A Single Center Open Label Early Feasibility Study to Evaluate the Efficacy and Safety of the RenewalNail™ Plasma Treatment System in Patients With Mild to Moderate Onychomycosis (Fungal Nail) of the Hallux Caused by Trichophyton Rubrum or Trichophyton Mentagrophytes.
Phase: NA
Conditions: Onychomycosis of Toenail, Onychomycosis
Sponsor: DeviceFarm, Inc.

 
 
 
 
 
Clinical Study Protocol 
 
 
 
A Single Center Open Label Early Feasibility Study to Evaluate the Efficacy and Safety of 
the RenewalNail™ Plasma Treatment System in Patients with Mild to Moderate 
Onychomycosis (Fungal Nail) of the Hallux caused by Trichophyton rubrum or Trichophyton 
mentagrophytes. 
 
Protocol Number: DFCR-0003 
 
 
Principal Investigator: 
 
David L. Kahan, DPM 
2 Scripps Drive, Suite 206 
Sacramento, CA 95825 
(916) 245-9398 
 
 
 
Sponsor: 
 
 
DeviceFarm, Inc.  
39655 Eureka Drive 
Newark, CA 94560 
925-895-1584 
 
Sponsor Contact: 
 
Jeffrey Roe, PhD 
CEO 
DeviceFarm, Inc. 
 
 
 
 
925-895-1584 
 
 
 
 
jeffnroe1@devicefarmtech.com 
 
Protocol Version: 
 
1.0  
Current Version Date:  
01 June 2017 
 
 
CONFIDENTIALITY STATEMENT 
The confidential information in this document is provided to you as an Investigator or 
consultant for review by you, your staff, and the applicable Institutional Review Board/ 
Independent Ethics Committee. Your acceptance of this document constitutes agreement that 
you will not disclose the information herein to others without written authorization from 
DeviceFarm, Inc. except to the extent necessary to obtain informed consent from persons who 
participate as Subjects in this study. 

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TITLE PAGE 
 
Study Title 
A Single Center Open Label Early Feasibility Study to Evaluate the Efficacy and Safety of the 
RenewalNail™ Plasma Treatment System in Patients with Mild to Moderate Onychomycosis (Fungal 
Nail) of the Hallux caused by Trichophyton rubrum or Trichophyton mentagrophytes. 
Project Name 
 
DeviceFarm Early Feasibility Study  
Protocol Number 
 
DFCR-0003 
Clinical Phase 
 
I 
Investigational Product 
 
RenewalNail™ Plasma Treatment System 
Subject Population/Indication 
 
Patients with mild to moderate distal subungual onychomycosis of one 
hallux nail who fulfill the inclusion/exclusion criteria 
Duration 
 
6 months 
Design 
 
Single-center, open-label 
 
This study will be performed in compliance with Good Clinical Practices (GCPs). This Protocol follows 
guidelines outlined by the International Council on Harmonization. All the data furnished to the 
Investigator and his/her staff and all data obtained through this Protocol will be regarded as confidential 
and proprietary in nature and will not be disclosed to any third party without the written consent of 
DeviceFarm, Inc.

CONFIDENTIAL
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Sponsor: DeviceFarm Inc. 
 
 
 
 
 
 
 
 
 
Protocol Number: DFCR-0003 
 
PROTOCOL APPROVAL PAGE 
 
A Single Center Open Label Early Feasibility Study to Evaluate the Efficacy and Safety of the RenewalNail™ 
Plasma Treatment System in Patients with Mild to Moderate Onychomycosis (Fungal Nail) of the Hallux caused 
by Trichophyton rubrum or Trichophyton mentagrophytes. 
 
SPONSOR: 
DeviceFarm, Inc. 
39655 Eureka Drive 
Newark, CA 94560 
 
 
 
Approvals 
Signature 
Date 
 Jeffrey Roe, PhD 
 CEO 
 DeviceFarm, Inc. 
 
  
 

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Sponsor: DeviceFarm Inc. 
Protocol Number: DFCR-0003 
 
SYNOPSIS 
 
Title of Study: 
A Single Center Open Label Early Feasibility Study to Evaluate the Efficacy and Safety of the RenewalNail™ 
Plasma Treatment System in Patients with Mild to Moderate Onychomycosis (Fungal Nail) of the Hallux 
caused by Trichophyton rubrum or Trichophyton mentagrophytes. 
Objective: 
To determine if a three-treatment protocol with the RenewalNail™ plasma treatment system over a week 
will result in mycological cure and/or clear nail growth on the treated hallux toe. 
Methodology: 
Single-center, open-label 
Number of Subjects (planned): 
5 Subjects 
Number of Sites and Number of Subjects Per Site: 
One (1) site, 5 Subjects 
 
Diagnosis and Main Criteria for Inclusion: 
Laboratory confirmed diagnosis of mild to moderate onychomycosis on at least one hallux toe caused by 
Trichophyton rubrum or Trichophyton mentagrophytes 
 
Male and female Subjects of any race between 21 and 75 years of age meeting specific inclusion/exclusion 
criteria 
 
Investigational Product: 
RenewalNail™ Plasma Treatment System (DFPD-003) 
Mode of Administration: topical 
Number of treatments: 3 
Duration of each treatment: 45 minutes 
 
Criteria for Evaluation: 
Efficacy: 
Mycological Cure: Two consecutive negative mycology cultures 
Clinical Cure: Photographic evidence of clear nail growth 
Safety: 
Adverse Events 

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Sponsor: DeviceFarm Inc. 
 
 
 
 
 
 
 
 
 
Protocol Number: DFCR-0003 
 
STUDY CONTACTS 
 
SPONSOR/SITE PERSONNEL 
Name/Title 
Affiliation/Address/Tel. 
Responsibilities 
 
Jeffrey N. Roe, PhD CEO 
 
DeviceFarm Inc. 
39655 Eureka Drive 
Newark, CA 94560-4806 
(925) 895-1584 
 
Sponsor Contact 
 
Timothy Grammer, PhD 
VP of Operations 
 
DeviceFarm Inc. 
39655 Eureka Drive 
Newark, CA 94560-4806 
(510) 295-5293 
 
Sponsor Contact 
 
Bruno Gagnon, BPharm, MSc 
Acting Head of Clinical 
Operations 
 
DeviceFarm Inc. 
39655 Eureka Drive 
Newark, CA 94560-4806 
(415) 246-7106 
 
Sponsor Contact/ 
Study Monitor 
 
David L. Kahan, DPM 
 
 
2 Scripps Drive, Suite 206 
Sacramento, CA 95825 
(916) 245-9398 
David.Kahan@drdavidkahan.com 
http://www.sacramentopodiatrists.
com/ 
 
 
Principal Investigator 
 

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1.0 INTRODUCTION 
 
Background and Rationale: Onychomycosis, the most common nail disease, accounts for 30% of all 
cutaneous fungal infections. The disease is a progressive chronic recurring fungal infection affecting an 
estimated 35 million people in the United States. Approximately 50% of elderly over the age of 70 are 
infected as well as 30% of diabetics. Although dermatophyte infections are rarely life threatening, their 
high incidence and prevalence makes them an important health problem. Onychomycosis is not just a 
cosmetic problem, but can cause pain, difficulty walking, and susceptibility to secondary infections such as 
cellulitis and osteomyelitis. 
 
Distal subungual onychomycosis (DSO) is the most common form of onychomycosis. DSO is characterized 
by nail discoloration, onycholysis, dystrophy of the nail plate, and accumulation of subungual debris. There 
is an average of 4.4 to 5.3 involved toes per patient, with an average of about 2.4 per foot. Approximately 
75% of patients have both feet involved. 
 
There are currently three groups of FDA-approved approaches to the treatment of onychomycosis: oral 
treatments, topical therapy, and laser treatments. Oral terbinafine (Lamisil®, Novartis Pharmaceuticals) is 
the lead therapy among oral medications consisting of a 250-mg tablet per day for 12 weeks for the 
treatment of toenail onychomycosis. Oral terbinafine yields the highest complete cure rates, between 38 
and 76% depending on the clinical trial design. Oral therapy might be adequate if not for the relatively 
high risk of liver toxicity and drug-drug interactions. Many patients and their physicians choose not to 
select oral therapy due to the associated risk. Rare cases of liver failure and serious skin reactions have 
been reported with oral terbinafine use (Lamisil® package insert). 
 
Topical treatment options have been researched/under development by many companies in order to 
provide an effective antifungal drug therapy without exposing the patient to the side effects and toxicity 
associated with oral antifungal drug therapy. FDA-approved topical treatments for onychomycosis include 
Jublia® (Valeant Pharmaceuticals), Penlac® Nail Lacquer (Dermik Laboratories) and Kerydin® (Anacor 
Pharmaceuticals). Topical formulations address the toxicity problem caused by the oral medications and 
are easy to apply. However, topical therapy has a much lower cure rate than oral therapy at 5-17% and 
requires significant compliance by the patient since the treatment is so long in duration (typically one 
year), and relatively labor intensive compared to oral therapy. Topical drug permeation can be enhanced 
by surgically removing the nail or disrupting the nail plate using physical techniques (manual or electrical 
nail abrasion, acid etching, and ablation by lasers) but the pain and inconvenience makes these unpopular 
choices. 
 
Laser treatments are relatively safe, but only offer temporary cosmetic improvement (i.e., no cure). 
Recent publications that review the most widely used laser treatments available on the market today have 
concluded that they are not effective in the treatment of onychomycosis. Examples include Clearsense® 
laser (Sciton), Pinpointe® Footlaser (Nuvolase), Noveon® laser (Nomir Medical Technologies), GenesisPlus® 
laser (Cutera), and Harmony® laser (Alma Laser). 
 
Despite improvements in outcomes with new topical antifungals and other treatment options, there is 
still no topical treatment that is greater than 20% effective. As a result, numerous strategies have 
evolved to improve efficacy and reduce reoccurrence while maintaining safety. 
 
The Sponsor DeviceFarm, Inc. has developed the RenewalNail™ plasma treatment system to topically treat 

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Sponsor: DeviceFarm Inc. 
 
 
 
 
 
 
 
 
 
Protocol Number: DFCR-0003 
 
fungal infected toenails. The goal of the RenewalNail™ therapy is to overcome the shortcomings of both 
topical and oral therapies by combining the safety of a topical treatment with the efficacy of an oral 
treatment. Thus, the RenewalNail™ plasma treatment system may avoid systemic adverse events, achieve 
high efficacy rates, and provide a method of therapy that is not dependent on labor-intensive, long-term 
patient compliance as are other topical applications on the market today. 
 
Please review the DeviceFarm Device Description-0003 document for more details on the technology and 
the RenewalNail™ plasma treatment system. 
 
2.0 STUDY OBJECTIVES 
 
The purpose of this study is to assess the clinical feasibility of DeviceFarm, Inc.’s RenewalNail™ system and 
the treatment protocol that was developed based on extensive laboratory testing on human cadaver nails. 
 
The primary objective of this study is to evaluate the efficacy and safety of the RenewalNail™ plasma 
treatment system and Protocol in achieving mycological cure for the patient. The Protocol calls for three 
45-minute treatments performed over a week to achieve mycological cure. Mycological cure will be 
assessed with two consecutive mycological culture tests done over a week. Two consecutive negative 
mycology culture results confirm the elimination of fungus causing onychomycosis infection, as 
recommended by recent FDA guidance. There will be no placebo arm in the study. 
 
Secondary objectives include: 
 
Will the treatment protocol result in clear nail growth for the patient over a 5-month interval? 
 
Is the instrument functional in a clinical setting as related to user instructions, user interface and 
human factor analysis? 
 
Are there treatment protocol or instrument changes that would improve the treatment results, 
patient safety, or patient comfort? 
 
Are there fungal species beyond Trichophyton rubrum and Trichophyton mentagrophytes that are 
not affected by the treatment, as seen in species identification from the nail scrapings? 
 
3.0 INVESTIGATIONAL PLAN 
 
3.1 Overall Study Design 
 
DeviceFarm, Inc.’s Early Feasibility Study will be conducted as a Single-center open-label study in Subjects 
who meet the specified inclusion/exclusion criteria. Informed consent will be obtained. Characteristics of 
patients including age, gender, disease severity, and disease history will be documented during the 
screening visit. 
 
Five Subjects with Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe 
(hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. 
 
Treatments will be performed at the office of the Investigator as elaborated in the 3.4 Conduct of Study 
section below. The treatment protocol outlines three 45-minute treatments over the course of the first 
week (within 7 calendar days).  
 
Primary study endpoint will be mycological cure, which is defined as two consecutive negative cultures 
following treatment. Mycological cultures will be collected (1) during screening, (2) after the third 
treatment, and (3) around a week (5-15 calendar days) after the third treatment. 

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Secondary study endpoint will be clear nail growth. Photographs of the target toes will be taken 
throughout the study to track clear nail growth. 
 
3.2 Discussion of Study Design 
 
This study will be conducted as a Single-center, open-label, pilot study involving 5 Subjects. After giving 
informed consent, each Subject will be screened for eligibility according to inclusion/exclusion criteria. A 
Subject will be considered evaluable if he or she satisfies all admission criteria for entry into the study and 
completes the treatment protocol. 
 
3.3 Selection of Study Population 
 
Five adult Subjects will be prospectively enrolled in the study by the study site. There are no restrictions 
based on gender, race, or ethnicity. No diabetics or immunocompromised people will be enrolled. No 
minors under the age of 21 will be enrolled. No pregnant women will be enrolled. 
 
  3.3.1 Inclusion Criteria 
 
 
Subjects who are between 21 to 75 years (inclusive) of age; 
 
 
Subjects who are in good general health and free from any clinically significant disease that might 
interfere with the study evaluations; 
 
 
Subjects with established clinical diagnosis of distal subungual onychomycosis; 
 
 
Subjects with at least one big toe nail involved with 20-75% infection; 
 
 
Subjects with both positive KOH and culture for onychomycosis dermatophytes in screening of nail 
samples; 
 
 
Subjects whose infection is confirmed to be caused by T. rubrum or T. mentagrophytes; 
 
 
Subjects who are willing and able to refrain from employing other (non-study) treatments 
(traditional or alternative) for his or her toenail onychomycosis throughout study participation; 
 
 
Subjects who are willing and able to refrain from the use of nail cosmetics such as clear and/or 
colored nail lacquers during the week of treatment (from Study Visits 1 through 3); 
 
 
Subjects who are willing and able to give written informed consent and able to adhere to 
procedures and visit schedules; 
 
 
Women of childbearing potential who are currently sexually active must agree to use a medically 
accepted method of contraception while receiving protocol specified treatment. Methods include 
condoms (male or female), diaphragm or cervical cap with spermicide, medically prescribed 
intrauterine device, oral or systemic hormonal contraceptive, surgical sterilization (e.g., 
hysterectomy or tubal ligation); 
 
 
Women of childbearing potential who are not currently sexually active must agree to use a 

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medically accepted method of contraception should they become sexually active while 
participating in the study; 
 
 
Women of childbearing potential must have a negative pregnancy test prior to start of study. 
 
  3.3.2 Exclusion Criteria 
 
 
Subjects with onychomycosis infection involving lunula of the affected toenail(s) or spikes of 
disease extending to nail matrix in the affected big toenail; 
 
 
Subjects whose foot is too large (larger than US men’s size 13) or too small (smaller than US 
women’s size 3) to properly fit into the plasma treatment device; 
 
 
Subjects whose affected big toenail cannot become normal in the opinion of the investigator; 
 
 
Subjects who received topical antifungal treatment of the nails within 2 weeks before study 
initiation; 
 
 
Subjects who received systemic antifungal treatment within 3 months before study initiation; 
 
 
Simultaneous participation in another clinical study or participation in another clinical study in the 
30 days directly preceding treatment; 
 
 
Subjects who are immunocompromised (e.g. adrenal insufficiency, diabetes mellitus, febrile 
neutropenia, and the human immunodeficiency virus infected); 
 
 
Subjects with any pacemakers, or any metallic implants or prostheses in the vicinity of the 
treatment site (such as ankle, foot, etc.); 
 
 
Subjects with any clinically significant condition or situation, other than the condition being studied 
that, in the opinion of the investigator, would interfere with study evaluations or optimal 
participation in the study; 
 
 
Subjects who feel they cannot sit for 45 minutes at a time during the treatment; 
 
 
Subjects who are part of the staff personnel directly involved with this study or who are family 
members of the investigational study staff; 
 
 
Subjects with known allergy to any of the tested treatment products [i.e. perfluorocarbons and 
plastic polycarbonate]; 
 
 
Women who are pregnant, breastfeeding, or planning pregnancy prior to the end of study 
participation; 
 
  3.3.3 Withdrawal Criteria 
 
Withdrawal criteria include but are not limited to the following: 
 

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 
Investigator’s request; 
 
 
Safety reasons (e.g., severe adverse reactions); 
 
 
Subject’s request; 
 
 
Poor compliance; 
 
 
Subjects lost to follow-up. The Investigator will try to reach the Subject, twice by telephone and 
once by certified letter, before considering the Subject lost-to-follow-up. These actions will be 
reported on the Final Case Report Form and a copy of the follow-up letter will be maintained in the 
Investigator’s file. 
 
Treatment may be discontinued at any time by the investigator if, in his/her clinical judgment, it is in the 
best interest of the Subject, treatment is deemed inappropriate by a physician evaluation, or if the Subject 
cannot comply with the protocol. All premature discontinuations and their causes must and will be 
carefully documented by the Investigator on the Final Case Report Form and, if need be, on the Adverse 
Event Case Report Form. 
 
Subjects who did not complete the entire study should be fully evaluated when possible. The procedures 
designated for the Final Visit should be completed for all Subjects discontinuing. Subjects are free to 
withdraw from participating in this study at any time and for whatever reason, specified or unspecified, 
and without prejudice. 
 
  3.3.4 Subject Identifiers 
Upon screening, the Subject will be assigned a unique 3-digit Subject number that increments sequentially 
at the site (i.e., 001, 002).   At Study Visit 1/Day 1, Subjects who are eligible for participation will retain the 
same Subject number for the remainder of the study.  This Subject number is to be recorded on the Case 
Report Form for future identification and outcomes reporting.  
 
3.4 Conduct of Study 
 
3.4.1 Study Overview by Visit 
 
  3.4.1.1 Screening Visit 
 
Subjects are to be screened at the Investigator’s facility to determine eligibility for the study. Written 
informed consent is to be obtained after a careful description of the study. Written, witnessed, informed 
consent will be obtained from each Subject prior to participation in the study. The Subject will be given 
adequate time to review the informed consent document as well as address questions and concerns. 
 
Once written informed consent is granted, Screening Visit activities will be carried out as specified in 
3.4.2.1. Namely, a medical history is taken and a brief physical examination is conducted. If the Subject is 
confirmed to meet the inclusion/exclusion criteria besides positive mycological testing, they are assigned a 
Subject number and results are recorded on the Case Report Form (CRF) for each Subject. Nail scrapings 
are collected for fungal infection testing by KOH assay and mycological culture. Culture results will be 
obtained within 4 weeks of Subject’s initial screening visit. 
 

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A screen failure is a Subject who received information about the study, including signing an informed 
consent, and possibly performing some study related procedures but was not enrolled, and did not receive 
study treatment. Only the Subject number, date of visit, date of consent, reason for screen failure, and 
study status (screen failure) will be captured in the CRF for every screen failure Subject. 
 
  3.4.1.2 Study Visit 1 
 
The Subject will be scheduled for the first treatment as soon as positive mycological testing results are 
available and the Subject is confirmed to meet all inclusion/exclusion criteria. A Subject meeting all of the 
entry criteria is enrolled into the study. Day 1 activities will be carried out as specified in 3.4.2.2. 
 
  3.4.1.3 Study Visits 2-6 
 
The Subject reports back to the Investigator’s facility for the remainder of treatments. Investigator 
inquires with Subject regarding compliance, adverse events and for clinical assessment of the treated area 
of the foot. 
 
Visit 2 and Visit 3 activities will be carried out as specified in 3.4.2.3 and 3.4.2.4, respectively. Mycological 
culture collected at Visit 3 will be the first of the two consecutive cultures for assessing mycological cure. 
 
Visit 4 activities are specified in 3.4.2.5. Mycological culture collected at this visit will be the second of the 
two consecutive cultures for assessing mycological cure. 
 
On Visit 5, mycological cultures will be collected to measure rates of reinfection/recurrence. Visit 5 
activities will be carried out as specified in 3.4.2.6. 
 
Visit 6 will be the last visit of the study and activities will be carried out as specified in 3.4.2.7. 
 
  3.4.1.4 Discontinuation 
 
If an eligible Subject drops out of the study for any reason, the Investigator must make every reasonable 
effort to obtain clinical assessments of adverse events. All data should be recorded in the CRF for the 
Subject and the reason for the drop out should be documented. 
 
In the event that a Subject drops out of the study due to an adverse event, the nature of the event and its 
clinical course must be fully documented. The Investigator must attempt to follow the Subject until the 
adverse event has resolved, become clinically insignificant, stabilized, or the Subject is lost to follow-up. 
 
Subjects who drop out of the study without completing the three 45-minute treatments over the course of 
the first week (within 7 calendar days) will be considered premature drop out. The Sponsor will take 
reasonable action to replace any of the Subjects who drop out prematurely to maintain the 5-Subject 
enrollment. 
 
3.4.2 Study Procedures by Visit 
 
Activities to be performed at each visit are listed below. Please review the DeviceFarm Device Description 
and the Instructions for Use documents for details about using the Device and taking photographs with the 
camera. 

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  3.4.2.1 Screening Visit – Baseline 
 
 
Obtain Subject’s written informed consent prior to initiating any study procedures. 
 
Document Subject’s Informed Consent in the Subject’s medical record. 
 
Screen potential Subject according to the study inclusion/exclusion criteria. 
 
Take the Subject’s medical history. 
 
Perform a brief physical exam. 
 
Perform urine pregnancy test on women of childbearing potential. 
 
Photograph the infected hallux nail(s). 
o If both hallux nails are infected and meet the inclusion/exclusion criteria, both nails can be 
photographed and tested for KOH and mycology. If both are positive for KOH and culture, 
the Investigator will choose one and only treat that one in the study. 
 
Perform KOH testing of infected hallux nail(s): Before obtaining a specimen, make sure the nail is 
clipped and cleansed with an alcohol swab to remove bacteria and debris. 
 
Collect mycology sample for lab culture: Prepare and ship the mycology samples according to the 
instructions from the designated mycology laboratory. 
 
  3.4.2.2 Study Visit 1 - Day 1 
 
 
Check for conformance to inclusion/exclusion criteria. 
 
Perform debridement on the infected nail to be treated. 
 
Notch the nail. 
 
Measure distance between proximal nail fold and notch. 
 
Insert the Disposable into the RenewalNail™ plasma treatment device. 
 
Brush the top, edges, and underside of the infected nail with the Nail Penetration Enhancer. 
 
Insert the Subject’s foot into the opening of the Disposable that was placed the device. 
 
Ensure that the Subject’s foot is properly inserted into the device with a seal of the Disposable 
flexible material around the foot. 
 
Push the device power button to start the treatment. 
 
Complete the 45-minute plasma treatment. 
 
Perform clinical evaluation of the toes after plasma treatment as specified in “5.0 Safety 
Assessment/Risks” 
 
Check on occurrence of adverse events. Stop protocol if any serious adverse events occur. 
 
Photograph the treated nail. 
 
  3.4.2.3 Study Visit 2 
 
Study Visit 2 should occur no sooner than 36 hours after Study Visit 1. In no circumstance should the Subject 
receive treatment on two (2) consecutive days. 
 
Check on occurrence of adverse events. 
 
Perform a plasma treatment per instructions in the Instructions for Use of the DeviceFarm 
RenewalNail Plasma Generator DFPD-003 document. 
 
Perform clinical evaluation of the toes after plasma treatment as specified in “5.0 Safety 
Assessment/Risks” 
 
Photograph the treated nail. 
 

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  3.4.2.4 Study Visit 3 
 
Study Visit 3 should occur no sooner than 36 hours after Study Visit 2, but within 7 calendar days from 
Study Visit 1. In no circumstance should the subject receive treatment on two (2) consecutive days 
 
 
Check on occurrence of adverse events. 
 
Perform a plasma treatment per instructions in the Instructions for Use of the DeviceFarm 
RenewalNail Plasma Generator DFPD-003 document. 
 
Perform clinical evaluation of the toes after plasma treatment as specified in “5.0 Safety 
Assessment/Risks” 
 
Perform fungal scrapings for mycological culture as instructed by the laboratory. 
 
Photograph the treated nail. 
 
  3.4.2.5 Study Visit 4 - Day 12 (+/- 3 days) 
 
 
Check on occurrence of adverse events. 
 
Perform fungal scrapings for mycological culture as instructed by the laboratory. 
 
Photograph the treated nail. 
 
  3.4.2.6 Study Visit 5 - Day 42 (+/- 3 days) 
 
 
Check on occurrence of adverse events. 
 
Perform fungal scrapings for mycological culture as instructed by the laboratory. 
 
Measure nail growth (renotch, if needed) 
 
Photograph the treated nail. 
 
  3.4.2.7 Study Visit 6 - Day 168 (+/- 5 days) 
 
 
Check on occurrence of adverse events. 
 
Measure nail growth 
 
Photograph the treated nail. 
 
3.4.3 After-Treatment Instructions 
After-treatment care will be discussed in detail with each Subject as follows: 
 
Nail polish or gels should not be applied to treated nails between treatments. 
 
Do not pick at the treated nail or the skin surrounding the nail. 
 
Do not use abrasive cleansers, exfoliants, or scrubs on the treated nail or skin around the nail. 
 
 
4.0 EFFICACY ASSESSMENT 
 
4.1 Photographic Documentation 
Baseline photographs will be taken of the infected nails at the Screening Visit prior to KOH and mycology 
sampling since these sampling procedures require much of the infected nail to be removed in order to 
reach the site of active infection. 
 
Photographs will be taken of the treated nail at the end of each Study Visit to document the appearance 

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of the nail following each visits’ procedures and to allow for photographic assessment of clear nail growth 
over the course of the study. 
 
All photographs should be done with the digital camera provided by the Sponsor and following the 
instructions provided in the Instructions for Use of the DeviceFarm Nail Photography document. 
 
4.2 Mycological Cure Assessment 
Mycological culture assays will be performed at an accredited mycology laboratory after Investigator has 
acquired a specimen of subungual debris obtained from the area as close to the cuticle as possible. This 
specimen will be shipped to the mycological lab according to the laboratory instructions. A mycological 
cure is defined as two consecutive negative cultures following completion of the week of treatment. 
 
4.3 Clear Nail Growth Assessment 
Clinical improvement is assessed by clear nail growth. Clear nail growth is ultimately a more successful 
aesthetic outcome for a patient than mycological cure, though the former is more important for 
preventing secondary infections. 
 
Clinical improvement will be judged by analyzing the nail photographs and assessing the amount of clear 
nail distance from the proximal end of the nail plate towards the distal end. Clearance will be quantified 
through the Investigator’s recording of nail growth measurements and serial digital photography of the 
affected nail. 
 
Nail Marking Protocol 
Marking a notch with a blade or file at the base of the nail dystrophy is helpful to more easily quantify clear 
nail growth when analyzing serial nail photographs. 
 
At Study Visit 1, a superficial notch will be made using a scalpel, triangular file or equivalent instrument, 
approximately 5 mm long on the target surface at the midline of the nail plate proximal to the 
onychomycotic border. 
 
At Study Visits 2-6, prior to taking photographs, the Investigator will refer to the previously marked notch. 
If the notch cannot be easily seen in the photographs, the Investigator will deepen the notch and/or use 
ink, marker or other means to improve the visibility of the notch. If a notch is not present, a superficial 
notch will be made as previously done at Study Visit 1.  A comment will be added on the CRF that a new 
notch was made at that specific visit.  
 
5.0 SAFETY ASSESSMENT/ RISKS 
 
Safety will primarily be measured by the occurrence of adverse events. Adverse Events will be assessed at 
every study visit. 
 
Possible risks from the RenewalNail™ plasma treatment system include: edema, erythema, heat, 
discomfort, itching, or blistering. The use of the Device is not expected to present any new or different 
risks to those known to be associated with other FDA approved plasma devices for skin resurfacing or for 
other energy-based onychomycosis treatments such as lasers. 
 

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Protocol Number: DFCR-0003 
 
Clinical evaluations of treated toes will be assessed at each visit, using scores for each of the two 
parameters (erythema and edema); each parameter will be rated as none, mild, moderate or severe (0-3) 
by the investigator. 
 
Definitions: 
 
Sign/Symptom
Description
Erythema 
Redness around the toe(s) 
Edema 
Swelling around the toe(s) 
 
Signs and Symptoms Scoring: 
Score 
Assessment 
Description 
0 
None 
Absent; symptom not present 
1 
Mild 
Slight, barely perceptible; symptom 
does not interrupt normal daily activities nor 
does it require medical management
2 
Moderate 
Distinctive presence; symptom causes some 
interruption of normal daily activities but 
does not require medical management 
3 
Severe 
Marked, intense; symptom interrupts 
normal daily activities and requires some 
medical management
 
5.1 Adverse Events 
 
An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated 
with the use of a medicinal product, whether or not considered related to the treatment. 
 
Each subject will be monitored for the occurrence of AEs, including SAEs, immediately after treatment 
initiation. At each visit, the investigator or other site staff will question the Subject about adverse events 
using an open question taking care not to influence the Subject’s answers (e.g., “Have you had any 
medical problems since your last visit?”). 
 
Any adverse event, whether or not it is related to the treatment procedure, will be reported on the 
Adverse Event form along with the date of onset, the severity, the relationship to the treatment, and the 
outcome. Under certain circumstances, additional information may be requested. 
 
When an adverse event persists at the end of the study, the Investigator will ensure a follow-up of the 
Subject until the Investigator agrees the event is satisfactorily resolved or no further follow-up is required. 
The study requires that Subjects be actively monitored for adverse events up to and including 14 days 
after last day of the study. 
 
The severity of an adverse event will be scored according to the following scale: 
Score 
  
Interpretation  
 

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1 
Mild 
Awareness of sign or symptom, but easily tolerated 
2 
Moderate 
Discomfort enough to cause interference with usual activity 
3 
Severe 
Incapacitation with inability to perform usual activity 
 
The relationship of an adverse event to RenewalNail™ plasma treatment is to be assessed according to the 
following definitions: 
 
Not related – no temporal association, or the cause of the event has been identified, or the 
RenewalNail™ plasma treatment cannot be implicated based upon available information. 
Possibly related – temporal association, but other etiologies are likely to be the cause. 
However, involvement of the RenewalNail™ plasma treatment cannot be excluded, based 
upon available information. 
Probably related – temporal association, other etiologies are possible, but unlikely, based 
upon available information. 
Related – established temporal or other association to the event is not reasonably explained 
by the Subject’s known clinical state or any other factor, based on available information. 
 
5.2 Serious Adverse Events 
 
A serious adverse event (SAE) or reaction is defined as any untoward medical occurrence that at any dose: 
 
results in death; 
 
is life-threatening, (the term “life-threatening” in the definition of “serious” refers to an event in 
which the Subject was at risk of death at the time of the event; it does not refer to an event which 
hypothetically might have caused death if it were more severe); 
 
requires inpatient hospitalization or prolongation of existing hospitalization; 
 
results in persistent or significant disability/incapacity; or 
 
is a congenital anomaly/birth defect. 
 
Any SAE occurring in a Subject receiving study solution, and any SAE occurring during the 30 days post-
treatment that the Investigator becomes aware of, must and will be reported by the Investigator or 
designee to the Study Medical Monitor within 24 hours even if the SAE does not appear to be 
RenewalNail™ plasma treatment related. This should be done by telephone and by sending a copy of the 
Serious Adverse Event form plus other supporting documentation, as required. 
 
All additional follow-up evaluations must be reported to the Sponsor immediately. All SAEs will be 
followed until the Investigator/Sponsor agrees the event is satisfactorily resolved or no further follow-up 
is required. 
 
The Investigator/Sponsor will be responsible for notifying the relevant authorities of any SAE, as outlined 
in the ICH Guidelines. The Sponsor will also ensure that the appropriate IRB is notified of the SAE. 
 
5.3 Risk Management 
Subjects will be followed closely during the course of the trial and will have access to the Investigator 
and/or study staff at all times via provision of after-hours telephone. All known risks will be disclosed to 

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the Subject via the informed consent process. Subjects will be informed both verbally and in writing in a 
timely manner of any new information that might relate to safety or their willingness to continue in the 
study. 
 
6.0 BENEFITS 
There is no guarantee of success for the treatment. To the extent that a Subject may be uncertain if they 
have a fungal nail infection, the screening in this study may provide them with a laboratory result that 
positively or negatively supports this diagnosis. Being in this study may reduce or eliminate their fungal nail 
infection, but this is an experimental study and there is limited information about the safety and 
effectiveness of plasma treatment for fungal nail infections. 
There may be a societal benefit from what is learned leading to improved onychomycosis treatment in the 
future. 
 
7.0 Test Materials 
 
7.1 Administration 
 
Device Name 
RenewalNail™ Treatment System DFPD-003 
Treatment Schedule 
45-minute treatments on Study Visits 1, 2 and 3 
Route of Administration 
Topical 
 
7.2. Packaging and Labeling 
 
Study Device (RenewalNail™ plasma treatment device) will be packaged to ensure safe transportation 
from the Sponsor’s site to the study site. Each Device and Disposable will be labeled with a unique ID 
number for tracking purposes. Instructions for Use and warnings will be included. 
 
Study Device label will include the Sponsor’s name, study protocol number, and warning: “Caution: 
Limited by Federal (United States) law to investigational use only.” 
 
7.3 Subject Treatment and Use Instructions 
 
Each Subject receiving treatment will receive verbal instructions as part of the informed consent regarding 
the treatment protocol. All site personnel taking part in the study will be trained on handling and use of 
the device. Each Subject’s plasma gas treatment will be done automatically and under the supervision of 
the Investigator. 
 
7.4 Accountability 
 
The Sponsor will provide the study Device, Disposables, Nail Penetration Enhancer (perfluorodecalin), and 
Instructions for Use documents to the Investigator. Receipt of all study supplies will be confirmed and 
documented by the site. In accordance with federal regulations, the Investigator must agree to keep all 
clinical supplies in a secure location with restricted access. All supplies provided to the Investigator must 
not be used in any unauthorized manner. All used and unused supplies will be appropriately inventoried 
and returned to the Sponsor. 

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7.5 Prior and Concomitant Therapy 
 
Therapies used within six months of signing the Informed Consent Form should be recorded on the 
Previous/Concomitant Therapy Form of the CRF. Washout medications should be listed on the 
Previous/Concomitant Therapy Form when applicable. 
 
Information on concomitant therapy should be recorded on the Previous/Concomitant Therapy Form of 
the CRF. Any therapy used by the Subject will be considered concomitant therapy (e.g., antifungal therapy, 
birth control pills, immunosuppressant therapy, etc.). Every attempt should be made to keep concomitant 
therapy dosing constant during the study. Any change to concomitant therapy should be noted on the 
Previous/Concomitant Therapy Form. An Adverse Event Form should be completed for any Subject 
starting a concomitant therapy (except therapies used prophylactically) to treat any health 
condition/event not identified in the Subject’s baseline medical history. 
 
8.0 Monitoring 
 
8.1 Clinical Monitoring/Auditing 
 
The Sponsor will ensure that a qualified monitor is available to oversee the conduct of the trial and that 
monitoring is performed in accordance with applicable procedures and regulations. The monitor will 
evaluate compliance with the investigational plan, FDA regulations, IRB guidelines, and the signed 
Investigator agreement. In addition, inspections or on-site audits may be carried out by the FDA or by the 
Sponsor’s independent Quality Assurance Department. The Investigator will allow the Sponsor’s 
representatives and any regulatory agency to examine all study records, CRFs, corresponding Subject 
medical records, and any other documents considered source documentation. The Investigator will allow a 
representative of the Sponsor to observe the treatment as part of a technical assessment about the 
performance of the instrument, as long as the Subjects have provided optional consent for this 
observation. The Investigator also agrees to assist the representative, if required. 
 
8.2 Regulatory Obligations 
 
The RenewalNail™ plasma treatment device is a Non-Significant Risk Investigational Device and as such is 
Subject to the abbreviated IDE regulations, including records and reporting, device disposition, and study 
monitoring. 
 
9.0 Statistical Methods Planned 
 
Due to the nature of the study and the small number of Subjects, no inferential statistical analyses will be 
performed. The results from this study will be used to determine whether the treatment can achieve 
mycological cure for onychomycosis Subjects fulfilling the inclusion/exclusion criteria. 
 
Mycological cure is defined as an achievement of negative culture results for both Trichophyton rubrum 
and Trichophyton mentagrophytes from both Visit 3 and Visit 4. 
 
The data is too small to summarize with descriptive statistics; therefore, Subject listings will be presented. 

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9.1 Safety Analyses 
 
The type, severity, duration, and frequency of reported adverse events will be tabulated. Adverse events 
will also be summarized for events that were considered treatment-related. Adverse events will be 
presented in Subject listings to include the start date and time, stop date and time, relationship to study 
procedure, severity, and action taken. Serious adverse events will be presented in a separate listing. The 
safety endpoints will be an assessment of: 
 
• 
Device-related adverse events 
• 
Overall rate and severity of all reported adverse events 
 
9.2 Changes in Study Conduct/Statistical Analyses /Amendments 
 
No change in the conduct of the study should be instituted without written approval from the Sponsor and 
the IRB. 
 
10.0 ETHICS AND GENERAL STUDY CONDUCT CONSIDERATIONS 
 
10.1 Institutional Review Board (IRB) 
 
This study and all appropriate amendments will be reviewed and approved by an Institutional Review 
Board according to the established IRB procedures. 
 
10.2 Ethical Conduct of the Study 
 
This study will be conducted in accordance with the ethical principles originating from the Declaration of 
Helsinki and GCPs. 
 
10.2.1 Principal Investigator 
The Principal Investigator is responsible for conducting this study in accordance with all applicable laws 
and IRB approved documents. The Investigator must ensure adherence to the procedures outlined in this 
Study Protocol. The procedures set out in this study protocol, pertaining to the conduct, evaluation, and 
documentation of this study, are designed to ensure that the Investigator abides by GCP as described in 
the ICH Guidelines Topic E6: “Guideline for Good Clinical Practice.” Compliance with these regulations also 
constitutes compliance with the ethical principles described in the current revision of the Declaration of  
Helsinki. The study will also be carried out in keeping with local legal and regulatory requirements. 
 
10.3 Record Keeping 
 
10.3.1 Data Collection 
 
Data for this study will be recorded in the Subject’s chart and transcribed onto the Subject Case Report 
Forms (CRFs) provided by the Sponsor. Data will be captured and compiled using procedures developed by 
the Sponsor or designee. Data must be recorded promptly, completely and accurately on the CRFs. 
Whenever possible, record the reason for missing data in the source document. Only individuals who are 
identified on the study personnel responsibility log and who have received appropriate training on the CRF 

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or data entry system may enter or correct data on the CRFs. 
 
10.3.2 Data Corrections 
 
Corrections of data entered on original CRFs must be made using standard good documentation practice. 
Incomplete or inconsistent data on CRFs will result in data queries that require resolution by the 
Investigator or designee. Corrections to the CRFs, including reasons for change, will be documented 
through the audit trail. The Sponsor Monitor will review the CRFs, evaluate them for completeness and 
accuracy, and ensure that all appropriate corrections are made. 
 
10.3.3 Source Documentation 
 
The Investigator must maintain detailed source records on all study Subjects. Subject source data must be 
maintained as original records or a certified copy. The Investigator and institution should take measures to 
prevent accidental or premature destruction of documents. Investigators must keep accurate separate 
records (other than the Case Report Forms) of all Subject visits which include all pertinent study related 
information including the original signed/dated Informed Consent Forms. As a minimum, a statement 
should be made indicating that the Subjects have been enrolled in the study and that they signed an 
Informed Consent Form prior to administration of any study-related procedure. Any and all side effects 
and adverse events must be thoroughly documented. Results of any diagnostic tests conducted during the 
study should also be included in the source documentation. Telephone conversations with the Subjects 
and/or Sponsor concerning the study must also be documented. 
 
10.3.4 Archives 
 
Case Report Forms will identify Subjects only by assigned study number and will be stored on site in a 
secure location. All pertinent data, correspondence, original or amended protocol, all reports and all other 
material relating to the study will be maintained securely in Sponsor/Investigator archives for either: 
(a) a period of at least 2 years following the date on which the treatment device is approved by 
FDA for marketing for the purposes that were the Subject of the clinical investigations, or 
(b) a period of at least 2 years after the date on which the entire investigation (all clinical trials) is 
terminated and FDA is notified. 
 
Access will be granted only to the clinical investigators, study staff, study Sponsor, and associated 
regulatory authorities. If the Principal Investigator retires, relocates, or for other reasons withdraws from 
the responsibility of keeping the study records, custody must be transferred to a person who will accept 
the responsibility. The Sponsor must be notified in writing of the name and address of the new custodian. 
 
DEVICE ACCOUNTABILITY 
 
The Devices to be used in this study are the sole property of the Sponsor. All provided products to be used 
for this study and their receipt, inventory, dispensing, and reconciliation records will be maintained in 
compliance with federal regulations. Upon completion or termination of the study the site will be 
responsible for returning or disposing of all partial and unused products under FDA regulations.

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11.0    INVESTIGATOR AGREEMENT 
 
I have read Protocol No: DFCR-0003 “A Single Center Open Label Early Feasibility Study to Evaluate the 
Efficacy and Safety of the RenewalNail™ Plasma Treatment System in Patients with Mild to Moderate 
Onychomycosis (Fungal Nail) of the Hallux caused by Trichophyton rubrum or Trichophyton 
mentagrophytes.” and agree that it contains all of the information necessary to conduct the study. I 
agree to conduct the study as described herein, and will complete the study within the time designated. 
In addition, I agree to conduct all my activities related to the study in accordance with ICH Guidelines 
for Good Clinical Practice, the Code of Federal Regulations, the Health Insurance Portability and 
Accountability Act (HIPAA) and local regulatory guidelines. I will discuss study-related information with all 
study personnel responsible to me to ensure that they are adequately informed regarding conduct of 
the study. I agree to keep records on all Subject information (case report forms, shipment and device 
return forms and all other information collected during the study) in accordance with FDA regulations. I 
will ensure that the rights, safety and welfare of Subjects under my care are protected. Only an 
Investigator designated on the Statement of Investigator (Form FDA 1572) may sign Case Report Forms. 
I will not enroll any Subjects into this protocol until proper regulatory, IRB and Sponsor approval is 
obtained. 
 
I will provide copies of the proposal and all information available on the RenewalNail™ plasma 
treatment system  relating to preclinical and prior clinical experience, which was furnished to me by 
the Sponsor to all physicians, nurses and other personnel responsible to me who will participate in this 
study. I will discuss this material with them to assure that they are fully informed regarding the device 
and the conduct of the study. 
 
I agree that the conduct and results of this study will be kept confidential. I agree that the case report 
forms and other data pertinent to this study are the property of DeviceFarm, Incorporated, who may 
utilize the data in various ways, such as for submission to government regulatory agencies, or in 
publication of the results of the study, if applicable. To prevent premature disclosure of trade secrets or 
other confidential information, I agree that the timing of a separate presentation or publication of the 
study by me will be subject to mutual agreement in advance with DeviceFarm, Incorporated. 
 
I further agree that DeviceFarm, Incorporated shall have access to any source documents from which case 
report form information may have been generated. 
 
 
 
 
 
 
 
 
Principal Investigator Signature 
Date 
 
 
 
 
Printed Name