Table of Contents

Introduction _____________________________________________

Voltaic Solutions’ Mission Executive Summary: Design & Technology________________________

Technology

Increased Recovery Time with Electric Field

TENS Pain Treatment

Design

Adhesive Electrode Bandage Strips

Microbattery Array and Gauze Section

Removable TENS Unit

Coverage Film

Manufacturing

Intellectual Property Strategy

Device Patentability

Patent Infringement

Licensing

Trademark

Risk Analysis

Risk Management

Failure Modes and Effects Analysis

Risk Mitigation

Executive Summary: Market Analysis and Entry____________________

The Bandage Market

Market Needs

Target Market and Users

Marketing Design: Logo, Packaging, Labelling

Marketing Materials

Market Competition

Market Penetration and Entry

2

Executive Summary: Regulations and Clinical Trial Strategy___________

Device Regulation

Device Classification

General Controls

Special Controls

510(k) Application

Quality System Regulation Requirements

Clinical Strategy

Preclinical Testing and IDEs

Model Feasibility, Safety and Efficacy Testing (In Vitro)

Animal Testing

Human Clinical Trials Strategy

Safety/Biocompatibility Trial Design

Efficacy Trial Design

Patient Eligibility Criteria

Executive Summary: Finances and Reimbursement__________________

Market Size Analysis

Financial Analysis

Assumptions

Financing

Production, Distribution, and Profits

The First Year of Business

Profit Forecast for Three Years

Future

Feasibility

Reimbursement Strategy

Reimbursement Coding

National and Local Coverage

Private Coverage

3

Feasability

References:______________________________________________ Appendices:______________________________________________ Introduction Voltaic Solutions’ Mission

Voltaic Solutions is a burgeoning Los Angeles­based medical startup company

dedicated to improving electroceutical technologies. Electroceutical technologies are

those that employ electrical stimulation, as opposed to drugs, to achieve desired

biological changes in the body. Voltaic Solutions’ mission is to produce novel devices

and treatments in the hopes of increasing quality of life for postoperative patients, the

elderly population, those with chronic afflictions, and everyday Americans. Voltaic

Solutions’ first signature device, BandWave™, is a bandage that targets the wound

healing and pain management sectors of the healthcare industry. BandWave™ uses

tailored electrical stimulation to accelerate wound closure rates and is a drug­free

alternative to other pain management options. Subsequent to the production of the

BandWave™ bandage, Voltaic Solutions will continue pioneering electroceutical

innovation with its sights set on electrical stimulation to relieve symptoms of arthritis,

among other applications.

4

Executive Summary: Design

BandWave™ by Voltaic Solutions is a dual­purpose bandage intended for

epidermal wounds. This innovative device integrates TENS technology and a micro

battery array in order to increase the speed of healing as well as relieve pain. Increasing

the speed of healing and decreasing pain of wounds have different but equally

important purposes. BandWave™ can be used on individuals that have an open

epidermal wound (burns, or broken or inflamed skin) or patients that have recently

received stitches. Currently, in order to relieve pain, patients must either apply analgesic

creams such as Tiger Balm or lidocaine creams or must ingest medication such as Advil

or Vicodin. Neither of the creams can be used on or around open wounds and the pain

relieving pills have undesirable side effects throughout the entire body, such as impaired

cognitive function. Although there are a few products that increase the speed of wound

healing, there is currently nothing on the market with the dual purpose of increasing the

speed of wound healing and reducing pain. BandWave™ fills in the market gap with the

revolutionary design that combines the pain relief from the TENS with the wound

healing of the micro battery array in a variable size bandage that blends into natural

skin tone and can be cut to support the healing of differently shaped wounds in different

areas of the body.

BandWave™ will be sold in bandage strips 16x13 cm in order to properly heal

large­sized wounds. BandWave™ has three perforations that it can be cut along in order

to use the bandage on flat surfaces (such as the chest, back, forearm) or on joints (such

as elbow, finger, and knee). The manual that is included with each bandage outlines the

specific cuts that must be made for each type of wound. Since there are ports for a TENS

unit on both sides of the bandage, cutting the bandage along specified perforations

allows the single bandage to become two usable bandages. On either side of the

microbattery array, there are adhesive electrodes that are used to keep the BandWave™

in place on the skin and to connect to the TENS device. The TENS apparatus is

removable and reusable and will have two wires that connect to the electrodes on the

bandage. The TENS apparatus is held in place by these wires and a thin adhesive and

waterproof film that covers the entire system of bandage plus the TENS apparatus itself.

The microbattery array constantly works to increase wound healing speed while the

5

TENS only works when the apparatus is plugged in and turned on, which means that the

patient has control over the pain management system.

In order to ensure that BandWave™ has a potential future in becoming a

successful device, we must examine its patentability. To determine whether or not it is a

patentable device, we analyzed the novelty, non­obviousness, and usefulness of the

device and concluded that it meets each of these individual criteria. After deeming this

invention patentable, existing patents with similar claims to those of BandWave™ were

researched through databases such as the US Patent Collection Database and the

European Patent Office. The patents that were found to be comparable were then closely

studied to determine if this device is at risk of patent infringement. If the threat of

infringement exists, a licensing strategy will be considered in order to mitigate risk. In

addition to patents and licenses, the pursuit of a registered trademark for BandWave™

will be considered for the purpose of providing identification and distinguishability from

the competition.

Throughout the design process of BandWave™, Voltaic Solutions has performed

risk analysis in order to identify and mitigate the hazards associated with usage of the

device. The risk management process is an essential element in device design and acts as

a tool for inventors in the creation of a safe and effective device. The specific failures

unique to each component of BandWave™, their cause, and their effect on the device as

a whole are listed in the Failure Modes and Effects Analysis table. Furthermore, the

recommended steps for mitigation of these risks are listed in the Risk Mitigation table.

6

Technology

Increased Recovery Time with Electric Field

Many recent scientific studies have shown that electrical stimulation of a wounded area

helps speed up recovery time, and these studies propose this as a revolutionary new

technique to aid the healing process. Because human skin naturally absorbs positive

sodium ions and secretes negative chloride ions, the area under the skin is positively

charged. When a cut is made to the skin (laceration), nothing is able to hold back the

electric current, which now flows out of the body in the area of the cut, creating a voltage

gradient. This voltage gradient is in part responsible for causing cells to divide faster

and more easily, facilitating the reparation of damaged tissue [1]. By increasing the

voltage gradient using a voltage/current­producing bandage, the healing processes can

be artificially sped up.

TENS Pain Treatment

7

TENS has been commonly used as a method for symptomatic relief, management of

long term pain, and treatment for post­surgical traumatic acute pain. This nerve

stimulation works by administering electrical current to help stimulate the nerves to

block pain signals from reaching the brain. The process has been known to be similar to

the results of acupuncture. TENS also stimulates the body to produce higher levels of

endorphins to relieve some of the pain from the wound [2]. The TENS unit in the electric bandage will utilize a similar design as the one shown below. The unit produces

a monophasic pulse of 50 mA at a frequency of 60 Hz and a pulse width of about 90

microseconds.

Design

Photo Realistic Rendered Image

8

9

Exploded View: Full Bandage

10

Layer Number Design Component

1 TENS Units

2 ETS Bandage Fabric

3 Electrode

4 Adhesive Gel (included on electrode)

5 Gauze

6 MicroBattery Array

Top of Bandage

11

Perforations are visible on the image for possible cuts. Wire connections are visible for

the TENS unit. The top of the bandage (ETS Fabric) will be sold in various shades to

match different skin tones.

Bottom of Bandage

The electrodes, gauze and microbattery array are visible on the bottom side of the

bandage.

12

Adhesive Electrode Bandage Strips

Purpose and Components:

BandWave™ is composed of two adhesive electrode strips separated by a middle

gauze section. The purpose of these strips is to allow for proper connectivity with the

patient’s skin for TENS stimulation. The electrodes act like normal electrical stimulation

electrodes, connecting to the TENS power source apparatus by a female connection port,

and delivering pulsations of electrical current to the patient’s body. The electrodes have

an adhesive coating on them to allow the electrodes to properly stick to the patient’s

body, as well as to allow for proper and effective connectivity for the TENS treatment.

The electrodes will encompass the full adhesive region, separated by the middle

section that contains the electric field source (microbattery array). This design allows for

13

the electrode to maintain a large surface area of contact with the skin. BandWave™ is

intended to be used in patients with pain due to serious epidermal wounds such as

stitches, blisters, or burns, and the electrode strips allow for the bandage to provide

pain­relieving TENS stimulation.

The long rectangular electrode strips are arranged on each side of the bandage,

with two connectivity ports for attaching the TENS stimulation apparatus. This aspect of

the design allows for variable bandage sizes. The bandage can be cut into two equally

sized bandages, or can be cut in any other fashion to adequately treat the intended

wounded area as long as there exists a connection port on both of the electrodes. The

TENS apparatus can be attached at any of the two connection points, which will power

the long electrode strip. This increases the usability, as well as the functionality of the

BandWave™, allowing this product to be used in the treatment of highly variable wound

types and sizes.

Dimensions:

The adhesive electrode strip is 16 cm in length by 4 cm in width. This allows for

the potential of having two bandages with an 8x4 cm electrode on each side of the

bandage, as well as many other bandages with variable widths. The electrodes and

coating adhesive gel have a total thickness of 0.3 cm. These dimensions were chosen

based on standard effective TENS electrode sizes, as well as effective thickness which

still allows for both proper stimulation, flexibility, and the ability to cut the electrode to

the desired dimensions.

Materials:

BandWave™ uses a carbon electrode coated in USA Tyco® Adhesive Gel to allow for durability and reliable connectivity with the patient's skin [3]. White wrapping paper

will cover the adhesive Tyco Gel to protect the sterility and adhesive properties of the

electrode before intended use.

14

Microbattery array and gauze section

Purpose and Components:

The middle section of the bandage, in between both electrodes, is composed of a

microbattery array. This section is intended to aid in healing wounds by promoting

regrowth of cells in the afflicted region, as well as acting as an antibacterial and antiviral

healing agent. The microbattery array forms an electric field around the wound which

stimulates cell growth and repair [4]. This portion of the bandage is modeled after the patent US 8224439 B2 microbattery array, which has proven to be an effective and

stable electric bandage. This will be licensed. The design uses silver and zinc to create an

electric field that extends across the wounded region.

There are four microbattery array strips in the center of each of the four sections

of the bandage. Above the arrays, there is a layer of gauze. The gauze prevents any

bodily fluids, such as blood, from leaking out of the bandage area. The gauze maintains

the sterility of the bandage and aids in the healing process. The cloth based microbattery

array is attached to the gauze which is part of the overlaying adhesive bandage. This

attaches the two electrodes to the middle array portion and forms one uniform cloth

bandage.

15

Dimensions:

Each of the four microbattery arrays is 3 cm by 3 cm and the gauze is 5 cm by 16

cm. The arrays are arranged in the center of each 4x13 cm section of the overall

bandage. The microbattery array is 0.2 cm and the gauze is 0.2 cm thick. These

dimensions allow for an effective electric field as well as 1 inch of gauze separating the

array from each electrode.

Materials:

The microbattery array portion of this device is a cloth based bandage lined with

conductive zinc and silver dots. The array is surrounded by medical gauze. The array,

gauze, and electrodes are attached by heated glue on the ETS bandage fabric.

Removable TENS apparatus

Purpose and Components:

BandWave™ utilizes a detachable TENS unit as a form of pain relief. The

detachable TENS unit is similar to traditional TENS units used in physical therapy and

is connected to the adhesive electrode bandage strips by two retractable connector

16

wires. This unit works by generating variable frequency and bandwidth to stimulate the

body’s peripheral nerves to block pain signals from reaching the brain and by

stimulating the production of endorphins in the body [5]. The unit also incorporates an ON/OFF button, which allows for the user to control the device when he or she requires

pain relief, and an internal LED to signal to the user that the device is connected.

Dimensions:

The TENS system needs to be 4 cm in width by 5 cm in length. This allows the

unit to cover the space between the two electrodes and to maximize the flexible area of

the bandage. The TENS system will have a thickness of 0.9 cm. The protruding wires

will have a length of 2.5 cm to allow for connectivity in all situations. These dimensions

were chosen to minimize the size of circuitry while maximizing the flexibility and overall

effectiveness of the bandage.

Materials:

The casing for the TENS system is made out of ABS plastic to waterproof the

circuitry. The protruding wire is made out of standard electrode wires. The internal

circuit is printed on a PCB board and housed inside the plastic casing. All these

materials were chosen to ensure durability and effectiveness of the system.

Coverage Film

Purpose:

The purpose of this film is to keep all the components stabilized and connected.

The film is waterproof and it prevents bacteria from coming into contact with the wound

underneath the bandage.

Dimensions:

The film is 18 cm in width by 15 cm in length. This dimension allows for full

coverage of the bandage and can also be cut based on the size of the bandage.

Materials:

17

This film is made out of a transparent adhesive film that allows the user to check

to make sure that the TENS unit is connected properly.

Manufacturing

BandWave™ will be manufactured overseas in Shanghai, China. The TENS

apparatus encasement is injection molded, the circuit will be printed and the electrodes

can be assembled by hand. These will be shipped to Voltaic Solutions’ assembly factory

where sterilized gauze and ETS fabrics will also be shipped. The assembly of all the

components in the complete device will be done by a supervised machining process.

A thin layer of glue is applied to an 1800 m roll of fabric and heated to 50C. The

glued roll is then cut into 13 cm strips. The microbattery array is cut into 3x3 cm strips

and glued onto the 5 cm width gauze. The gauze and microbattery array are then glued

to the ETS fabric, which is followed by the addition of the electrodes to the remaining

length of the ETS fabric. A coating of Tyco Gel is applied to the electrodes before they

are assembled onto the fabric, and a protective plastic cover is placed on the bottom of

the bandage. The assembled bandage is finished after being cut into its final 13x16 cm

size and is packaged into a box with one bandage, one TENS apparatus, and two film

covers per box. Once the bandages, TENS apparatuses, and film covers are packaged

into boxes, they are packaged into larger shipping boxes, and labeled with the company

name (“Voltaic Solutions”) and the destination for distribution.

Intellectual Property Strategy

Device Patentability

A patent is defined as the exclusive right to create, sell or employ a new process,

machine, manufacture, or composition of matter for a defined period of time. The

purpose of a patent is to create a contract between the patent­holder and the public in

which each party benefits uniquely. The inventor benefits by establishing a monopoly

over the patented material while the public gains all relevant knowledge about the

material that would otherwise be kept private. To be considered patentable, an

18

invention must be deemed novel, nonobvious, and useful. A device is considered novel if

it is different in a significant way from any previous invention in the field. It is

nonobvious if it would be considered unexpected to someone familiar with the subject

matter, and it is useful if it will be beneficial in some way. Once these criteria are met, an

invention can be patented, thus securing a company's intellectual property, and

preventing other individuals from profiting off of it.

BandWave™ satisfies each of the three conditions listed above making its

patentability a viable option for Voltaic Solutions. Although the device combines two

existing technologies – electrically stimulated wound healing and TENS – the

combination of these two methods in a single device is revolutionary and thus satisfies

the novelty requirement. Since both technologies have been in existence for several

decades on their own and have never been previously integrated into one device,

BandWave™ may be considered a non­obvious invention. This proves that the

combination of the two methods is not obvious to a professional in the field because a

considerable amount of time has passed in which the combination has not been

successfully carried out. Lastly, BandWave™ combines the element of accelerated

wound healing in addition to pain relief, proving its usefulness as a medical device.

Due to the demonstrated patentability of BandWave™, it would be highly

beneficial for Voltaic Solutions to pursue a patent for this innovative device. The utility

patent is the standard patent type in the medical device field and is the patent that

Voltaic Solutions will pursue. The utility patent encompasses novel or improved

machines, processes, and matter, and grants the inventor a 20­year monopoly on the

protected material, starting from the date of application. BandWave™ falls under the

utility patents category due to its nature as a medical device, utilizing electrical power to

achieve its end result of wound closure and pain management.

Patent Infringement

Though it is clear that the BandWave™ is itself an innovative invention, it does

utilize components, methods, and claims that products already on the market also use.

If the creation and distribution of BandWave™ is pursued without obtaining the

19

permission of the owners of these similar, patented technologies, Voltaic Solutions runs

the risk of committing patent infringement. In order to avoid infringement, we must

first determine which specific patents are at risk of being violated. From the US Patent

Collection Database, two patents were found to have claims very similar to those of

BandWave™. An additional two patents were located through the European Patent

Office relating specifically to the TENS technology utilized in our device. The analysis

and comparison of these patent claims are clarified below.

Patent 7,410,497: “Stimulation of cell growth at implant surfaces” – filed by

Hastings, et al. in August 12, 2008, describes a device that contains at least one tissue

contacting surface that is configured to undergo a variation in surface charge in

response to a signal derived from the patient. This “variation” would enhance or inhibit

cellular growth around the surface in contact. Although their claims are very general,

they still do address wound healing applications later in the patent that are very specific

to the generation of electric fields in closing cuts. Our electric bandage falls into their

first claim and overall concept of a device that changes its surface charge based on the

patient; thus, a license should also be obtained from these owners [6].

Patent 8,224,439: “Batteries and methods of manufacture and use” – filed by Skiba, et al. in July 17, 2012, presents the claim of a substrate surface that has multiple

first reservoirs of both an oxidizing and reducing agent and multiple composite

reservoirs that interact with the first reservoirs to generate current for penetration into

biological tissue. In order to do this, the device utilizes a variety of silver and zinc dots

placed on a cloth membrane. Our design conflicts with this patent because of the

method of using reservoirs to generate current in the tissue. Patent infringement on this

patent may be avoided by either creating a different way to augment the natural electric

field that the body produces or to obtain a license from the patent owner [7].

Patent US4989605A: “Transcutaneous electrical nerve stimulation (TENS)

device” – published by Rossen, et al. in February 5, 1991, describes the pain­relieving

component integrated into BandWave™. Due to the fact that this patent was filed over

20 years ago, the protection offered by the patent has now expired, allowing anyone to

use and profit from the technology presented in the patent. In our case, this means that

20

we will not have to purchase licensing for the TENS technology. Our device can readily

use the circuit construction for TENS involving a micro­current monophasic DC carrier

that can be turned on and off. We will have very similar claims: that a pair of electrodes

will be used for making surface contact with the skin and supplying electrical current in

order to alleviate pain. The voltage range and frequency may be altered from 25­900

micro amps and 0.3 Hz to 10,000 Hz based on clinical trials that will demonstrate which

voltage and frequency produces the best results. It is important to note that this patent

does not claim anything with regards to increased healing speeds; its only claims are

related to pain reduction. However, our device will incorporate this TENS circuit for

both purposes. In this specific case, patent infringement is not a risk due to the

expiration of the patent, and thus, a license need not be pursued [8].

In patent US8588918: “Assembly arrangement for bandage holding a

transcutaneous electrical nerve stimulation device” – filed by Bighetti on December 16,

2010, a bandage is described that has an embedded TENS unit. The TENS device has 3

buttons to control different settings as well as an ON/OFF LED. We do have very similar

claims in that BandWaveTM has a central module fitted with a dashboard controlling electric current between two electrodes and two side tabs on the central module

opposite of each other adapted to contact the user’s body. Though this patented bandage has similar claims, BandWaveTM does not infringe on this patent’s claims because the

TENS unit is detachable and only has one current setting. Therefore, a license will not

be pursued for this patent [9].

Licensing

Licensing is understood as an agreement that grants the licensee – the individual

pursuing the license – the right to use specific intellectual property that is owned by the

licenser. There are varying strengths and durations of licenses, which are determined by

mutual agreement between the licensee and licensor. To fully protect BandWave™

against patent infringement on the specific patents described above, it is in the best

interest of Voltaic Solutions to pursue licensing of several of the specific technologies

listed.

21

For the first two patents described, different licenses should be obtained. These

components include term, territory, renewal, and exclusivity rights. Term licenses

guarantee the validity of a license for a particular length of time while territory ones

stipulate what area the rights are applicable to. The licenses can also be exclusive or

non­exclusive, depending on how much freedom the licensee wishes to pursue.

Non­exclusive licenses, however, do not completely protect the licensee because they

may still be infringing on other patents. In order to have the most competitive edge in

the market, the licenses needed to develop BandWaveTM require all of these components

and high exclusivity to block out competition. Although this would be costly, these rights

will provide the company with the niche it needs to be successful.

Trademark

An additional type of intellectual property that Voltaic Solutions, as the inventor

of BandWave™, will pursue is that of trademarks. A trademark is defined as a

distinctive visual mark that represents a particular product with the intention to provide

identification and distinguishability from competing goods or services. Unlike patents,

once attained, trademarks do not expire so long as the mark continues to be used. In the

case of BandWave™, a combination of the name and its symbol will be trademarked in

the state of California where distribution of the device will begin. The trademarked

name and logo are visible below.

22

If the dissemination of BandWave™ expands beyond California after the several

years of successful production, Voltaic Solutions will officially register the trademark by

filing an application with the USPTO in Washington, D.C.

Risk Management Process

Risk Management

Risk management is defined as a process to help designers and manufacturers

identify any possible hazards, estimate risks and develop strategies to minimize these

risks and potential for adverse events. The process is implemented as early as the design

input stage and continues throughout the entire product life cycle. Risk management is

covered in ISO 14971, ISO 13485 and the FDA’s Quality System Regulation

Requirements for Risk Analysis. The Risk Management Plan (RMP) for BandWave™

includes the identification of device components and the conditions leading to their

failure in the form of a Failure Modes and Effects Analysis (FMEA) table. Additionally, a

Risk Mitigation table is enclosed and addresses the safety hazards and failure modes

presented by the FMEA table and the steps that Voltaic Solutions has taken in order to

reduce these risks. The plan also covers acceptability criteria and a device verification process. NEED TO INCLUDE THIS

Risk Management File

The purpose of the risk management file is to provide traceability and

documentation of records of risk analysis, evaluation results, control measures for every

hazard and the acceptability of any residual risks. Voltaic Solutions has maintained this

documentation throughout the risk management process.

Risk Analysis

Risk analysis consists of documentation of the intended use and foreseeable

misuse of BandWave™, possible known hazards associated with BandWave™ and the

estimated risk for each hazardous situation identified.

23

(Put this under the FMEA table as a description)

Every individual failure and associated hazard are identified in this stage of risk

analysis and the criteria for each of these situations are defined by using an FMEA table.

The table lists each component of BandWave™ and all possible failure modes associated

with that component. Each failure was assigned ratings based on severity, probability

and detectability for the risk. Each of these categories is ranked on a scale of 1­5, 1 being

least and 5 being greatest. Overall relative risk was calculated using the following

equation:

isk r = detectabilityprobability×severity

(Put this under the Risk Mitigation table as a description)

For each effect of failure estimated in the risk evaluation stage, a

recommendation was made to mitigate and minimize risk for each effect by using a risk

mitigation table, seen below. Specific tasks, including preventative measures in terms of

modification of design or the system and soft controls such as labeling, training and

instructions for use, were included in this stage, plus specific descriptions for each

strategy.

Risk Management Report

The purpose of the Risk Management Report (RMR) is to be sure that the RMP is

implemented and that measures are in place to obtain production and post­production

information.

Failure Modes and Effects Analysis

Component Substi

tuent

Comp

onent

Failur

e

Mode

Cause

of

Failur

e

Effect

of

Failur

e

Sev

erit

y

Probabil

ity

Detectability Risk Level

24

TENS Unit Plastic

Housi

ng

Plastic

casing

breaks

Stress

exceedi

ng the

materi

al’s

yield

stress

TENS

Unit is

no

longer

protect

ed and

subject

to

liquid

contact

(and

further

subseq

uent

electric

al

failure

s)

2 2 5 0.80

Printe

d

Circuit

Board

Short­

circuit

Contac

t with

liquid

Therap

eutic

effect

is lost

5 1 5 1.00

Discha

rge of

curren

t into

user

5 1 5 1.00

Heatin

g of

circuit

4 1 5 0.80

25

compo

nents

leading

to

release

of

fumes

Wire

connec

tion

port

breaks

Stress

exceedi

ng the

materi

al’s

yield

stress

TENS

Unit

would

be

unable

to

connec

t to

bandag

e,

renderi

ng it

ineffec

tive

5 2 4 2.50

LED

does

not

light

up

Connec

tion

failure

within

the

system

or bulb

malfun

ction

User

would

not

know

whethe

r the

device

was

workin

g

4 1 2 2.00

26

correct

ly

ETS Fabric N/A Fabric

tears

Stress

exceedi

ng the

materi

al’s

yield

stress

Microb

attery

array,

gauze,

and

TENS

unit

may be

displac

ed

3 2 5 1.20

Loss of

adhesi

on

Manuf

acture

error:

not

enough

adhesi

ve

applied

Electro

des

and

microc

ell

arrays

displac

ed

3 2 5 1.20

Electrodes N/A Wiring

discon

nect

Cutting

of

wires

while

cutting

bandag

e to

tailor

size

Loss of

TENS

therap

eutic

effect

5 1 4 1.25

27

and

shape

Loss of

adhesi

on

Manuf

acture

error:

not

enough

adhesi

ve

applied

5 1 4 1.25

Loss of

condu

ctivity

User

error:

inappr

opriate

electro

de

placem

ent

5 2 3 3.33

Gauze N/A Tearin

g

Stress

exceedi

ng the

materi

al’s

yield

stress

was

applied

Gauze

may

tear

due to

bodily

move

ment

or

initial

placem

ent

2 2 4 1.00

28

Not

compl

etely

steriliz

ed

Manuf

acture

or

packag

ing

error

Increa

sed

likelih

ood of

infecti

on at

wound

site

3 1 1 3.00

Inadeq

uate

absorp

tion of

bodily

fluids

Absorp

tion or

size of

gauze

was

misjud

ged by

device

design

ers

Additi

onal

gauze

is

necess

ary to

achiev

e

proper

absorp

tion

2 2 4 1.00

Microbattery

Array

N/A Circuit

betwee

n

device

and

epider

mis is

not

compl

eted

Not

enough

conduc

tive

fluid

presen

t

Increa

sed

wound

healing

effect

may be

lost

4 1 2 2.00

Array

is not

in

direct

4 1 2 2.00

29

contact

with

skin

Eleme

ntal

silver/

zinc

microc

ells

detach

from

dressi

ng

Adhesi

on of

microc

ells to

wound

Possibl

e

irritati

on at

applica

tion

site

3 2 3 2.00

Manuf

acture

error:

inadeq

uate

metal

printin

g

3 1 3 1.00

Outer Film N/A Tearin

g

Stress

exceedi

ng the

materi

al’s

yield

stress

Banda

ge

longer

protect

ed and

subject

to

liquid

contact

2 2 5 0.80

Positio

ning of

TENS

device

on

2 2 5 0.80

30

bandag

e is no

longer

mainta

ined

Inadeq

uate

adhesi

on

Manuf

acture

error

Banda

ge

longer

protect

ed and

subject

to

liquid

contact

2 1 4 0.50

Positio

ning of

TENS

device

on

bandag

e is no

longer

mainta

ined

2 1 5 0.40

Risk Mitigation

Component Effect/Fault Risk Mitigation

TENS Unit TENS Unit is no

longer protected and

Manufacture stronger

plastic material

31

subject to liquid

contact (and further

subsequent electrical

failures)

Provide instructions

indicating delicate care of

the device

Short circuit:

discharge of current

into patient, heating of

circuit components

leading to release of

fumes

Protective, adhesive film

covering added to device

TENS Unit would be

unable to connect to

bandage, rendering it

ineffective

User buys a new device

User would not know

if device was working

correctly (LED failure)

User provided with

replacement device (if no

evidence of liquid damage is

found)

ETS Fabric Microbattery array,

gauze, and electrodes

unit may be displaced

Protective, adhesive film

added to device

Electrodes Loss of TENS

therapeutic effect

Provide instruction manual

including directions on how

to properly cut bandage

without cutting the wires

and how to properly place

electrodes

Apply enough adhesive

during manufacturing to

32

adhere to gauze and ETS

fabric

Gauze Gauze may tear due to

bodily movement or

initial placement

Advise that users do not

perform excessively

strenuous activity while

wearing device, especially if

placed at joint

Use higher strength material

Increased likelihood of

infection at wound site

Sterilize device properly

during manufacturing

Additional gauze is

necessary to achieve

proper absorption

Low probability: user will

have to purchase additional

gauze

Microbattery array Increased wound

healing effect may be

lost

Low probability, instruct

user to handle with care

Possible irritation at

application site

Low probability: warning

provided for users allergic to

silver or zinc

Outer film Bandage no longer

protected and subject

to liquid contact

Instruct user to employ

caution when applying

protective adhesive film and

to be conscious of bandage

placement so as not to

accidentally rip it

Positioning of TENS

device on bandage is

no longer maintained

33

Bandage longer

protected and subject

to liquid contact

Positioning of TENS

device on bandage is

no longer maintained

34

Executive Summary: Market Analysis and Entry

The bandage and wound healing markets are projected to be $39.3 billion by

2016 and will continually increase by an estimated 5.3% annually. Driven by various

factors, this industry is led by developed countries that have consistently rising numbers

of injuries per year and an aging population. More advanced bandages are in demand

due to deeper and harder to heal wounds caused by surgical cuts and deep lacerations.

With the number of surgical incisions growing at an annual rate of 3.1%, there is a need

for a more reliable dressing that can both accelerate healing and improve pain

management. In addition, the growing number of elderly and chronic diseases patients

that lack a healthy healing time and an effective inflammatory and immune response

creates a need for a bandage that reduces the risk of infection by closing the wound

more quickly. A bandage that can speed recovery and decrease pain would dramatically

reduce the chance of admittance to a hospital or care facility, saving hospitals money,

and would decrease the risk of death due to infections. Thus, for BandWave™, the

target users will be post­operative patients and their medical staff, the elderly, and

people with chronic diseases that cause skin wounds.

Using BandWave™ on surgical incisions will benefit hospitals because it reduces

the length of stay for patients as well as decreases the chance of readmittance and

follow­ups. In addition to medical staff, BandWave™ will also be available for the

general public that can also benefit from faster healing times from normal surface

injuries, such as cuts and scrapes. Currently, the companies that dominate this market

are more focused on low­end, general care; therefore, BandWave™ could fill in the

niche for more innovative, advanced bandages. Studies have shown that while

conscious buyers are more likely to purchase cheaper, less­effective dressings for

everyday use, they are still willing to spend more for bandages with newer technology

for more serious wounds, like surgical incisions and deep injuries. BandWave™ has

unparalleled benefits that the target users are willing to pay for, which indicates great

potential for success.

In order to be most effective in entering the market, Voltaic Solutions should

partner with either Johnson & Johnson or a growing competitor such as 3M, in order to

expand the consumer base and reach a larger market than would be possible by

35

operating as a small, distribution­based company. While BandWave™ is innovative and

can drastically save unnecessary costs due to infection and less­advanced bandages, this

product must first catch the attention of both the hospital staff as well as the general

public. With connections and resources from a bigger, more established company, the

demand and return for BandWave™ could be exponentially bigger than if Voltaic

Solutions tried to break into an established market by itself. However, in order to be

recognized by Johnson & Johnson or 3M, Voltaic Solutions must become recognized

through sales representatives hospital visits, convention appearances, public

demonstrations, advertisements towards the target users, and social media. In addition,

special attention and presentations will be given to surgeons in order to gain support

and acceptance of the product in the medical and wound care fields. With backing from

both users and medical professionals, Voltaic Solutions and BandWave™ could become

large enough for bigger device companies to partner with or purchase. BandWave™ has

the potential to help an industry giant further innovation and fill the other advanced end

of the bandage spectrum.

The Bandage Market

The current bandage market consists of a large portion of wound management

products. Dominated by temporary, adhesive dressings for everything from light

scratches to surgical sites, the total value of the global market for these types of devices

is increasing annually by 5.3%. In 2016 alone, the world demand for healing agents and

products is projected to be $39.3 billion (Freedonia) 10. Led by the United States, developed regions will account for a large portion of the market while demand increases.

The growth of the bandage market has been largely been driven by the rapidly

increasing number of surgeries per year and recreational activities by all age groups.

Surgical wounds alone have been growing at an annual rate of 3.1% (Mediligence 11). Rising incidences of chronic diseases such as diabetes and obesity, which can cause

chronic diabetic ulcers, along with the increasing number of wound infections, creates a

need for innovative bandages that facilitate faster and more advanced healing.

BandWave™ would drastically improve the current state of wound recovery by

36

accelerating wound closure, decreasing rehabilitation time, and reducing the rate of

pathological infection.

Other drivers of the wound healing market are the rapidly increasing populations

of older adults and people with diabetes or HIV. The estimated population of elderly

individuals from 2012 will double to 83.7 million by 2050 (Ortman 12). Although older adults can heal most wounds, they have drastically slower healing times and a delayed

inflammatory immune response. Because of this, the elderly are much more susceptible

to infection and further injury. Patients with illnesses such as diabetes or HIV also have

weakened healing and less protection against bacterial or fungal infection. About 33%

of the current 29.1 million diabetics in the United States will have a skin disorder or

wound in their lifetimes (dailyRX, CDC 13). BandWave™ would aid in remodeling and

recover lost healing time in order to counteract these age­ and disease­related

differences.

The bandage market is extremely broad and highly aggressive. However, with so

many factors driving it, the market has several, specific niches that can still be explored

and filled. Many of the industry leaders have shifted their focus to more general, at

home care, leaving the advanced bandage sector relatively untouched. BandWave™

would advance the bandage industry by incorporating novel wound­healing technology

and reduce the significant economic burden of common wound and surgical site

infections, which extend the lengths of hospital stays and increase the costs of treatment

(de Lissovoy 14). Market Needs

Currently, normal and general bandages would heal by only covering the wound.

They keep the injured skin from drying out and prevent exposure to dirt and germs;

however, they do not aid in pain management or accelerated cell proliferation and

remodeling. For post­operative patients, the elderly, and those with open wounds, it is

crucial to minimize healing time to reduce hospital stay and complications from

infection and scarring. As the populations of these groups grow, BandWave™ can help

solve the following newer, unmet needs:

37

Accelerated Wound Healing: The technology for bandages has been unchanged for years. By limiting the wound’s exposure to the air, bandages serve as a barrier

against bacteria and water while the skin heals; however, they do not help granulation

tissue migrate and differentiate. BandWave™ helps the proliferative phase of healing by

augmenting the body’s own electrical healing process. When the epithelium is

disrupted, the skin naturally creates an endogenous electric field across the wound with

the negative potential focusing near the center axis of the incision. Cells are drawn

towards each other from both sides of the incision where they begin re­epithelialization.

BandWave™ increases the electric potential of the skin around the wound to better

direct and accelerate cell movement. Faster wound closure would not only speed

recovery time, but it would also reduce chances for infection and save hospital stay

costs.

Reduced Pain: Most bandages in today’s market do not have an effective pain reduction system. Although many have a layer of antiseptic gel on the inner layer of the

dressing, users generally have to combine the bandage with pain relief ointments and

sprays, like Neosporin or Bactine, or oral medication, like Advil or Tylenol. Oral

medication is not recommended because it affects the entire body instead of a localized

area. BandWave™, which utilizes an electric­based structure, solves this problem by

using transcutaneous electrical nerve stimulation (TENS) technology. The

microcurrents and pulses stimulate nerves non­invasively to reduce both acute and

chronic pain. For post­operative patients, the first stage in healing ­ the inflammatory

phase ­ causes warmth, swelling, and pain. With BandWave™, the pain can be

dramatically reduced.

Reduced Scarring: Scars are naturally formed when collagen fibers begin the remodeling new skin across the damaged skin. When wounds take a long time to heal,

the body can produce too much collagen, causing scars to be hypertrophic or raised.

Faster–healing injuries would therefore reduce scarring. BandWave™ would improve

the appearance of the skin after healing.

38

Customization: If a patient has two different sized injuries, he or she must purchase two different kinds of bandages because they are mostly sold in specific

dimensions. In addition, most are only secured on two sides of the dressing, leaving the

two other edges exposed to water and germs. BandWave™ solves this issue by giving

the user size options. The large bandage strip (16 by 13 cm) is has perforations to direct

the individual to cut the bandage for different parts of their body or for different sized

wounds. The large bandage can be cut into two separate bandages (three different

potential sizes) and the TENS can be used on both bandages. This allows flexibility for

the user as well as a high range of uses.

Reusability: Because dressings are continuously absorbing fluids from the wound, they need to be changed often to decrease the risk of contamination. Thus, most

general bandages are disposable and indicated for one­time use. While the dressing and

gauze portion of BandWave™ should be changed regularly to discourage infection, the

TENS unit is removable and can be reused for new dressings. Because the TENS unit is

reusable, each package of BandWave™ will be sold with one TENS unit and multiple

bandages.

Target Market and Users

Post­operative patients and older adults purchase a significant number of

bandages, especially high­end adhesive bandages, each year. Approximately 40 million

surgeries that require incisions are performed in the United States per year (CDC 15). The length and size of these surgical cuts range from a quarter of an inch to 8 inches

with an average of 3 inches (SSM). BandWave™ fits into this market niche by providing

protection, healing, and pain management for up to 6 inches of a wound or surgical

incision. Because the skin serves as a natural barrier against bacteria and other harmful

toxins, surgical sites are much more likely to develop an infection within 30 days after

surgery (Hopkins). Because BandWave™ both increases recovery time and provides

effective pain management, physicians are more likely to recommend and use it to

decrease hospital stay and reduce the chance of infection and costly follow­ups. Thus,

the primary targets are post­operative patients and their physicians.

39

The more general users would include the elderly and those with chronic diseases

that cause epithelial wounds. One out of three older adults aged 65 and older fall each

year (NIH Senior Health). Twenty to 30% of those who fall suffer moderate to severe injuries that include deep lacerations, hip fractures that require surgery, and head

traumas (CDC). People with diabetes or HIV also have delayed immune responses and weak remodeling systems. Diabetic and pressure ulcers have tremendous consequences

and costs (Diabetes). The Center for Medicare Services estimates that the average cost per ulcer for Medicare patients was $43,180 in 2007 (Armstrong). These wounds, if not healed quickly, can lead to hospitalization or long­term facility care, and they also

increase the risk of early death. BandWave™ could significantly reduce these risks with

its wound healing technology. With it’s large size and easy application, BandWave™ can

be applied to any site or kind of injury, including small cuts, surgical incisions, and even

pressure ulcers. Due to their slow healing time and decreased immune response, the

elderly and people with diseases like diabetes or HIV will be a part of the target market.

Marketing Design: Logo, Packaging, Label

In order to attract target users, the product and packaging should incorporate

graphics or eye­catching designs that stand out against similar products and imply

safety and comfort. The logo for Voltaic Solutions can be seen below:

This design is simple and comprised of basic shapes, including yellow O’s, which

are calming and appealing against the sharper edges of the other letters. The yellow

color reflects the symbolic color of electricity, which is a major technological part of the

BandWave™ design. The clean, wide font can be used on a range of backgrounds, giving

flexibility to its application on packaging as well as advertisements.

For the BandWave™ brand, the logo is displayed below:

40

Because of all the potential applications, this logo is also versatile and can work

on a variety of background colors. Even if the font is very small, it is still distinct enough

to be legible. While the overall ‘Greek Cross’ shape is a distinctive sign for first aid and

medicine, the blue ripples within the medical cross symbolize waves of regeneration.

The packaging for BandWave™ can be seen below. On the front, the logos for

BandWave™ and Voltaic Solutions and a brief description of the product stand in

contrast against a comforting yellow­green background. A small viewing window made

of plastic is also on the front to show the portable TENS control unit. On the side panel,

there is a list of injuries and wounds that BandWave™ can be used for. Explanations

about the two technologies incorporated into the product are on the back of the box,

along with a warning for users allergic to zinc or silver. Customers that are interested in

learning more about BandWave™, Voltaic Solutions, and associated products can scan

the QR code which will direct them to the website. This will also be the way in which

patients and users can interact with the company by offering questions, concerns, and

feedback.

41

The back side of the packaging describes the technology and the mechanisms of

action employed by BandWave™ so that the consumer has a better understanding of the

benefits of using this product. The labeling is as follows:

What is TENS?

TENS is a pain management therapy that send gentle electrical pulses through the skin

to reduce pain in the area of application. Pain is reduced by blocking pain signals from

reaching the brain and by stimulating the release of endorphins, the body’s natural

painkillers.

What is microcurrent technology?

Microcurrents are small loops of weak electrical that are generated where the bandage

contacts the skin. These currents are generated by elemental silver and zinc microcells

printed on the bandage when they are moistened. These currents stimulate cell

regeneration to speed up the healing process, and reduce scarring.

Package Contains:

42

Reusable TENS stimulator device

Once 13cm by 16cm bandage

Two adhesive film covers

The bandage can be cut along the specified lines to tailor its size and shape to your

needs.

Read directions carefully before use.

WARNING: This product contains elemental silver and zinc. Those with allergies to

these metals should not use this product.

Marketing Materials

Marketing campaigns must be targeted at both medical staff and general

consumers in order to tackle the largest market. Voltaic Solutions will use various

methods in gaining recognition and acceptance in the bandage market. For the rollout

of BandWave™, the following strategies and materials will be implemented.

Sales Representatives: The best way to help BandWave™ gain attention is to have sales representatives show consumers how effective it is compared to current bandages. To do this, product demonstrations will be made in classes, medical device and healthcare conferences, advertisements, hospitals, and more to promote acceptance of the product (Research&Markets 21). Sales representatives will start by visiting hospitals and care facilities around the Los Angeles region to start a local following. As the business grows, other sales teams can be established throughout California, and eventually throughout the country to start redefining the standard for wound healing and pain management.

Advertisements: To gain attention and establish BandWave™ as a commonly

used product, BandWave™ needs to be advertised in media and areas that are

associated with the target users. Because the primary intended consumers are

post­operative patients, surgeons, nurses, and other medical staff, these groups must

43

learn about this product. Therefore, magazines such as The American Journal of Surgery, Outpatient Surgery Magazine, and Surgical Products Magazine would give exposure to this new product to those who could recommend the product to patients.

To target the more general consumers (the elderly or people with chronic diseases),

magazines such as Living Well Magazine, Diabetes Forecast, and HIV Plus Magazine will help in giving BandWave™ a name.

Pamphlets/Brochures: Along with advertisements, pamphlets and brochures will be distributed in areas that are often frequented by the target users. These would

include hospitals, elderly care facilities, pharmacies, and health clinics. Laced with facts

and testimonials, these fliers will get customers interested and excited about

BandWave™. When they shop for bandages, they will be more familiar with the product

and recognize it among other bandage types.

Social Media: To appeal to users of all ages and demographics, BandWave™ and

Voltaic Solutions will have a broad social media presence. Through the website,

Facebook, Twitter, Instagram, and other social media platforms, customers will be able

to learn more about the company, the products, and the technologies, and to ask

questions or share testimonials. These platforms will also allow users to interact with

designers and engineers to encourage product improvement. Every advertisement,

brochure, and product packaging will include QR codes to ease access to these sites.

Market Competition

Currently, the biggest companies in the wound management and bandage market

are Johnson & Johnson, 3M, and several private labels. Medical device giant Johnson &

Johnson has a brand of adhesive bandages named Band­Aid®, which has become a

genericized trademark for any kind of wound dressing. Although J&J has dominated

the bandage market for decades and holds a 55% market share today, 3M has been

edging them out with more innovative bandages. 3M now has a 13.8% share of the

market by shifting its focus to home care and redeveloping dressing technologies used in

hospitals. Although 3M only entered the consumer bandage market four years ago, they

44

have already gained enough ground to become the second largest company in the

bandage market. Private labels make up approximately 13.6% of the market with the

rest being other labels (Hua 22).

In addition to the adhesive bandage giants, there are several smaller companies

that are utilizing electric field and microcurrent technology in their dressings. Vomaris

Innovations, Inc. has a brand called Procellera which sells bandages that have both

silver and zinc on the device surface. This matrix of metal dots creates multiple

microbatteries that generate currents that recruit new cells and promote recovery.

Vomaris also recently partnered with Arthrex, Inc., a global medical device company in

orthopaedics and sports medicine (PR Newswire 23). They are strong competition against BandWave™; thus, BandWave™ could benefit from partnering with other

bandage companies for a better chance of success.

Market Penetration and Entry

The most conscious buyers of bandages are those looking for general use,

low­end adhesive bandages. Many private label brands have headed towards this end of

the market to cater to these buyers; however, consumers of high­end, “smart” bandages

are more willing to pay higher prices in order to gain the additional benefits of more

advanced products. BandWave™ has high potential in leading the advanced bandage

market niche. For BandWave™ to be successful, however, the market entry must be

aggressive.

There are two main possibilities for BandWave™ to penetrate the bandage and

wound healing market. The first mode of entry would be to independently market,

manufacture, and sell the new bandage directly to the target users: physicians,

post­operative patients, people with chronic diseases, and the caretakers of the elderly.

Everything from clinical trials to focus groups to building relationships with hospitals

and stores would be done solely by Voltaic Solutions.

The second mode of entry would be to partner with an existing company in the

bandage market. Because Johnson & Johnson is the leader of the wound management

45

industry, Voltaic Solutions could benefit greatly from partnering with them and helping

them fill their need for more innovative and advanced products. In doing so, Voltaic

Solutions would not have to purchase their own factories or penetrate an established

market that has been consistently controlled by only a handful of companies. Because

Voltaic Solutions would have already assumed the risks and funded the clinical trials

and all of the regulatory and quality paperwork, BandWave™ would be fully developed

and FDA approved. Thus, BandWave™ would be established and attractive to Johnson

& Johnson, which can partner with Voltaic Solutions for licensing and distributing

rights or purchase it altogether. With 3M slowly capturing more of the bandage market,

Johnson & Johnson could use BandWave™ to regain their control of the advanced

dressing niche. The cost of just bringing BandWave™ to market would be too much for a

start­up; therefore, the second mode of entry would be more successful.

46

Sources

Freedonia.

http://www.freedoniagroup.com/World­Wound­Management­Products.html

Freedom&Markets.

http://www.researchandmarkets.com/reports/365799/u_s_adhesive_bandages_mark

et

Hua. http://articles.latimes.com/1998/sep/10/business/fi­21303 CDC. http://www.cdc.gov/nchs/fastats/inpatient­surgery.htm Hopkins.

http://www.hopkinsmedicine.org/healthlibrary/conditions/surgical_care/surgical_site

_infections_134,144/

Mediligence.

http://blog.mediligence.com/2009/08/24/surgical­traumatic­burn­and­chronic­woun

ds­driving­wound­care­products­market/

Ortman. http://www.census.gov/prod/2014pubs/p25­1140.pdf de Lissovoy. http://www.ncbi.nlm.nih.gov/pubmed/19398246 CDC AdultFalls. http://www.cdc.gov/HomeandRecreationalSafety/Falls/adultfalls.html PR Newswire.

http://www.prnewswire.com/news­releases/vomaris­and­arthrex­announce­exclusive­

global­distribution­agreement­for­procellera­technology­300028013.html

CDC Diabetes. http://www.cdc.gov/diabetes/data/statistics/2014statisticsreport.html dailyRX. http://www.dailyrx.com/diabetes­patients­have­increased­risk­skin­problems Armstrong DG, Ayello EA, Leask Capitulo K,Fowler E, Krasner DL, Levine JM, Sibbald G, Smith APS, Opportunities to Improve Pressure Ulcer Prevention and Treatment: Implications of the CMS Inpatient Hospital Care Present on Admission (POA) Indicators/Hospital­Acquired Conditions (HAC), Policy Wounds 2008;20(9):A14­A26.

47

Executive Summary: Regulations and Clinical Trial Strategy

BandWave™ will be submitted to the FDA as a Class II medical device. This

classification requires adherence to regulatory requirements known as general and

special controls. General controls were enacted through the FD&C Act and include

regulations on subjects such as adulteration, misbranding, and records and reports on

devices. Special controls include topics such as performance standards, postmarket

surveillance, and the creation of patient registries. The purpose of each of these types of

controls is to set a standard for device design, manufacture, and distribution.

An essential part of the FDA device submission is submission of the 510(k), which

establishes substantial equivalence of BandWave™ to one or more predicate devices

already on the market. The 510(k) submission will include a CDRH Premarket Review

Submission Cover Sheet, a 510(k) Acceptance Checklist, and a detailed statement on the

indications of use for the device. However, the bulk of the 510(k) submission for

BandWave™ will be focused on its substantial equivalence to two different predicate

devices, Vomaris Innovations Inc’s Procellera® Wound Dressing (510(k) # K130350)

and Hivox Biotek Inc’s RapidRelief™ Pennypad® (510(k) # K140650) device. The

former device was chosen for its equivalent method of employing microcurrent

stimulation for wound closure and the latter for its utilization of TENS technology.

These two predicate devices together can be used to justify substantial equivalence for

BandWaveTM.

In order to ensure that the design and manufacture of BandWave™ meets the

standards set for distribution, Voltaic Solutions will adhere to the Good Manufacturing

Practices (GMP) and Quality System Regulation (QSR) processes set in place by the

FDA. Voltaic Solutions has established design controls, component specifications, and a

formal labeling control process to guarantee a high quality final product and to comply

with these FDA regulations. Additionally, a process quality system has been established

to oversee a multitude of different manufacturing processes. An essential part of the

quality system regulation process is that of maintaining formal documentation of the

manufacturing process. For the production of BandWave™, documentation will be

maintained in the form of Design History Files (DHF), device master records, history

48

records, maintenance schedules, complaint files and personnel training records to verify

that procedures have been accurately fulfilled. Lastly, the approval and quality

acceptance of the final product is achieved by verifying the quality assurance of all

procedures performed.

In order to move forward with device production, an Investigational Device

Exemption (IDE) must be obtained to allow BandWave™ to have the opportunity to

advance with human clinical trials. Clinical trials will begin with in vitro testing of

BandWave™ as a means of determining the biocompatibility of this device without

posing any risk to living animals or humans.

Once the biocompatibility of BandWave™ has been demonstrated through in

vitro testing, animal testing will be performed to further demonstrate the

biocompatibility of this product.

Assuming all in vitro and animal testing have yielded favorable results, Voltaic

Solutions will move forward with human clinical trials of BandWave™. Unlike the in

vitro or animal testing, the human clinical trials must first be approved by an

Institutional Review Board (IRB) before Voltaic Solutions may proceed with actual

testing. A first round of clinical trials will be performed to evaluate the biocompatibility

of the device and a second round of trials will investigate the effectiveness of the

technology in order to develop marketing claims. To yield the most characteristic results

of the proposed market, it is essential that the subjects used for the human clinical trials

are representative of all demographic backgrounds. This will be achieved by using

randomly sampled subjects.

Device Classification — Class II Device

All medical devices are classified by the FDA. The purpose of the device

classification system is to ensure that higher risk devices are subject to more inspection

than lower risk ones. Device classification is determined by the safety, the complexity,

and the historical experience of the device in question. Classification is broken up into

three categories: Class I, Class II, and Class III.

49

Description Market

Share

Regulatory

Controls

Approval

Process

Class

I

Safest devices 46% General controls No FDA

approval

needed

Class

II

Some risk due to misuse 46% General controls and

special controls

FDA clearance

required

Class

III

Serious injury or death

may result from misuse

8% General controls and

premarket approval

FDA approval

required

Device classification is based on the primary intended use of the product, rather

than all possible applications. BandWave™ will be submitted to the FDA as a Class II device. It will be classified as a Class II device because although there are no

life­threatening risks associated with misuse or failure of this device, there is a greater

potential for harm than most Class I devices. Because of the circuitry involved in this

bandage, the device could pose a greater risk to patients than regular bandages, which

are Class I devices. As a Class II device, BandWave™ is subject to both general and

special controls.

General controls are regulatory requirements created by the FD&C Act. General controls include such things as adulterated devices, misbranding, registration of device

producers and premarket notification requirements, banned devices, notifications,

recalls, and other remedies, records and reports on devices, and general provisions for

devices intended for human use. All devices, regardless of classification, are subject to

these regulations.

Special controls for class II devices are typically specific to device categories.

These controls include performance standards, postmarket surveillance, patient

registries, specific labeling requirements, premarket data requirements, and other

guidelines. Class II devices are exempt from pre­market approval (PMA).

General Controls

50

Adulteration

Adulteration is defined under Section 501 of the FD&C Act. A device is

adulterated if it contains any filthy, putrid, or decomposed substance, or if it is prepared

or packaged under any unsanitary conditions.

Misbranding

Misbranding is covered under Section 502 of the FD&C Act. A device is

misbranded if the labeling is false/misleading, its packaging does not bear a label or its

label does not bear adequate directions for use.

Registration of Device Producers and Premarket Notification Requirements

The medical device manufacturers must submit a list of all devices produced and

register their establishments to the FDA. The FD&C Act requires the manufacturer to

submit a 510(k) to the FDA at least 90 days before introducing the device into the

market.

Banned Devices

The agency is authorized to ban any device that presents substantial risk of illness

or injury. If the device presents a risk and can be corrected by a change in labeling, the

agency will notify the person responsible for the risk or deception. If the labeling is not

changed in the specific time period in which the change should be made, the agency may

affirm, modify or revoke the regulation. In the case where the final regulation is

published, the device will be banned and cannot be legally marketed.

Notifications and Other Remedies

Section 518 is meant to protect public health and also provide a compensation

process for customers who have been sold defective medical devices. The FDA will

require manufacturers to provide all health information and risks to health

professionals who use the device. FDA may order a notification if the device presents the

potential for public harm and may follow a set of procedures including repair,

replacement or refund notifications.

Records and Reports on Devices

Section 519 requires manufacturers to maintain records and reports to avoid any

adulterated or misbranded devices. These records should include the purpose of

submission of information and procedures.

Restricted Devices

51

Section 520(e) allows the FDA to restrict the sale, use and distribution of a

medical device if there is no assurance of safety and effectiveness. If a device is

restricted, it may still be authorized to be sold by a licensed practitioner under regulated

conditions.

Special Controls

Performance Standards

Under Section 514, performance standards for a Class II device include

reasonable assurance of safety and effective performance, periodic evaluation,

establishment of a standard and recognition of a standard.

Postmarket Surveillance

Conducting postmarket surveillance for any Class II or III device may be ordered

if the device could potentially lead to any serious adverse health consequences, have a

significant amount of usage in pediatric populations, if the device could be implanted in

the human body for more than a year or if it is a life­sustaining device used outside the

user.

Patient Registries

Patient registries are meant to track outcome data from device usage and are

designed to give manufacturers information about characteristic populations in which

BandWave™ is used.

510(k) Application

FDA Submission Report

As part of the traditional 510(k) submission, a Medical Device User Fee Cover

Sheet (Form FDA 3601) will be submitted along with a CDRH Premarket Review

Submission Cover Sheet as the cover pages of the 510(k) submission. The CDRH

52

Premarket Review Submission Cover Sheet includes information such as the type of

submission, applicant contact information, reason for application, information about

predicate devices and substantial equivalence, product classification, manufacturing and

packaging information, and standards recognized. A table of contents will be included

after the cover pages.

FDA Registration

Voltaic Solutions will submit electronic registration to the FDA as a producer of

medical devices as well as a payment of $3,646 for the year of 2015. The company will

also follow up with annual re­registration subject to 21 CFR Part 807. Companies are

required to register themselves as producers of medical devices to maintain

transparency and offer a method of holding companies responsible for adverse events

associated with their device(s), commensurate with section 510 of the FD&C Act.

Device Classification

BandWave™ will be classified as a Class II device because the electronic

components pose a greater risk than most Class I devices, yet is not life sustaining or life

threatening enough to be classified as a Class III device. The BandWave™ product is a

combination of TENS therapy and electrical stimulation for wound healing. The TENS

component is the primary mode of action and therefore the device will submitted under

regulation number 21CFR882.5890, which includes transcutaneous electrical nerve

stimulators for pain relief. TENS devices have been cleared by the FDA for OTC and

prescription use from as early as 1979 and have been continually improving since, with

multiple new devices given clearance every year. BandWave™ is a further improvement

to past devices and will continue the evolution of this technology.

Predicate Devices

The BandWave™ 510(k) submission will make use of two predicate devices, as

the device is a novel combination of two pre­existing technologies. Voltaic Solutions will

utilize the Procellera® Wound Dressing (510(k) # K130350) as the predicate for its

53

microcurrent wound healing component, and Hivox Biotek Inc’s RapidRelief™

Pennypad® (510(k) # K140650) device as predicate for the TENS component.

Wound Healing Predicate Overview

The Procellera® Wound Dressing provides microcurrent stimulation to the site

of a wound, promoting cell proliferation and migration, subsequently speeding up the

healing process. The dressing is primarily constructed from an antimicrobial polyester

substrate. Embedded in this material is a matrix of biocompatible microcells (composed

of elemental zinc and silver) which produce a predetermined amount of current at a

voltage similar to that observed in skin injuries. The microcells produce this stimulation

in the presence of a conducting fluid such as wound exudate or exogenous fluids,

including saline. The dressing also conforms to the wound for maximum mobility and

comfort. As an OTC product, the wound dressing is intended for the management of

superficial wounds such as minor cuts, scrapes, abrasions, blisters, etc. In clinical

settings, the wound dressing is applicable to surgical incisions and chronic or more

serious wounds. (510(k) # K130350) (http://procellera.com/procellera/technology)

TENS Predicate Overview

Hivox Biotek Inc’s RapidRelief™ Pennypad® TENS device generates small

pulses of electrical current and delivers this current through the skin to activate

underlying nerves for the regulation of pain. The electrical stimulation is provided

through two self­adhering conductive electrode pads which are connected through

wiring extensions to the pulse generator. Multiple stimulation parameters, such as pulse

width, time, and intensity, are programmable into the device. To stimulate a desired

location on the body, the electrode pads are placed in such a manner that the source of

pain lies between them. The stimulation activates peripheral nerves to block pain signals

from being sent to the brain and stimulates the release of endorphins. The

RapidRelief™ Pennypad® is intended for temporary relief from pain. (510(k) #

K140650)

BandWave™ Overview

54

Voltaic Solution’s BandWave™ product is a bandage with electrical components.

A circuit attached to the bandage (TENS Unit) generates pulses of electrical stimulation

which are applied to the skin and underlying peripheral nerves. This electrical

stimulation of the nerves blocks pain signals from being sent to the brain and stimulates

the release of endorphins. In addition to TENS pain relief, BandWave™ uses an

antimicrobial polyester gauze as primary contact with the skin/wound surface. This

gauze is embedded with a matrix of microcells of elemental zinc and silver. These cells

produce measured microcurrents at voltages that are slightly elevated compared to

those specific to naturally healing wounds in the presence of conducting fluid.

Statement of Indications for Use

The indications for use (IFUs) are statements that will be included on the label of

all devices under the brand name BandWave™ that are produced by Voltaic Solutions.

BandWave™ is intended for the temporary relief of localized pain and management of

wounds, increasing healing speed. BandWave™ is indicated for use with any

non­mucosal breached surfaces of the human body. It may be placed over a section of

the epidermis where the skin has been breached. BandWave™ may be used in clinical

settings by a physician’s assistant or nurse, or it may be used in nonclinical settings

(OTC) by the patient himself. The target population for this product is all people ages 12

and up. For patients under the age of 12, this product is not recommended. These

bandages are indicated for one­time use and it is recommended that each bandage be

changed approximately every 5 to 7 days. The TENS unit is reusable until the LED no

longer lights up with application to the bandage.

Substantial Equivalence

BandWave™ is substantially equivalent to the Procellera® Wound Dressing

because there exists no change in the design and technology, nor the intent for use. The

same material is used in both products in the same manner and for the same purpose.

The only difference is that the dressing’s effect is a secondary action to the TENS in

BandWave™. BandWave™ is substantially equivalent to the RapidRelief™ Pennypad®

55

because both utilize the pulsing stimulation characteristic of TENS devices.

BandWave™ operates within the same electrical specification bounds and through the

same mechanism as the predicate device, albeit on a smaller, more portable scale. The

novel combination of these two technologies has no impact on the safety and efficacy of

either component, and serves as a significant improvement over each device

individually.

Predicate Chart Comparison

Device Name Rapid ReliefTM

Pennypad PP­904

BandWave™™

Indication for

applied area for

pain relief

Arm, Leg, and Lower

Back

Epidermis surrounding open

wound

Dimensions 113L*70W*9.7H mm 160L*40W*3H mm

Waveform Symmetrical Biphasic Monophasic

Shape Rectangular

Maximum

Output Voltage

(Volts) (±20%)

57.6Vpp @500Ω 45Vpp @500Ω

89.6Vpp @2KΩ

96.0Vpp @10KΩ

Maximum

Output Current

(±20%)

115.2mA @500Ω 50mA @2kΩ

44.8mA @2kΩ

9.6mA @10kΩ

Pulse Duration

(μSec)

200 μSec (fixed) 90uSec (fixed)

56

Frequency (Hz) 2, 5, and 40 60

Net

Charge

(μC) per

pulse

@500

Ω

0.2304 .1208

Maximu

m

Charge

(μC)

@500

Ω

23.04 12.08

Maximu

m

Current

Density

(mA/cm2, r.m.s)

@500

Ω

2.828 1.633

Maxium

Average

Power

Density

(W/

cm2)

@500

Ω

0.163 0.095

ON Time (sec) 120 75

OFF Time (sec) 0 0

Additional

Features

N/A Wound Healing

Quality System Regulation Requirements

57

Voltaic Solutions has established a set of quality regulations that are put in place

in order to assure that all products designed and manufactured by the company are held

up to high standards and have an acceptably low probability of failure.

The manufacturing of BandWave™ complies with current good manufacturing

practices (CGMP’s) and the FDA’s Quality System Regulation and global ISO Standards.

The QSR process will be monitored and inspected by the FDA to affirm compliance with

these requirements. Performance requirements will be established before production of

the device. During the manufacturing process, manufacturers should ensure that device

components are compatible with each other. Adequate packaging materials will be

selected once production is completed. Quality system report documents will also be

provided to the manufacturers to ensure compliance with CGMPs. These documents

include, but are not limited to, employee training procedures, cleaning/sterilizing

procedures, safety procedures, general design control procedures, workmanship

standards and inspection procedures.

Design Controls

The manufacturing engineers at Voltaic Solutions will establish and maintain

design control procedures for BandWave™. A product assurance system and

production/design QA system will be established. The quality system team will play a

role in the review, evaluation and documentation of the device design with development

and validation data through customer feedback. Any adverse events will be reported to

the FDA (21 CFR Part 803 ­ Medical device reporting).

Component Selection

The specifications for component and raw material selections included in the

design phase will include valid and well­understood methods of sampling and

acceptance so that there is no confusion with suppliers, contractors, and consultants, in

order to create high quality final products. This process will lie mainly in the hands of

manufacturers who will establish procedures to ensure that the raw materials will meet

the specified requirements.

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Labeling Content

To insure compliance with the FD&C Act, a formal labeling control process will

be established, in which any software and printing labeling is reviewed prior to its use,

in order to meet regulatory requirements. The use of correct labels and attachment will

be ensured through this process.

Process Quality

The process quality system will cover a number of manufacturing processes such

as welding, molding, lyophilizing, sterilization, and packaging in addition to validation.

These methods will be implemented before production and will be documented

throughout the production process as well. Any adverse effects during this stage will be

identified followed by acceptance methods that the quality engineers will implement.

Management Responsibility

Manufacturing managers have the executive responsibility of maintaining an

organized structure of all personnel involved in quality assurance and manufacturing in

accordance with GMP requirements. They must ensure that quality system

requirements are established and maintained continuously throughout the

manufacturing process.

Formal and Documented Quality System

Keeping records such as design history files (DHF), device master records,

history records, maintenance schedules, complaint files and personnel training records

is essential and will be maintained throughout the quality system process. Device

history will be reviewed to verify that the procedures were properly conducted.

Approval and Quality Acceptance of Product

59

All tests and processes must be performed correctly and inspected afterwards.

After quality assurance of the procedures including packaging, labeling and materials

has been conducted, finished devices are ready to be approved for use.

Employee Training

Any personnel involved in quality system activities must given formal training

and be well­equipped and able to identify, evaluate and solve any quality system

problems that may arise. Additionally, employees must be able to verify solutions to

these quality problems. The manufacturing line where the BandWave™ products are

made will be equipped with detailed instructions for the manufacturing procedure,

including both text and visual diagrams.

Clinical Trials Regulation

Preclinical Testing and IDEs

An Investigational Device Exemption (IDE) permits a device that has not yet

been submitted to the FDA via a pre­market notification to be used for investigational

purposes in human clinical trials. IDEs are required for all significant risk devices that

will be used in human clinical trials. However, an IDE application is considered

automatically approved if the device is not considered a significant risk device (U.S.

Department of Health and Human Services). The designation of a device as “significant

risk” or “not significant risk” is determined by the IRB. If the device is not a significant

risk device, the sponsor must label the device in accordance with 21 CFR 812.5. In

addition, approval of the IRB and informed consent of all human subjects are required

in order to conduct a study with this device (U.S. Department of Health and Human

Services). Voltaic Solutions will present to the IRB a justification as to why the

BandWave™is not a significant risk device and if this justification is accepted, then an

IDE application will not need to be submitted. The justification for why BandWave™ is

not a significant risk device is that it does not present a potential for any serious risk to

human health or safety, as defined in 21 CFR 812.3.

60

Biocompatibility

Biocompatibility should be established for a device as a whole and not merely the

individual components and materials of a medical device. Biocompatibility will be

established through both nonclinical (in vitro) and clinical trials using either the device

as a whole or an extract of the device.

Model Feasibility, Safety and Efficacy Testing (In Vitro)

Purpose/Scope

The purpose of in vitro biocompatibility testing is to establish

biocompatibility of this device in a way that does not pose any risks to living animals or

humans. Cytotoxicity is the only test that is able to be performed in vitro before

beginning animal trials. The reason for this is that the other tests that will be performed

in animal and human clinical trials study the immunological response to the material,

which cannot happen in a sample of cells.

Materials and Methods

1. Cytotoxicity

The device to be tested will be made into an extract to concentrate the

chemicals found in the device, and this extract will be used in this study. ISO 10993­12

details the procedure by which extracts must be made for use in clinical studies. The

device to be tested should be a representative sample of a finished product, including

any coatings, surface treatment, sterilization, etc. that are performed on a product

before it is sold. Two extracts will be made: a physiological saline solution extract, and a

vegetable oil extract. These solvents are recommended by ISO 10993­12 because the

saline solvent will create an extract from the polar materials in the device, and the

vegetable oil will create an extract from the nonpolar materials in the device. Both of

these solvents are harmless to cells.

The figure below shows the recommended extraction ratio, expressed as the ratio

of the surface area or mass of the test sample to the volume of extractant used, for

various materials and thickness of the part.

61

Extractions of high­density polyethylene will be used as negative controls, since

this material is recommended in ISO 10993­12 and has been shown to have no toxic

effects on cells or tissues.

In­vitro cell cultures will be prepared and soaked in each of these extractions:

saline extraction of device, vegetable oil extraction of device, saline control (high­density

polyethylene extraction), and vegetable oil control (high­density polyethylene

extraction). The parameter to be measured is cell growth inhibition. If the cell growth is

not inhibited, this indicates that the device extraction is not cytotoxic (Medical Device

and Diagnostic Industry).

Animal Testing

Animal studies are required by the FDA for medical devices which contain

materials not known to be biocompatible with the human body. Although BandWave™

contains only materials known to be biocompatible with the human body, it is still

62

advisable that animal studies be performed prior to human clinical trials, because

ensuring human safety and welfare is of utmost importance. Three tests will be

performed in this animal study: sensitivity, irritation and intracutaneous reactivity, and

acute systemic toxicity.

The objectives of each of these tests are described in detail in the following

sections. Cytotoxicity will not be performed in animal trials because an in vitro study is

sufficient to determine whether or not this device is toxic to cells.

Sensitization

Sensitization is an immune reaction of the body such as redness, irritation,

itchiness, or swelling that is caused by repeated or prolonged exposure to the chemicals

within the product in question. The objective of this sensitivity study is to determine

whether BandWave™ is an irritant to human skin.

Irritation and Intracutaneous Reactivity

Irritation in this context includes skin, eye, and mucosal irritation. ISO 10993

defines irritation as "localized inflammatory response to single, repeated, or continuous application of the test substance, without involvement of an immunological

mechanism." Chemicals within certain products can cause irritation of various tissues of the body. The purpose of this study is to demonstrate that the materials and chemicals

used in BandWave™ do not cause irritation of bodily tissues.

Acute Systemic Toxicity

Acute systemic toxicity is defined as any adverse effect occurring within a short

time after administering a dose of a particular substance (or an extract). This test is

required for all devices that make contact with blood. Since BandWave™ is designed to

be placed over an open wound, it will come into contact with blood, and therefore a test

for acute systemic toxicity should be performed. The objective of this study is to

demonstrate that no adverse systemic effects occur because of this product.

Materials

For all animal trials, BandWave™ will be made into an extract to concentrate the

chemicals found in the device. This extract will be used in each of the three studies to be

63

performed during the animal trials. ISO 10993­12 details the procedure by which

extracts should be made for use in clinical studies. The device to be tested should be a

representative sample of a finished product, including any coatings, surface treatment,

sterilization, etc. that are performed on a product before it is sold. Two extracts will be

made: a physiological saline solution extract and a vegetable oil extract. These solvents

are recommended by ISO 10993­12 because the saline solvent will create an extract from

the polar materials in the device, and the vegetable oil will create an extract from the

nonpolar materials in the device. Both of these solvents are harmless to cells.

The extraction ratio for each test will be determined from the same table as was

used in the in vitro studies. Extractions of high­density polyethylene will be used as

negative controls, since this material is recommended in ISO 10993­12 and has been

shown to have no toxic effects on cells or tissues.

Methods

1. Sensitization

Sensitization is an immune reaction of the body such as redness, irritation,

itchiness, or swelling that is caused by repeated or prolonged exposure to the chemicals

within the product in question. The objective of this sensitivity study is to determine

whether this BandWave™ is an irritant.

Guinea pigs will be used in this study because this species is nearly as responsive

to dermal sensitizers as humans are. A patch of fur on the guinea pig’s back will be

shaved off to make the skin more visible. The Magnuson­Kligman test method will be

used for this test (Medical Device and Diagnostic Industry). In this test, separate groups

of guinea pigs are given an injection of one of the extracts, along with an adjuvant,

which is intended to enhance the immune response to the extracts for maximum

sensitivity. After this, the guinea pigs receive a topical application of the extract. The

guinea pigs are given a two­week period of recovery, and then are covered with a topical

patch containing the extract. After this, the animals are examined for patches of redness

or swelling that are not present in the negative­control animals.

2. Irritation and Intracutaneous Reactivity

The irritation/intracutaneous reactivity test will be conducted using two extracts

of the medical device described in the “Materials” section. One extract will be made in a

saline solvent and the other will be made in a vegetable oil solvent. The control materials

are pure saline and pure vegetable oil. In this study, a small volume of either the saline

64

or the oil extract will be injected intracutaneously into multiple different locations on

the shaved backs of albino rabbits via a sterilized small­bore needle. In addition, each

subject will also be given multiple intracutaneous injections of the control solution that

corresponds to whichever extract they were given.

At 24, 48, and 72 hours after the injection, the rabbit’s skin will be

assessed by a trained and blinded observer for signs of erythema and edema, and the

results will be scored based on severity of the irritation. Extracts that produce a

significantly greater irritation response in this test will be considered irritants (Medical

Device and Diagnostic Industry).

3. Acute Systemic Toxicity

Acute systemic toxicity refers to a short­term exposure to the substance in

question. Short­term exposure is considered to be a period of 72 hours for the sake of

this study. In this study, a group of mice will be given an injection of the extract and will

then be weighed. An equal number of mice will be used as a control group, and these

mice will be injected with the extraction solvent (either saline or vegetable oil) with no

device extract.

The mice are then observed for the next three days for signs of systemic toxicity

(convulsions, prostration, etc.) and these results are compared to the results in the

control mice to determine if there are any acute systemic toxic effects caused by this

device (Medical Device and Diagnostic Industry).

Human Clinical Trials Strategy

Summary

The first round of human clinical trials will be completed after in vitro testing has

been performed. Assuming the in vitro studies demonstrate biocompatibility and there

are no indications of cytotoxicity caused by the device extract, the human clinical trials

will proceed as detailed below. The purpose of the first round of human clinical trials is

to demonstrate that this device is biocompatible in humans. The clinical trials protocol

was based on the biocompatibility test matrix from ISO­10993, shown below.

65

BandWave™ is a surface device that is applied to breached or compromised

surfaces with a limited (<24 hours) or prolonged (24 hours­30 days) contact duration,

depending on the physician’s judgment. According to this matrix, the necessary

biocompatibility tests include cytotoxicity, sensitization, and irritation or intracutaneous

reactivity. The tests that are recommended include acute systemic toxicity and

subchronic toxicity. The acute systemic toxicity test will be performed. The subchronic

toxicity test will not be performed because the device does not contain any materials

that have ever been shown to cause either short­term or long­term harm to the human

body, and the acute systemic toxicity test will sufficiently demonstrate the absence of

toxic effects on human tissue.

A second round of human clinical trials will be conducted to assess the

effectiveness of BandWave™ in wound healing and pain relief. Two trials will be

conducted. The first study will assess the efficacy of the TENS pain relief system. The

second study will assess the efficacy of the rapid wound healing therapy using the

microbattery array.

66

Board Approval

The FDA requires that Institutional Review Board (IRB) approval be

acquired before any clinical trials involving human subjects begins (21 CFR 812). An

IRB is defined as a group that has been designated to monitor and review research

involving human subjects with the purpose of protecting the rights and welfare of these

subjects. IRBs are required to register with the FDA before they can approve any clinical

studies, per 21 CFR 56.106. The role of the IRB is to review the clinical trial design, have

authority to approve or disapprove of the study, and require modifications if necessary.

Clinical Trials Protocol

This clinical trial will be conducted in accordance with Good Clinical Practice

(GCP) guidelines and the Code of Federal Regulations on the Protection of Human

Subjects (45 CFR 46). All personnel involved in the conduct of this study have

completed human subjects protection training. Informed consent will be obtained prior

to enrolling patients in the study.

There are three different tests that will be performed within this study with the

objective of assessing the biocompatibility of BandWave™. Each patient enrolled in this

study will be placed into one of these three categories and assessed for that specific form

of biocompatibility. The three categories are sensitivity, irritation or intracutaneous

reactivity, and acute systemic toxicity.

Cytotoxicity will not be performed on human subjects because an in vitro study is

sufficient to determine whether or not the device extract results in cytotoxicity.

The two tests that will be performed to determine the efficacy of this product are

pain relief assessment and rate of wound healing.

Safety/Biocompatibility Trial Design

Materials

For the sensitization test and the acute systemic toxicity test, the device itself will

be used as the only material. The device must be a representative sample of a finished

product, including any coatings, surface treatment, sterilization, etc. that are performed

67

on a product before it is sold. The use of the BandWave™ in this study is explained in

the methods section below.

For the other test, the device to be tested will be made into an extract to

concentrate the chemicals found in the device, and this extract will be used in the

irritation/intracutaneous reactivity study. ISO 10993­12 details the procedure by which

extracts must be made for use in clinical studies. The device to be tested should be a

representative sample of a finished product, including any coatings, surface treatment,

sterilization, etc. that are performed on a product before it is sold. Two extracts will be

made: a physiological saline solution extract, and a vegetable oil extract. These solvents

are recommended by ISO 10993­12 because the saline solvent will create an extract from

the polar materials in the device, and the vegetable oil will create an extract from the

nonpolar materials in the device. Both of these solvents are harmless to cells.

The extraction ratio for each test will be determined from the same table as was

used in the in vitro studies. Extractions of high­density polyethylene will be used as

negative controls, since this material is recommended in ISO 10993­12 and has been

shown to have no toxic effects on cells or tissues.

Methods

1. Sensitization

Sensitization is an immune reaction of the body such as redness, irritation,

itchiness, or swelling that is caused by repeated or prolonged exposure to the chemicals

within the product in question. The objective of this sensitivity study is to determine

whether this BandWave™ is an irritant to human skin. This device will be used

externally and so testing will be performed on both healthy, unbroken skin and open

wounds.

To test BandWave™ on healthy, unbroken skin, first, a small patch of skin on the

patient’s arm or leg will be shaved to expose a greater surface area of tissue. The patch

that is shaved will be the same size as the smallest size bandage that can be cut from the

BandWave™™. A second small patch 1­2 inches away from the first site will also be

shaved. This will be used as a control site. The BandWave™ will be cut to size with a

clean, sterilized pair of stainless steel or surgical scissors, so as to prevent

contamination. The bandage will be applied to the shaved patch of skin by a trained

68

nurse wearing hypoallergenic (nitrile) gloves, and the bandage will remain on the

patient’s skin for 23 hours (plus or minus 1 hour daily) for 21 days consecutively. Each

time the bandage is removed (once per day), the skin should be evaluated for signs of a

reaction (redness, swelling, irritation, etc.). If a serious reaction occurs, the bandage

should be removed completely and the patient should be released from the study. The

daily evaluation should be performed by a trained and blinded observer, using the

following scale as an evaluation guide:

0­ negligible sensitivity (e.g. clear skin, no redness, swelling or irritation)

1­ slight sensitivity (e.g. light red/pinkish color, or light swelling)

2­ moderate sensitivity (e.g. some signs of irritation, moderate redness, moderate

swelling)

3­ severe sensitivity (e.g. heavily irritated skin, lots of redness, heavy swelling)

These results will be recorded by the observer and the results will later be

analyzed.

2. Irritation and Intracutaneous Reactivity

The irritation/intracutaneous reactivity test will be conducted using two

extracts of the medical device described in the “Materials” section. One extract will be

made in a saline solvent and the other will be made in a vegetable oil solvent. The

control materials are pure saline and pure vegetable oil. In this study, 0.2mL of either

the saline or the oil extract will be injected intracutaneously into two different locations

on the forearm of each subject via a sterilized syringe. In addition, each subject will also

be given two 0.2mL intracutaneous injection of the control solution that corresponds to

whichever extract they were given. Each injection will be at least 1 inch away from all

other injection sites.

At 24, 48, and 72 hours after the injection, each subject’s skin will be

assessed by a trained and blinded observer for signs of erythema (redness) and edema

(swelling). The results will be scored based on a similar scale as described in the

sensitization test. Extracts that produce a significantly greater irritation response in this

test will be considered irritants.

3. Acute Systemic Toxicity

69

Acute systemic toxicity refers to a short­term exposure to the substance in

question. Short­term exposure is considered to be a period of 72 hours for the sake of

this study. In this study, acute systemic toxicity will be assessed by using the whole

bandage rather than an extract.

Each patient will be given a small cut, 0.5 inch in length, with a sterilized scalpel

on one of their legs, and the bandage will be placed over the cut. The bandage will be

activated electrically to simulate actual intended use. The bandage will be left in place

for 72 hours, with a brief removal occurring once every 24 hours in order to clean the

wound. During the period of 72 hours each patient will be assessed for any adverse

systemic events, and every adverse systemic event will be recorded by a trained

observer. These results will be compared to a hypothetical control of no adverse events.

After the period of 72 hours, the bandage will be removed and the wound will be

cleaned. The patient will be monitored for another 48 hours after removal of the

bandage, and after these 48 hours the patient will be released from the study.

Efficacy Trial Design

Materials

In the efficacy trials, the BandWave™ itself will be used. The bandage must be a

representative sample of a finished product, including any coatings, surface treatment,

sterilization, etc. that are performed on a product before it is sold. The use of the

BandWave™ in this study is explained in the methods section below.

Methods

1. TENS Efficacy

In this study, the efficacy of the TENS pain management unit will be assessed. This

study will be randomized and blinded. Patients with chronic wounds such as diabetes

ulcers will be recruited for this study. Patients will be randomly assigned to either the

test group or the control group. Those in the control group will not be given any pain

relief medication or cream for their wounds, but the wound will be covered with a

normal hospital bandage. The other wound will be covered with BandWave™ and the

TENS unit will be turned on to start the pain relief therapy. The patient will be asked to

rank their pain on a scale of 1 to 10 every two hours for the next 72 hours.

70

2. Microbattery Array Efficacy

In this study, the efficacy of the microbattery array on the bandage will be

assessed. This study will be randomized and blinded. This study will occur

simultaneously with the TENS efficacy test, and it will be performed on the same

patients in order to cut down on clinical trial costs. The wounds in the control patients

will not be given any pain relief medication or cream, but it will be covered with a

normal hospital bandage. The other cut will be covered with BandWave™. If there is no

moisture or bodily fluids on or near the cut, a few drops of water will be applied to

ensure that the microbattery array will be activated. Every 12 hours, the two bandages

will be removed and the length of the cut will be measured and recorded. This trial will

continue until either all the wounds have fully healed, or until 120 hours have passed,

whichever occurs first.

Patient Eligibility Criteria

Sample Size

In a surgical wound healing study done at Ohio State University by Ronald Glaser

et al. (L. McGuire, K. Heffner, R. Glaser source), patients with surgical wounds rated their pain on a scale of 1­10. From the figure above, the median amount of time it took for

patients to rate their pain as 4 or lower was approximately 21 days. Based on this data, it

is estimated that BandWave™ can heal wounds 45.4% faster. However, to be on the

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conservative side for clinical study purposes, an expected rate of 10% faster healing will

be used to calculate the sample size. The following equation is used, where N = total

number of subjects required, zα = standard normal deviate for α, zβ = standard normal

deviate for , S = standard deviation of the outcome variable, E = expected effect size.

10% of 21 days = 2.1 days

S = estimated to be approximately 10 days

Data Management

All data will be collected using the software, Oracle Clinical. A Case Report Form

is first designed to translate protocol­specific activities into data being generated. Then

a Data Management Plan is developed based on database design, data entry,

discrepancy management and database locking guidelines along with a Data Validation

Plan containing edit­checks to be performed and identifying discrepancies. Oracle

Clinical contains “system validation” which includes data security, user requirements,

regulatory compliance, objectives, intervals, visits, investigators and patients. The

investigator collects data into the system with an e­CRF method to prevent errors and

faster resolution of discrepancies. Any entries made in the CRF will be monitored by the

Clinical Research Associate to track any missing or illegible data or clarification. Edit

check programs are written to validate the data and identify discrepancies in the entered

data that are initially tested with dummy data containing discrepancies to ensure

effectiveness. Discrepancies are defined as any inconsistent data, missing data,

deviations from protocol, etc. and are run frequently and at regular intervals.

Discrepancy management is resolved by the investigator and includes reviewing

discrepancies, investigating the reason and resolving them with documentation. After

quality checks, the final data is run for validation. If there are no discrepancies, the data

is finalized in consultation with the statistician. Once approval is obtained, the database

is locked followed by archival.

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Ethical Considerations

The degree of all risks and benefits associated with BandWave™ are evaluated to

maximize benefits while minimizing risk to determine a favorable ratio for each

individual patient. Before clinical trials, an Institutional Review Board, in accordance

with the Food and Drug Administration/Investigational Device Exemption, reviews the

proposal to confirm an ethically designed trial while also monitoring the study while it is

ongoing. All individuals taking part in the trial undergo an informed consent process

where they are accurately informed of the purpose, risks, benefits, methods, etc. of the

trial, understand the information of BandWave™ and how it relates to their personal

clinical situation, make a voluntary decision about participating and then provide a

written form of consent. Individuals’ information and privacy are kept confidential and

are notified of any new information on the trial. The individual's’ welfare is monitored

throughout the study.

Subject Recruitment

Subjects used for this trial are individuals from all demographic backgrounds. We

will be recruiting patients, who currently suffer from chronic wound, of all ages,

ethnicities, sexes, and medical backgrounds since wounds and wound healing affects all

individuals. Patients will be pulled by way of their physicians (preferably the principal

investigator) and recruitment will be aided by in­practice recruiting tools and by paper

or EMR chart reviews. Patients with more minor wounds not requiring medical

attention will also be recruited from television advertisements, social media, billboards,

radio advertisements, email targeting and also outside services such as patient networks

and patient recruitment companies.

Investigator Recruitment

The principal investigator will be recruited by submitting the clinical trial

proposal on websites such as CenterWatch.com and ClinicalTrials.gov. Online databases

of potential investigators, such as CROs including PPD, will also be a useful tool in

finding a principal investigator. Advertising, personal contact and networking are also

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possible avenues. The principal investigator will be chosen based on knowledge and

interest in wounds and wound healing.

Site of Trials

The site of clinical trials will be chosen based on special populations more at risk

for wounds and where these populations are concentrated. These populations include

bariatric patients, ICU patients, HIV and AIDS patients and geriatric patients. Since a

portion of the trial and targeted market will be patients with surgical wounds, we will

select the Los Angeles Surgical Center. Los Angeles is one of the most diverse cities in

the nation in terms of age, gender and race so we will be able to acquire surgical patients

from all backgrounds in Los Angeles, while also being accessible for individuals from all

socioeconomic backgrounds for non­surgical wounds.

Executive Summary: Finances and Reimbursement

After analyzing the market for the BandWave™, Voltaic Solution has identified that the BandWave™ has the ability to positively affect a projected population of nearly 60,000,000 people. This estimation includes post­operative patients, the growing elderly population, and those with chronic diseases that cause epithelial wounds. With such a large market, Voltaic Solutions will slowly ease into the market by supplying first to hospitals, followed by the general consumer population in future years. In order to begin production of the BandWave™, Voltaic Solutions will require an investment of $18,392,320 to cover the costs of clinical trials, manufacturing expenses of 1,000,000 units from overseas production near the Zhangjiang Hi­Tech Park facility in Shanghai, China, shipping costs in order to deliver the product to the storage and distribution site in Los Angeles, California, and marketing. The cost to produce one unit of the BandWave™ is $17.01. The outsourced manufacturing and shipping costs will increase the price of each BandWave™ unit to $18.10. In order to incentivize hospitals to buy the BandWave™, we will offer a 15% bulk­discount from the consumer­based selling price of $30. The selling price of the BandWave™ will be $25.50 for hospitals and $30 for consumers. Given the 121 hospitals in Greater Los Angeles, Voltaic Solutions will evenly distribute the 1,000,000 units to these hospitals, ensuring that each of these hospitals buys 8,264 units of the BandWave™, thus generating $25,498,572 in revenue. After

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subtracting the costs of the $18,392,320 from the initial investment, the total profit is projected to be $7,106,252. This is only the beginning of the BandWave™’s projected expansion into the second year. In the second year, BandWave™ will increase production to 1,500,000 units in order to accommodate increased sales in the Los Angeles area. The increase in sales will cause expenses to increase to $27,148,297 due to increased production and expenses that go along with an increased amount of units. Sales are projected to continue increasing given that Voltaic Solutions has barely tapped into the projected consumer base. We will now assume that each of the 121 hospitals in Greater Los Angeles buys 10,505 units, and that each of the 83 closest Nursing Homes stores each buy 2,673 units. Expenses in the second year will be $27,148,297, and Voltaic Solution anticipates that every BandWave™ will be sold in order to generate a revenue of $39,068,948 . The resulting net profit after expenses are subtracted from the revenue is $11,920,651. The combined year 1 and year 2 profits is $19,026,903. Voltaic Solutions will continue expansion into the third year to hospitals throughout California, as well as continued sales at the 83 Nursing Homes locations. After increasing production to 2,000,000 units per year, the expenses for the third year are estimated at $36,190,240. Voltaic Solutions will continue to sell 2,673 units to each of the 83 Nursing Homes stores, 10,505 units to the 121 Los Angeles Hospitals, but will sell the remaining 500,000 units to various hospitals throughout California. Assuming that all of the BandWave™ units are sold, the net profits from the third year will be $15,628,708. The profit from the first three years combined will total $34,655,610. After the third year, Voltaic Solutions will face the decision of whether to seek a buy­out from a large corporation, or to grow from a small business model into a larger business or corporation. From a cost analysis and projected growth standpoint, Voltaic Solutions will partner will seek to partner with Johnson & Johnson. This merge will benefit both Voltaic Solutions and Johnson & Johnson given that Voltaic Solutions will now be capable of tapping into a larger consumer base in order to better affect positive change while helping Johnson & Johnson to address their need for innovation and advanced products. Market Size Analysis

Market Size Estimate

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Total Number of All U.S. Registered Hospitals 5,686

Surgeries per year in U.S. +50,000,000

Surgeries without incisions/year ­10,000,000

Elderly people who fall/year +20,000,000

Potential BandWave™ Consumer Base 60,000,000

From our analysis, we have determined that the market for the BandWave™ is very large and promising. Based on our estimates from researching the current situation, we believe that the BandWave™ could positively benefit nearly 60 million people in just the United States alone. Because of the novelty, convenience, and reasonable price of the BandWave™, there is not currently any competition on the current market. However, although Voltaic Solutions estimates a market of 60,000,000 potential customers, we find it unlikely that this projection will be achieved for various reasons. With standard healing applications, such as bandage protection, it will be essential to market the product in such a way that consumers see the benefits of the product. Additionally, because of the reimbursement codes, hospitals and patients should not need to experience the majority of the additional cost. Based on the 60,000,000 market estimate, we will predict that 25% of this estimate will be reached within the first year, and will continue to rise by 10% each additional year following. However, as mentioned previously, given that Voltaic Solutions will run as a small business initially, we will produce and plan to sell 1,000,000 units in the first year. Because Voltaic will preliminary limit sales to the Los Angeles area, the target audience will be both hospitals and Nursing Homes. In addition to the number of invasive surgeries increases, leaving patients with open wounds in need of healing, Voltaic Solutions also seeks to address the needs of a growing elderly population. In the Los Angeles area alone, the United States Census Bureau reports an elderly population of 1,684,181 people over the age of 65. Additionally, there are 83 Nursing Homes in Los Angeles, thus creating a growing target population of elderly citizens seeking a faster and less painful recovery period.

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Financial Analysis Assumptions In order for to analyze the costs and profitability of selling the BandWave™, it was necessary to make several assumptions. First, the cost analysis of manufacturing the BandWave™ excludes tax and inflation. The figures we are using are current prices and estimated prices for buying in bulk. Because the inclusion of tax and inflation would significantly complicate the financial analysis, we chose to exclude them. Our main customers for the BandWave™ will be both hospitals and civilians seeking to reduce the healing time of their wound. As can be seen below, the estimated cost to produce one unit, including shipping and storage costs, is $18.10. This was determined through a cost analysis of the necessary materials as well as the manufacturing process. All proposed sales and profit forecasts are conducted under the assumption that Voltaic Solutions will be run as a small business. This allows for a lower number of manufacturing costs for the initial products and lower expenses for utility, storage, and shipping costs to reduce risks. Financing We expect that a significant amount of our startup capital will come from loans, and a small percentage from investors. The financing plan includes the creation of brochures to advertise the revolutionary healing process that the BandWave™ will initiate, as well as a profit projection and design plan in order to entice investors to provide startup capital to fund our clinical trials and regulatory costs. These will be the same brochures that we will provide to hospitals to convince them of the profitability of our product. Given that Voltaic Solutions will not be expanding beyond California until at least year four, we will be dedicated towards selectively branding the BandWave™ in order to excite the rest of the market for our expansion. Our technology and marketing will demonstrate that the BandWave™ is a safe investment and will generate a high return on an investment. Additionally, hospitals will be incentivized to order the BandWave™ in bulk in that Voltaic Solutions will offer a bulk discount of 15% off of the regular unit selling price of $30 so hospitals will only be paying $25.50 per unit. Production, Distribution, and Profits The first year of business:

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For the first year that BandWave™ is on the market, 1,000,000 units will be manufactured. The product will be manufactured at a manufacturing company in Shanghai, China, and shipped to the Port of Long Beach, California, where it will then be transported by ground to the USC area. The product will then be stored until distribution is necessary. The total cost to manufacture the BandWave™ was calculated by multiplying the 1,000,000 units by the approximate cost per unit of $17.01. To cargo ship all 1,000,000 units across the ocean, we estimate that the entire order will fit into 200 pallets. A standardized pallet is 48 inches by 40 inches, and capable of holding 5,000 pounds [US Plastics]. Given that each BandWave™ unit is 1 pound, this will allow 1,000,000 units to be shipped in 200 pallets. According to an estimate by XpressRate.com, shipping 25 “full container loads,” 200 pallets, will cost $53,250. The total shipment cost is $53,250 from Shanghai, China to Long Beach, CA. (XpressRate) From Long Beach, the product cargo will be delivered to the USC area. From freightcenter.com, the ground transport will cost $22,750 for 200 pallets. The truck will start from the docks of Long Beach and unload the product at the storage site near USC. For storage, Voltaic Solutions will use Public Storage because of the valued prices and numerous locations across the country. The small business storage is an effective starting point for distribution. For the largest unit available, the rate is $310 per month for a 10 foot by 20 foot storage space. For the second and third year of business, with an estimated increase in production by 500,000 units per year, this increase in pallets would result in the necessity of two large storage units. Based on these figures, the first year of storage would cost $3,720, and the second and third year would cost $7,440. (PublicStorage) For marketing and distribution of the BandWave™, Voltaic Solutions will have a sales team. The sales team will have an annual budget of $3,000 to go towards marketing materials. For the first year of business, the sales team will go out and market to the 121 hospitals in the Los Angeles metropolitan area while supplying to the hospitals. Estimating gas prices at $4.50 per gallon, Voltaic Solutions estimates 150 gallons of gas per month, thus costing $8,100 for the year. The following table shows the cost of production for the BandWave™ as well as shipping, storage, and marketing costs. The cost of clinical trials has been added to the preliminary investment in year 1, but does not affect yearly expenses thereafter. Additionally, a more detailed cost estimate of clinical trials can be found below. The total expense for production and transportation of one unit is $18.10 based on the

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estimates. The price was estimated with the knowledge that the materials would be purchased and the units manufactured in bulk.

Item Cost Per Unit

USA Tyco Adhesive Gel

coated 2 carbon electrodes $2.16

Microbattery Array 3x12cm $7.50

Medical Gauze 5x16cm $0.45

ETS Fabric $0.65

PCB board $5.00

Adhesive Film 18x15cm $0.50

Components for PCB Board $0.50

LED Light $0.25

Total Costs $17.01

Clinical Trials

Study Categor

y Cost

Irritation Animal $1,800

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Sensitization Animal $6,000

Acute Systemic Toxicity Animal $900

All safety tests Human $182,00

0

All efficacy tests Human $100,000

Cytotoxicity In vitro $800

Tota $291,50

0

Storage, Distribution, and Marketing Costs

Year 1 Year 2 Year 3

Clinical Trials $291,500 0 0

Units Produced 1,000,000 1,500,000 2,000,000

Cost to produce $17,010,00

0 $25,515,00

0 $34,020,00

0

Transoceanic Shipping of 4 Pallets (China to

California) $53,250 $82,282 $106,500

Ground Transport $22,750 $34,125 $45,500

Storage $3,720 $7,440 $7,440

Distribution $8,100 $9,450 $10,800

Marketing $3,000 $3,000 $3,000

Total $18,392,32

0 $27,148,29

7 $36,190,24

0

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Cost per Unit 18.10 18.10 18.10

Profit Forecast for Three Years In order for the BandWave™ to become profitable in Year 1, it must meet the first year expense of $18,392,320. At the hospital discount price of $21.25 it would require BandWave™ to sell 721,268 units in order to begin generating a profit. The following table shows the total profit for the first year of business at the $21.25 selling price for hospitals. This figure indicated that we have not yet reached out to the retail consumer market.

Number of Units Sold

Total Profit in USD

0 $18,392,320

100,000 $15,842,320

300,000 $10,742,320

400,000 $8,192,320

500,000 $5,642,320

600,000 $3,092,320

700,000 $542,320

800,000 $2,007,680

900,000 $4,557,680

1,000,000 $7,107,680

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Because the goal of Voltaic Solutions is to begin marketing to hospitals, the first year business plan of advertising will be dedicated towards hospitals in the Los Angeles area. This will allow the BandWave™ to revolutionize the healing process of patients who are recovering from surgery, and elderly patients who have suffered a fall.

Year One Number of Places

Number of Sold Units

Price per Unit Profit

Hospitals 121 8,264 $25.50 $25,498,572

Nursing Homes 0 0 0 $0

Revenue $25,498,572

Expenses ­$18,392,320

Total $7,106,252

In the second year of production, Voltaic Solutions plans to expand its market beyond hospitals in the Los Angeles area to include the average American consumer as well. In addition to the post­op surgical application of BandWave™, the device may also be used to speed wound healing of everyday cuts and scrapes in addition to alleviating pain.

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Thus, BandWave™ will be distributed to Nursing Homes in the Los Angeles area to provide accessibility to a wider range of consumers. As the market size increases, so does the yearly net profit. After year two, we see an increase in profit from $7,106,252 to $11,920,651, indicating 67.75% projected increase in net profit.

Year Two Number of Places

Number of Sold Units to each

location

Price per Unit Profit

Hospitals 121 10,505 $25.50 $32,413,178

Nursing Homes 83 2673 $30 $6,655,770

Revenue $39,068,948

Expenses ­$27,148,297

Total $11,920,651

BandWave™ will continue to increase its presence as a viable wound healing and pain relieving solution into its third year of production. Its original market will be expanded from the Los Angeles area to include the entire state of California. The net profit will increase from the second year yield of $11,920,651 to $15,628,708. This indicates an increase in net revenue of 32% from year two to year three.

Year Three Number of Places

Number of Sold Units

Price per Unit Profit

Hospitals 121 10,505 $25.50 $32,413,178

Nursing Homes 83 2673 $30 $6,655,770

Other Hospitals tbd 500,000 $25.50 $12,750,000

Revenue $51,818,948

Expenses ­$36,190,240

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Total $15,628,708

Future As Voltaic Solution continues to expand and tap into the expected market of 60,000,000 potential patients, our small business will hope to transition into a larger business by year three. Moving from a storage­based distribution, Voltaic Solutions hopes to buy a functional office location to house employees, manage distribution, and continue marketing and sales. Additionally, Voltaic Solutions will tap into new markets throughout the country and continue to revolutionize the healing process. Along the way, Voltaic Solutions will continue to refine the BandWave™ in order to meet customer needs and satisfaction, and experiment with new components of the product in order to minimize price and make the BandWave™ as accessible to consumers as possible. Feasibility The revolutionary technology of the BandWave™ will capture the attention of millions of patients seeking to quicken their recovery process while simultaneously minimizing pain in the process. Instead of using the standard bandage on a wound and applying inconvenient gels or creams to the affected wound, the BandWave™’s dual technology will address both pain management and recovery time. While this product can positively affect any person with a recovering wound, Voltaic Solutions will primarily focus on the Los Angeles area in order to mitigate costs of reaching out to a large market before we have the capacity to do so. By selectively having presence in a select market, word of mouth and advertising will spread the word of the BandWave™ before we are able to expand. Continuing into the second year, Voltaic Solutions is working to expand presence to a greater extent in the Los Angeles Area by reaching out to Nursing Homes throughout Los Angeles. While expansion into the Nursing Home market is taking place, the sales team will simultaneously be preparing to spread across California in the upcoming year. Profits made during the first and second year will be allocated towards increased advertising and salespeople. It is essential to be forward thinking and to continue working towards growth areas and expansion.

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As Voltaic Solutions enters into the third year of sales, the BandWave™ will begin entering markets throughout the state of California. It is at this point that Voltaic Solutions will establish whether to continue expansion throughout the country, and perhaps internationally, or pursue getting bought out by a larger corporation. Additionally, we will heavily considering relocating to an office location and develop capabilities of production, storage, and distribution instead of outsourcing production overseas and incurring unnecessary expenses. However, throughout these years and continuing on into the future, Voltaic Solutions will make necessary alterations along the way in regards to business practices, BandWave™­related production, and any other necessary means to increase customer satisfaction. The BandWave™ has the potential to revolutionize the healing process as we know it, and our mission is to affect the most amount of change as possible, in an affordable and customer­friendly way. Reimbursement Strategy In the consideration of reimbursement strategies for our product, we considered both public and private payers. In terms of public payers, we will focus on Medicare and Medicaid, both falling under the Centers for Medicare and Medicaid Services, which is a federal agency. Medicare is an entitlement run by the government to provide health insurance to beneficiaries either 65 years of age and older, to people of all ages with certain disabilities, and to people with End­Stage Renal Disease. Medicaid is a program based on financial eligibility rather than age, and serves low­income American families. While private payers make up the majority of medical reimbursements, there are many more variables and minutia to take into consideration when providing reimbursement via this route given that there not a uniform standard. The BandWave™ by Voltaic Solutions is a device that is not limited to certain ages, and can be considered for reimbursement by Medicare, Medicaid, and private means. The BandWave™ will be readily available to both hospitals and to those wishing to benefit from the novel technology. (Centers for Medicare and Medicaid Services) Reimbursement Coding Regardless of whether the insurance provider is public or private, the appropriate code must be submitted in order for a medical center to get reimbursed. This method of coding serves to simplify the billing procedure, allowing the code to be analyzed as the

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language that describes a medical encounter and dictates the billing procedure. The three types of reimbursement codes include Current Procedural Terminology (CPT), Healthcare Common Procedure Coding System (HCPCS), and International Classification of Diseases (ICD). The CPT coding system describes how to report procedures or services. HCPCS codes are used to identify physician procedures, devices, supplies, and drugs. The ICD­9­CM is a system of codes used by healthcare professionals to report diagnoses and disorders, but are often not accepted for billing purposes by third party payers. (U.S. Food and Drug Administration) The majority of HCPCS services are not included in CPT codes, such as ambulance services, drugs, and durable medical equipment when used outside of a physician’s office. The federal government frames and maintains these codes, which have become mandatory for transactions involving health care since 1996 when the Health Insurance Portability and Accountability Act (HIPAA) was passed. HCPCS may also give temporary codes for new technologies and services, given that the applications for new codes are effective the following year. Level 1 of HCPCS coding is comprised of CPT, a numeric coding system maintained by the American Medical Association. Level II consists of a standardized coding system to identify services that are not included by the CPT, and consist of a single letter followed by 4 numeric digits. Level III codes, originally referred to as local codes, were eliminated by HIPPA. The BandWave™ will use three pre­existing HCPCS codes for reimbursement: A4558, A4630, E0720.

HCPCS Code

Category Descriptor

A4558 Conductive gel or paste, for use with electrical device (e. G. , tens, nmes),

A4630 Replacement batteries, medical necessary, transcutaneous electrical stimulator, owned by patient

E0720 Transcutaneous electrical nerve stimulation (tens) device, two lead, localized

We will not be required to apply for new codes, and will instead use existing ones. However, it may be necessary that we apply for a minor modification of code E0720 for

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the TENS device due to the fact that Voltaic Solutions will be producing its own version of the TENS device into a more accessible unit. We are not changing anything about the existing product that would affect the reimbursement procedures. Instead, we are using existing technology, TENS, coupled with electric field wound healing in order to reduce pain simultaneously with the recovery period.

HCPCS Code

Status Reimbursement

A4558 New Purchase $6.05

A4630 New Purchase $5.89

E0720 New Purchase $346

Additionally, the International Classification of Diseases (ICD) is managed by the World Health Organization, and is unique internationally. These codes are diagnosis based, and serve to identify the reason for the exam and describe the medical necessity. The ICD­9 will transition to a new, longer coding system ICD­10 in October of 2015. The current ICD­9 codes that match with the BandWave™ are as follows: 874.8 Open wound of other and unspecified parts of neck without complication 875.0 Open wound of chest without complication 876.0 Open wound of back without complication 877.0 Open wound of buttock without complication 879.2 Open wound of abdominal wall anterior without complication 879.4 Open wound of abdominal wall lateral without complication 897.6 Open wound of other and unspecified parts of trunk without complication 879.8 Open wound of unspecified site without complication 880.09 Open wound of multiple sites of shoulder and upper arm without

complication 881.0 Open wound of forearm without complication 884.0 Multiple and unspecified wound of upper limb without complication 890.0 Open wound of hip and thigh without complication 894.0 Multiple and unspecified open wound of lower limb without complication

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In order for a hospital to get reimbursed, they must provide both the diagnosis (ICD­9 diagnosis codes) and device codes (HCPCS codes), while third party payers may only be responsible for the HCPCS code. (Centers for Medicare and Medicaid Services) National and Local Coverage In the United States, Health Insurance coverage is classified into either federal government­based and state government­based insurance called either national or local coverage policies. National coverage policies account for nearly 10% of all coverage determinations, while local coverage policies account for the remaining 90%. National coverage will always supersede local coverage, and local coverage policy may expand national coverage, unless national policy is exclusionary. Medicare and Medicaid fall under federal­government based insurance. Given that the BandWave™ technology utilizes the existing TENS technology, we will plan to use the similar reimbursement codes. Medicare Part B pays 80 percent of the Medicare­approved amount for the purchase of a covered TENS device with certain medical cases. (Noridian Healthcare Solutions) Private Coverage Private insurance companies are the biggest contributors to health insurance coverage in the United States. It is important to obtain their coverage for the success of Voltain Solution’s BandWave™. Different companies use different reimbursement rates, and some of the largest private health insurance companies include Aetna, Blue Cross, and Blue Shield Association. Feasibility

By assessing the feasibility of Voltaic Solution’s BandWave™, the manufacturing costs in combination with the current market needs indicate that the BandWave™ is not a feasible product. While the projected market predicts a large enough consumer base with a large potential profit, the existing bandages on the market have potential to prevent hospitals from deeming it worthwhile to spend the additional money on the BandWave™. The more expensive price tag associated with the innovative technology that the BandWave™ offers may cause Medicare and Medicaid to deem the cost an unnecessary expenditure. The cost of production and initial marketing of the

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BandWave™ would require considerable capital, which our company believes is not realistic. Voltaic Solutions is a revolutionary company that strives to make excellent devices, but unfortunately BandWave™ would require too much money to be a feasible and profitable device. Furthermore, the reimbursement codes we are claiming for our product are not guaranteed, which leaves the company at risk of not obtaining reimbursement. This report allowed us to understand the scope of what is required to develop a medical device and has allowed us to distinguish our product as an unfeasible device with no future for production. Contribution Design, Technology and Safety Issues Desmond Dizon, Maksym Tsvetkov, Douglas Yuk Market Requirements and Reimbursement Strategy Regulatory and Clinical Trials Strategy References

XpressRate.com

PublicStorage.com

freightecenter.com

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTob

acco/CDRH/CDRHTransparency/ucm203018.htm

https://www.dmepdac.com/index.html

http://www.lni.wa.gov/claimsins/files/providerpay/feeschedules/2012fs/fshcpcs

.pdf

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https://www.cms.gov/Medicare/Coding/ICD10/index.html?redirect=/icd10/01_

overview.asp

http://www.healthcare.philips.com/main/products/mother_and_child_care/po

st_natal_care/well_baby/monitoring/smarttrace/

http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?sr

c=bkmk

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/

GeneralandSpecialControls/ucm055910.htm

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