A Multicenter, Prospective, Treat and Resect Feasibility Study of the CellFX System for the Treatment of Low-Risk Basal Cell Carcinoma (BCC) Lesions
Phase: NA
Conditions: BCC - Basal Cell Carcinoma, BCC, Excision Margin
Sponsor: Pulse Biosciences, Inc.

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Clinical Investigational Plan 
 
 
Study Title: A Multicenter, Prospective, Treat and Resect IDE Feasibility Study of the 
CellFX® System for the Treatment of Basal Cell Carcinoma (BCC) Lesions 
 
 
 
Short Title: CellFX Treat & Resect BCC Feasibility Study 
 
 Protocol No: NP-TR-014 
Version 2.0 
29-APR-2021 
 
 
IDE Number: G210100  
NCT: 04918381 
 
 
Study Sponsor: 
 
Pulse Biosciences, Inc. 
3957 Point Eden Way 
Hayward, CA 94545 
 
 
This document is a confidential communication of Pulse Biosciences, Inc.  The recipient agrees that no unpublished information 
contained herein will be published or disclosed without prior written approval of Pulse Biosciences, Inc. except that this document 
may be disclosed to appropriate institutional review boards, ethics committees or duly authorized representatives of the U.S. Food 
and Drug Administration or other responsible regulatory authorities under the condition that confidentiality is maintained. 
 
PROPRIETARY AND CONFIDENTIAL 
 
 
 
 
 

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TABLE OF CONTENTS 
 
STUDY CONTACTS .............................................................................................................................. 4 
1.0 
INTRODUCTION AND BACKGROUND ................................................................................ 5 
1.1 
Basal Cell Carcinoma Lesions ............................................................................................... 5 
1.2 
Current Care .......................................................................................................................... 5 
1.3 
Non-Surgical Approach .......................................................................................................... 5 
1.4 
Surgical Approach .................................................................................................................. 7 
1.5 
Alternative Approach .............................................................................................................. 8 
1.6 
Study Rationale ...................................................................................................................... 8 
2.0 
STUDY DEVICE DESCRIPTION ........................................................................................... 9 
2.1 
Pulse Bioscience CellFX® System ......................................................................................... 9 
2.2 
Proposed Indication for Use................................................................................................. 10 
3.0 
PROTOCOL ......................................................................................................................... 10 
3.1 
Study Objectives .................................................................................................................. 10 
3.2 
Study Design ........................................................................................................................ 11 
3.3 
CellFX Procedure ................................................................................................................. 12 
3.4 
Site Selection ....................................................................................................................... 12 
3.5 
Number of Subjects ............................................................................................................. 13 
3.6 
Clinical Study Duration ......................................................................................................... 13 
4.0 
STUDY PROCEDURES ...................................................................................................... 13 
4.1 
Screening ............................................................................................................................. 13 
4.2 
Subject Selection ................................................................................................................. 13 
4.2.1 
Inclusion Criteria .................................................................................................................. 13 
4.2.2 
Exclusion Criteria ................................................................................................................. 14 
4.3 
Process for Obtaining Informed Consent ............................................................................. 14 
4.3.1 
Process for Obtaining Informed Consent ............................................................................. 15 
4.3.2 
Addition of New Information ................................................................................................. 15 
4.4 
Schedule of Events and Evaluations ................................................................................... 16 
4.5 
Screening / Enrollment Procedures (Visit 1) ........................................................................ 17 
4.5.1 
Activities prior to or on same day as study enrollment ........................................................ 17 
4.5.2 
Definition of Enrollment ........................................................................................................ 17 
4.5.3 
CellFX Treatment Procedure ............................................................................................... 17 
4.6 
3-Day Follow-up Visit (Visit 2) .............................................................................................. 18 
4.7 
7-Day Follow-up Visit (Visit 3) .............................................................................................. 18 
4.8 
14-Day Follow-up Visit (Visit 4) ............................................................................................ 18 
4.9 
30-Day Follow-up Visit (Visit 5) ............................................................................................ 18 
4.10 
60-Day Follow-up Visit (BCC Surgical Excision Day – Visit 6) ............................................ 18 
4.11 
14-Day Post-Excision Follow-up Visit (Visit 7) ..................................................................... 19 
4.12 
30-Day Post-Excision Follow-up Visit (Visit 8) ..................................................................... 19 
4.13 
60-Day Post-Excision Follow-up Visit (Visit 9) ..................................................................... 19 
4.14 
Subject Withdrawal .............................................................................................................. 19 
4.15 
Discontinuation of CellFX Treatment Session ..................................................................... 20 
4.16 
Lost to Follow-Up ................................................................................................................. 20 
5.0 
BENEFITS AND RISKS ....................................................................................................... 20 
5.1 
Benefits ................................................................................................................................ 20 
5.2 
Risks .................................................................................................................................... 21 
5.3 
Mitigation of Risks ................................................................................................................ 21 
6.0 
STATISTICAL CONSIDERATIONS ..................................................................................... 22 
6.1 
General Approach ................................................................................................................ 22 
6.2 
Analysis of the Primary Effectiveness Endpoint .................................................................. 22 
6.3 
Analysis of Secondary Endpoints ........................................................................................ 22 
6.3.1 
Change in Lesion Size ......................................................................................................... 22 

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6.3.2 
Lesion Reduction Category.................................................................................................. 22 
6.3.3 
Partial response of target (study) lesion as assessed by WHO  criteria ............................. 23 
6.3.4 
SCAR-Q Appearance Scale (Subject) ................................................................................. 23 
6.3.5 
Manchester Scar Scale (Investigator) .................................................................................. 23 
6.3.6 
Healing assessment questions (Investigator) ...................................................................... 23 
6.4 
Safety Endpoints .................................................................................................................. 24 
6.4.1 
Primary Safety Endpoint ...................................................................................................... 24 
6.4.2 
Investigator Local Skin Reaction Assessment ..................................................................... 24 
6.4.3 
Participant Assessment of Procedural Pain......................................................................... 24 
6.5 
Sample Size Determination ................................................................................................. 25 
6.6 
Populations for Analyses ..................................................................................................... 25 
6.7 
Sub-Group Analyses ............................................................................................................ 25 
6.8 
Interim Analyses .................................................................................................................. 25 
6.9 
Missing Data ........................................................................................................................ 25 
6.10 
Exploratory Analysis ............................................................................................................ 25 
7.0 
CLINICAL PHOTOGRAPHY ................................................................................................ 26 
8.0 
ADVERSE EVENTS ............................................................................................................ 26 
8.1 
Adverse Event Definitions .................................................................................................... 27 
8.1.1 
Adverse Event (AE): (ISO 14155:2011 3.2)......................................................................... 27 
8.1.2 
Adverse Device Effect (ADE): (ISO 14155:2011 3.1) .......................................................... 27 
8.1.3 
Serious Adverse Event (SAE) (ISO 14155:2011 3.37) ........................................................ 27 
8.1.4 
Serious Adverse Device Effect (SADE): (ISO 14155:2011 3.36) ........................................ 27 
8.1.5 
Unanticipated Adverse Device Effect (UADE): (21CFR812.3) ............................................ 28 
8.2 
Device Deficiencies (ISO 14155:2011 3.15) ........................................................................ 28 
8.2.1 
Definitions ............................................................................................................................ 28 
8.3 
Safety Reporting Requirements ........................................................................................... 28 
9.0 
STUDY MANAGEMENT (SPONSOR RESPONSIBILITIES) .............................................. 29 
9.1 
Sponsor Ethical and Regulatory Considerations.................................................................. 29 
9.2 
Selection of Clinical Sites..................................................................................................... 29 
9.3 
Site Training ......................................................................................................................... 29 
9.4 
Investigator Training ............................................................................................................ 30 
9.5 
Monitoring of Study Sites ..................................................................................................... 30 
9.5.1 
Monitoring Methods ............................................................................................................. 30 
9.5.2 
Periodic Monitoring Visits (Onsite and Remote) .................................................................. 30 
9.5.3 
Site Close-out Visit ............................................................................................................... 31 
9.6 
Protocol Deviations .............................................................................................................. 31 
9.7 
Study Completion ................................................................................................................. 31 
9.8 
Audits / Inspections .............................................................................................................. 31 
9.9 
Publication Policies .............................................................................................................. 32 
9.10 
Data Management ............................................................................................................... 32 
9.11 
Case Report Forms /Transmission of Data ......................................................................... 32 
9.12 
Data Retention ..................................................................................................................... 32 
10.0 
INVESTIGATOR RESPONSIBILITIES ................................................................................ 33 
10.1 
IRB Approval and Informed Consent ................................................................................... 33 
10.2 
Data Collection and Reporting ............................................................................................. 33 
10.3 
Source Documents / Records Retention ............................................................................. 34 
10.4 
Device Accountability ........................................................................................................... 34 
11.0 
REFERENCES .................................................................................................................... 35 
12.0 
APPENDICES ...................................................................................................................... 35 
12.1 
Appendix A: Patient Informed Consent ................................................................................ 35 
12.2 
Appendix B: Case Report Forms ......................................................................................... 35 
APPENDIX A: Patient Informed Consent ........................................................................................ 36 
APPENDIX B: Case Report Forms .................................................................................................. 37 
 

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STUDY CONTACTS 
 
Name, Address and Contact 
Study Sponsor 
Pulse Biosciences, Inc. 
3957 Point Eden Way 
Hayward, CA 94545 
  
Official Sponsor Correspondent 
William A. Knape   
VP, Clinical, Regulatory, and Quality Affairs 
Pulse Biosciences, Inc. 
3957 Point Eden Way 
Hayward, CA 94545 
Phone: 919.757.2033  
bknape@pulsebiosciences.com 
Central Institutional Review Board 
Advarra Institutional Review Board 
6940 Columbia Gateway Drive, Suite 110 
Columbia, MD 21046 USA 
Phone: 410.884.2900 
Dermatopathology/Core Lab 
 
Darius Mehregan, M.D. 
Aurora Diagnostics  
Pinkus Dermatopathology Laboratory 
1314 North Macomb St 
Monroe, Mi. 48162 
Phone: 800.746.5870   
 
Clinical Photography 
 
Canfield Scientific, Inc. 
4 Wood Hollow Road 
Parsippany, NJ 07054 
 
 
 

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1.0 INTRODUCTION AND BACKGROUND 
1.1 Basal Cell Carcinoma Lesions 
Basal cell carcinoma (BCC) arises from the basal cell layer of the epidermis and is the most 
common cancer among Caucasians globally.1 The lesions usually occur on sun-exposed skin in 
adults, and locations are stratified by risk.  Medium- and high-risk locations are the head, neck, 
genitals, hands, feet, and pretibial while low risk areas are the trunk and extremities (aside from 
the ankles and other areas included in the medium- and high-risk locations).2 BCC lesions are 
rarely life threatening and the primary goal of treatment is complete removal of the tumor with 
maximum preservation of function and cosmesis.2  
 
1.2 Current Care 
The current care of BCC lesions includes topicals such as imiquimod cream, radiotherapy, 
curettage and electrodesiccation, cryosurgery, photodynamic therapy, MOHs surgery and 
surgical excision depending on multiple factors such as sub-type of the BCC, risk status, lesion 
size, anatomic location, patient age, etc. The currently recommended treatments of 
electrodessication and curettage, surgical excision/MOHs surgery or other modalities are often 
dependent upon the technique of the health care professional for adequate results and often 
leave scars and require down time for healing.3   
 
1.3 Non-Surgical Approach  
 
Topical Treatments 
Topical Imiquimod 5% Cream 
Topical 5% Imiquimod Cream is indicated for use on primary superficial BCC lesions. It requires 
doses 5 times per week for 6 weeks and is applied by the patient. Imiquimod is a toll-like receptor 
(TLR)-7 agonist and is thought to exert its anti-tumor effect via modification of the immune 
response and stimulation of apoptosis in BCC cells.4 Intense local inflammatory reactions can 
occur with side effects including itching, pain and tenderness at the target site, burning, 
erythema, scabbing, excoriation/flaking, induration, edema, ulceration and vesicles.5 The 
cosmetic outcome for topical imiquimod cream is superior to surgical excision but inferior in cure 
rate. 5% Imiquimod cream may also be used as pretreatment to Mohs in order to decrease tumor 
size and furthermore reduce surgical defect size or as an adjuvant therapy.6 
 
Topical 5-fluorouracil 
5-fluorouracil is a pyrimidine analogue which induces apoptosis due to cytotoxic metabolite 
incorporation into DNA and RNA.7 This treatment modality is approved for use for superficial 
BCCs and involves topical application two times per day for a minimum of two weeks. This 
method has similar efficacy, safety, and cosmetic outcomes as imiquimod.2 The most common 
skin effects include erythema, pruritus, dermatitis, burning sensation and photosensitivity.7 
 
Oral Medications/Systemic Therapies 
Hedgehog Pathway Inhibitors 
Current FDA approved hedgehog pathway inhibitors, such as vismodegib and sonidegib, are used 
for locally advanced BCCs in which curative radiotherapy and surgery are not feasible. 
Vismodegib is FDA approved for treatment in adults with metastatic BCC or locally advanced BCC 

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that has recurred following surgery or who are not candidates for surgery or radiotherapy. 
Drawbacks for hedgehog pathway inhibitors are that resistance can be developed in advanced 
BCCs and AEs were seen in almost all subjects in clinical trials conducted. The most common AEs 
seen included muscle spasms, alopecia, nausea, weight loss and fatigue.2 
 
Intralesional Interferon   
Intralesional injection of interferon alpha-2b can be effective in treating low risk BCC lesions but 
it does not offer much patient convenience as it requires injections 3 times a week for 3 weeks 
and can be expensive. Side effects include erythema and flu-like symptoms.1,8 
 
Physical Destruction 
Radiotherapy (RT)/Radiation Therapy 
Radiotherapy, along with surgical excision and Mohs surgery have the lowest failure rates among 
treatment options for BCC with overall 5-year cure rates ranging from 79%-100%.9 This 
treatment modality is often utilized for lesions in areas that are difficult to resect, where patients 
are not good candidates for surgery and is recommended for patients over the age of 60. The 
length of the treatment regimens may vary, as the total dose and dose per fraction of 
radiotherapy used differ. The main concerns with this therapy are acute toxicity to normal cells, 
late radiation toxicity and long-term side-effects due to radiotherapy. Most published studies 
have concluded cosmetic outcomes to be satisfactory where evaluated. A visible scar is common 
based on the dose regimen. Other cosmesis related effects include alopecia, pigmentation 
change, telangiectasia, fibrosis/scar, atrophy, contraction and epiphora; and rarely soft tissue 
necrosis, bone necrosis, cataracts, dry eye, conjunctival scarring, and eyelid deformity in 
published studies.9 
 
Cryosurgery 
This treatment method involves the application of extreme cold to the lesion area with liquid 
nitrogen. The direct cooling applied to the BCC lesion disrupts the cellular architecture, 
membrane integrity, and enzymatic activity. Malignant cells are particularly sensitive to cryo 
therapy due to their nature of high-water content, high metabolism and microcirculation.7 Once 
the growth freezes, it tends to fall off within days. Treatment results may vary with this 
procedure; past research has shown that pigmentary changes such as hypopigmentation are 
common, as well as erythema, edema, blistering, hypertrophic scarring, alopecia, tissue 
distortion and milia or pyogenic granuloma formation. 7 The cosmetic outcome is lower for 
cryotherapy compared to other treatment modalities. The pigmentary changes that arise due to 
treatment is shown to be dependent on the patient’s Fitzpatrick Scale ranking.  
 
Lasers & Photodynamic Therapy (PDT) 
Photodynamic therapy is a light emitting therapy where low risk BCC lesions are treated with 
combined use of visible light and a photosensitizing agent, commonly 5-aminolevulinic acid 
(ALA), methyl aminolevulinate (MAL) or porfimer sodium. The skin is pre-treated using a 
photosensitizing, prescription gel that reacts with the light source, either IPL (Intense pulsed 
light) or a 405-420 nanometer blue light laser.10 Generally, this mode of treatment will require 
several treatment visits, such as 4 sessions at 4-week interval when using the 405-420nm blue 
light laser.10 Debulking prior to PDT has shown to be more efficacious and has become standard 
practice with this treatment method.7  This method has greater cosmesis when compared to 
surgical excision, with effects seen including ulcerations but is reserved for superficial BCC lesions 
less than 1-2mm thick due to insufficient penetration of the photosensitizer and light source. 7 

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PDT has similar efficacy as cryo, imiquimod and 5-FU but higher recurrence rates compared to 
imiquimod and higher patient pain reported compared to other modalities.1 
 
Treatment of BCC with lasers include treatments with long pulsed 1064nm NDYAG Lasers and 
595 pulsed dye lasers. Lasers work to treat BCCs by specifically targeting the vasculature that 
supplies the tumor to reduce tumor burden or eliminate the BCC.11 Multiple treatments are often 
required. Post laser treatment a crust appears and tends to fall off after a week. Treatments may 
lead to transient side-effects including infection, erythema, edema, crusting and discoloration. 
The pigmentary changes that arise post-treatment may be dependent on Fitzpatrick Scale 
ratings. 
 
Curettage and Electrodesiccation (C&E) 
This treatment modality is a recommended treatment option for low-risk basal cell carcinomas 
in non-hair-bearing areas that do not involve tissue past the subcutaneous layer. 1  
The electrocautery procedure uses a pencil-shaped metal instrument or needle to destroy or 
heat the growth via a high-frequency electric current that is applied within the lesion.  
Curettage involves scraping off the BCC lesion with a sharp knife or small, spoon-shaped tool 
down to a firm layer of normal epidermis.1 Curettage may be combined with electrocautery to 
prevent regrowth of the lesion and it can also be used in conjunction with liquid nitrogen to 
produce better results than just using liquid nitrogen alone.  
When the two procedures are combined, first, a curette is used to scrape off undesirable cells 
down to the level of uninvolved tissue. This is then followed by electrosurgery to widen the 
region of cell destruction and removal, and to cauterize the wound in order to limit bleeding. The 
healing process for such procedures can take a few weeks or longer, depending on the size of 
the wound and other factors. A scab forms and will generally fall off in a few days. The procedure 
can cause post-inflammatory hyperpigmentation in the treated area and although 
electrocauterization provides complete removal, there is no guarantee that another lesion will 
not develop nearby. Risk factors include reopening of wounds, scarring, temporary or permanent 
nerve damage (in regions with extensive nerves), subcutaneous bleeding and/or infections. 
 
1.4 Surgical Approach 
 
Standard Surgical Excision 
This treatment modality is the standard of care for off-face BCC lesions, as it is the most effective 
and efficient for eliminating the BCC Lesion. This therapeutic method will be utilized in this study 
60 days post-NPS treatment (Visit 6). It involves a standard excision with 4-mm clinical margins 
and post-operative margin assessment with second intention healing, linear repair or skin graft.2 
This treatment modality often leaves a scar and some areas are difficult to excise rendering this 
method infeasible. 
Mohs Micrographic Surgery (MMS) 
Mohs Micrographic Surgery with margin assessment is also a standard of care and has the lowest 
5-year recurrence rate (1% and 6% of primary and recurrent BCC lesions, respectively). It allows 
intraoperative analysis of 100% of the excision margin. 1 
 

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1.5 Alternative Approach  
CellFX® System 
The CellFX System is intended to be used for dermatological procedures in adult patients (greater 
than or equal to 22 years old) for the reduction, removal, and/or clearance of cellular-based 
benign lesions and low-risk basal cell carcinoma (BCC), as an alternative to surgery and other 
more destructive methods for removing skin lesions. The CellFX System utilizes localized delivery 
of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.  
The effect on tissue takes place in a very shallow depth of skin directly below the sterile 
treatment tip. Histology of skin treated with CellFX has demonstrated selective effects on cellular 
structures, including melanocytes, epidermal cells, and adnexal structures, including sebaceous 
glands and eccrine glands, with no apparent damage to the adjacent acellular dermis.  The device 
delivers less energy to tissue, and does not emit thermal energy like laser, electro-surgery, or 
electro-cautery equipment. 
 
Prior Clinical Studies Summary 
Thirteen (13) clinical studies have been or are currently being conducted using IRB approved non-
significant risk protocols and consent with the Nano-Pulse Stimulation (NPS) device. Two 
approved IDE pivotal studies are currently being conducted. A combined total of approximately 
3,600 NPS application cycles have been delivered to about 700 adult Subjects. Anatomic 
locations where NPS has been used include the face, trunk, neck, arms, legs, hands, and feet. 
Discomfort in all protocols was managed with localized injected buffered Lidocaine, often with 
epinephrine. Side effects consisted of relatively minor reactions consistent with routine wound 
healing. No device or procedure complications and no serious related adverse events were 
reported. Only minor expected adverse skin effects were observed that are expected to resolve. 
 
A Non-Significant Risk (NSR) Acne Feasibility study (NP-AF-009) was conducted using the Nano-
Pulse Stimulation (NPS) device on back acne. The study involved the treatment of acne lesions in 
a 7cmx7cm area of the back with 49 cycles of energy delivered via the 10.0mm x 10.0mm 
treatment tip across a range of energy settings. The entire treatment area healed as expected 
with some residual hyperpigmentation, which is expected to resolve over time. 
 
An initial NSR BCC feasibility study (NP-BC-005) demonstrated that the NPS Device was successful 
in treating basal cell carcinoma lesions without safety concerns. A portion of 1-2 biopsy 
confirmed BCC lesions were treated in the 48 Subjects enrolled. 48 NPS treated areas were 
evaluated by a board certified dermatopathologist. There was no presence of BCC located within 
the NPS treated area in all samples analyzed for superficial and nodular low risk BCC lesions. The 
treated areas showed favorable healing clinically. 
 
 
1.6 Study Rationale  
The rationale for this treat-and-resect BCC IDE feasibility study is to collect data on the safety 
and effectiveness of the CellFX System for the treatment of low-risk BCC lesions in adult subjects. 
The data derived from this feasibility study will additionally be utilized to determine an optimal 
treatment for basal cell carcinoma and design a pivotal study to support FDA approval for such 
intended use. 
 
 

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2.0 STUDY DEVICE DESCRIPTION 
The study device being evaluated is the Pulse Bioscience CellFX® System. 
 
2.1 Pulse Bioscience CellFX® System  
The CellFX System is manufactured by Pulse Biosciences, Inc. and consists of an electrical pulse 
console (similar to devices used to electro-coagulate tissue) combined with a handpiece which is 
held by the clinician during application of pulses to the skin surface. The handpiece is coupled to 
a sterile, single patient-use treatment tip.  
Once the electrical pulse console is turned on and a predetermined treatment energy setting is 
selected, a sequence of pre-programmed electrical pulses is administered to an area of skin 
directly beneath the treatment tip.  A common commercially available sterile contact gel may be 
applied to the skin or treatment tip surface to ensure good electrical contact to the tissue. The 
three system components are as follows, shown in Figures 1-3.  
1. CellFX Console including a built-in touch screen for setting selection. 
2. CellFX Handpiece (re-usable) 
3. Sterile Single Patient-Use CellFX Tip (multiple different tip sizes available) 
 
Figure 1: CellFX Console 
 
Touchscreen Display
Accessories Drawer
Standby Indicator
Handpiece Connector
Locking Casters

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Figure 2: CellFX Handpiece 
 
 
 
 
 
 
 
 
 
 
 
 Figure 3: CellFX Tips 
 
2.2 Proposed Indication for Use 
The Pulse Biosciences’ CellFX System is investigational in the U.S. and the system is indicated for 
dermatologic procedures requiring ablation and resurfacing of the skin including the treatment 
of benign and non-malignant lesions. 
 
 
3.0 PROTOCOL 
3.1 Study Objectives 
The primary objectives of this study are to evaluate the safety and effectiveness of the CellFX 
System in adults with low-risk basal cell carcinoma. Table 1 below reflects the study endpoints 
associated with the two objectives. 
 
 
 
 
 
 
 
 
 
 
 
LED Indicator
Side Button –
Treatment Level 
Selectio
n
10 Ft. Cable
Tip Receptacle
Hook – For Hanging Handpiece
Finger Switch – Cycle Start
Console Connector
7.5mm x 7.5mm Tips 
10.0mm x 10.0mm 
5.0mm x 5.0mm Tips 

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Table 1. Study Objectives and Endpoints 
 
Objectives 
Endpoints 
Safety 
To evaluate the safety of the 
CellFX System in adults with 
low-risk basal cell carcinoma 
Primary:  
• 
No serious adverse events related to CellFX Treatment or Procedure 
Secondary: 
• 
Local Skin Reactions (Investigator) 
• 
Procedural pain assessment (Subject) 
Effectiveness 
To evaluate the effectiveness of 
the CellFX System in adults with 
low-risk basal cell carcinoma 
Primary:   
• 
Complete histological clearance of the target lesion on microscopic 
evaluation of hematoxylin and eosin stains 
Secondary:   
• 
Visible/clinical clearance of the target lesion by 
clinical/dermatoscopic evaluation  
• 
Partial response of the study lesion as assessed by WHO criteria 
(≥ 50% decrease in the product of the longest perpendicular  
diameters of each target lesion) 
• 
SCAR-Q Appearance Scale (Subject) 
• 
Manchester Scar Scale (Investigator) 
• 
Healing assessment questions (Investigator) 
 
 
3.2 Study Design  
This study is designed as a prospective, multicenter IDE feasibility study in up to 30 adult 
participants with low-risk basal cell carcinoma utilizing the CellFX System at up to 6 sites within 
the United States. The study will consist of a single treatment session with the CellFX System 
followed by surgical tumor excision (with 5 mm margins) 60 days post-treatment.  
Eligible subjects with 1-2 histologically confirmed, primary BCC lesion(s) who meet the inclusion 
and exclusion criteria will be enrolled. The BCC lesion(s) may be present anywhere on the body 
except neck, axilla, hands, feet, or genitals. In cases where the subject has more than 1-2 BCC 
lesions that meet the study criteria, the PI will select the lesion(s) to include in the study.  
The subject will receive treatment of their confirmed BCC lesion(s) with the CellFX system. The 
treatment area will be evaluated at 3-days, 7-days, 14-days, 30-days and 60-days post-NPS 
treatment. At the 60-day follow-up visit, participants will undergo complete surgical excision of 
the tumor plus 5 mm margins. The subject will return for 3 more follow-up visits post-excision at 
14 days (suture removal), 30 days and 60 days (typical skin check post-surgical excision) for a 
total of 9 study visits. The 3-day, 7-day, and 30-day post-NPS treatment follow-up visits as well 
as the 30-day post-surgical excision visit may be performed as telemedicine visits.  
The excised tissue at the 60-day post-treatment visit will be shipped for histological analysis. 
Preparation and analysis of the excised tissue will be performed by Pinkus Dermatopathology 
Laboratory and a board certified dermatopathologist who has extensive experience in 
interpreting cutaneous neoplasms. Details of the preparation, shipment and analysis of the 
excised tissue are provided in the Tissue Handling and Analysis Procedure. 
Photography of the study lesion(s) will be captured along with the investigator’s assessments at 
all in-office visits. Detailed instructions for photography of the lesion area are provided in the 
photography instruction manual. 

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3.3 CellFX Procedure 
The intended CellFX treatment device is described as the CellFX® System using the skin contacting 
component referred to as the “tip”. The three available tip sizes for this study are the 5.0mm x 
5.0mm, 7.5mm x 7.5mm, and 10.0mm x 10.0mm tips defined in length and width, which may 
range from 2.0mm to 3.0mm in depth. When a treatment tip is attached, the CellFX Handpiece 
delivers a timed series of energy pulses, referred to as a “Cycle”. The subject will be treated with 
appropriate tip sizes according to the size of the BCC lesion.  The tip depth will be selected 
according to the guidelines defined in Table 2a below. The BCC lesion(s) will be treated with a 
pre-determined treatment energy level per tip size within the range provided in Table 2b.   
Table 2a: Treatment Tip Depth Selection Guidance 
Tip Depth 
(mm) 
Criteria  
2.0 
Standard recommended treatment depth tip  
 
3.0 
Lesions with BCC located in the deeper dermis in the diagnostic biopsy sample. 
 
Diagnosed nodular/non-superficial BCC lesion located on the back or shoulder 
where skin is thicker and where the 2mm depth tip may not be sufficient. 
 
Table 2b: Treatment Level Range per Tip 
Tip 
Size 
(L x W, mm) 
Minimum 
Treatment Level 
per Cycle 
 (mJ/mm3)  
Maximum 
Treatment Level 
per Cycle 
(mJ/mm3) 
5.0 x 5.0 
45 
155 
7.5 x 7.5 
40 
85 
10.0 x 10.0 
20 
85 
 
For this device, the term treatment level (TL) refers to the energy density value (mJ/mm3) 
delivered to the tissue by the treatment tip per cycle.  These treatment levels do not exceed the 
maximum safe ranges of settings previously tested in clinical studies. Multiple cycles of energy 
may be delivered with one or more tip sizes in order to treat the entire BCC lesion(s) along with 
a defined 5 mm margin during a single CellFX treatment session. 
 
A tattoo will be applied prior to the CellFX treatment to identify the treatment area for 
evaluation. Four tattoo marks will be placed to identify the margin of the treatment zone within 
the tissue area of the eventual ellipse of the excision. The tattoo may be “touched up” or re-
applied at future visits as needed. The tattoo will be applied to the area of the skin designated 
to be removed during the surgical excision of the BCC lesion on Day 60 (Visit 6). An analgesic will 
be used to manage potential treatment discomfort during the CellFX treatment.  
                                                 
3.4 Site Selection 
The study will be conducted at up to 6 clinical research sites. The sites will be selected based on 
the appropriate patient population, board certified dermatologist, and sufficient resources to 

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support this IDE study. 
 
3.5 Number of Subjects 
Up to 30 subjects at up to 6 sites will be enrolled.  
 
3.6 Clinical Study Duration 
It is anticipated that the enrollment of subjects in this study will take approximately 2-3 months 
in duration. All subjects included in this IDE feasibility study will return for follow-up visits at 3-
days, 7-days, 14-days, 30-days, and 60-days post-NPS treatment. At the 60-day follow-up visit, 
participants will undergo complete surgical excision of the tumor plus 5 mm margins. The subject 
will return for 3 more follow-up visits at 14-days, 30-days, and 60-days post-excision for a total 
of 9 study visits. The total study duration will be 7 months.   
 
4.0 STUDY PROCEDURES 
4.1 Screening 
Recruitment will be conducted via direct communication by the investigator and/or his/her 
designated staff, advertisement and/or office ads. The Informed Consent discussion and 
signature process will be conducted by the investigator and/or designated staff. No study-
specific assessments will be performed prior to obtaining consent. 
 
A Screen Failure will be defined as a subject who did not meet one or more of the following 
criteria: 
• 
Did not meet all inclusion and/or exclusion criteria 
• 
Did not sign informed consent 
• 
Signed the informed consent but did not subsequently undergo a treatment with the 
CellFX system 
 
A screen failure will not be assigned a subject ID and information on this subject will not be 
entered in the electronic database. Information will be transcribed on the enrollment/screen 
failure log.   
 
4.2 Subject Selection 
The study population includes Adults with low-risk basal cell carcinoma.  
 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known 
as protocol waivers or exemptions, is not permitted. 
4.2.1 
Inclusion Criteria 
Candidates for this study must meet ALL the following criteria: 
1. Subject is at least 22 and no older than 85 years of age. 
2. Subject has 1-2 primary, non-recurrent, superficial, or nodular visible basal cell 
carcinoma lesion up to 1.5 cm in size with well-defined borders that has been 
verified by biopsy. 
3. Lesion(s) is appropriate for full linear excision with 5 mm margins.  
4. Subject is capable of giving signed informed consent, which includes compliance 
with the requirements and restrictions listed in the ICF and in this protocol. 

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5. Subject gives voluntary, written informed consent to participate in this clinical 
investigation and from whom consent has been obtained. 
6. Subject is willing to have BCC lesion(s) treated in a single treatment session and must 
comply with all study procedures including follow-up visits. 
7. Subject consents to have photographs taken of the BCC lesion(s). 
8. Subject agrees to refrain from using all other lesion removal products or treatments 
(topical medication including over-the-counter medications or treatments from PI or 
another physician) during the study period. 
9. Subject agrees to refrain from prolonged sun exposure of the treatment area during 
the study period. 
 
4.2.2 
Exclusion Criteria 
Candidates will be excluded from the study if ANY of the following apply: 
1. Subject has an implantable electronic medical device (i.e., pacemaker, implantable 
cardioverter defibrillator). 
2. Subject has an active infection or history of infection in designated test area within 
four weeks prior to treatment. 
3. Subject is not willing or able to sign the Informed Consent. 
4. Subject is known to be immune compromised/has a history of immunosuppression 
(e.g., organ transplant, long-term use of psoralen) or genetic disease (e.g., nevoid 
basal cell carcinoma syndrome [Gorlin syndrome], xeroderma pigmentosum). 
5. The basal cell carcinoma lesion intended for treatment with the CellFX System is on 
the face, neck, scalp, axilla, hands, feet, or genitals. 
6. The basal cell carcinoma intended for treatment with the CellFX System is a high-risk 
BCC subtype including perineurial, infiltrative, sclerosing, morpheaform, 
desmoplastic, micronodular, basosquamous or exhibiting aggressive growth 
patterns. 
7. Subject is known to be a keloid producer. 
8. Subject has allergies to Lidocaine or Lidocaine-like products. 
9. Subject has a history of radiation to the area intended for treatment. 
10. Subject has current or prior metastatic BCC. 
11. Subject is currently being treated or has been previously treated with Sonidegib or 
Vismodegib. 
12. Subject has recurrent BCC lesions.  
13. Subject has a systemic infection. 
14. Subject has a history of epilepsy.  
15. Subject has a history of cardiac arrhythmia, myocardial infarction or structural heart 
disease.  
16. Subject is employed by the sponsor, clinic site, or entity associated with the conduct 
of the study. 
17. Subject has any condition or situation which, in the Investigator’s opinion, puts the 
subject at significant risk, could confound the study results, or may interfere 
significantly with the subject’s participation in the study.  
18. Subject has a history of use of any other investigational drug, therapy, or device 
within the past 30 days of enrollment or concurrent participation in another research 
study, with the exception of participation in a COVID vaccination related clinical trial. 
 
4.3 
Process for Obtaining Informed Consent 

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Prior to undergoing any study-specific tests or procedures, the subject must sign and date the 
site’s current and approved Institutional Review Board (IRB) informed consent from to be eligible 
for study participation. The informed consent must contain all elements required by 21 CFR Part 
50 and ISO 14155:2011/AC:2011 and comply with the ethical principles of the Declaration of 
Helsinki. 
 
4.3.1 
 Process for Obtaining Informed Consent 
The patients will be informed by the Investigator or Investigator’s designee that they are 
free to refuse participation in this research study. If they elect to participate, it will be 
made clear that they may withdraw from the study at any time without prejudicing 
further care. 
 
The Investigator or the Investigator’s designee will inform patients that their medical 
records will be subject to review by the sponsor or appropriate regulatory bodies. This 
information will be used during the analysis of the results of the clinical study, but the 
patients’ identities will be treated as confidential. Patients will be assigned a unique 
study subject code that will not reveal the patients’ identity, and this code will be used 
on all data and data collection forms during the study period. The Investigator will 
explain the conditions of the study, giving the patient sufficient time to ask questions 
and to consider whether to participate. Eligible patients who agree to participate will be 
asked to sign and date an IRB approved informed consent. If the patient agrees, an IRB 
approved consent form will be provided to the patient for signature and date. One copy 
shall be returned to the Investigator and filed in the patient’s case history; the other copy 
is for the patient to keep. 
 
4.3.2 
Addition of New Information 
Pulse Biosciences, Inc. will revise the written informed consent form whenever new 
information becomes available that may be relevant to the subject’s confirmed 
participation in the study. The revised information will be sent to the Investigator for 
approval by the IRB. After approval of the IRB, a copy of this information must be 
provided to the participating subjects, and the informed consent process as described 
above needs to the repeated. Please follow the central IRB guidelines on the process of 
re-consenting subjects. 
 
 

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4.4 
Schedule of Events and Evaluations 
Schedule of events and evaluations required for this study are provided in Table 3. 
 
Table 3. Schedule of Events 
Study Activity/ 
Procedure 
Visit 1 
Screening/ 
Enrollment 
& Tx 
Visits 2-4 
3, 7, 14-days  
Post-Tx  
Visits 5 
30-days  
Post-Tx 
Visit 6 
Excision 
(60-days 
Post-Tx) 
Visit 7 
14-days 
Post 
Excision 
Visit 8 
30-days 
Post 
Excision 
Visit 9 
60-days 
Post 
Excision 
Study Day 
0 
3/7/14 
30 
60 
74 
90 
120 
Visit Window 
Day 0 
±2 days 
±5 days 
±5 days 
±3 days 
±5 days 
±5 days 
Type of Visit 
OV – In-Office Visit Required 
OV/TM – In-Office Visit or      
                 Telemedicine Visit 
 OV 
Visit 2 & 3: 
OV/TM 
 
Visit 4: OV 
OV/TM 
OV 
OV 
OV/TM 
OV 
Inclusion/Exclusion   
Informed Consent 
   
 
 
 
 
 
 
Demographics, Medical HX, 
Fitzpatrick Skin Type, etc. 
   
 
 
 
 
 
 
Lesion History 
   
 
 
 
 
 
 
History of Pigmentary 
Changes 
   
 
 
 
 
 
 
Photographs  
  a 
  * 
  * 
  a 
  a 
  * 
   
Lesion Assessment 
(Investigator) 
  a 
  * 
  * 
  a 
   
  * 
   
Tattoo Treatment Area 
   
 
 
 
 
 
 
CellFX Treatment 
   
 
 
 
 
 
 
Procedural Pain Assessment 
(Subject) 
   
 
 
   
 
 
 
Surgical Excision 
 
 
 
   
 
 
 
Suture Removal (as 
applicable) 
 
 
 
 
   
 
 
SCAR-Q Appearance Scale 
(Subject) 
 
 
 
  b 
 
 
   
Manchester Scar Scale 
(Investigator) 
 
 
 
  b 
 
 
   
Healing Assessment 
Questions (Investigator) 
 
 
 
  b 
 
 
   
Lesion Measurement 
   
 
 
  b 
 
 
 
Clinical Clearance 
Assessment  
 
 
 
  b 
 
 
 
Adverse Events 
   
   
   
   
   
   
   
Study Exit 
 
 
 
 
 
 
   
a 
Pre- and post-procedure / Surgical Excision / Suture Removal 
b 
Pre-procedure / Surgical Excision  
* Required for in-office visits only 
 
 

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4.5 
Screening / Enrollment Procedures (Visit 1) 
The following activities are required at the time of the subject screening/enrollment visit. The 
order of the activities may vary within reason as long as all activities are performed after 
consent is obtained. The Screening Visit and Treatment Visit (subject enrollment visit) may 
occur on different days. 
4.5.1 
Activities prior to or on same day as study enrollment 
• 
Evaluation for Inclusion/Exclusion criteria. 
• 
Collect Demographic information and medical history including but not limited to 
age, gender, race, ethnicity, dermatologic conditions, and Fitzpatrick skin type.                      
• 
Sign the consent form prior to any study activities.  
• 
Receive a copy of the signed consent form. 
 
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. Procedures conducted as part of the participant’s 
routine clinical management and obtained before signing of the ICF may be utilized for 
screening or baseline purposes provided the procedures met the protocol-specified 
criteria. 
4.5.2 
Definition of Enrollment 
Once the subject has been consented and has received a CellFX treatment, the subject 
will be considered enrolled and each enrolled subject will be assigned a unique Study 
Identification Number.  
4.5.3 
CellFX Treatment Procedure 
• 
1-2 clinically diagnosed BCC lesion(s) that meet the study criteria will be selected by 
the treating investigator. The identified lesion(s) will be labeled. 
• 
Baseline photographs will be taken (prior to use of analgesic for pain management 
and prior to tattooing). 
• 
Baseline clinical measurements of the BCC lesion(s) shall be taken 
• 
The site investigator will perform a baseline lesion(s) assessment.  
• 
A template will be applied to the skin and used to map out the treatment application. 
• 
A tattoo (4 marks) will be applied within the area designated for excision to mark the 
treatment zones for the purpose of identifying the treatment area during evaluation. 
• 
An analgesic for pain management, such as local injection of lidocaine, will be 
administered to the selected study lesion area(s).  
• 
Each study lesion will be treated with the CellFX system per Table 2 according to the 
treatment tips utilized. 
• 
The total number of treatment cycles with the CellFX system will be recorded.  
• 
The subject will be asked to rate his/her pain immediately after the treatment 
session for each lesion treated with the CellFX system by using a numerical rating 
score, depicted in Figure 4. 
• 
Post-procedure lesion assessment will be performed by the investigator. 
• 
Post-procedure photographic images of each selected lesion will be taken. 
• 
A light bandage and/or any physician recommended dressing may be applied before 
the subject leaves. 
• 
Any adverse events will be identified and documented. 
 

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4.6 
3-Day Follow-up Visit (Visit 2) 
• 
This visit may be performed in-office or as a telemedicine visit. 
• 
Photographic images of each study lesion will be taken. Photographs are not required if the 
visit is not performed in-office.  
• 
All lesions will be examined and clinically assessed by the site investigator. If the visit is not 
performed in-office, clinical assessment is not required.  
• 
A light bandage and/or any physician recommended dressing may be applied post-
evaluation. 
• 
Any adverse events will be identified and documented. If the visit is not performed in office, 
the clinical site must inquire regarding any adverse events either by phone call, text, e-mail 
or video conference. 
 
4.7 
7-Day Follow-up Visit (Visit 3) 
• 
This visit may be performed in-office or as a telemedicine visit. 
• 
Photographic images of each study lesion will be taken. Photographs are not required if the 
visit is not performed in-office.  
• 
All lesions will be examined and clinically assessed by the site investigator. If the visit is not 
performed in-office, clinical assessment is not required.  
• 
A light bandage and/or any physician recommended dressing may be applied post-
evaluation. 
• 
Any adverse events will be identified and documented. If the visit is not performed in office, 
the clinical site must inquire regarding any adverse events either by phone call, text, e-mail 
or video conference. 
 
4.8 
14-Day Follow-up Visit (Visit 4) 
• 
Photographic images of each study lesion will be taken.  
• 
All lesions will be clinically assessed by the investigator.  
• 
A light bandage and/or any physician recommended dressing may be applied post-
evaluation. 
• 
Any adverse events will be identified and documented. 
 
4.9 
30-Day Follow-up Visit (Visit 5) 
• 
This visit may be performed in-office or as a telemedicine visit. 
• 
Photographic images of each study lesion will be taken. Photographs are not required if 
the visit is not performed in-office.  
• 
All lesions will be examined and clinically assessed by the site investigator. If the visit is not 
performed in-office, clinical assessment is not required.  
• 
Any adverse events will be identified and documented. If the visit is not performed in 
office, the clinical site must inquire regarding any adverse events either by phone call, text, 
e-mail or video conference. 
 
4.10 
60-Day Follow-up Visit (BCC Surgical Excision Day – Visit 6)  
• 
Photographic images of each study lesion will be taken.  
• 
All lesions will be clinically assessed by the investigator.  
• 
The site investigator shall assess each treatment area based on the Manchester Scar Scale 

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prior to excision. 
• 
The site investigator shall complete the healing assessment questions for each treatment 
area prior to excision. 
• 
Clinical measurements of the BCC lesion(s) shall be taken 
• 
The site investigator shall complete the clinical lesion clearance assessment for each 
treatment area prior to excision. 
• 
The subject shall assess each treatment area based on the SCAR-Q Appearance Scale prior 
to excision. 
• 
A complete surgical tumor excision will be performed by the investigator with at least 5mm 
margins for each study lesion. 
• 
The subject will be asked to rate his/her pain immediately after surgical excision by using a 
numerical rating score. 
• 
All tissue shall be handled and shipped to the dermatopathology laboratory per the Tissue 
Handling and Analysis Procedure. 
• 
Any adverse events will be identified and documented. 
 
4.11 
14-Day Post-Excision Follow-up Visit (Visit 7) 
• 
Photographic images of each study area will be taken. 
• 
Each study area will be clinically assessed by the investigator.  
• 
Sutures shall be removed, as applicable. 
• 
Photographic images of each study area will be taken post-suture removal.  
• 
Any adverse events will be identified and documented. 
 
4.12 
30-Day Post-Excision Follow-up Visit (Visit 8) 
• 
This visit may be performed in-office or may be performed as a telemedicine visit. 
• 
Photographic images of each study area will be taken. Photographs are not required if the 
visit is not performed in-office.  
• 
Each study area will be examined and clinically assessed by the site investigator. If the visit 
is not performed in-office, clinical assessment is not required.  
• 
Any adverse events will be identified and documented. If the visit is not performed in office, 
the clinical site must inquire regarding any adverse events either by phone call, text, e-mail 
or video conference. 
 
4.13 
60-Day Post-Excision Follow-up Visit (Visit 9) 
• 
Photographic images of each study area will be taken.  
• 
Each study area will be clinically assessed by the site investigator.  
• 
The site investigator shall assess each treatment area based on the Manchester Scar Scale. 
• 
The site investigator shall complete the healing assessment questions for each treatment 
area. 
• 
The subject shall assess each treatment area based on the SCAR-Q Appearance Scale. 
• 
Any adverse events will be identified and documented. 
 
 
4.14 
 Subject Withdrawal 

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A study subject has the right to discontinue participation at any time without penalty or loss of 
benefits to which the subject is otherwise entitles or may be withdrawn at any time at the 
discretion of the investigator for safety, behavioral, compliance, or administrative reasons. A 
withdrawn subject will be treated according to standard of medical care and will not be replaced. 
If the participant withdraws consent for disclosure of future information, the sponsor may retain 
and continue to use any data collected before such a withdrawal of consent. 
If a participant withdraws from the study, he/she may request destruction of any samples taken 
and not tested, and the investigator must document this in the site study records. 
 
4.15 
Discontinuation of CellFX Treatment Session 
A participant may be discontinued from treatment with the CellFX System prior to completion of 
the entire treatment session in the event of intolerable pain or system failure of the CellFX 
System. If the study subject elects not to complete the treatment session, a study exit form shall 
be completed and documented as early termination. System failure of the CellFX System or 
component failure shall be documented on the Device Malfunction Form.  
 
4.16 
Lost to Follow-Up 
A study subject will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• 
The site must attempt to contact the participant and reschedule the missed visit as soon as 
possible, counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain whether or not the participant wishes to and/or will continue in the 
study. 
• 
For  the surgical excision visit (Visit 6), the sites must confirm the surgical excision date with 
the participant 1-2 times, 1 week to 1 day prior to the visit day and reiterate the importance 
of completing the surgical excision visit in order to ensure the cancer does not return or 
spread. If the subject does not confirm and/or does not come in on their schedule excision 
date, the site must attempt to contact the participant with at least three phone calls. If the 
site cannot reach the participant, the site is to send a certified letter to the participant’s last 
known mailing address or local equivalent methods. 
• 
Before a participant is deemed lost to follow up, the investigator or designee must make 
every effort to regain contact with the participant (where possible, 3 telephone calls and, if 
necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts are to be documented in the participant’s 
medical record. 
• 
If the participant continues to be unreachable, he/she will be considered to have withdrawn 
from the study.  
5.0 
BENEFITS AND RISKS 
5.1 
Benefits 

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There are no guaranteed benefits from participation in this study. Participation in the study 
offers another dermatological approach to accomplish the same clinical effect as the typical 
topicals, surgical devices or surgical excision currently used to treat patients with BCC lesions. 
The information learned from this study may contribute to the ultimate use of a safer and more 
effective device and the availability of the device to treat benign and non-benign lesions as an 
alternative for use in future patients.  
 
 
5.2 Risks 
For detailed information on the risks of the devices used in the study procedure, including a 
complete list of warnings, precautions, and potential adverse events, please refer to the 
Instructions for Use (IFU) for the Pulse Bioscience CellFX® System. 
An additional risk for study participants is the delay in performing surgical excision of the tumor; 
however, basal cell carcinomas are slow-growing, so a delay of 60 days is considered a minimal 
risk.  The wait times for standard surgical excisions are often longer than 60 days in some areas 
and practices. Because biopsy and surgical excision are standard of care for basal cell carcinoma 
and will also be occurring in this study, risks of these procedures are not considered in the 
benefit/risk assessment. 
 
5.3 Mitigation of Risks 
As with any dermatological procedure, appropriate safety precautions will be followed. Risks 
observed or theoretical adverse events have been mitigated through the Instructions for Use, 
physician training, and patient selection in the study protocol. The subject will receive full care 
of their BCC lesion(s). 
All efforts will be made to minimize these risks by: 
• 
Site Selection 
• 
Patient Population that represents the demographics of the U.S  
• 
Ensuring compliance to the protocol and IFU 
• 
Study monitoring 
• 
Safety processes-protocol adverse events reporting requirements  
 
The following plan is set in place in order to mitigate the risk of the study participant treated with 
the CellFX system not returning for their surgical excision visit to receive full care of their BCC 
lesion(s): 
• 
Prominent language is added to the Informed Consent Form to emphasize that the CellFX 
treatment has not yet been shown to remove all cells from a skin tumor, and therefore 
surgical removal is of the utmost importance to ensure that the cancer does not return or 
spread. 
• 
Training of the PI and their clinical study staff will emphasize the importance of subject 
selection in selecting subjects who will commit to all study visits, an explanation of the 
importance for all subjects to complete their surgical excision of the diagnosed BCC lesion, 
training to remind and confirm the study visits with the subjects at each visit, with emphasis 
on the surgical excision visit. 
• 
Subject compensation is structured to motivate the subject to complete the surgical 
excision, and safety follow up visits with the highest compensation assigned to the surgical 
excision visit (Visit 6), higher monetary values assigned to the later follow-up visits (visits 7-
9), as well as an all-visit bonus offered for subjects who complete all study visits. 

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• 
Site compensation includes an all-visit bonus to motivate the site to closely follow-up with 
the study subjects to ensure all visits are completed. 
• 
Remote and on-site monitoring of subject visits at all participating sites to ensure 
compliance of subject attending scheduled study visits. 
 
 
6.0 STATISTICAL CONSIDERATIONS 
 
 
6.1 
General Approach 
For descriptive statistics, counts and percentages will be calculated for categorical variables. 
Continuous variables will be summarized using the mean, standard deviation, median, 
minimum and maximum. No inferential tests are planned for this study, but 2-sided confidence 
intervals will be produced where appropriate. Where 2-sided p-values are calculated, they 
should be interpreted as descriptive only. 
 
6.2 
Analysis of the Primary Effectiveness Endpoint 
The count and proportion with the primary endpoint of histological clearance will be calculated 
along with a 95% confidence interval (CI). The primary population for this analysis will be the 
Per-Protocol population, though estimates will be produced for the modified intent-to-treat/ 
safety population (patients who begin treatment) and Complete Treatment population 
(subjects who complete all required cycles of treatment).   
 
6.3 
Analysis of Secondary Endpoints 
No formal hypothesis testing is planned for secondary endpoints. Any p-values comparing 
groups should be considered descriptive. The secondary endpoints will be evaluated using the 
modified intent-to-treat/ safety population, but these analyses may be repeated for complete 
treatment and per-protocol populations as well. 
 
6.3.1 
Change in Lesion Size 
Lesion size (as measured by the productof the longest perpendicular diameters) will be 
calculated at baseline and at follow-up day 60 post-NPS treatment. The two longest 
diameters (longest length and longest perpendicular width) of each study lesion will be 
measured and the product will be calculated for each individual study lesion at baseline 
and at 60 days-post NPS treatment study visits. Calipers will be provided to each study 
site to perform the measurements per standardized procedures. A standard adhesive 
ruler will also be included in photographs taken of each study lesion. Within-lesion 
change in lesion size from baseline to the 60-Day follow-up time-point will be calculated. 
A mixed model for repeated measures will be used to estimate the mean reduction and 
its 95% confidence interval. Baseline lesion size will be included as a fixed effect.  
 
6.3.2 
Lesion Reduction Category 
The visible/clinical clearance of the target lesions will be rated according to the lesion 
reduction categories listed in Table 4. The lesion reduction category will be derived from 
the lesion size measurements at baseline and follow-up day 60 Post-NPS treatment 
described in Section 6.3.1. The % reduction will be calculated as the change in lesion size 
divided by the baseline value. This percentage will be categorized according to the table 
4 below: 

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Table 4. BCC Lesion Reduction Categories 
 
BCC Lesion Reduction Categories 
CLEAR 
0mm/100% reduction  
MOSTLY CLEAR 
99-51% reduction 
PARTIALLY CLEAR 
50-25% reduction 
NOT CLEAR 
<25% reduction 
 
 
6.3.3 
Partial response of target (study) lesion as assessed by WHO  criteria  
Partial response will be assessed using the WHO criteria. Partial response is defined as a 
≥ 50% decrease in the product of the perpendicular diameters of each target/study BCC lesion 
compared to baseline. The 50% reduction will be determined through the product  of the 
longest perpendicular bidimensional diameters (longest length and longest perpendicular 
width) of each study lesion treated. Calipers will be provided to each study site to perform 
the measurements per standardized procedures. A standard adhesive ruler will also be 
included in photographs taken of each study lesion. Partial response will be assessed for in-
clinic measurements at follow-up day 60 Post-NPS treatment. The number and proportion 
of lesions meeting the definition of partial response and confidence interval for the 
proportion will be calculated. 
 
6.3.4 
SCAR-Q Appearance Scale (Subject) 
The SCAR-Q is a patient-reported outcome instrument designed to measure outcomes 
specific to any type of scar.  This instrument has subscales for scar appearance, psychosocial 
impact and scar symptoms. Least-square means and confidence intervals will be calculated 
for each scale and subscale using generalized linear models with lesion size included as a 
fixed effect.  
 
6.3.5 
Manchester Scar Scale (Investigator) 
The Manchester Scar Scale evaluates the following five characteristics of scar: color (score: 
1–4), distortion (score: 1–4), contour (score: 1–4), texture (score: 1–4), and transparency 
(score: 1–2). The distribution of responses will be summarized for each characteristic. Least-
square means and confidence intervals will be calculated for the total score using generalized 
linear models with treatment lesion size included as a fixed effect.  
 
 
6.3.6 
Healing assessment questions (Investigator) 
The following assessment questions will be asked on the Day 60 post-NPS treatment visit 
prior to surgical excision as well as on the Day 60 post-surgical excision visit: 
a. 
Is the healing pattern cosmetically acceptable? (yes, no) 
b. 
How likely is a scar? (1 = unlikely, 2 = possible, 3 = probable) 
c. 
Once healed, how do you anticipate the treated area will look compared to curettage 
and desiccation? (1 = better, 2 = the same, 3 = worse) 
d. 
Once healed, how do you anticipate the treated area will look compared to surgical 

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excision? (1 = better, 2 = the same, 3 = worse) 
The distribution of responses will be summarized for each question. 
 
6.4 
Safety Endpoints 
Unless otherwise noted, the safety population will be used to assess safety endpoints. 
6.4.1 
Primary Safety Endpoint 
The primary safety endpoint is the incidence of any serious AEs or complications associated 
with the application of NPS (procedure and treatment). Information about AEs and 
complications will be solicited by site investigators at scheduled follow-up visits. The count 
and proportion with the primary safety endpoint will be calculated along with a 95% 
confidence interval.  Adverse events and complications will also be summarized by MedDRA 
preferred term. 
 
6.4.2 
Investigator Local Skin Reaction Assessment  
The Investigator will perform clinical assessments on the local skin reaction of the treatment 
area based on the following characteristics: presence and severity of erythema, edema, 
exudate, eschar, peeling scaling, bleeding, ulceration, scarring, and pigmentary changes. 
Assessment will be based on a validated 5-point scale: None, Mild, Moderate, Moderate to 
Severe, Severe. The wound healing characteristics will be assessed by the investigator at the 
14-Day and 60-Days Post-NPS visits. The 3-Day, 7-Day, and 30-Days Post-NPS visits are 
optional in-office and will be summarized separately and included as a descriptive analysis. 
The rate of each event individually and a composite of any of these events will be calculated 
for each treated lesion area. The number and proportion of lesions with any reporting of any 
erythema, edema, exudate, eschar, peeling scaling, bleeding, ulceration, scarring, or 
pigmentary changes (regardless of severity) will be summarized by time-point.  
 
6.4.3 
Participant Assessment of Procedural Pain  
The participant will give an assessment of procedural pain on an 11-point scale ranging from 
0 (no pain) to 10 (worst pain imaginable). The Pain Assessment Chart with an assigned 
numerical rating between 0 (smiling) and 10 (crying) will be used to assess pain at Day 0, as 
reference in Figure 4. The pain scale will be assessed immediately after each lesion treatment 
session.  
Pain levels will be grouped into four categories: No Pain (Score of 0), Mild Pain (Scores of 1-
3), Moderate Pain (Scores of 4-6) and Moderate-to-Severe Pain (Scores of 7-10). The number 
and percentage will be tabulated for each category of pain, averaged for overall pain and 
may be analyzed against other parameters.  
 
 
 
 
 
Figure 4: Pain Assessment Chart 

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6.5 
Sample Size Determination 
No formal hypothesis tests will be performed for this study, so the sample size was selected to 
produce a representative sample of BCC lesions to determine whether treatment effects are 
consistent across study participants. A maximum of 30 participants will be treated to allow for 
assessment of the endpoints outlined in this protocol.  
 
6.6 
Populations for Analyses 
The following populations are defined in Table 5. 
 
Table 5. Population Descriptions for Analysis 
Population 
Description 
Modified Intent-to-treat / 
Safety Population 
All enrolled participants who began treatment with the CellFX system, 
irrespective of completed study treatment session, subsequent 
withdrawal, or deviation from the protocol.  
Complete Treatment 
This population consists of mITT participants who completed the entire 
CellFX treatment session.  
Per-Protocol 
Participants who received treatment, completed the CellFX treatment 
session, excision surgery and all required study visits. 
 
6.7 
Sub-Group Analyses 
Subgroup analyses will be performed for the following subgroups:  
o Lesion Size Tertiles 
o Fitzpatrick skin type 
 
6.8 
Interim Analyses 
No interim analysis is planned for this study.  
 
6.9 
Missing Data 
All possible efforts will be made to minimize missing data in this study. However, based on 
previous studies, any missing data that does occur is likely due to missed follow-up visits. 
However, the sensitivity of the final results to missing data will be examined by comparing the 
primary outcomes to the results using a longitudinal model with the 60-day post treatment 
results, and a tipping-point analysis will be performed for the endpoints at 60 days to determine 
whether the missing data could change the inference compared to the primary models. 
6.10  Exploratory Analysis 

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 Exploratory analysis may be performed to compare the different BCC subtypes. Wound healing 
characteristics for the post-excision area will also be assessed and compared to the wound 
healing characteristics post-NPS.  
Exploratory analysis may be performed for dermatologic similarities of skin type based on 
anatomic subcategories: 
▪ 
Sun-exposed limbs 
▪ 
Non-sun exposed limbs 
▪ 
Torso 
 
 
7.0 CLINICAL PHOTOGRAPHY  
  The Sponsor will use standardized photographic capture methods described in the photography 
instruction manual. Photographs will be taken at each in-office study visit. In order to ensure consistent 
serial clinical photography is achieved during the study, all subject photographs will be reviewed 
(monitored) on an ongoing basis. Digital images will be transferred/stored in a secure, password 
protected portal. 
 
 
8.0 ADVERSE EVENTS 
Pulse Biosciences will classify each reported Adverse Event according to ISO 14155:2011. All protocol 
specific AEs, whether device-related or not, will be recorded on the AE case report form and reported. 
Data to be collected will include the description of the AE, onset, and resolution dates (or whether the 
AE is ongoing), severity, management/treatment, outcome, and determination of the relationship to the 
device and/or procedure. All AEs related to the lesion site(s) should be reported and classified by the site 
Investigator and be followed by the Investigator to determine the relationship of the AE to the device or 
the study procedure.   
All AE information will be collected from enrollment through the last study visit at 60 days following the 
surgical excision of the BCC lesion(s) (120 Days after the CellFX treatment session). All AEs will be followed 
until the event has resolved (in the case of permanent impairment, the event will be followed until it 
stabilizes, and the overall clinical outcome has been ascertained). Medical occurrences that begin before 
receiving a CellFX treatment but after obtaining informed consent will be recorded on the Medical 
History section of the CRF rather than the AE section. 
 
When reporting AEs/SAEs, the Investigator should include the following information: 
• 
Description of event  
• 
Onset of event 
• 
Duration of event (including resolution dates or whether the AE is ongoing) 
• 
Severity 
• 
Relationship to device or procedure 
• 
Action taken 
• 
Subject outcome 
 
Severity describes the intensity of an event and will be assessed as: 
• 
Mild: The AE does not interfere in a significant manner with the subject’s normal functioning 
level.  
• 
Moderate: The AE produces some impairment of function but not hazardous to health. 
• 
Severe: The AE produces significant impairment of function or incapacities and/or it is a hazard 
to the subject. 

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Relationship to device or procedure will be assessed as: 
• 
Unlikely: There is no indication that the AE was caused by the investigational or standard of 
care device.  
• 
Possibly: It cannot be excluded that the AE was caused by the investigational or standard of 
care device. 
• 
Likely: A causal relationship between the investigational or standard of care device and the AE 
is at least a reasonable possibility, i.e. there is evidence or argument suggesting a causal 
relationship.  
 
8.1 
Adverse Event Definitions  
8.1.1 
Adverse Event (AE): (ISO 14155:2011 3.2)  
Any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users, or other 
persons, whether or not related to the investigational medical device.  
NOTE 1: This definition includes events related to the investigational medical 
device.  
NOTE 2: This definition includes events related to the procedures involved. 
*For the purposes of this protocol, only dermatologic AEs will be reported to 
the Sponsor. 
 
8.1.2 
Adverse Device Effect (ADE): (ISO 14155:2011 3.1)  
Adverse event related to the use of an investigational medical device  
NOTE 1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the investigational medical device.  
NOTE 2: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device  
 
8.1.3 
Serious Adverse Event (SAE) (ISO 14155:2011 3.37)  
 Adverse event that  
a) led to death,  
b) led to serious deterioration in the health of the subject, that either resulted 
in  
1) a life-threatening illness or injury, or  
2) a permanent impairment of a body structure or a body function, or  
3) in-patient or prolonged hospitalization, or  
4) medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function,  
 c) led to fetal distress, fetal death or a congenital abnormality or birth defect.  
NOTE 1: Planned hospitalization for a pre-existing condition, or a procedure 
required by the CIP, without serious deterioration in health, is not considered a 
serious adverse event. 
 
 
 
8.1.4 
Serious Adverse Device Effect (SADE): (ISO 14155:2011 3.36)  

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Adverse device effect that has resulted in any of the consequences characteristic 
of a Serious Adverse Event.  
 
8.1.5 
Unanticipated Adverse Device Effect (UADE): (21CFR812.3)  
Any serious adverse effect on health or safety or any life-threatening problem 
or death caused by, or associated with, a device, if that effect, problem, or death 
was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application, or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects.  
 
8.2 Device Deficiencies (ISO 14155:2011 3.15)  
8.2.1 
Definitions 
Device Deficiency is an Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety, or performance.  
 
NOTE: Device deficiencies include malfunctions, use errors, and inadequate labelling. 
 
Device Malfunction is a failure of the study device to perform in accordance with its   
intended purpose when used in accordance with the instructions for use or study 
protocol. 
 
8.3 Safety Reporting Requirements 
Table 6 summarizes the time sensitive requirements for adverse events and device deficiencies.  
The Sponsor is the contact person for these reporting requirements.  
 
                             Table 6. Investigator Responsibilities for Submitting Adverse Events to the Sponsor 
Type of Adverse Event 
Reporting Timeframe 
*Serious Adverse Device Effects 
(SADE), including Unanticipated 
Serious Adverse Device Effect 
(USADE) 
As soon as possible, but in no case later than 3 calendar days 
after the clinical site first learns of the event or of new 
information in relation with an already reported event  
**Serious Adverse Events (SAE)  
 
As soon as possible, but in no case later than 3 calendar days 
after the clinical site first learns of the event or of new 
information in relation with an already reported event  
Adverse Device Effects (ADE)  
 
As soon as possible, but in no case later than 3 calendar days 
after the clinical site study team first learns of the event or of 
new information in relation with an already reported event 
All other AEs  
(dermatologic only) 
Submit in a timely manner after the clinical site first learns of 
the event  
**Device Deficiency with SADE 
potential  
 
As soon as possible, but in no case later than 3 calendar days 
after the clinical site study team first learns of the deficiency 
or of new information in relation with an already reported 
deficiency  
All other Device Deficiencies  
 
Submit in a timely manner after the clinical site first learns of 
the deficiency  
 

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*The Sponsor will report the results of an evaluation of an unanticipated serious or serious adverse 
device effect to the FDA and all reviewing IRBs and investigators within 10 working days after the 
Sponsor first received notice of the adverse effect per 21 CFR 812.150.  
 
**It is the responsibility of the investigator to inform their IRB of serious adverse events and device 
deficiencies as required by their IRB guidelines. 
 
 
9.0 STUDY MANAGEMENT (SPONSOR RESPONSIBILITIES) 
9.1 
Sponsor Ethical and Regulatory Considerations 
As the Sponsor of this clinical study, Pulse Biosciences has the overall responsibility for the 
conduct of the study, including assurance that the study meets US federal and local regulatory 
requirements appropriate to the conduct of the study and is conducted according to the 
Declaration of Helsinki, Protection of Human Volunteers (21 CFR 50), Institutional Review Boards 
(21 CFR 56), and Obligations of Clinical Investigators (21 CFR 312). The study sponsor will adhere 
to sponsor general duties as described in ISO 14155:2011, Clinical investigation of medical 
devices for human subjects – Good clinical practice, and CFR Part 812, 50, 56, 54 and the World 
Medical Association Declaration of Helsinki. 
 
To maintain confidentiality, all evaluation forms, reports and other records will be identified by 
a unique subject identification code (ID number). All study records will be kept in a locked, secure 
area and clinical information will not be released without written permission of the subject, 
except as necessary for monitoring by the FDA. The Investigator must also comply with all 
applicable privacy regulations (e.g., Health Insurance Portability and Accountability Act of 1996). 
 
General Duties 
Pulse Biosciences will ensure that the application is submitted to the appropriate regulatory 
authorities, obtaining copies of IRB approvals and ensuring documentation of IRB approvals prior 
to the shipping of devices, ensuring proper clinical site monitoring, ensuring patient informed 
consent is obtained, providing quality data that satisfies regulations and informing the 
Investigators and IRBs of unanticipated adverse device effects, events, and deviations from the 
protocol as appropriate. 
 
9.2 
Selection of Clinical Sites 
The primary requirements of site and Investigator selection and continued participation in the 
Trial include adequate experience, commitment to safety, consistency in adherence to the 
protocol, and patient volume. The clinical site must have facilities that are capable of processing 
patients in the manner prescribed by the protocol. 
 
The study sponsor, Pulse Biosciences, and its designees will select qualified Investigators, ship, 
or deliver devices only to participating Investigators, obtain signed study agreements, and 
provide Investigators with the information necessary to conduct the study. 
 
9.3 
Site Training 
The training of appropriate clinical site personnel will be the responsibility of the Sponsor. The 
Investigator is responsible for ensuring that his/her staff conduct the study according to the 
protocol. To ensure proper device usage, uniform data collection, and protocol compliance, the 

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Sponsor will present a formal training session to study site personnel which will review the 
Instructions for Use of the device, the Investigational Plan, instructions on data collection, 
schedules for follow-up with the study site coordinators, and regulatory requirements. Detailed 
feedback regarding completion of forms will be provided by the Sponsor through the regular site 
monitoring. 
 
 
9.4 
Investigator Training 
The Sponsor will provide appropriate Investigator training on the use of the CellFX System, 
Handpiece, and Treatment Tips. Training will take place prior to the initiation of the clinical 
investigation. Training will address topics including indications for use of the device, 
management of complications, and instructions to subjects. Training will be documented for 
each physician on a training log, signed by both the physician and training representative. 
Photography training as well as training on the electronic data capture system and photo 
management system will also be conducted. 
 
 
9.5 
Monitoring of Study Sites 
9.5.1 
Monitoring Methods 
Monitoring functions for this study will be conducted by Pulse Biosciences. The study will 
be monitored to ensure that the protocol, applicable regulations, and Good Clinical 
Practice Guidelines are followed. The study monitor will ensure that the rights and well-
being of subjects are protected, and the clinical trial data are accurate, complete, and 
verifiable. Specific monitoring requirements are detailed in the study specific Monitoring 
Plan. 
Prior to subject enrollment, the Sponsor will obtain the essential regulatory documents 
required to initiate the study. The Sponsor will be responsible for the review and 
approval of the following essential documents: 
 
• 
Current Protocol Revision 
• 
Investigator Agreement 
• 
IRB approval letter for the protocol and consent form 
• 
IRB approved consent form 
• 
IRB membership roster or assurance number 
Copies of file documents will be maintained by the Sponsor. 
 
9.5.2 
Periodic Monitoring Visits (Onsite and Remote) 
Periodic monitoring visits will be made at the investigational site throughout enrollment 
of the clinical study to assure that the Investigator obligations are fulfilled, and all 
applicable regulations and guidelines are being followed. These visits will assure that the 
facilities are still acceptable; the protocol and investigational plan are being followed, 
the IRB/HREC has been notified of approved protocol changes as required, complete 
records are being maintained, appropriate and timely reports have been made to the 
Sponsor and the IRB, device and device inventory are controlled and the Investigator is 
carrying out all agreed activities. The monitor will verify accuracy of CRF or EDC 
completion against source documents maintained at the site. 
 

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During monitoring visits, the Monitor will perform a review of study eligibility, 
Inclusion/Exclusion criteria, informed consent, all reports of device malfunction, all 
events meeting criteria for serious adverse event reporting as well as safety and efficacy 
endpoints. 
Additional review will be performed on a site-by-site basis, as warranted by the findings 
of previous monitoring visits. 
The monitor will ensure that Investigators are aware of the regulatory requirement to 
maintain information in the study subject’s medical records which corroborate data 
collected on the CRF or EDC system.  To comply with these regulatory requirements, the 
following information will be maintained and made available as required by the sponsor 
and/or regulatory inspectors: 
The monitor will compare key variables (demographics, inclusion/exclusion criteria, and 
safety) on the CRFs or EDC database with each subject’s source documents. Any 
discrepancies will be noted and resolved.  
 
9.5.3 
Site Close-out Visit 
Upon completion of the clinical study (when all subjects enrolled have completed the 
follow-up visits and the CRFs or EDC and queries have been completed), the Sponsor will 
notify the site of closeout and a study closeout visit will be performed. All CRFs, unused 
study devices, and any unused study materials will be collected and returned to the 
Sponsor. The Monitor will ensure that the Investigator’s regulatory files are up to date 
and complete and that any outstanding issues from previous visits have been resolved. 
Other issues which will be reviewed at this visit include discussing retention of study 
files, possibility of site audits, publication policy, and notifying the IRB of study closure.  
 
9.6 
Protocol Deviations 
A protocol deviation is defined as an event where the clinical Investigator or site personnel did 
not conduct the study according to the Investigational Plan or the Investigator Agreement. 
Deviations shall be reported to the Sponsor regardless of whether medically justifiable, pre- 
approved, or taken to protect the subject in an emergency. Subject specific deviations will be 
reported on the provided protocol deviation form. Non-subject specific deviations will be 
reported to the sponsor in writing. Investigators will also adhere to procedures for reporting 
study deviations to their IRB in accordance with their specific IRB reporting policies and 
procedures. 
Good Clinical Practice (GCP) regulations require that Investigators maintain accurate, complete, 
and current records, including documents showing the dates and reasons for each deviation from 
the protocol. 
 
9.7 
Study Completion 
The study is considered completed after all subjects have undergone all of their protocol required 
follow-up visits, all eCRFs have been submitted, all queries have been resolved, and all action 
items have been closed. All unused study materials and study devices will be collected and 
returned to Pulse Biosciences or appropriately discarded as per instruction. After study closure, 
a final report will be completed. 
 
9.8 
Audits / Inspections 
Pulse Biosciences, national/international regulatory authorities and IRBs may conduct initiated 

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audits or inspections at the study sites during the course of, or after completion of the study. 
The Investigator shall allow access to the original medical records and provide all requested 
information. 
 
9.9 
Publication Policies 
Publications based on the results of the study will follow the process outlined in the Investigator 
Agreement.  The study will be registered on www.clinicaltrials.gov. 
 
9.10 
Data Management 
Pulse Biosciences will be responsible for database creation and validation. Prior to finalizing and 
locking the database, all decisions concerning the inclusion or exclusion of data from the analysis 
for each subject will be determined by appropriate clinical and statistical personnel. All 
exclusions related to either safety or efficacy will be documented in subject listings. Data 
management will follow department SOPs during the conduct of this feasibility study. 
 
9.11 
Case Report Forms /Transmission of Data 
All required data for this study will be collected via web-based electronic data capture (EDC) 
system and entered in electronic Case Report Forms (eCRFs).  A unique study identifier will be 
assigned to each study subject. The database will contain only the study identifier to identify the 
subject.  
Required data will be recorded on the appropriate electronic Case Report Forms at the time of 
or as soon as possible after the subject visit. This will enable timely monitoring visits. 
Any data discrepancies identified during data review or a monitoring visit will be queried by Pulse 
Biosciences and must be resolved by the site staff and Investigator in a timely manner. 
 
9.12 
Data Retention 
Pulse Biosciences will maintain copies of correspondence, data, shipment of devices, adverse 
device effects, Investigator agreements and other records related to the clinical study. All study 
records and reports will remain on file at the sites for a minimum of 2 years after completion of 
the Study and will further be retained in accordance with local guidelines as identified in the 
clinical study agreement. Study records are to be discarded only upon notification by the study 
Sponsor. The Investigator must contact the study Sponsor before the destruction of any records 
and reports pertaining to the study to ensure they no longer need to be retained. In addition, 
the Sponsor should be contacted if the Investigator plans to leave the investigational site. All 
required data for this study will be collected on standardized CRFs or an electronic data capture 
system. All information and data sent to the Sponsor concerning subjects or their participation 
in this study will be considered confidential. All data used in the analysis and reporting of this 
evaluation will be used in a manner without identifiable reference to the subject. The Principal 
Investigator consents to visits by the staff of the Sponsor and its authorized representatives and 
the U.S. Food and Drug Administration or any other local governmental body to review the study 
subjects’ medical records including any test or laboratory data that might have been recorded 
on diagnostic tests media (e.g., photographs, etc.). 
 
 
 
 

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10.0 INVESTIGATOR RESPONSIBILITIES 
The role of the Principal Investigator is to implement and manage the conduct of the clinical study at 
their site, as well as ensure data integrity and the rights, safety, and well-being of the participating 
subjects. 
The Investigator shall ensure that all work and services described herein, or incidental to those 
described herein, shall be conducted in accordance with the highest standards of medical and clinical 
research practice. The Investigator will provide current copies of the study protocol to all Sub-
Investigators or other site personnel responsible for study conduct. 
Upon completion or termination of the study, the Investigator will submit a final written summary to 
the IRB. The summary should be submitted to the Sponsor within three (3) months of study completion 
or termination. The Investigator will provide the Sponsor with copies of all IRB/HREC actions regarding 
the study. 
 
10.1 
IRB Approval and Informed Consent 
The clinical study must be reviewed and approved by the IRB before subject enrollment may 
begin. All proposed changes to the investigational plan must be reviewed and approved by Pulse 
Biosciences. Prior to shipment of study devices, a signed copy of the IRB Committee approval 
letter identifying the clinical study must be submitted to Pulse Biosciences, signifying study 
approval. Investigators are responsible for obtaining and maintaining approval of the study by 
the IRB. 
Written informed consent is mandatory and must be obtained from all subjects prior to 
performing any study procedures in this clinical study. Pulse Biosciences will provide the site with 
a Sponsor approved consent template. Each site is expected to modify the template, if necessary, 
to meet their facilities requirements. Modified ICF templates must be reviewed by the Sponsor 
prior to submission to their IRB. 
Informed consent must be obtained and shall inform the subject as to the objective and 
procedures of the study and possible risks involved. The subjects must be informed about their 
right to withdraw from the study at any time and for any reason without sanction, penalty, or 
loss of benefits to which the subject is otherwise entitled and that withdrawal from the study 
will not jeopardize their future medical care. The clinical study informed consent must be used in 
addition to any institutional standard consent form for participation in clinical research. The 
institutional standard subject consent form does not replace the study consent form. 
It is the responsibility of the investigator to obtain both an authorization for patient health 
information and study consent. 
The IRB approved Informed Consent Forms must be retained at the site along with the other 
investigational case report forms or source documents. A signed copy of the consent form must 
be given to each subject enrolled in the study. 
 
10.2 
Data Collection and Reporting 
Case report forms or source documents will be used to record demographic, procedural, and 
follow-up data, as well as any adverse events which may occur during the study period. The AEs 
and incidence of morbidity and mortality will be reviewed with Investigators to assess the safety 
of the device and the procedure. 
The Investigator must comply with the safety reporting requirements specified in Section 8.3. 
Qualified study staff at each clinical site will perform primary data collection drawn from source- 

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document (hospital or clinic chart) reviews. The Monitor will perform clinical monitoring, 
including review of CRFs, source documents and/or Electronic Data Capture (EDC) system with 
verification of study eligibility, informed consent process, scheduled follow-up visits and AEs to 
the source documentation. 
 
10.3 
Source Documents / Records Retention 
The investigator shall maintain accurate, complete, and current records relating to the 
investigator's participation in an investigation including records of each subject's case history 
and exposure to the device. Case histories include the case report forms and supporting data 
including, for example, signed and dated consent forms and medical records including, progress 
notes of the physician, the individual's hospital or clinic chart(s), and the nurses' notes. Such 
records shall include: 
 
1. 
Documents evidencing informed consent and, for any use of a device by the investigator 
without informed consent, any written concurrence of a licensed physician and a brief 
description of the circumstances justifying the failure to obtain informed consent. The case 
history for each subject shall document that informed consent was obtained prior to participation 
in the study. 
 
2. 
All relevant observations, including records concerning adverse device effects (whether 
anticipated or unanticipated), information and data on the condition of each subject upon 
entering, and during the investigation, including information about relevant previous medical 
history and the results of all diagnostic tests. 
 
Investigator files containing all records and reports of the investigation should be retained for a 
minimum of 5 years after the completion or termination of the investigational study or until two 
years after they are no longer needed to support product approval. They may be discarded upon 
notification by Pulse Biosciences. To avoid any error, the Investigator should contact Pulse 
Biosciences before destroying any records and reports pertaining to the study to ensure they no 
longer need to be retained. 
 
10.4 
Device Accountability 
The Investigator shall maintain adequate records of the receipt and disposition of all study 
devices. When the enrollment is complete, the Investigator shall return any unused devices to 
the Sponsor. At the completion of the study, all devices shall be returned to the Sponsor. The 
Investigator’s copy of the Device Accountability Log must document devices that have been 
returned to the sponsor. 
 
The device accountability log will include records of receipt, use or disposition of a device that 
relate to: 
 
1. 
The type and quantity of the device, the dates of its receipt, and the lot number. 
2. 
The names of all persons who received, used, or disposed of each device. 
3. 
Why and how many device(s) were returned to the Sponsor, or otherwise disposed of. 
 
 

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nonmelanoma skin cancer. Br J Dermatol. 2012;166(5):1069-1080. 
2. National Comprehensive Cancer Network. Clinical practice guidelines in oncology. Basal cell 
skin cancer version 1. 2018. 
3. Migden MR, Chen L, Silapunt S, eds. Basal cell carcinoma. Advances in treatment and 
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4. Oldfield, V., Keating, G.M. & Perry, C.M. Am J Clin Dermatol (2005) 6: 195. 
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5. Geisse JK, Rich P, Pandya A, Gross K, Andres K, Ginkel A, Owens M. Imiquimod 5% cream for 
the treatment of superficial basal cell carcinoma: a double-blind, randomized, vehicle-
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6. Van der Geer S, Martens J, van Roij J, Brand E, Ostertag JU, Verhaegh ME, Neumann HA, 
Krekels GA. Imiquimod 5% cream as pretreatment of Mohs micrographic surgery for nodular 
basal cell carcinoma in the face: a prospective randomized controlled study. Br J Dermatol. 
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7. Bahner JD, Bordeaux JS. Non-melanoma skin cancers: photodynamic therapy, cryotherapy, 
5-fluorouracil, imiquimod, diclofenac, or what? Facts and controversies. Clin Dermatol. 2013 
Nov-Dec;31(6):792-8. doi: 10.1016/j.clindermatol.2013.08.020. PMID: 24160289. 
8. R. Cornell, et all. Intralesional interferon therapy for basal cell Carcinoma. AAD VOLUME 23, 
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9. Cho M, Gordon L, Rembielak A, Woo TC. Utility of radiotherapy for treatment of basal cell 
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10. Megna M, Fabbrocini G, Marasca C, Monfrecola G. Photodynamic Therapy and Skin 
Appendage Disorders: A Review. Skin Appendage Disord. 2017;2(3-4):166-176. 
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pulsed dye laser on superficial and nodular basal cell carcinomas. 08 July 2009. 
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12. Klassen AF, Ziolkowski N, Mundy LR, Miller HC, McIlvride A, DiLaura A, Fish J, Pusic AL. 
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Scars: The SCAR-Q. Plast Reconstr Surg Glob Open. 2018 Apr 24;6(4):e1672. doi: 
10.1097/GOX.0000000000001672. PMID: 29876160; PMCID: PMC5977950. 
13. Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring 
devices. Eplasty. 2010;10:e43. 2010 Jun 21. 
 
12.0 APPENDICES 
12.1 Appendix A: Patient Informed Consent 
12.2 Appendix B: Case Report Forms  
 
 

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APPENDIX A: Patient Informed Consent  
 
Patient Informed Consent will be provided as a separate attachment. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX B: Case Report Forms 
 
Case Report Forms will be provided as a separate attachment.