Empowering people
by providing life-enhancing
and cost-effective
diagnostic solutions.
Featuring BreastCare DTS™,
patented and FDA cleared
as an adjunct to mammography
and other established
procedures for the detection
of breast disease, including
breast cancer.
EVENT CARDIO GROUP, INC. (ECGI)
Business Plan for BreastCare DTS™
This Business Plan is highly confidential. It has been prepared solely for the use of those individuals to whom it is
delivered by ECGI. You may not reproduce or distribute this Business Plan, in whole or in part, and you may not
disclose the contents of this Business Plan or use any of the information contained herein for any purpose other than
determining whether to obtain additional information about ECGI. By accepting delivery of this Business Plan, you
agree to the foregoing and to maintain the information contained herein in confidence and to discuss the same only
with those advisors you choose to rely on to evaluate the information contained herein and only after they have
agreed to the foregoing restrictions. This Business Plan is not an offering of securities or a solicitation of an offer to
buy securities. Any such offer or solicitation will be made only pursuant to such documents as are determined
necessary and appropriate by ECGI, any party to which it may determine to offer securities and their respective
counsel. You further agree, upon request, to return this Business Plan to ECGI.
The following ECGI Revenue Forecast and the other projected figures and numerical assumptions contained herein
regarding ECGI’s future expenses, revenues and operating results, are forward looking statements. These forecasts
and projections are based upon management’s best estimates as of the date hereof and are subject to numerous
risks and uncertainties which could cause critical amounts to vary from those assumed herein or cause actual results
to differ substantially from those projected herein. Readers are not to place undue reliance on the projections and
forecast contained herein which are presented solely to enable the reader to understand what the financial results of
ECGI could be if management’s estimates and the assumptions underlying the projections are, in fact, realized.
Statements in this business plan may be regarded, in certain instances, as "forward-looking statements" pursuant to
certain sections of the Securities Act 1933 and the Securities Exchange Act 1934, respectively. "Forward-looking
statements" are based on expectations, estimates and projections at the time the statements are made, and involve
risks and uncertainties, which could cause actual results or events to differ materially from those currently
anticipated, including, but not limited to delays, difficulties, changed strategies, or unanticipated factors or
1
circumstances affecting ECGI and its business. There can be no assurance that such forward-looking statements will
ever prove to be accurate and readers should not place undue reliance on any such forward-looking statements
contained herein.
TABLE OF CONTENTS
Page
I.
EXECUTIVE SUMMARY .................................................................................................................................................. 3
The Company.................................................................................................................................................................... 3
Principal Offices ................................................................................................................................................................ 3
Product Overview .............................................................................................................................................................. 3
FDA Clearance and Clinical Studies ................................................................................................................................. 4
Manufacturing ................................................................................................................................................................... 4
The Medical Device & Breast Cancers Detection Industry .............................................................................................. 4
Product Launch: Overseas and Domestic......................................................................................................................... 4
Milestones Accomplished to Date………………………………………………………………………………..…….................5
II.
PROPOSED BUSINESS ................................................................................................................................................... 5
Company Mission and Values……………….…………………………………………………………………………………..…5
BreastCare DTS™ Advantage .......................................................................................................................................... 6
Estimated Potential Market Size ....................................................................................................................................... 6
Marketplace Trends .......................................................................................................................................................... 6
BreastCare DTS™ Product Description ............................................................................................................................ 7
Regulatory Approvals and Patents.................................................................................................................................... 8
Safety and Efficacy of BreastCare DTS™ ........................................................................................................................ 9
Manufacturing ................................................................................................................................................................. 10
Cost Effectiveness of BreastCare DTS™ ....................................................................................................................... 10
Assessment of Existing Detection Options and Other Techniques ................................................................................. 11
Marketing Initiatives ........................................................................................................................................................ 11
III.
BOARD OF DIRECTORS, MANAGEMENT AND ADVISORY BOARDS ....................................................................... 13
Management ................................................................................................................................................................... 13
Advisory Board ………...……………………………………………………………….…………………………….…………..13
2
I. EXECUTIVE SUMMARY
THE COMPANY
Event Cardio Group, Inc. (ECGI) intends to become a global leader in providing life-enhancing, low cost medical diagnostic
testing devices to the public through partnerships with non-profit organizations, corporations, health care providers,
academia, the government, and individuals to bring about a successful outcome in the fight against breast cancer and
other life-threatening illnesses. The Company’s initial business focus is in the cardiac medical device innovation, patient monitoring
and cardiac event prediction industry and the breast cancer detection and diagnostic technologies. This business plan is focused on
the BreastCare DTS™ device.
ECGI has been granted the exclusive License for manufacture and distribution of BreastCare DTS™ from Life
Medical Technologies to the U.S., Canada, Asia (China, Vietnam, Cambodia, Japan, Taiwan, North and South
Korea, Thailand, Malaysia and the Philippines,) and non-exclusive as to the balance of the world, other than
Latin America and entered into a Joint Venture with respect to distribution in the country of India. Also under
the Licensing Agreement ECGI has claimed the countries of Australia, New Zealand, Singapore, Indonesia,
Vietnam, Laos, Myanmar and Bangladesh. The License includes proprietary rights, including, but not limited to,
patents, trademarks, copyrights, United States Food and Drug Administration ("FDA") filings, clinical studies,
data, techniques, trade secrets, contract rights, concepts and know-how, relating to BreastCare DTS™.
The Company operates according to triple bottom line principles that define success based on fulfilling
economic, ecological and social criteria. The Company will provide a return for all stakeholders including
shareholders will donate a percentage of sales to support breast cancer education and research and will work
with non-profit and government policy-makers to promote early detection. The Company will utilize sustainable
manufacturing and packaging practices; and participate in employee organizational hiring and policies that
respect people and ethics.
PRINCIPAL OFFICES
ECGI’s corporate headquarters are located 3 Park Ave 16th floor New York, NY 10016 ECGI’s telephone
number is 212- 321-0091 and its website address is: www.eventcardiogroup.com.
PRODUCT OVERVIEW
BreastCare DTS™ is an easy-to-use, single-use device, which has been cleared by the FDA to be marketed as
an adjunct to mammography and other procedures for the detection of breast disease, including breast cancer.
The patented device consists of two, soft, disposable pads that are lightweight and non-invasive, and are
applied around the surface of each breast and worn for 15 minutes. 1,188 temperature sensitive sensors
embedded in wafer-thin foil layers in each pad sense heat in the underlying tissues, changing color and
highlighting regional temperature differences which can signify abnormal cellular activity associated with tumors
or metabolic changes.
BreastCare DTS™ is a non-invasive device which allows women to safely and affordably screen for breast
disease throughout the year, when used in conjunction with annual or biannual mammography and clinical
breast examination.
BreastCare DTS™ has been shown in clinical studies to be particularly effective in detecting early tumors. The
use and expanded availability of screening tests globally is crucial to lower mortality by detecting breast cancer
at its earliest stage. The fact that stage 0 (noninvasive) and stage 1 (early invasive) breast cancers are highly
curable (with 5-year survival rates of 100%) cannot be overemphasized. Early breast cancer detection and
3
education are being emphasized by the U.S. and other governments, healthcare companies and the general
public as a way to reduce long-term healthcare costs and significantly reduce mortality from breast cancer.
FDA CLEARANCE AND CLINICAL STUDIES
BreastCare DTS™ has received FDA 510K clearance for marketing in the United States to be used by
healthcare professionals as an adjunct to routine physical examination including palpation, mammography and
other established procedures for the detection of breast disease including breast cancer. Clinical studies have
been conducted on over 5,000 women in prestigious cancer centers in the U.S., Europe and Latin America,
including Memorial Sloan-Kettering in New York and M.D. Anderson in Houston, Texas. Positive results have
included finding 87.5% of early stage tumors and attaining a specificity of 86.5%; false negative rates of 3% –
13%; a positive predictive value of 98%; and a negative predictive value of 93% - 94%.
MANUFACTURING
ECGI has retained Ceres Technologies to engineer and design of the BreastCare DTS production line.
ECGI anticipates contract manufacturing the BreastCare DTS device with Ceres Technologies. Ceres
Technologies is an industry leader in electronics grade ultra high-purity and precision delivery systems for
gases and precursors. The Company will also manufacture at other locations around the world as demand for
BreastCare DTS™ increases.
The intellectual property underlying the production process may provide additional protection from future
potential competitors. Ceres has completed the design of the Company’s manufacturing line and performed a
bench test to show that the proprietary dispensing system functions successfully according to specifications
and needs only to be scaled to full production. The Company will employ sustainable manufacturing practices
to minimize waste and energy utilization during processes, packaging and shipping.
THE MEDICAL DEVICE AND BREAST CANCER DETECTION MARKET
Globally Nearly 1.7 million new breast cancer cases were diagnosed in 2012. Breast cancer is the second most
common cancer in women and men worldwide. In 2012, it represented about 12 percent of all new cancer
cases and 25 percent of all cancers in women. Breast cancer is the most frequently diagnosed cancer among
women in 140 of 184 countries worldwide. Since 2008, worldwide breast cancer incidence has increased by
more than 20 percent. Mortality has increased by 14 percent.1 In the U. S. 231,840 new cases of invasive
breast cancer will be diagnosed in women in 2015 and 62,570 new cases of breast carcinoma in situ (noninvasive, has not invaded nearby tissue), including ductal carcinoma in situ and lobular carcinoma in situ. It is
projected that in the U. S. 40,290 women will die from breast cancer in 2015. Additionally 2,350 new cases of
breast cancer will be diagnosed in men, 440 men will die from breast cancer.2
More than $3 billion is spent annually in the U.S. for breast cancer screening, yet only modest progress in
reducing the death rate has been achieved. Mammograms are less effective in identifying cancers for women
under 50; of the 231,840 women that will be diagnosed in the U. S. in 2015, 24,630 will be younger than 45 and
207,210 will be between 45 and 64. Lack of availability of mammography and other screening methods in
developing countries has led to more than two-thirds of women in developing countries not being diagnosed
until their cancers are locally advanced or have already metastasized.
PRODUCT LAUNCH:
ECGI currently intends to launch the BreastCare DTS™ device in the Australia and China through its network
of distribution partners. ECGI will utilize education and media publicity campaigns to create awareness and
acceptance. In developing countries where many women lack access to medical doctors and mammogram
1
2
World Cancer Research Fund International
American Cancer Society, Cancer Facts & Figures 2015
4
technology, the Company’s will enlist governmental and private sector-funded health programs to help
introduce the device.
Current market research indicates a retail price point for BreastCare DTS™ at $39.95. At this price, we
anticipate gross margins in the 73 to 78% range. The wholesale price will be adjusted based on individual
contract parameters. ECGI anticipates selling 756,000 units in Year One revenues of $18 MM with Profits of
$6.6 MM; 5,449,000 units in Year Two with revenues of $116 MM with Profits of $50 MM and 13,788,000 units
in Year Three with revenues of $283 MM with Profits of $154 MM based on production ramp-up and current
sales discussions and projections. It is anticipated that 100% of the sales are projected to be outside the US in
Year One. The U.S. and other licensed markets will follow once production is scaled up to handle additional
volume.
MILESTONES ACCOMPLISHED TO DATE
ECGI has acquired the exclusive distribution rights for BreastCare DTS™ to the U.S., Canada, Asia
(China, Vietnam, Cambodia, Japan, Taiwan, North and South Korea, Thailand, Malaysia and the
Philippines,) and non-exclusive as to the balance of the world, other than Latin America.
Under the Licensing Agreement ECGI has claimed the countries of Australia, New Zealand,
Singapore, Indonesia, Vietnam, Laos, Myanmar and Bangladesh.
The intellectual property licensed and the FDA clearance include:
Intellectual property underlying the BreastCare DTS™ device and the use of FDA clearance, and,
among other things, to begin to develop the infrastructure for a global product launch and to attract
potential customers and influential individuals in the value chain.
Manufacturing and production:
Ceres has completed an important first milestone that will provide BreastCare DTS™ devices for
testing and registration purposes while the full production line is being completed for larger production
capacity. The full production line is expected to be capable of producing 1.8 million units per year with
a single operation shift and as demand for the device increases can be ramped to include 2 or 3 shifts.
The full manufacturing line is projected to commence production during the first quarter of 2016 and is
expected to rapidly produce pairs of pads while maintaining strict quality control standards with only
three operators.
II.
PROPOSED BUSINESS
COMPANY MISSION AND VALUES
The mission of ECGI is to bring low-cost medical diagnostic testing devices and education about the benefits of
early detection of disease to people worldwide. The Company intends to operate according to triple bottom line
(TBL) principles that define success based on fulfilling economic, ecological and social criteria.
Economic. The Company will provide value for all stakeholders including shareholders.
Ecological. The Company will operate globally according to sustainable manufacturing and packaging
practices that minimize waste and energy utilization. The Company will be developing life-cycle assessment for
our products.
Social. The Company intends to donate a percentage of sales of the BreastCare DTS™ to support breast
cancer education and research. The Company is exploring the option of establishing a foundation to direct the
5
disbursement of donations. In addition to the percentage of sales, the Company plans to host awareness
events in conjunction with the education program. Profits from these events will also be donated to support
education and research. The Company will collaborate with non-profit and government policy-makers to
promote early detection. ECGI will strive to create a work environment for ECGI employees to provide a higher
quality of life with respect, encouragement, integrity and fairness, always communicating honestly, allowing for
creativity and will expect the same values reflected from ECGI employees, customers and suppliers. The
Company will encourage volunteerism by employees to charities and causes of their choice and will sponsor
volunteer activities and programs.
BREASTCARE DTS™ ADVANTAGE
The Company’s current plans to manufacture and sell BreastCare DTS™ are premised on the following:
1.
BreastCare DTS™ is a noninvasive, easy-to-use device that allows all women to affordably screen for
breast cancer throughout the year in conjunction with mammography and clinical breast examination.
BreastCare DTS™ is inexpensive, lightweight and portable. Test results are shown on the device itself in
a simple easy-to-read format.
2.
BreastCare DTS™ is affordable to consumers in the developed world and to governments and health
care providers in developing countries.
3.
In developing countries with significant populations lacking access to screening methods such as
mammography common in developed countries, BreastCare DTS™ has the potential to become the
core of government-sponsored and other breast cancer screening programs.
4.
By utilizing cause-related marketing, ECGI believes BreastCare DTS™ will resonate with the value chain
and end-users that form a powerful community working at preventing the loss of lives due to breast
cancer.
ESTIMATED POTENTIAL MARKET SIZE
The $3.5 billion per year market size that was estimated in the January 2008 Capgemini report that Life Medical
Technologies commissioned was created using models to predict adoption rates of the BreastCare DTS™
device by age group and country for the first three years of marketing. Markets for various geographical regions
were estimated using assumptions about increased or decreased number of uses per year of the device by age
group and country, estimated wholesale price, population data, how healthcare is paid for in the region, that is
through national health insurance or a blend of public and private coverage, and increased or decreased
adoption rates. The Company’s projections for sales are less than 10% of the Capgemeni estimates for the
world market.
MARKETPLACE TRENDS
The medical device market is about one-half the size of the world pharmaceutical market and is growing faster
than its drug counterpart. Point-of-Care (PoC) testing is one of the most rapidly growing segments within
medical devices and diagnostics. PoC tests include those conducted at a patient’s hospital bedside, in
emergency rooms and clinics, in doctors’ offices, and by the patient at home.
The global PoC testing market is projected to reach $18.7 billion in 2011, up from $10.3 billion in 2005. ECGI
believes that BreastCare DTS™ meets all the major criteria for a successful PoC test. In the U.S. alone the
combined breast cancer detection/diagnostic market was valued at more that $2.2 billion in 2008, and is
expected to continue in a stable growth pattern over the next 5 years, increasing at a conservative growth rate
of approximately 5.4% to rise to an estimated $2.8 billion in 2013.
6
The continued increase in awareness of the benefits and importance of early breast cancer detection and an
increasingly aging population in the U.S. will increase demand for additional and adjunctive screening methods.
Direct medical costs associated with treating breast cancer exceed $6 billion annually in the United States.
When detected early, breast cancer can cost between $10,000 and $15,000 to treat. In more advanced stages,
it can cost between $60,000 and $230,000.
BREASTCARE DTS™ PRODUCT DESCRIPTION
BreastCare DTS™ is patented, non-invasive and FDA-cleared as an adjunct to mammography and other
established procedures for the detection of breast disease, including breast cancer. DTS stands for “Differential
Temperature Sensor,” indicating the ability of the device to compare temperatures in one breast with the other.
The BreastCare DTS™ device consists of two mirror image, lightweight and disposable foam pads with three
wafer-thin foil sensors on each pad. Each of the three segments on each pad contains 18 rows of heatsensitive chemical dots. The device is easy to use and requires no electricity or probes. The test is completely
non-invasive.
The pads are easily placed on a woman’s breasts inside the bra for 15 minutes. The device measures the deep
heat energy that is transferred to the surface of the skin. Each heat-sensitive dot is calibrated to record the
temperature of the surface of the breast. The dots themselves change color from blue to pink when exposed to
specific temperatures. The results are clearly displayed and can be immediately evaluated. The heat-sensitive
dots have embedded memory, which allows the results to be read after each test is completed. An average
temperature differential of 2 F or greater may indicate the presence of increased metabolic activity and a
potential underlying pathology such as breast cancer.
The BreastCare DTS™ device is not a definitive test for breast cancer; only a biopsy can diagnose breast
cancer through extraction of cells from the breast. It is not intended to replace mammography and other
detection methods, but to be used as an adjunct to other screening methods. The value of measuring elevated
temperature as a risk marker for breast cancer is based on extensive published research pertaining to
“angiogenesis.” Angiogenesis, the process by which new blood vessels are formed to facilitate the growth of a
tumor, is one of the most heavily funded areas in the history of cancer research according to the Angiogenesis
Foundation. The existence of a “tumor angiogenesis factor,” originally postulated by Nobel Prize winner Dr.
Judah Folkman at Harvard University Medical School in 1971, has since been demonstrated as an indicator of
breast cancer.
The development of lesions or tumors in the breast results in temperatures near the lesions or tumors that is
higher than the surrounding tissue, as a result of an increase in metabolism. Profound vascular changes occur
at the site of tumor growth and lead to temperature changes that are transmitted to the surface of the skin.
7
Research related to angiogenesis spurred the development of the BreastCare DTS™ device. The chemical
heat measurement technology utilized in the BreastCare DTS™ product is the first application of that
technology to be employed in the detection of breast abnormalities.
REGULATORY APPROVALS AND PATENTS
The BreastCare DTS™ device received 510K clearance for marketing by the U. S. Food and Drug
Administration (“FDA”) as an adjunct to mammography and clinical breast examination for the detection of
breast disease, including breast cancer. In addition, it has received the following international certifications:





Health Canada sales clearance, allowing for over-the-counter sales in Canada.
Previously sold under “CE” marking which allowed sale in the European Economic Area (EEA, the 27
Member States and EFTA countries Iceland, Norway, Liechtenstein and Turkey).
Registration in Brazil with the Ministry of Health and through ANVISA, the government’s medical
department with which it has importation clearance.
Registration approval from the Federal Examination Service in the Region of the Protection of
Consumer Rights and Welfare of People in the Chechen Republic.
Registration approval from Comision Federal Para La Proteccion Contra Riesgos Sanitarios in Mexico.
The US patent (#6,086,247 for BreastCare DTS™ Approximately four years remain on the current patent for
the BreastCare DTS™ device before it expires. ECGI intends to file additional patents for BreastCare DTS™ if
it is able to make improvements that qualify for patent protection, as to which no assurances can be given.
SAFETY AND EFFICACY OF BREASTCARE DTS™
BreastCare DTS™ is intended for use by women of all ages when used as an adjunct to mammography and
other procedures for the detection of breast disease including breast cancer. It is non-invasive and can be used
safely at frequent intervals. Clinical studies conducted with over 5,000 women over an extended period in
world-renowned medical institutions have thus far reported no adverse events or side effects.
8
SUMMARY OF CLINICAL STUDIES COMPLETED WITH BREASTCARE DTS™
Institution & Study
Number
Study 1 Memorial SloanKettering Cancer Center,
M.D. Anderson Hospital
& Tumor Institute,
Brotman Memorial
Hospital
Study 2 Memorial SloanKettering Guttman
Diagnostic Center
No. in
Study
179
Study 3 University Louis
Pasteur Hospital
348
Study 4 Multiple Centers
in Brazil
1,009
Study 5 North Shore
University Hospital,
European Institute of
Oncology
2,805
151
Principal
Investigator
Dr. Ruth Snyder
Dr. Gerald Dodd
Dr. Harold
Karpman
Quotes from Investigators
“Use of the BreastCare DTS™ device is expected to
materially reduce the likelihood of missing a significant breast
abnormality.”
“Of significance, the BreastCare DTS™ device found 87.5%
of the cancers in a tumor less than 1.0 centimeters in size.
”In 99.6% of the screenings, the clinic findings either
confirmed the BreastCare DTS™ results or indicated that the
device produced a positive result not in agreement with the
clinical evaluation.”
Dr. Philp Strax
Dr. Michel
Gautherie
“Based on this study of 319 symptomatic women, the
BreastCare DTS™ test appears to be objective and effective.
Of the total of 43 cancers including 7 T0 (smaller 1 cm) and
18 T1 (1.0 – 1.9 cm) carcinomas, the sensitivity (true positive
rate) was 83%.”
Dr. Alfredo Barros
“If breast physical examination is suspicious of cancer and
the BreastCare DTS™ test is positive, the probability of
having cancer is 98%.”
“It is remarkable the fact that there have been 11 cases of
cancer histologically confirmed in absence of clinical
suspicion (8 = 3). Of these 11 cases, BreastCare DTS™ was
(+) 8 times, that is to say, 3 cancers were lost. Moreover, of
these 3 cancers, 2 were in situ forms and only 1 an invasive
carcinoma.”
“The high negative predictive values from these studies
indicate that few cancers will be missed in a screening test
with BreastCare DTS™.”
Dr. Virgilio
Sacchini
“Considering 40% of the patients tested are less than 50
years old (a group for whom negative predictive values from
mammography screening are generally low), the results of
the two studies on BreastCare DTS™ are very encouraging.”
Study 6 Multiple Centers
in Uruguay
Total Patients in All Trials
699
Dr. Alvaro Ronco
Dr. José A.
Carambula
Dr. Alfredo Barros
5,191
“A high diagnostic accuracy of BreastCare DTS™ was
achieved, mainly based on its high negative predictive value
(above 93%).”
The Company believes the completed clinical trials demonstrate that BreastCare DTS™:
 Identifies a present manifested form of angiogenesis that is feeding a tumor.
 Identifies an abnormality in the breast that suggests the risk of breast cancer in the patient.
 Successfully detected breast cancer in a patient as verified by a follow-up biopsy
9
MANUFACTURING
ECGI has retained Ceres Technologies to engineer and design of the BreastCare DTS production line.
ECGI anticipates contract manufacturing the BreastCare DTS device with Ceres Technologies. Ceres
Technologies is an industry leader in electronics grade ultra high-purity and precision delivery systems for
gases and precursors. The company also supplies advanced semiconductor vacuum deposition equipment and
XRF metrology instrumentation. Ceres leverages this expertise to offer OEM, outsource design and build
services, and contract manufacturing. The Company believes that through leveraging Ceres value-engineered
equipment design, manufacturing, and turnkey system level integration, ECGI will be able to duplicate its
operations at other locations around the world as demand for BreastCare DTS™ increases. This will allow
ECGI to manufacture in additional locations while protecting the intellectual property of the device.
The computer-controlled production line will take the process from raw materials through a final packaged product. The
system is designed with the capability to package in virtually any language to enable ECGI to rapidly address the global
market. Ceres has completed phase one of the development and bench proof of the proprietary process and is
progressing to building the full scale manufacturing line.
The FDA guidelines require that BreastCare DTS™ be manufactured under Good Manufacturing Practices for
manufacturing, packaging and labeling and that proper documentation and records compliance guidelines be followed.
ECGI intends to operate its manufacturing line five days per week with a double shift, producing six million units per year.
Each additional manufacturing line is currently estimated to cost approximately $1,300,000, with what the Company
believes will be a capability of producing four million units per year which should generate an estimated $65 Million of
revenue per year if there is sufficient product demand.
The Company currently anticipates that the first new manufacturing line will begin production in the first quarter of 2016.
COST EFFECTIVENESS OF BREASTCARE DTS™
ECGI believes that BreastCare DTS™ is the only viable non-invasive, easy-to-use device that will allow all women in the
US and other developed countries to safely and affordably screen for breast cancer throughout the year, in conjunction
with annual or biannual mammography and clinical breast examinations. ECGI believes that in developing and more
financially challenged countries with significant populations lacking access to screening methods commonly found in the
US and other developed countries, such as mammography, BreastCare DTS™ has the potential to become the core of
government-sponsored and other breast cancer screening programs.
SUMMARY OF KEY FEATURES ASSOCIATED WITH EXISTING DETECTION OPTIONS
Technology
Overall Efficacy
Primary Clinical
Utility Value
Women > 40 years
old
Cystic/solid mass
discrimination
Price per System
Price per Scan
Mammography
66-88% sensitivity
Up to $600,000
$100 - $300
Ultrasound
48% sensitivity
Up to $250,000
Up to $300
MRI
80% sensitivity
Multiple
malignancies
Up to $2.5 million
Up to $1,500
Nuclear Imaging
(PET)
80% sensitivity
Recurring cancers
Up to $2.5 million
Up to $5,000
10
ASSESSMENT OF EXISTING DETECTION OPTIONS AND OTHER TECHNOLOGIES
* Too early to tell
** When used as an adjunct to clinical breast examination and mammography
Capgemini prepared above tables. The Company believes that no current technology achieves all of the critical success
factors associated with an effective breast cancer-screening tool. However, does believe the BreastCare DTS™ device as
an adjunct has the potential to address each area noted in the Assessment Chart above.
MARKETING INITIATIVES
Global Market
Breast cancer is the most common cancer in women worldwide, with nearly 1.7 million new cases diagnosed in 2012
(second most common cancer overall). This represents about 12% of all new cancer cases and 25% of all cancers in
women. The global market for breast cancer diagnostic and drug technologies was about $20.8 billion in 2012. This market
reached about $22.3 billion in 2014 and is expected to reach $27 billion in 2019, registering a compound annual growth
rate (CAGR) of 4% through 2014-2019.
ECGI has been actively engaged in obtaining purchase commitments outside the U.S., for the bulk of the first year’s
anticipated production. Currently, the Company:

Has signed a licensing agreement with MedPac Asia Pacific PTY Ltd, of Australia, granted the exclusive
distribution rights for the BreastCare DTS™ device in Australia, New Zealand, Singapore, Thailand, Malaysia,
Indonesia, Philippines, Vietnam, Laos, Cambodia, Myanmar and Bangladesh. It is anticipated that the
distribution agreement will become a blanket purchase order for 25,000 units per month for year one of
production and to increase as demand and production capability for the BreastCare DTS™ device increases.

Is in the final stages of signing a licensing agreement with a Chinese company for China, Hong Kong, Japan,
Korea and Taiwan. It is anticipated that the distribution agreement will become a blanket purchase order for
75,000 units per month for year one of production and to increase as demand and production capability for the
BreastCare DTS™ device increases.

Is also involved in discussions with potential distributors in a number of other countries.
11
U.S. Market
The United States market represents an excellent opportunity. It is projected that in the U. S. 40,290 women will die
from breast cancer in 2015. Additionally 2,350 new cases of breast cancer will be diagnosed in men, 440 men
will die from breast cancer.3 North America has the highest incidence rate for breast cancer in the world (92.9 cases
per 100,000 people in the U. S. and 80 per 100,000 people in Canada). Despite the high incidence rate, only 72.6% of
women aged 50 – 74 had a mammogram in the past 2 years, (National Cancer Institute Cancer Trends Progress Report –
2009/2010 - 2015 Update.) In a New York Times May 4, 2011 article regarding the recent New York City Public Hospital
Audit, women had to wait up to 148 calendar days for routine screening mammograms and, when cancer was suspected,
50 working days for diagnostic mammograms.
The U.S. healthcare insurance system is dominated by private carriers, which in 2013 represented 64% of the market. In
2013 approximately 42 million people are uninsured and government insurance covers the remaining population.
Mammograms are reimbursed by Medicare once between the ages of 35 and 39, and then annually after 40. Medicare
does not reimburse for mammograms in women under 35.
Marketing a medical device in the U.S. is highly challenging and expensive, as promotional advertising targets both
physicians and consumers. ECGI currently intends to partner with a distribution partner, the Company will also develop an
in-house sales capability for physicians interested in purchasing the product directly.
Physicians
The initial marketing program for the US has been developed by the Company with input from physicians on ECGI’s Health
Advisory board and other interested medical providers. It is currently anticipated that the program will initially target groups
of approximately 100 physicians, and later approximately 1,000 physicians who have been selected on the basis of their
expertise, reputations, and expressed interest in BreastCare DTS™.
It is anticipated by the Company that BreastCare DTS™ is to be used in physician offices during patient visits as a
screening device for breast abnormalities as part of a woman’s annual examination. It is then to be used by the woman six
months later if she is not in a high-risk group, and every three months if she is in a high-risk group. It is not intended to
replace mammography and other detection methods, but to be used as an adjunct to other screening methods.
The Company believes symposiums and conferences will also be effective venues for educating large groups of
physicians and medical personnel within a short timeframe. Physicians can see the product, discover how it works, and
place group orders. Select panels of medical experts can speak about clinical trial results.
BreastAware Community Breast Health Education Campaign
ECGI intends to build awareness for its product through a Breast Health Education Campaign. Informal relationships have
been established by the Company with federal and state health agencies, breast cancer support groups, corporate
wellness programs, local hospital outreach programs, high schools, colleges and religious organizations.
The BreastAware Campaign will focus on breast cancer education, risk reduction and early detection. The education
program will be similar to marketing strategies employed by major pharmaceutical companies in raising awareness to
develop consumer demand.
The objectives of the BreastAware Campaign are:
 To empower women with accurate, comprehensive and up-to-date information on reducing the risk and
increasing the early detection of breast cancer;
 To involve both patients and physicians in creating personal breast health programs;
 To increase awareness about mammography and other breast health modalities;
 To increase awareness about breast cancer and BreastCare DTS™; and
 To build a grassroots social network of women.
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American Cancer Society, Cancer Facts & Figures 2015
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When the Company’s product becomes available for commercial sale in large quantities, the BreastAware Campaign is
intended to begin. The free program will provide women with a basic understanding of how to take greater control of their
breast health. Management anticipates women will leave the program with information they can share with their doctors
about BreastCare DTS™, and how they can access the product through their doctors. The program will target groups that
can reach women in large numbers, in comfortable and familiar community venues that offer a sense of camaraderie. The
bonding experience in these settings can provide a built-in “support group” for women who participate in our database.
Electronic Initiatives
The ECGI website (http://www.eventcardiogroup.com) features an animated 3D video showing how the device works. It
illustrates the development of ancillary blood vessels, which feed a breast tumor. Research information about BreastCare
DTS™ is also currently on the website. It is anticipated that the website’s content will be substantially expanded after
product launch to create an interactive Web 2.0 social networking site along with utilizing crowd-sourcing software to reach
large numbers of individual women as well as community support groups that will tie into the database program.
Public Relations
ECGI intends to gain significant exposure in the marketplace through a strong, cost-effective PR campaign leveraging
several media. The Company believes breast cancer is a popular health topic in the news. ECGI believes that once it
begins production of its products, it will obtain significant free media coverage through collaborative relationships with
celebrity breast cancer survivors, sports organizations, and television talk shows. The Company contemplates that the
community breast health education program will also reach out via newsletters, posters, postcards, mass e-mails and
banner links on websites.
III.
BOARD OF DIRECTORS, MANAGEMENT AND ADVISORY BOARD
MANAGEMENT
Directors and Executive Officers
The Company’s Board of Directors is comprised of 1director, John Bentivoglio
John Bentivoglio is President and CEO Mr. Bentivoglio is also a senior partner with Profit Consultants, Inc. an
international consulting firm with offices in Houston, Texas, Montreal, Canada and London, UK. Mr. Bentivoglio’s
accomplishments include mergers and acquisitions of publicly traded companies together with General Management
roles and treasury management. Mr. Bentivoglio has an education in Business Administration.
ADVISORY BOARD
Nicholas (Nick) Bozza (Medical) CPO- Chief Product Officer
Mr. Bozza has ten years’ experience in the cardiology testing area and is the current President and CEO of Canadian
Arrhythmia Institute (CAII) which he also founded in August 2008. Mr. Bozza has gained expert-level knowledge of the
cardiac diagnostics market through the development of CAII and his key relationships with payers, physicians and
patients. Mr. Bozza holds a Bachelor of Arts with a major in Marketing and Economics along with a Bachelor of Arts in
Health Sciences.
David Bard VP Sales, Marketing and Business Development
Mr. Bard is an entrepreneur, business leader, consultant, speaker and author. He has 20 years of leadership experience
in pharmaceutical, diagnostic and medical device commercialization and has worked with leading healthcare companies
across North America. David’s passion is launching new products and delves into marketing, sales and training
leadership across more than 20 therapeutic areas. His company, Pharma Launch Inc. was founded to address several
significant gaps in the marketplace. Dave holds a Master of Business Administration degree in Marketing and Business
Strategy and a Bachelor of Business Administration. He is an active volunteer within his community.
Dr. Carlos A. Morillo, Cardiologist and Electrophysiologist
Dr. Morillo is the Program Director EP & Autonomic Physiology Fellowship at McMaster University in Hamilton Ontario
Canada and is the former Director of the Arrhythmia Service at McMaster University. His main research interests are
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related to the development of clinical trials in the area of cardiac arrhythmia and syncope. He has a long-standing
interest in developing new therapeutic approaches for the treatment of atrial fibrillation and autonomic disorders. Dr.
Morillo developed the rapid atrial pacing model of atrial fibrillation and reported the first successful ablation of atrial
fibrillation in an experimental model. Dr. Morillo has published 130 articles in peer-reviewed journals and several book
chapters in well-known cardiology textbooks. He has also developed clinical pathways to improve management and
assessment of patients with atrial fibrillation and syncope that present to emergency departments.
Dr. Howard J. Miller, M.D. Internist practicing Non-Invasive Cardiology, Internal Medicine and is Geriatric
accredited by the American Board of Internal Medicine
Currently Medical Director at Canadian Arrhythmia Institute in the Niagara Peninsula, Ontario Canada and Private
Practice in Internal Medicine – Coudersport, PA USA. Graduated UCLA School of Medicine, 1980 M.D. Internship &
Residency 1983 School of Medicine Pennsylvania State University Milton S. Hershey Medical Center, Hershey, PA,
Internal Medicine, MD Temple University Medical School, BS Degree Psychology & Mathematics Johns Hopkins
University, 1975.
Dr. Lorne Finkelstein, M.D. F.R.C.P.(C) F.A.C.C. Cardiology
Active Staff, Department of Cardiology, St. Joseph’s Hospital, Hamilton, Ontario Canada. Private Practice, Clinical
Cardiology since 1977. OMA Member and former OMA Board of Directors Member. Providing ECGs, Exercise Testing,
Echocardiography, Holter Monitoring, and Loop (Event) Recording. Graduated University of Western Ontario Medical
School, Cardiology Fellow Montreal General Hospital.
Carol Fitzgerald, Vice Chair and Exec Vice President of Corporate Development of Life Medical Technologies
Ms. Fitzgerald is a seasoned executive with more than 30 years experience with companies ranging from start-up
organizations to Fortune 500 companies. Her special area of expertise is women’s health. Ms. Fitzgerald joined Life MT
in 2007 and has spent the last eight years developing global strategic relationships with leaders in breast cancer
diagnosis, treatment and patient care; raising more than $8.5 million in funding; streamlining technology development
and manufacturing processes; recruiting a top management team; and developing marketing strategies and channels to
bring the BreastCare DTS product to market. Prior to joining Life Medical Technologies in 2007, Ms. Fitzgerald was
founder and CEO of a consultancy practice serving corporate clients such as DuPont and Corning as well as a host of
start-up companies in the health and environmental sectors. A nationally recognized expert and speaker on emerging
economies, collaborative innovation, and private-public philanthropic marketing models, Ms. Fitzgerald and her network
of professionals helped select clients increase sales through community, e-commerce and one-on-one marketing;
develop innovative.
Richard Smith, Richard Smith is CEO and co-founder of CONTEX International Technologies (Canada) Inc.
With more than 25 years of management and engineering experience, Mr. Smith is focused on developing CONTEX as
premier high technology companies. Prior to founding CONTEX, Mr. Smith held key executive roles spanning both the
Health Care and Aerospace Industries. Mr. Smith also had previously co-founded a mid-sized Aerospace company
called Tricom Technologies Inc. (TTI) in 1995. TTI developed Flight Simulators for commercial and military aircraft. TTI
customers were worldwide and represented several major airlines. Mr. Smith successfully sold his interest in TTI in
2005. Mr. Smith holds a B.Sc. in Computer Science
Dr. Steve Ryan, PhD, Healthcare Educator and Patient Advocate for Patients with Atrial Fibrillation
Dr. Ryan is author of the book, Beat Your A-Fib: The Essential Guide to Finding Your Cure, and known as the AFib
Coach for his personal counseling of A-Fib patients seeking relief from the burden of Atrial Fibrillation. After struggling
to find his own A-Fib cure in 1998, Dr. Ryan started Atrial Fibrillation: Resources for Patients (A-Fib.com), now in its
tenth year. A-Fib.com is a source of well-researched, unbiased information on current and emerging treatments,
resources and medical research – all written in plain language. Every month tens of thousands of A-Fib patients and
their families visit A-Fib.com seeking hope and guidance. Healthcare professionals around the world refer their patients
to A-Fib.com. Dr Ryan is North America’s first Patient Advocate for Arrhythmia in North America. Patients find it
increasingly difficult to navigate their way through the medical system especially when they do not receive time with their
personal medical practitioners. When serious decisions have to be made with specialist, patient knowledge through Dr
Ryan’s personal coaching can assist patients to make informed decisions for their arrhythmia health.
Dr. Gifford Jones, Patient Advocate Advisor/Consultant
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Dr. Gifford-Jones (AKA Ken Walker) is a graduate of The University of Toronto and The Harvard Medical School. He
took post-graduate training in surgery at the Strong Memorial Hospital in Rochester, McGill University in Montreal and
Harvard. During his medical training he has been a family doctor, hotel doctor and ship’s surgeon. He is a Fellow of The
Royal College of Surgeons and author of seven books. His medical column is published by 70 Canadian newspapers,
several in the U.S. and the Epoch Times, which has editions in a number of European countries. He was Senior Editor
of the Canadian Doctor, a regular contributor to the magazine Fifty Plus and other publications. He was awarded a
certificate of merit by The Mitchener Foundation for his efforts to legalize heroin to ease the suffering of terminal cancer
patients. His Gifford-Jones Foundation donated $500,000 to establish The Gifford-Jones Professorship in Pain Control
and Palliative Care at The University of Toronto Medical School. During his career he has travelled extensively to
interview a number of internationally renowned scientists and researchers. You can also find Dr Gifford-Jones as a
regular guest on Hamilton’s CHML 900AM Doc Talk Program in the Province of Ontario Canada. His website is:
www.docgiff.com
Dr. Victor Rosenberg, World Renowned Plastic Surgeon
Dr. Victor Rosenberg has led a prolific career and is widely recognized as one of America’s top plastic and reconstructive
surgeons. He attended Mount Sinai Medical Center, Beth Israel Medical Center, and Albert Einstein Medical Center. Dr.
Rosenberg has been on the American Board of Plastic Surgery since 1969, and has managed his own private practice
since 1970. Dr. Rosenberg is an active member of many professional associations including the American Society of
Plastic Surgeons, International College of Surgeons, and Aesthetic Plastic Surgeons. Dr. Rosenberg is on the advisory
board of Life Medical Technologies, Licensor of BreastCare DTS. He invented instruments for use in Plastic Surgery and
other surgical procedures, and in addition was the first plastic surgeon to publish an article introducing fiber optic retractors
for face, nose, and breast surgery, into the field of Plastic Surgery. Dr. Rosenberg also initiated many innovative medical
and public health projects such as the First Responder Medical Emergency Program. He is also the cofounder of the
“Worth-A-Life” program, a comprehensive medical training and risk management program for residential and commercial
buildings. Dr. Rosenberg is often called upon by fellow practitioners for medical consultations, and by the media for
information for the general public. He was the first plastic surgeon to perform make-overs on Live with Regis and Kathy
Lee, and has been on numerous talk shows in including Oprah, The Joan Rivers Show, and Mike Douglas Show.
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