. 
Drawing blood may cause transient discomfort and fainting. Fainting is usually transient and 
managed by having the subject lie down and elevate his/her legs. Bruising at the blood draw site 
may occur but can be prevented or lessened by applying pressure to the blood draw site for a few 
minutes after the blood is taken. 
Extensive evaluation of the RD19 and similar energy-based devices routinely used for oral and 
skin care purposes have resulted in the Sponsor, after careful consideration, making the 
determination that RD19 as a “Not Significant Risk” (NSR) device per FDA guidelines. 
EmitBio™ RD19 is expected to be without significant risk for acute adverse events when used 
as directed. If the RD19 device is not used as directed, for example is inserted into the oral 
cavity improperly it is possible the user could induce a gag reflex.  If the RD19 device is used 
for a period of time in excess of the time directed, it is possible the user could experience mild 
to moderate erythema, and under extreme overuse conditions the user could experience oral 
mucosal thermal injury, especially to the uvula.  
Eye exposure is to be avoided. Direct illumination of unprotected eyes can result in damage to 
the retina, and especially the macula. Other eye structures can also experience thermal injury. 
Study staff must ensure volunteers understand to never point the RD19 device toward their or 
anyone else's eyes. 
Risks to Privacy: Subjects will be asked to provide personal health information (PHI). All 
attempts will be made to keep this PHI confidential within the limits of the law. However, there 
is a chance that unauthorized persons will see the subject’s PHI. All study records will be kept 
in a locked file cabinet or maintained in a locked room at the participating clinical trial site(s). 
Electronic files will be password protected. Only people who are involved in the conduct, 
oversight, monitoring, or auditing of this trial will be allowed access to the PHI that is collected. 
Any publications from this trial will not use information that will identify subjects by name. 
Organizations that may inspect and/or copy research records maintained at the participating 
clinical trial site(s) for quality assurance (QA) and data analysis include groups such as the IRB 
and the FDA. 
A description of this clinical trial will be posted on http://www.ClinicalTrials.gov. This web 
site will not include information that can identify subjects. 
There may be other risks, discomforts or side effects that are entirely unknown at this time. 

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2.2.2 
Known Potential Benefits 
 
There is no guaranteed benefit to study participants. There is the potential for benefit to society 
resulting from insights gained from participation in this study due to the widespread, and 
accelerating, threat of SARS-CoV-2 and COVID-19. Use of EmitBio™ RD19 may or may not 
provide protection against SARS-CoV-2 infection and subsequent COVID-19 disease. 

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3. STUDY DESIGN 
3.1 Overall Design 
This first-in-man (FIM) phase I study will evaluate the acute safety, tolerability, and device 
acceptability for use among 25 healthy volunteers between the age of 18 and 45. Based on the 
results of numerous preclinical studies, a single dose (9 joules/cm2) and schedule (twice a day, 
separated by at least 4 hours, preferably 8 to 12 hours apart) will be evaluated. 
Safety and tolerability (local reactogenicity) will be assessed actively at the following study 
days: screening (baseline set), 1, 7 and 14, and on non-clinic visit days by collection of 
these data by history during clinic visits via a memory aid (diary cards). Volunteers will be 
encouraged to promptly contact designated clinical trial staff or the one of the Sponsor’s 
Emergency Response Team for AEs of a medically urgent nature. 
A Comprehensive Metabolic Panel, as well as CBC with differential, urinalysis, and pregnancy 
testing will be performed at screening and at Day 14 or early termination (and potentially during 
unscheduled) clinic visits. Hematological safety assessments (evaluation of methemoglobinemia) 
will be performed at all visits. 
Study volunteers will be asked to immediately contact the clinical coordinator and/or the PI in 
all instances where they experience an AE of greater than moderate intensity. Volunteers will 
be instructed to report to the clinical trial unit for an unscheduled visit or to seek the 
appropriate level of medical care based on the nature of their AE/SAE. In all such instances, all 
relevant information pertaining to these significant medical events will be captured on the 
appropriate e-CRFs. 
Hematology safety laboratory evaluations will be performed at screening, as well during 
all scheduled clinic visits. Laboratory assessments may be part of the evaluation of 
medically attended AE evaluation and for all SAEs. 
 
Upon ratification of the CTA, the site will begin pre-recruitment outreach efforts of potential 
volunteers within M3-WRA’s database to ascertain “interest in general” in this study. Official 
recruitment which may include fliers, letters, telephone calls, etc. and specific recruitment of 
potential subjects who have previously participated in other clinical studies conducted at the 
site will occur only after formal IRB approval. Other forms and/or mechanisms of recruitment 
may also be used. The IRB will approve the recruitment process and all materials prior to use.  
Schedule of assessments can be found in Section 1.2, Schedule of Activities (Table 3). 

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3.2 Objectives and Outcomes 
OBJECTIVES 
ENDPOINTS 
(OUTCOME MEASURES) 
Primary 
• Evaluation of the acute safety of the 
EmitBio™ RD19 device. 
• Frequency, grade and attribution of each 
incident local and systemic AE during the 
14 day study period. 
• Frequency and attribution of any 
incident SAEs during the 14 day study 
period. 
Secondary 
• Evaluation of  the acceptability 
of the EmitBio™ RD19 device. 
• Ease of use, clarity of user instructions, 
& compliance with per protocol 
schedule and, if out of compliance, 
reason(s) for noncompliance. 
 
 
3.3 Scientific Rationale for Study Design 
The EmitBio™ RD19 device is designed to place a protective countermeasure in the hands of at 
population-risk individuals in order to reduce the incidence of SARS-CoV-2 and COVID-19. At 
population-risk individuals are those living where community-transmission of SARS-CoV-2 is 
likely to occur and where community transmission is actively occurring. Through the identified 
mechanisms of virus killing and inhibition of virus replication, the RD19 device is expected to 
reduce SARS-CoV-2 viral load which in combination with other lifestyle measures, may help 
reduce the incidence of SARS-CoV-2 infection.  This type of active protection is urgently needed 
for high-risk individuals (e.g. individuals exposed to a known infected person and healthcare 
workers and eldercare facility staff exposed to SARS-CoV-2 infected / COVID-19 patients and 
residents, respectively). The RD19 device has been engineered with the intent to help curb 
community transmission of SARS-CoV-2, thereby reducing the incidence of COVID-19. The 
CDC estimates that 40% of secondary coronavirus transmission occurs before people feel ill, 
highlighting the need for a broadly distributed protective countermeasure. 

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The RD19 optical illumination device is inserted into the mouth to shine light on the proximal 
repository for respiratory tract pathogens in the pharynx. The RD19 device uses a precise color 
of visible blue light (absent of UV light) to stimulate host defense and eliminate invading 
pathogens. This color of blue light has been found to both stimulate the instantaneous release of 
the body’s reserves of nitric oxide and to increase endogenous production of nitric oxide in 
barrier epithelial cells. This naturally produced nitric oxide is substantially elevated over 
background levels and promotes innate immune responses capable of disrupting SARS-CoV-2 
infection and inhibit viral replication of human coronaviruses. In addition to its direct antiviral 
activity, nitric oxide is an important pro-inflammatory cell signal to elicit induction and 
recruitment of other innate immune effectors, including NK cells, neutrophils, and macrophages. 

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3.4 Justification for Dose 
In repeated experiments, including experiments conducted by third party external laboratories, it 
has been determined that the light emitted by the EmitBio™ RD19 device provides for potent 
antiviral activity against SARS-CoV-2.  Reductions in viral infectivity of ≥99% have been 
observed after a single illumination at an energy level of 9 Joules/cm2. Separately, the yield of 
replicating SARS-CoV-2 virus in infected cells is inhibited by ≥ 99.9% in the range of 9 – 15 
J/cm2. Dosing twice a day (total of 18 J/cm2) also allows endogenous nitric oxide levels to be 
elevated to an extent and for a time period expected to result in high level antiviral effects. 
 
4. STUDY POPULATION 
Twenty-five (25) males and non-pregnant females, 18 to 45 years of age inclusive, who are in 
good health and meet all eligibility criteria will be enrolled. The target population should reflect 
the community at large. The estimated time from initiation of enrollment to completion of the 
day 1 visit for the last subject enrolled is one week.  
Subject Inclusion and Exclusion Criteria must be confirmed by a study clinician, licensed to 
make medical diagnoses and signatory to The Statement of Compliance as the site PI. 
Exemptions will be only be granted on Subject Inclusion or Exclusion in rare instances and 
based on the approval of the Sponsor’s Chief Medical Officer. 

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4.1 Full Inclusion Criteria 
A subject must meet all of the following criteria to be eligible to participate in this study: 
1. Provides written informed consent prior to initiation of any study procedures. 
2. Agrees to comply with planned study procedures and be available for all study visits. 
3. Agrees to the collection of venous blood per protocol. 
4. Male or non-pregnant female, 18 to 45 years of age, inclusive, at time of enrollment. 
5. Body Mass Index 18-35 kg/m2, inclusive, at screening. 
6. Woman of childbearing potential must have a negative urine pregnancy test within 7 
days prior to study initiation. 
7. Oral temperature is less than 100.0°F (37.8°C). 
8. Pulse no greater than 90 beats per minute. 
9. Systolic BP is 85 to 150 mmHg and Diastolic BP ≤ 90 mmHg, inclusive. 
10. Clinical screening laboratory evaluations are within acceptable normal reference ranges 
at the clinical laboratory being used. 

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4.2 Full Exclusion Criteria 
A subject who meets any of the following criteria will be excluded from participation in this 
study: 
1. Positive urine pregnancy test at screening. 
2. Has any medical disease or condition that, in the opinion of the site PI or appropriate sub- 
investigator, precludes study participation.1 
3. Plans to travel away from the study site area during the term of study to a location or in a 
manner that may interfere with full completion of the study per protocol. 
4. Presence of self-reported or medically documented significant medical or psychiatric 
condition(s).2 
5. Has an acute illness3, as determined by the site PI or appropriate sub-investigator, with or 
without fever [oral temperature >37.8°C (100.0°F)] within 72 hours of study day 1. 
6. Reports a recent positive test result for hepatitis B surface antigen, hepatitis C virus 
antibody, or HIV-1 antibodies at screening. 
7. Currently enrolled in or plans to participate in another clinical trial with an 
interventional investigational agent that will be received during the study 
period.5 
 
8. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized 
urticaria, angioedema, other significant reaction) to nitrates, nitrites or sun exposure. 
9. Active use of any medications that may be associated oral pharyngeal or mucosal 
irritation. 
10. Has any blood dyscrasias or significant disorder of coagulation. 
11. Has a history of alcohol abuse or other recreational drug (excluding cannabis) use 
within 1 month of Study Day 1. 
12. Has any oral abnormality that would interfere with device use, or intra-oral metal body 
piercings that cannot be removed for the duration of the study. Metal orthodontia is 
permitted as braces will be covered by the device mouthpiece. 
13. Receipt of any other SARS-CoV-2 or COVID19 experimental coronavirus 
investigational product within 30 days of screening. 
1Including medical diseases or conditions that would place the subject at an 
unacceptable risk of injury, render the subject unable to meet the requirements of the 
protocol or may interfere with the evaluation of responses or the subject’s successful 
completion of this trial. 
2Significant medical or psychiatric conditions include but are not limited to: respiratory 
disease (e.g., chronic obstructive pulmonary disease [COPD], asthma) requiring current 
daily medication.  
Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, 
ischemic heart disease). 
Neurological or neurodevelopmental conditions (e.g., epilepsy, stroke, seizures in the last 3 
months, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, 
encephalomyelitis or transverse myelitis). 

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Ongoing malignancy or malignancy in remission within the last six months excluding basal 
cell and squamous cell carcinoma of the skin, which are allowed. 
An autoimmune disease without a defined non-autoimmune cause. 
Any active immunodeficiency of any cause. 
3An acute illness which is nearly resolved with only minor residual symptoms remaining is 
allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual 
symptoms will not interfere with the ability to assess safety parameters as required by the 
protocol. 
4study drug, biologic or device. 
5Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or 
medication. 

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4.3 Study Volunteer Selection, Retention & Compensation 
4.3.1 
Recruitment 
Potential subjects will learn about the study via IRB-approved recruitment strategies, including 
direct mailing, recruitment from an IRB-approved trial registry and local advertisements/flyers. 
Screening will begin with a brief IRB-approved telephone call from study staff. Information 
about the study will be presented to potential subjects and questions about their health and ability 
to comply with the study visit schedule will be asked of potential subjects to presumptively 
determine eligibility. Appointments will be made at the clinical trial unit for potential subjects 
who are interested in the study for further screening procedures and additional protocol-specific 
information. 
4.3.2 
Retention 
Study retention strategies will include education and explanation of the study schedule and 
procedures during screening and enrollment visits and restriction of enrollment to persons who 
can attend all study visits. Participating subjects will be reminded of subsequent visits during 
each visit, and study staff will contact subjects prior to appointments. Study staff will contact 
subjects who miss appointments to encourage them to return for completion of safety 
evaluations. 
 
4.3.3 
Compensation Plan for Subjects 
Subjects will be compensated for their participation in this trial. Compensation will be in 
accordance with local IRB requirements, and subject to local IRB approval. Reimbursements 
will be disbursed at specific timepoints during the study with the total amount contingent on 
completing study procedures. 
 
4.3.4 
Costs 
There is no cost to subjects for the research tests, procedures/evaluations or study device 
while taking part in this trial. Procedures and treatment for clinical care may be billed to the 
subject, subject's insurance or third party. 

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5. STUDY DEVICE 
5.1 Regulatory Considerations 
5.1.1 
Preliminary Regulatory Pathway for EmitBio™ RD19 
The Food and Drug Administration (FDA) plays a critical role in protecting the United States 
from threats such as emerging infectious diseases, including the COVID-19 pandemic. To date, 
the agency has utilized various mechanisms to expand access for drugs, grant emergency use 
authorization (EUA) for certain diagnostic and treatment approaches and has issued policies 
for medical devices without premarket notification during the COVID-19 public health 
emergency. 
 
The most applicable policy document for the EmitBio™ RD19 device and its proposed 
indication for use is the “General Wellness: Policy for Low Risk Devices” issued by the Food 
and Drug Administration Center for Devices and Radiological Health (FDA-CDRH) on 
September 27, 2019.  
 
At this time RD19 is one of multiple products under development at EmitBio™ across the 
respiratory infection landscape.  The safety data collected will be useful in determining the final 
regulatory pathway for RD19 and subsequent devices.   
With the above guidance and policy documents from the FDA, and the company’s assessment 
that RD19 is a Not Significant Risk (NSR) device (August 3, 2020), EmitBio™ will follow the 
guidance of 21 CFR 812 as an NSR device and seek IRB approval for this protocol as a minimal 
risk protocol requiring only IRB, but not FDA-CDRH, review and approval. 
 
EmitBio™ will undertake a Phase I clinical trial, RD19-01-3Q20, under 21 CFR 812 as a Not 
Significant Risk (NSR), Minimal Risk protocol to assess the acute safety and local 
reactogenicity of RD19 commencing this month (August 2020). Results will be available in 
September 2020. 

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5.1.2 
Proposed Label Claim/Indication for Use: 
The EmitBio™ RD19 device uses blue light to boost the body’s natural immune response, 
which when combined with social distancing and proper mask use as part of healthy living, may 
help to reduce the risk of infection by respiratory viruses like influenza and SARS-CoV-2. 
 
5.1.3 
Medical Device Quality System: 
EmitBio™ will operate under an established Quality Management System, with a 
commitment for continuous improvement and effectiveness, in accordance with the 
requirements of the customers and applicable international standards. Specifically, the 
EmitBio™ Quality Management System is compliant with the requirements of the FDA 
Quality Systems Regulations (QSR). 
 
 

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5.2 Study Device and Use 
5.2.1 Device Description 
 
The EmitBio™ RD19 Device has been designed for ease of assembly in mass production and is 
comprised of the following three primary building blocks: 
 
Aluminum Housing – The aluminum housing has been engineered for function and designed for 
ergonomics.  The housing contains the LED metal core printed circuit board, the electronic LED power 
management circuit, an on/off switch interlocked with a timer, a rechargeable battery, and a removable 
cap for battery access.  Dynamic modeling has been utilized to improve the dissipation of excess heat 
from the LED array by the housing to keep the RD19 within safe operating temperature limits.  
Incorporating a right angle, the housing also provides an ergonomic transition from the light source to the 
light delivery assembly as well as for single-handed use. 
 
Light source - Located inside of the aluminum housing, the light source consists of an array of LEDs on 
a metal core circuit board, an electronic LED power management circuit, and a rechargeable battery.  
The quantity and characteristics (e.g. optical power and wavelength) of the individual LEDs in the LED 
array have been chosen to promote light-stimulated release and upregulation of nitric oxide.  The focused 
zoom assembly has been engineered to improve homogenization of the light emitted from the LED array, 
transmit the pre-shaped beam into the oral cavity to a position approximately 9 cm from the target area, 
and to disperse the transmitted light over the target area for stimulation of the host tissue. 
 
Mouthpiece – A comfort shield made of biomedical grade plastic is applied to the exterior of the optical 
element to enhance oral comfort during use and to improve light delivery.  The positioning guard 
provides for repeatable placement of the RD-19 device while also preventing over insertion and 
preventing the lips from coming into contact with the aluminum housing.  While the RD-19 device is in 
use, the mouthpiece is fixed to the aluminum housing and the tongue rests beneath the extended tongue 
depressor.  When not in use, the assembly is removable for cleaning and, if necessary, replacement. 
 
Each of the building blocks described are designed to allow the assembled device to meet 
specific criteria based on targeted safety and efficacy. The key target product device 
characteristics are summarized in: 
Table 4: RD19 Device Characteristics 
 
Characteristic 
Target 
Route of Administration 
Oral Illumination 
Device Configuration 
Hand-held, rechargeable 
Blue Light Source 
Non-coherent, light emitting diode (LED) array 
UVA Content (315 nm – 400 nm) 
<1% 
UVB Content (280 nm - 315 nm) 
not detectable* 
UVC Content (100 nm - 280 nm) 
not detectable* 
Target Exposure Area 
Oropharynx and surrounding tissues 
Exposure Time 
3 min per treatment, 2X/day at least 4 hrs apart 
Single Light Dose (@ 90 mm) 
~ 9 J/cm2 
Joules = Watts x seconds 
Total Daily Dose (@ 90 mm) 
~ 18 J/cm2 
Depth of Tissue Penetration 
< 0.5 mm 
Temperature (IEC 60601-1) 
< 48 °C (for durations <10 min) 
*UVA/UVB not detectable in Labsphere 1M Integrating Sphere equipped with CDS-610 Mini CCD Array Spectrometer 

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5.2.2 
Selection of Study Dose 
In repeated experiments, including experiments conducted by external academic collaborators, it 
has been determined that the EmitBio™ RD19 device provides for a powerful reduction in viral 
infectivity of host cells after a single five (3) minute illumination at a modest energy level of 9 
Joules/cm2. SARS-CoV-2 virus infectivity is inhibited by 99% (approximately 2 logs) at this dose. 
Viral replication is inhibited by 99.9% (3 logs). Dosing twice a day allows NO levels to be 
elevated to an extent and for a time period expected to result in a high level anti-viral effect. 
5.3 Use / Storage & Maintenance / Accountability 
5.3.1 
Acquisition and Accountability 
The sponsor will provide 27 RD19 (25 volunteers with two reserves) devices packaged in 
appropriately labelled separate clear containers containing all components as well as instructions 
for use by study participants.  Each RD19 device will be stamped on its power unit with a serial 
number.  Study staff will ensure that each device’s serial number is assigned to a specific study 
subject and the link between device serial number and study subject study number will be 
maintained on an accountability log.  Subjects will be requested to bring their device to the clinic 
for each scheduled visit and study staff will confirm serial number and subject number are in 
concordance.  Upon termination of a subject’s participation in the trial, all RD19 devices and 
components must be returned to the study site and then to the study sponsor. 
5.3.2 
Device Appearance 
RD19 Handle: ~6in.; Optic: ~3in. 

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5.3.3 
Device Storage and Maintenance 
All RD19 devices will be stored in a locked device storage room at the clinical trial site until 
needed for assignment to an enrolled study volunteer.  Upon acquisition by the study subject, 
devices should be stored in a dry climate-controlled environment in the original plastic container 
in which it was provided.  The device should be stored securely out of the reach of children who 
may mistakenly misuse the device, especially illumination of eyes – which is always to be 
avoided. The mouthpiece of the device is removable for rinsing with mild soap and warm water.  
The device tongue depressor and power housing may be cleaned with a soft cloth that has been 
dampened in mild dish detergent diluted in water; pieces should then be dried with a soft cloth.  
The optic device can be wiped gently with a dry cloth suitable for cleaning optical glasses. 
5.3.4 
Preparation for Use and Use 
[Refer to Appendix 1: User Instructions]  
 
5.5 Device Discontinuation 
5.5.1               Study Pausing Criteria 
RD19-01-3Q20 will be paused if any of the following events occur: 
• Any subject experiences an SAE after use of the RD19 Device that is considered 
related to RD19. 
• Any subject experiences laryngospasm, bronchospasm or anaphylaxis within 
2 hours after use of the RD19 Device that is considered related to RD19. 
• Two (2) or more subjects experience an allergic reaction such as generalized 
urticaria (defined as occurring at three or more body parts) within 72 hours after 
administration of light that is considered related to RD19. 
• Three (3) or more subjects experience a ≥ Grade 3 AE (systemic and/or clinical 
laboratory abnormality), in the same SOC grouping of Preferred Terms based on 
the Medical Dictionary for Regulatory Activities (MedDRA) coding, considered to 
be related to RD19. 
Study device use and enrollments may resume only after review of the AEs that 
caused the pause results. 
5.5.2 
Subject Elects to Discontinue 
 
A study volunteer may elect to discontinue participation in the trial at any time. 
Investigative staff will ask the volunteer to return for an early termination, but they are 
under no obligation to do so. All study subjects must return the RD19 device at study 
termination. 
 
5.5.3 
Investigator Decision to Discontinue Subject Use of Device 
A subject may be removed from the study for the following reasons post initial device use; 
however, whenever possible the subject should be followed for safety evaluations per 
protocol: 
• 
Study non-compliance to protocol requirements that in the opinion of the 
participating clinical site PI or appropriate sub-investigator poses an increased risk 
(e.g., missing safety labs) or compromises the validity of the data. 

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• 
Lost to follow-up. (A subject will be considered lost to follow-up if he or she fails 
to appear for a follow-up assessment. Extensive effort (i.e., generally three documented 
contact attempts via telephone calls, e-mail, etc., made on separate occasions) will be 
made to locate or recall the subject, or at least to determine the subject’s health status. 
These efforts will be documented in the subject’s study file.) 
• 
Medical disease or condition, or new clinical finding(s) for which continued 
participation, in the opinion of the participating clinical site PI or appropriate sub- 
investigator, might compromise the safety of the subject, interfere with the 
subject’s successful completion of this study, or interfere with the evaluation of 
safety. 
• 
If any AE, clinical laboratory abnormality or situation occurs such that 
continued participation in the study would not be in the best interest of the 
subject. 
• 
The occurrence of a SAE. 
• 
 If the subject is using the device in any manner inconsistent with instructions and 
protocol directives and procedures. 
If the subject agrees, every attempt will be made to follow all AEs through resolution 
or stabilization. 
Subjects who withdraw, or are withdrawn from this study, or are lost to follow-up after 
signing the informed consent form (ICF) and use of the RD19 device will not be replaced. 
Subjects who withdraw, or are withdrawn from this study, or are lost to follow-up after 
signing the ICF but before use of the device may be replaced. 
The reason for subject discontinuation or withdrawal from the study will be recorded on 
the appropriate e-CRF. 
5.5.4 
Follow-up of Study Subjects Who Discontinue Device Use 
Discontinuation of study device use does not constitute discontinuation from the study, 
and the study procedures for early termination should be completed as indicated by the 
SOA (Table 3). If a clinically significant finding is identified, including, but not limited to, 
changes from baseline, after enrollment, the participating clinical trial site PI or qualified 
designee will determine if any change in subject management is needed. Any new 
clinically relevant finding will be reported as an AE. 

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6. STUDY ASSESSMENTS AND PROCEDURES 
6.1 Screening Assessments 
6.1.1      Screening Procedures 
There is a small amount of risk to subjects who report that they are in good health but have an 
unknown health problem at the time of screening. At the screening visit, and prior to any other 
study-related activities, the participating clinical site PI or appropriate sub- investigator will 
provide the subject with detailed study information and will obtain written informed consent. 
Some or all of the following assessments are performed during the screening visit to 
determine eligibility requirements as specified in the inclusion and exclusion criteria: 
• 
Obtain medical history focusing on conditions per protocol exclusion criteria. 
• 
Review pre-study medications and therapies up to 10 days prior to the start of screening 
that could impact the use of, or response to, the device and record on the appropriate e-CRF. 
• 
Measure vital signs (HR, BP, and oral temperature) and height and weight for 
determination of BMI. 
• 
Perform full physical examination which will include assessments of the following 
organs and organ systems: skin, head, ears, eyes, nose, and throat (HEENT), neck, lungs, heart, 
liver, spleen, abdomen, extremities, lymph nodes (axillary and cervical), and nervous system. 
• 
Obtain blood and urine for clinical screening laboratory evaluations: 
o 
Hematology 
▪ 
CBC with differential 
▪ 
Methemoglobin level (Pulse Ox method) 
o 
CMP (fasting or non-fasting) 
o 
Urine pregnancy test (in women of childbearing potential) 
 
• 
Review inclusion and exclusion criteria. 
Clinical screening laboratory evaluations will be performed locally by the site laboratory.  
The overall eligibility of the subject to participate in the study will be assessed once all 
screening values are available. The screening process can be suspended prior to complete 
assessment at any time if exclusions are identified by the study team. 
Study subjects who qualify for inclusion will be scheduled for enrollment and their day 1 visit. 
If a physiologic parameter, e.g., vital signs or clinical laboratory value, is outside of the 
protocol-specified range, then the measurement may be repeated once if, in the judgment of the 
participating clinical site PI or appropriate sub-investigator, the abnormality is the result of an 
acute, short-term, rapidly reversible condition (e.g., stress, anxiety or “white coat syndrome”) or 
other source of error. A physiologic parameter may also be repeated if there is a technical 
problem with the measurement caused by malfunctioning, or an inappropriate measuring device 
(i.e., inappropriate-sized BP cuff). 
 
 
 
 

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A subject may be re-screened if there is a transient disease status (e.g., subject complained of a 
“cold or fever” and met a temporary delaying enrollment criterion of acute illness or fever), or 
if a protocol eligibility criterion that is not met at the initial time of screening, will be met by 
rescreening within the next 2 days. 
No subjects may be screened more than twice due to a screening failure result as defined above. 
Subjects will be provided the results of abnormal clinical laboratory test values or abnormal 
clinical findings necessitating follow-up with their primary care provider. 
6.1.2   Procedures to be Followed in the Event of Abnormal Clinical Laboratory Test 
Values or Abnormal Clinical Findings 
If a physiologic parameter, e.g., vital signs, or clinical laboratory value, is outside of the 
protocol-specified range, then the measurement may be repeated once if, in the judgment of 
the participating clinical trial site PI or appropriate sub-investigator, the abnormality is the 
result of an acute, short-term, rapidly reversible condition (e.g., stress, anxiety or “white coat 
syndrome”) or other source of error. A physiologic parameter may also be repeated if there is a 
technical problem with the measurement caused by malfunctioning, or an inappropriate 
measuring device (i.e., inappropriate-sized BP cuff). 
All abnormal clinical findings or abnormal clinical laboratory tests values that occur 
post RD19 device use will be considered AEs. 
6.1.3    Informed Consent – See Section 8.1.1 
 
6.2 
Safety and Other Assessments 
Study procedures are specified in the SOA (Table 3). A study clinician, licensed to make 
medical diagnoses as the participating clinical site PI or appropriate sub-investigator, will be 
responsible for all study-related medical decisions. 
o Medical history: 
o A complete medical history will be obtained by interview of subjects at the 
screening visit. Subjects will be queried regarding a history of significant medical 
disorders of the head, ears, eyes, nose, throat, mouth, cardiovascular system, 
lungs, gastrointestinal tract, liver, pancreas, kidney, urologic system, nervous 
system, blood, lymph nodes, endocrine system, musculoskeletal system, skin, and 
genital/reproductive tract. A history of any allergies, cancer, immunodeficiency, 
psychiatric illness, substance abuse, and autoimmune disease will be solicited. 
o At all subsequent visits an interim medical history will be obtained by interview 
of subjects and any changes since the previous clinic visit will be noted. The 
interim medical history should include an assessment for new medical conditions 
and symptoms suggestive of an AE. 
o Physical examination: 
o A full physical examination will be performed at the screening visit and a 
symptom-directed (targeted) physical examination will be performed if indicated 
at all other timepoints specified in the SOA. 
▪ A full physical examination will include assessments of the following 
organs and organ systems: skin, HEENT, neck, lungs, heart, liver, spleen, 
abdomen, extremities, lymph nodes (axillary and cervical), and nervous 
system. 
 

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▪ Height and weight will be measured, and BMI calculated, at the screening 
visit only. 
 
▪ Note presence of signs or symptoms consistent with solicited AEs to 
establish a baseline for subsequent assessment purposes (see Sec 6.2.2). 
o A symptom-directed (targeted) physical examination will be performed if 
indicated at all other timepoints specified in the SOA. 
▪ Targeted physical examinations should also include an assessment for 
signs and symptoms suggestive of AEs. Interim or unscheduled physical 
examinations will be performed at the discretion of the participating 
clinical site PI or appropriate sub-investigator, if necessary, to evaluate 
AEs or abnormal clinical laboratory test results. 
 Reactogenicity assessments will include an assessment of illumination 
site reactions – erythema, edema/induration, pain and difficulty 
swallowing, as well as systemic reactions–fever, chills, headache, and 
nausea. Pre-illumination reactogenicity assessments will be performed 
immediately prior to first RD19 use to establish a baseline, then the use of 
the RD19 device will occur. 
o Subjects will be observed in the clinic for at least 60 minutes post each 
RD19 illumination. The illumination site will be examined, post-use 
reactogenicity assessments will be performed, and any AEs/SAEs will be 
recorded on the appropriate e-CRF prior to discharge from the clinic. 
The oropharynx and surrounding tissues will also be examined on Days 
1, 7, 14 and during unscheduled visits and early termination visits. 
o Vital signs:  
o 
   Vital sign measurements will include systolic and diastolic BP, HR, and oral 
temperature. Vital signs will be measured at timepoints specified in the SOA. 
On Days 1, 7 and 14, vital sign measurements will be collected prior to device 
administration. Vital signs assessed on Day 1 prior to the first use of RD19 will 
be considered as baseline. Subjects must not eat or drink anything hot or cold 
within 10 minutes prior to taking their oral temperature or using the RD19 
device. 
o 
Clinical laboratory evaluations: 
o Fasting is not required before collection of clinical laboratory evaluations. 
o Urine pregnancy test will be performed locally by the site laboratory at the 
screening visit and at the final study visit. Results must be confirmed as negative 
prior to randomization on Day 1 and allocation and use of the RD19 device. 
o Clinical screening laboratory evaluations (CMP and CBC (diff) will be performed 
locally by the site laboratory).  
▪ Clinical safety laboratory evaluations will be performed locally by the site 
laboratory.  
▪ Methemoglobin will be measured prior to use of the device in the clinic 
and just prior to discharge from the clinic after 1 hour. 
▪ Blood and urine will be collected at timepoints specified in the SOA. 
 

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o Diary Cards: 
o All subjects will complete a Diary Card daily for the entire 
term of the study. Diary Cards will be reviewed with the 
subjects for any AEs (solicited injection site and systemic 
reactions, as well as unsolicited AEs), SAEs and 
concomitant medications. Diary Cards will be collected at 
the end of a volunteer’s participation in the study. 
o Acceptability Assessment: 
o All subjects will complete a brief survey of device 
tolerability and acceptability. This will be completed during 
the 60 minute follow-up period after device use in the clinic. 
6.2.1 Definition of Adverse Event (AE) 
AE means any untoward medical occurrence associated with the use of an intervention 
in humans, whether or not considered intervention-related (21 CFR 312.32 (a)). An AE 
can therefore be any unfavorable and unintended sign (including an abnormal clinical 
laboratory finding), symptom or disease temporally associated with the use of 
medicinal (investigational) product. 
Any medical condition that is present at the time that the subject is screened will be 
considered as baseline and not reported as an AE. However, if the severity of any pre-
existing medical condition increases, it should be recorded as an AE. 
AEs can be further divided into solicited AEs and unsolicited AEs. Solicited AEs are 
those for which the study team will specifically query the subject whether they 
occurred. Unsolicited AEs are those events that the subject report occurring without 
being queried about the specific event. 
All AEs will be assessed for severity and relationship to study intervention. Reporting 
of all AEs, solicited and unsolicited, will occur during the period from study device 
administration on Day 1 through Day 14 or until an early termination visit. 
All AEs, solicited and unsolicited, will be captured on the appropriate e-CRFs. 
Information to be collected for AEs includes event description, date of onset, 
assessment of severity, relationship to study product and alternate etiology (assessed 
only by those with the training and authority to make a diagnosis as the participating 
clinical site PI or appropriate sub-investigator), date of resolution, seriousness, and 
outcome. AEs occurring during the study-collection and reporting period will be 
documented appropriately regardless of relationship. 
AEs will be followed to resolution or stabilization. 

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6.2.2 Solicited Adverse Events 
Solicited AEs are anticipated local and systemic AEs for which consistent collection of 
information is desired. Study clinicians will follow and collect resolution information for 
any reactogenicity symptoms that are not resolved during the active study period. 
Solicited AEs (i.e., reactogenicity) will be collected using a diary card and recorded on the 
appropriate e-CRF from the during the entire course of the study. 
For this study, solicited AEs include: 
• 
Illumination site Pain 
• 
Illumination site Erythema 
• 
Illumination site Edema/Induration 
• 
Headache 
• 
Difficulty swallowing 
• 
Nausea 
• 
Fever 
• 
Chills 
 
6.2.3 Unsolicited Adverse Events 
All AEs spontaneously reported by the subject and/or in response to an open question from 
study staff or revealed by observation, physical examination or other diagnostic procedures 
must be recorded on the appropriate e-CRF. 
Unsolicited AEs of all severities will be reported from the time of study device 
administration through study termination. 
 
6.2.4 Adverse Event Reporting 
 
Information on all AEs should be recorded on the appropriate e-CRF. All clearly related 
signs, symptoms and results of diagnostic procedures performed because of an AE should 
be grouped together and recorded as a single diagnosis. If the AE is a clinical laboratory 
abnormality that is part of a clinical condition or syndrome, it should be recorded as the 
syndrome or diagnosis and be described in terms of duration (start and stop date). 
 
6.2.5 Definition of a Serious Adverse Event (SAE) 
An SAE is defined in 21 CFR 312.32 as follows: “An AE is considered serious if, in the view 
of either the participating clinical site PI or appropriate sub-investigator or the sponsor, it 
results in any of the following outcomes: 
• 
Death, 
• 
A life-threatening AE, 

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• 
Inpatient hospitalization or prolongation of existing hospitalization, 
• 
A persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions, 
• 
Or a congenital anomaly/birth defect. 
Important medical events that may not result in death, are not immediately life-
threatening, or require hospitalization may be considered serious when, based upon 
appropriate medical judgment, they may jeopardize the patient or subject and may 
require medical or surgical intervention to prevent one of the outcomes listed in this 
definition. An example of such a medical event would be an allergic bronchospasm 
requiring intensive treatment in an emergency room or at home to prevent the 
development of one of the definitions above. 
“Life-threatening” refers to an AE that at occurrence represents an immediate risk of 
death to a subject. An event that may cause death if it occurs in a more severe form is not 
considered life-threatening. Similarly, a hospital admission for an elective procedure is 
not considered an SAE. 
All SAEs, as with any AE, will be assessed for severity and relationship to study 
intervention. All SAEs will be recorded on the appropriate SAE e-CRF. 
 
All SAEs will be followed through resolution or stabilization by a study clinician, 
licensed to make medical diagnoses and listed as the participating clinical site PI or 
appropriate sub-investigator. 
All SAEs will be reviewed and evaluated by the Sponsor and will be reported to the 
IRB. This report will include severity, association with the study device, action(s) 
taken, and outcome. 
 
6.2.6 Serious Adverse Event Reporting 
Any AE that meets a protocol-defined criterion as an SAE must be submitted 
immediately (within 24 hours of site awareness) on an SAE form to EmitBio Inc. 
Pharmacovigilance: 
EmitBio™ Pharmacovigilance  
SAE Hot Line: 1-843-540-3550 or 1-610-570-7425  
Text Immediate Report: 1-843-540-3550 
SAE Email: jmcneil@emitbio.com 
In addition to the SAE form, all SAE data must be entered into the SAE e-CRF. 
Other supporting documentation of the event may be requested by EmitBio™ 
Pharmacovigilance and should be provided as soon as possible. The Sponsor Medical 
Monitor will review and assess the SAE for regulatory reporting and potential impact on 
study subject safety and protocol conduct. 
At any time after completion of the study, if the participating clinical site PI or 
appropriate sub-investigator becomes aware of an SAE that is suspected to be related to 
study product, the participating clinical site PI or appropriate sub-investigator will report 
the event to the EmitBio™ Pharmacovigilance Group. 
 
 
 

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Regulatory Reporting of Device-related SAEs 
Following notification from the participating clinical site PI or appropriate sub-
investigator, EmitBio Inc., as the sponsor, will report to the FDA and will copy the 
clinical site investigators on all reports of potential serious risks from clinical studies of 
RD19, as soon as possible. EmitBio Inc. will report to the FDA any unexpected fatal or 
life-threatening suspected adverse reaction as soon as possible, but in no case later than 7 
calendar days after the sponsor’s initial receipt of the information. If the event is not fatal 
or life-threatening, an SAE safety report will be submitted within 15 calendar days after 
the sponsor determines that the information qualifies for reporting as specified in 21 CFR 
Part 312.32. 
 
Relevant follow-up information to the safety report will be submitted as soon as the 
information is available. Upon request from FDA, EmitBio™ will submit to the FDA any 
additional data or information that the agency deems necessary, as soon as possible, but 
in no case later than 15 calendar days after receiving the request. 
SAEs that are not considered related to RD19 will not be reported to the FDA. 
 
6.2.7 
Classification of an Adverse Event 
The determination of seriousness, severity and causality will be made by an on-site 
investigator who is qualified (licensed) to diagnose AE information, provide a medical 
evaluation of AEs and classify AEs based upon medical judgment. This includes, but is not 
limited to, physicians, physician assistants and nurse practitioners. 
 
6.2.8 
Severity of Adverse Events 
All AEs or SAEs will be assessed for severity, according to the toxicity grading scales 
provided at Appendix 2. 
For AEs not included in the protocol-defined grading system, the following guidelines will 
be used to describe severity. 
 
• Mild (Grade 1): Events that are usually transient and may require only minimal or no 
treatment or therapeutic intervention and generally do not interfere with the subject’s 
usual activities of daily living. 
• Moderate (Grade 2): Events that are usually alleviated with additional specific 
therapeutic intervention. The event interferes with usual activities of daily living, causing 
discomfort but poses no significant or permanent risk of harm to the research subject. 
• Severe (Grade 3): Events interrupt usual activities of daily living, or significantly affects 
clinical status, or may require intensive therapeutic intervention. Severe events are 
usually incapacitating. 

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AEs characterized as intermittent require documentation of onset and duration of each 
episode. The start and stop date of each reported AE will be recorded on the appropriate e-
CRF. Changes in the severity of an AE will be documented to allow an assessment of the 
duration of the event at each level of intensity. 
 
6.2.9 Relationship to Study Intervention 
For each reported adverse event, the participating clinical site PI or qualified designee must 
assess the relationship of the event to the study device using the following guidelines: 
• 
Related – The AE is known to occur with the study intervention, there is a reasonable 
possibility that the study intervention caused the AE, or there is a close temporal 
relationship between the study intervention and event. Reasonable possibility means that 
there is evidence to suggest a causal relationship between the study intervention and the AE. 
• 
Null Determination – The direction and magnitude towards related and not related is 
null. The investigator is stating simply, “I cannot determine a relationship”. 
• 
Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study 
intervention and event onset, or an alternate etiology has been established. 
 
6.2.10 Time Period and Frequency for Event Assessment and Follow-Up 
For this study: 
• Solicited and Unsolicited AEs will be recorded by volunteers daily on the Diary Card 
and collected on Clinic visit days 7, 14 and any unscheduled clinical trial unit visits.  
 
6.2.11 Adverse Event Reporting to Study Subjects 
 
• All device-attributed AEs and SAEs will be reported to participants in the study to better 
inform them of the potential risks vs. benefits of participation. 
 
6.2.12 Pregnancy Reporting 
 
• All positive urine pregnancy tests will be reported during screening and at the end of the 
study. Women who screen positive for pregnancy will be encouraged to see their primary 
health care provider for a serological confirmatory test. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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7. 
STATISTICAL CONSIDERATIONS 
7.1 
Statistical Hypotheses 
This is a phase I, open-label, safety study and is not designed to test any statistical hypotheses. 
Rather, this is a descriptive study intended to obtain preliminary estimates in healthy adults of 
the safety, including reactogenicity, of the EmitBio™ RD19 Device. 
 
7.2 
Sample Size Determination 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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7.3 
Populations for Analyses 
The full safety analyses population is by intention-to-treat (ITT) including all subjects who 
received at least a single use of RD19. 
A modified per protocol population for analyses will include all study volunteers who 
complied with study procedures and remained on study, per protocol, until at least the day 7 
clinic visit. 
The per protocol population for analyses will include all study volunteers who complied will 
all protocol procedures and remained on the study until their day 14 visit. 
 
7.4 
Statistical Analyses 
7.4.1   Primary Safety Analyses 
Summaries and analyses of safety data will be presented for the Safety Analysis Population. 
Solicited AEs will be summarized overall and by maximum severity post through study day 7, 
post study period days 7 -14 and overall. Additionally, solicited AEs will be analyzed by 
taking the most severe response (grouped as either modified per protocol or per protocol), 
dichotomizing into a binary variable (none versus mild, moderate, or severe) and using 
standard techniques, such as exact confidence intervals (CI), to summarize the proportion of 
subjects reporting each solicited sign or symptom. 
Unsolicited non-serious AEs will be collected from the time of first device use through study 
day 14. Unsolicited AEs will be coded by MedDRA™ for preferred term and system organ 
class (SOC). All SAEs will be collected from the time of first device use through the study 
day 14. The number of SAEs will be reported by detailed listings showing the event 
description, MedDRA™ preferred term and SOC, study day of occurrence, severity, 
relatedness, and outcome for each event. Non-serious unsolicited AEs will be summarized as 
number and percentage of subjects reporting at least one event in each MedDRA□preferred 
term and SOC, cross tabulated by severity and relationship to the study device. Additionally, 
the proportion of subjects and exact 95% CIs of AEs in aggregate and by MedDRA□categories 
will be computed. 
Clinical laboratory data, including methemoglobin measurements, will be summarized by 
severity and as the maximum numeric value over the entire study. Graphical presentations 
may include box plots and shift plots. 
7.4.2 Analysis of the Secondary Endpoint(s) 
Summaries and analysis of acceptability variables will be presented for both the modified and 
per-protocol study populations. 
Device use and protocol procedures compliance rates will be calculated and presented. 
 
A device acceptability source document has been created and provided to DCAC for database 
build and e-CRF production.  Descriptive statistics for each variable will be calculated and 
presented. 
 
7.4.3 Baseline Descriptive Statistics 
Summaries of demographic variables such as age, sex, ethnicity, and race will be presented. 
Summaries of baseline clinical laboratory values will be presented. 
Absolute numbers and ratios of Screened:Enrolled, Enrolled:Modified Per-Protocol and 
Enrolled:Per-Protocol will be presented.

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8. 
OPERATIONAL CONSIDERATIONS AND 
SUPPORTING DOCUMENTS 
8.1  Ethical Considerations 
This study will be conducted in conformity with the principles set forth in The Belmont 
Report: Ethical Principles and Guidelines for the Protection of Human Subjects of 
Research (US National Commission for the Protection of Human Subjects of Biomedical 
and Behavioral Research; April 18, 1979), and the federal policy for the Protection of 
Human Subjects codified in 45 CFR Part 46, 21 CFR Part 50 (Protection of Human 
Subjects), and the ICH E6(R2). 
An OHRP-registered IRB will review and approve this protocol, associated informed 
consent documents, recruitment material, and handouts or surveys intended for the 
subjects, prior to the recruitment, screening, and enrollment of subjects. The IRB review 
shall be in accordance with 45 CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), 21 CFR 812 
and other federal, state, and local regulations and policies, as applicable. 
Any amendments to the protocol or informed consent documents will be approved by the 
IRB before they are implemented. The participating clinical site PI will notify the Sponsor 
of deviations from the protocol and reportable SAEs, and, as applicable, to the IRB. 
EmitBio Inc must receive the documentation that verifies IRB approval for this protocol, 
informed consent documents, and associated documents prior to the recruitment, 
screening, and enrollment of subjects and the provision of adequate numbers of RD19 
devices to conduct the protocol. 
 
8.1.1   Informed Consent Process 
Informed consent is a process that is initiated prior to an individual agreeing to participate 
in a trial and continuing throughout the individual’s trial participation. Investigators or 
designated research staff will obtain a subject’s informed consent in accordance with the 
requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56, state and local regulations and 
policy, and ICH E6 GCP before any study procedures or data collection are performed. 
The participating clinical site PI or other study staff may obtain oral or written information 
for the purpose of screening, recruiting, or determining the eligibility of prospective 
subjects without the informed consent of the prospective subject if the process is approved 
by the IRB. 
At the screening or first study visit, informed consent will be obtained and documented 
before any study procedures are performed. Subjects will receive a concise and focused 
presentation of key information about the clinical trial, verbally and with a written consent 
form. The key information about the purpose of the study, the procedures and 
experimental aspects of the study, study device, potential risks, benefits and discomforts, 
the expected duration of the subject’s participation in the trial, and alternative treatments 
and procedures that may be available to the subject. The explanation will be organized and 
presented in lay terminology and language that facilitates understanding why one might or 
might not want to participate. 

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Subjects will receive an explanation that they will be compensated for their participation 
on a per visit basis, and medical treatments are available if device-related injury occurs, 
and, if so, what that treatment is, or where further information may be obtained. Subjects 
will be informed of the anticipated financial expenses, if any, to the subject for 
participating in the trial, as well as any anticipated prorated payments, if any, to the 
subject for participating in the trial. They will be informed of whom to contact (e.g., the 
participating clinical site PI and the Sponsor) for answers to any questions relating to the 
research project. Information will also include the foreseeable circumstances and/or 
reasons under which the subject’s participation in the trial may be terminated. The 
subjects will be informed that participation is voluntary and that they are free to withdraw 
from the study for any reason at any time without penalty or loss of benefits to which the 
subject is otherwise entitled.  
Subjects will be informed that records identifying the subject will be kept confidential, 
and, to the extent permitted by the applicable laws and/or regulations, will not be made 
publicly available. If the results of the trial are published, the subject’s identity will remain 
confidential. Subjects will be informed, even if identifiers are removed, that information 
collected from this research and/or specimens may be used for secondary research, 
including the sharing of deidentified data.  
Subjects will be informed that the monitor(s), auditors(s), IRB, and Sponsor will be 
granted direct access to the subject’s original medical records for verification of clinical 
trial procedures and/or data without violating the confidentiality of the subject, to the 
extent permitted by the applicable laws and regulations, and that, by signing a written ICF, 
the subject is authorizing such access. 
ICFs will be IRB-approved, and subjects will be asked to read and review the consent 
form. Subjects must sign the ICF prior to starting any study procedures being done 
specifically for this trial. Once signed, a copy of the ICF will be given to the subject for 
their records. 
New information will be communicated by the participating clinical site PI to subjects 
who consent to participate in this trial in accordance with IRB requirements. The informed 
consent document will be updated, and subjects will be re-consented per IRB 
requirements, if necessary. 
 

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8.1.2 Confidentiality and Privacy 
Subject confidentiality is strictly held in trust by the participating investigators, their 
staff, and the sponsor(s) and their agents. This confidentiality is extended to cover 
clinical information relating to subjects, test results of biological specmens and all other 
information generated during participation in the study. No identifiable information 
concerning subjects in the study will be released to any unauthorized third party. Subject 
confidentiality will be maintained when study results are published or discussed in 
conferences. 
The study monitor, other authorized representatives of the sponsor and representatives of 
the IRB may inspect all documents and records required to be maintained by the 
participating clinical site PI, including, but not limited to, screening, medical and 
laboratory results for the subjects in this study. The participating clinical site will permit 
access to such records. 
All source records, including electronic data, will be stored in secured systems in 
accordance with institutional policies and federal regulations. 
All study data and research specimens that leave the site (including any electronic 
transmission of data) will be identified only by a coded number that is linked to a subject 
through a code key maintained at the clinical site. Names or readily identifying 
information will not be released unless strictly required by law. 
 
8.1.3 Clinical Monitoring 
 
Monitoring for this study will be performed by EmitBio Inc.’s Clinical Program Manager. 
Monitoring will be conducted at frequent time points during the conduct of the trial. and will 
include, but is not limited to, source document verification, review of regulatory files, 
device accountability records, e-CRFs, ICFs, medical and laboratory reports, training 
records, and protocol and GCP compliance. The monitor will have access to  all study 
related documents  and will meet with  appropriate clinical site staff to discuss any problems 
and outstanding issues. Visit findings and discussions will be documented.  Some 
monitoring visits make be conducted remotely. 
 
8.1.4 Quality Control (QC) and Quality Assurance (QA) 
To ensure the reliability of study data, the clinical sites must maintain a Clinical Quality 
Management Plan (CQMP). The CQMP describes routine internal quality control (QC) 
and quality assurance (QA) activities for the purposes of measuring, documenting and 
reporting study conduct, protocol adherence, human subjects’ protections, and reliability 
of the protocol-driven data collected independent of sponsor site monitoring.Data 
Handling and Record Keeping 
8.1.5 
Data Collection and Management Responsibilities 
Data collection is the responsibility of the study staff at the participating clinical trial site 
under the supervision of the participating clinical site PI and the overall study PI. The 
participating clinical trial site PI must maintain complete and accurate source 
documentation. Clinical research data from source documentation, including, but not 
limited to, AEs/SAEs, concomitant medications, medical history, physical assessments, and 
clinical laboratory data, will be entered by the participating clincial site into eCRFs via a 21 
CFR Part 11-compliant internet data entry system provided by the Sponsor’s delegated data 
coordinating and analysis clinical support organization (TAB Clinical, Inc; Cary, NC). The 
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range checks, to identify data that appear inconsistent, incomplete, or inaccurate. AEs and 
concomitant medications will be coded according to the most current versions of MedDRA 
and WhoDrug, respectively. 
TAB Clinical Inc will be responsible for data management, quality review, analysis, and 
reporting of the study data for this study. 
The study sponsor is responsible for review of data collection tools and processes, and 
review of data and reports. 
AEs will be coded according to the MedDRA dictionary version 23.0 or higher. 
8.1.6 
Source Documents 
Source documents contain all information in original records (and certified copies of 
original records) of clinical findings, observations, or other activities in a clinical trial 
necessary for the reconstruction and evaluation of the trial. Source data should be 
attributable, legible, contemporaneous, original, accurate, and complete. Each 
participating clinical site will maintain appropriate medical and research records for this 
trial, in compliance with ICH GCP, regulatory, and institutional requirements. Data 
recorded in the e-CRF derived from source documents should be consistent with the data 
recorded on the source documents. 
Interview of subjects is sufficient for obtaining medical history. Solicitation of medical 
records from the subject’s primary care provider is not required. 
At the end of the study, a copy of all datasets, including annotated CRFs and data 
dictionary, will be provided to EmitBio Inc. 

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8.1.7 
Study Record Retention 
Study-related records, including the regulatory file, study device accountability records, 
consent forms, subject source documents and electronic records, should be maintained for 
a period of 2 years following the date a marketing application is approved for the 
investigational device for the indication for which it is being investigated; or, if no 
application is filed or if the application is not approved for such indication, until 2 years 
after the investigation is discontinued and the Sponsor is notified. These documents should 
be retained for a longer period, however, if required by local policies or regulations. No 
records will be destroyed without the written consent of EmitBio™.  
 
8.1.8 
Protocol Deviations 
A protocol deviation is any non-compliance with the clinical trial protocol, any process 
that is noted in the protocol and refers to details in the protocol or GCP requirements, or 
any critical study procedures with specific instructions in ancillary documents referenced 
in the protocol. 
The non-compliance may be either on the part of the subject, the participating clinical site 
PI, or the study site staff. Following a deviation(s), corrective actions should be developed 
by the site and implemented promptly. All individual protocol deviations will be 
addressed in study volunteer study records. 
It is the responsibility of the participating clinical site PI and study staff to use continuous 
vigilance to identify and report deviations within five working days of identification of the 
protocol deviation, or within five working days of the scheduled protocol-required 
activity. All deviations must be promptly reported to EmitBio Inc’s Senior Clinical 
Program Manager. Protocol deviations must be sent to the IRB of record. The 
participating clinical site PI and study staff are responsible for knowing and adhering to 
the IRB requirements. A completed copy of an approved Protocol Deviation Form must be 
maintained in the Regulatory File, as well as in the subject’s chart if the deviation is 
subject specific. 

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8.1.9 
Publication and Data Sharing Policy 
All study data and reports of study data are the property of the study sponsor. The sponsor 
my grant the PI the right to publish the results of this research in a scientific journal, 
conditional upon the review and concurrence of the sponsor.  
 
8.1.10 Conflict of Interest Policy 
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, is critical. Therefore, any actual conflict of interest of persons who 
have a role in the design, conduct, analysis, publication, or any aspect of this trial will be 
disclosed and managed. Furthermore, persons who have a perceived conflict of interest will 
be required to have such conflicts managed in a way that is appropriate to their 
participation in the design and conduct of this trial. EmitBio Inc requires that all study team 
members disclose any conflict of interest. Clinical Study sites are required to maintain a 
mechanism for the management of all reported dualities of interest. 
8.1.11 Research Related Injuries 
For any potential research related injury, the participating clinical site PI or designee will 
assess the subject. Study staff will try to reduce, control and treat any complications from 
this trial. Immediate medical treatment may be provided by the participating clinical site, 
such as giving emergency medications to stop immediate allergic reactions. As needed, 
referrals to appropriate health care facilities will be provided to the subject. The 
participating clinical site PI should then determine if an injury occurred as a direct result of 
procedures or the device used in this trial. 
If it is determined by the participating clinical site PI that an injury occurred to a subject as 
a direct result of the procedures or device used in this trial, then referrals to appropriate 
health care facilities will be provided to the subject. No financial compensation will be 
provided to the subject by EmitBio Inc. or the participating clinical site for any injury 
suffered due to participation in clinical research. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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9. 
REFERENCES 
9.1.   https://pubmed.ncbi.nlm.nih.gov/7690156/  
9.2.   https://pubmed.ncbi.nlm.nih.gov/8390481/  
9.3.   https://pubmed.ncbi.nlm.nih.gov/23562771/  
9.4.   https://pubmed.ncbi.nlm.nih.gov/31319090/ 
9.5.  https://pubmed.ncbi.nlm.nih.gov/15650225/  
9.6.  https://pubmed.ncbi.nlm.nih.gov/28933406/  
9.7.  https://pubmed.ncbi.nlm.nih.gov/9663649/  
9.8.  https://pubmed.ncbi.nlm.nih.gov/11238631/  
9.9.  https://pubmed.ncbi.nlm.nih.gov/19519946/  
9.10.  https://pubmed.ncbi.nlm.nih.gov/15546092/ 
 
 
Approved: __John G. McNeil____ 
                   John G. McNeil, MD MPH PHD