Portable, Power-independent, Affordable Medical Instrument Sterilization

PORTABLE, POWER-INDEPENDENT, AFFORDABLE SURGICAL INSTRUMENT

STERILIZATION A Unique Solution to a Global Problem

March,  2014    

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Table of Contents

I.  Eniware Overview 3

II.  Executive Management and Advisory Board 8

III.  Eniware’s Competitive Advantage 9

IV.  Testimonials 11

V.  Why We Start in Sub-Saharan Africa 12

VI.  The Business Model and Strategy 13

VII.  Eniware Benefits from Strong Market Drivers 17

VIII.  Commercial Viability 18

Appendix A: Company Overview and History 19

Appendix B: Product Development Implementation 20

Appendix C: Eniware Executive Management 21

Appendix D: Key Collaborators 22

Appendix E: Technical Data 23

Appendix F: Licensed Patents 24

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Table of Contents

I. Eniware Overview

!  The Eniware Portable Sterilizer (EPS) meets a critical, growing, global need for sterile instruments for essential surgery

!  Eniware has an exclusive global license to use patents for nitrogen dioxide as a sterilant, and for the sterilization system and devices used in power-independent applications

!  Eniware is currently the only company able to meet this need for low-resource environments

!  Traditional “razor/razor-blade” business model generates consistent positive cash flow

! We believe Sub-Saharan Africa presents a highly compelling market opportunity •  Accelerating and diversified economic growth •  Favorable demographic and urbanization trends •  Improving macroeconomic and political stability •  Steadily increasing percentage of GDP being spent on healthcare

!  Experienced, diverse team with more than 30 combined years of experience in healthcare entrepreneurship, management, and international programs

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I. Eniware Overview

I. Eniware Overview

!  Roughly 25% of the cost inflicted by disease on numerous economies is caused by conditions that can be treated with essential surgery

!  Essential surgery can only be performed safely with properly sterilized instruments – disinfection is not the same as sterilization

!  Effective and reliable sterilization is currently impossible without electricity but can be done with the Eniware Portable Sterilizer (EPS)

!  70% of Sub-Saharan Africa does not have access to electricity – the population is booming and electrification efforts cannot keep up

!  The inability to provide essential surgery to treat many disabilities and prevent death hinders growth of emerging economies 4  

I. Eniware Overview

World Without Power

The world’s least developed countries will have the most population growth between now and 2050, most of which will occur in Sub-Saharan Africa

Source: Population Reference Bureau 5  

I. Eniware Overview

I. Eniware Overview !  EPS effectively sterilizes surgical instruments and equipment without

electricity for ~$5 per use !  Eniware’s state-of-the-art nitrogen dioxide (NO2) sterilization technology will

be adapted into portable form-factors for use in low-resource environments !  The NO2 technology already has been patented and commercialized for the

U.S. and European markets by Noxilizer (see Appendix A)

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I. Eniware Overview

I. Eniware Overview Eniware has an exclusive license from Noxilizer for applications of its technology

to meet the ongoing needs in the developing world, and the global military, disaster, and veterinary markets.

Developing world shown in blue

GLOBAL MILITARIES

GLOBAL VETERINARY

27,000 vet practices in US alone

GLOBAL DISASTERS

357 in 2012

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I. Eniware Overview

II. Executive Management and Advisory Board

Board of Directors

Lawrence Bruder

CEO, Noxilizer

James Bernstein, MD Chairman and CEO, Eniware

Michael Steele Co-Founder, Purple Nations Solutions,

former Chairman, RNC

Management Team Selected Advisory Board Members

James Bernstein, MD, Co-founder and CEO •  35 years experience as a serial healthcare entrepreneur •  Worked as a surgeon in Peru and India •  Health policy expert at NIH, Georgetown, and for

President Carter’s election campaign Huma Malik, Co-founder and COO •  18 years of diplomatic and non-profit experience •  Founder of Walkabout Development Solutions

International, sustainable development org. in Pakistan •  Co-editor of Modernization, Democratization, and Islam

(CSIS, 2005) Majdi Shomali, VP of Product Development •  Over 20 years experience in new product development

in the medical device and gas detection industries

Dr. Rifat Atun – member Executive Management Team of the Global Fund; chaired WHO task force on health systems Dr. Catherine deVries – Author of Global Surgery and Public Health: A New Paradigm (2012) Laura S.L. Herman – Leads FSG’s health practice area, author of Private Sector Engagement Guide Dr. Patricia Hibberd – Chief of the Division of Global Health, Mass General Hospital Dr. Sulayman S. Nyang – former chairman, African Studies Dept., Howard University, D.C. Dr. Edgar Rodas – former Minister of Public Health, Ecuador

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II. Executive Management and Advisory Board

III. Eniware’s Competitive Advantage

Cost-Effective Less than $500 per unit

Less than $5 for consumables needed for each use.

Power-independent Requires no electricity, batteries, or other fuel source to operate

Better Material Compatibility

Allows for re-use of instruments and supplies

Portable Enables essential mobility for remote healthcare delivery

Eniware is currently the only company able to provide effective sterilization with these advantages

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III. Eniware’s Competitive Advantage

III. Eniware’s Competitive Advantage A Scalable Solution

•  Building a robust/competent management team and supporting staff

•  Developing a powerful communications team – clear messaging, effective advocacy, and vigorous customer interaction to assure local acceptance

•  Creating strong, effective alliances with community influentials

•  Paying strict attention to profitability

•  Focusing on quality and reproducible models effective across different cultures, emphasizing standards, quality, and evaluation

•  Introducing strong incentives in markets for growth, demand and performance

!  Eniware pays close attention to critical requirements for extensive scaling:

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III. Eniware’s Competitive Advantage A Scalable Solution

IV. Testimonials

!  The need for the EPS has been repeatedly confirmed by global health experts, public health officials, and healthcare workers on the ground

Dr. Ndekezi Deogratias demonstrates use of the EPS for Nurse Goretti Musabayimana at Gasiza

Health Center in Rwanda. After the demonstration, nurse Musabayimana asks,

“What’s the delay? We need this now!”

•  Uganda: Dr. Ian Clarke, CEO of International Medical Group is prepared to partner with Eniware to bring the EPS to his network of hospitals and health centers throughout Uganda

•  Kenya: The Kenyan Red Cross plans to equip their ambulances, servicing every county in Kenya, with an EPS. The Governor of Nakuru County has invited Eniware to set up a manufacturing plant with his support  

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IV. Testimonials

V. Why We Start in Sub-Saharan Africa

Accelerating & Diversified Economic Growth

!  Average GDP growth of 6% between 2013 and 2018 making it one of the fastest growing regions in the world1

!  The healthcare market is primed to reach $35 billion by 2016, and will continue to grow as the middle class expands2

Favorable Demographic Trends

!  Sub-Saharan Africa has a population of over 800 million, 40% of whom are under the age of 153

!  Only 30% of this population has access to electricity4

Improved Macroeconomic & Political Stability

!  Average number of serious conflicts in Africa declined significantly from 4.8 per year in 1990s to 2.6 per year in 2000s5

!  Macroeconomic stability improved - inflation fell 64% and fiscal imbalances improved 55% over the last decade1

1.  World Economic Outlook Database 2013 2.  Business, Pharma & Healthcare, Ventures Africa 3.  UN World Population Prospects: The 2012 Revision 4.  African Development Bank Group 5.  “Lions on the Move,” McKinsey Global Institute, 2010

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V. Why We Start in Sub-Saharan Africa

VI. The Business Model and Strategy

!  The Eniware business is built on the traditional “razor/razor blade” model based on one-time purchase of an EPS unit, and recurring revenue from consumables for each sterilization cycle

!  The high number of health centers without electricity in Sub-Saharan Africa (and throughout the developing world) drives a rapid year on year revenue growth

The Business Model Razor/Razor Blade •  Eniware Portable Sterilizer ~$500 •  Consumables ~$5

•  Gas cartridge/ampoule •  Scrubber •  Chemical indicator

Each EPS generates $1500-4500 revenue/year •  Gross margin of 52% after accounting for direct cost of

sales

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VI. The Business Model and Strategy

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Eniware Uniquely Meets the Needs for Portable, Power-independent Sterilization in Four Markets

1.  The developing world !  Drivers

"  Exploding population in the developing world "  Increased public and private health care spending "  8% GDP spending gap on health between Africa and OECD Countries

!  Customer Value Proposition "  Low-cost solution for Essential Surgery

!  Size Estimate: "  $ Over $900 million/year

2.  Disaster relief, refugee camps !  Drivers

"  Increased number of natural and man-made disasters "  Need for immediate surgical triage, intervention "  Total absence of electricity

!  Customer Value Proposition "  Power independent sterilization permits immediate intervention and saves lives

!  Size Estimate: "  $ Up to $50 million/year

VI. The Business Model and Strategy The Markets

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VI. The Business Model and Strategy The Markets

Eniware Uniquely Meets the Needs for Portable, Power-independent Sterilization in Four Markets

3.  Militaries !  Drivers

"  Need for mobility "  Need for immediate triage, intervention "  Absence of power "  Changing nature of conflicts

!  Customer Value Proposition "  Power independent sterilization permits immediate intervention and saves lives

!  Size Estimate: "  $ Large, undocumented to date

4.  Veterinary !  Drivers

"  Large number of mobile veterinary applications "  Small animal practices need less expensive sterilization solutions

!  Customer Value Proposition "  Supports mobile service delivery "  Provides inexpensive sterilization capacity

!  Size Estimate: "  TAM in excess of $50 million

VI. The Business Model and Strategy The Markets

VI. The Business Model and Strategy Eniware Value Creation – Revolutionizing Healthcare Delivery

!  Eniware will use existing traction in East Africa to establish local distribution channels through local partners and international NGOs (MSF, ICRC etc.)

!  Eniware will provide access to its network of partners committed to enabling safe essential surgery in low-resource environments

•  Creates opportunities for training of health workers in sterile procedure and technique

•  Provides ways to remove other barriers to safe surgery without electricity

!  After establishment in East Africa, that experience will be channeled into expansion efforts throughout Africa and ultimately into South-East Asia •  Eniware’s expertise in expanding safe surgical care will be exercised throughout the

developing world 16  

VII. Eniware Benefits from Strong Market Drivers

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!  Strong global demand for essential surgery technologies that do not require electricity •  Essential surgery is a cost-effective means of improving the health of populations •  Essential surgery capacity within the health system is economically imperative for emerging

economies – “surgery is an integral, indivisible component of any properly functioning health system”1

•  Electrification of Sub-Saharan Africa cannot keep pace with exploding population growth !  Growing incentives and capability for healthcare spending

•  As the middle classes of Sub-Saharan African countries expand, an increasing percentage of GDP will be spent on healthcare (There is approx. 8% of GDP spending gap compared to OECD)

•  In recognition of the fact that improved population health contributes to increased GDP, governments are moving towards universal healthcare coverage

!  Razor/razor-blade business model •  Revenue from EPS units and recurring revenue stream from sale of consumables drives high cash

flow and enterprise value !  Huge global markets

•  Potential for expansion into all of Africa, Latin America, Asia (except for Japan), global militaries, global disaster relief, and the global veterinary markets

•  Total addressable market: >$500 Million

1. Lancet, Surgery and Global Health, December 2013

VII. Eniware Benefits From Strong Market Drivers

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VIII. Commercial Viability

! Ministry of Health, Tanzania is committed to working with Eniware to bring the product to hospitals and health centers throughout the country

!  Eniware’s partnership with International Medical Group, Uganda (IMG) has formed a new Ugandan company, The Essential Surgery Company LTD with Eniware as a 49% shareholder headed by Ian Clarke, MD, CEO of IMG, and a well-known figure in Ugandan politics. This company will market and oversee distribution of the EPS in East Africa.

!  Formal partnership with JHPIEGO – Johns Hopkins global health affiliate with operations throughout Africa – for user training and product evaluation

!  Feb. 2014: President Yowari Museveni of Uganda ordered 1,000 EPS units for Uganda’s Ministry of Health, and 1,000 EPS units for Uganda People’s Defense Force.

Appendix A: Company History and Overview The Noxilizer – Eniware Evolution

2004 Noxilizer founded by Dr.

James Bernstein

Initial funding and research -

$17 million invested in Noxilizer

2008-2013 Noxilizer issued patents for NO2

2012 Noxilizer RTS

360 commercialized in US market

2011 Dr. Bernstein and Huma Malik found Eniware and obtain license for NO2 in

low-resource settings

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2013-2014 Eniware Portable Sterilizer developed and tested for

target markets Noxilizer acquires assets of

SAIAN, Japan

! Co-founded in 2011 by James Bernstein and Huma Malik

! Headquartered in Washington D.C.

! Current investors: Noxilizer, Inc., individuals, family offices

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Appendix B: Product Development Implementation !  The organizational ground-work for development of the EPS has been laid, and the first

phase of the 4-phase implementation plan is nearly complete

!  By the end of phase III the EPS will be validated and ready for manufacture ramp-up and product launch

Abridged Implementation Plan Phase I – nearly completed

•  Product concept & market research; financial analysis; technical & customer requirements •  Patent search; adverse event research; creation of risk management file

Phase II – 6 months •  Product design; product verification; customer feedback; finalize regulatory approval •  Vendor review

Phase III – 3 months •  Preliminary production run; establish sales channel partners/supplier value chains; train staff •  Product validation; customer feedback; design traceability matrix •  IP protection; regulatory approval; final design review; transfer to production

Phase IV – continual activities •  Production ramp-up; market intro/launch; quality review

Appendix C: Eniware Executive Management

!  Dr. James Bernstein has more than 35 years experience as a healthcare entrepreneur in the U.S. and abroad. Co-Founder and CEO

•  Trained in general and transplant surgery; former assistant to the President of the Jonas Salk Institute •  Health policy expert – served in leadership positions at NIH, Georgetown University Health Policy Center,

and President Carter’s health policy advisory group for the election campaign •  Founded and led successful health companies – General Health Inc., InforMax, Age Wave, Noxilizer •  Recognized expert on entrepreneurship – Kaufman Foundation Fast-Trac advisor, lecturer at Tuck,

University of Maryland, and Georgetown business schools

!  Huma Malik has over 18 years experience in the non-profit sector extensive international experience. Co-Founder, COO, and Sr. VP International Programs

•  Founder of WDSI, a sustainable economic development organization active in Pakistan •  Co-editor of Modernization, Democratization and Islam (CSIS, 2005) •  Recipient of Award of Distinction for outstanding service from the School of Foreign Service, Georgetown

University •  MA in International Peace & Conflict Resolution from American University

!  Majdi Shomali has over 20 years experience in new product development. VP Product Dev. •  Has worked in the medical device and gas detection industries •  Developer of award-winning technical products •  Holds an MBA and Electrical Engineering Degree

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Appendix D: Key Collaborators

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!  Noxilizer (www.noxilizer.com) •  Provides sterilization knowledge, design advice, microbiological testing, regulatory support

!  JHPIEGO (www.jhpiego.org) •  Global health affiliate of Johns Hopkins •  Collaborates on product design specs and pilot testing of form factors •  Potential customer for Voluntary Male Circumcision Programs

!  Population Services International (psi.org)

•  Collaborator for local distribution, market feedback

!  International Medical Group, Uganda (img.co.ug) •  Agreed partner in Uganda •  The Essential Surgery Company shareholder

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Appendix E: Technical Data

! Nitrogen Dioxide is a common, well studied gas which effectively destroys bacteria, viruses, and spores so that they cannot replicate

!  Small molecule – good at diffusing into complex devices

!  Safe – dramatically less explosive, less carcinogenic than similar sterilant gases such as hydrogen peroxide and ethylene oxide

! Compatible (does not damage) with most medical equipment

!  Low boiling point and low concentrations required for effective sterilization mean no residual toxicity and no condensation on sensitive devices

NITROGEN DIOXIDE (NO2) Molecular weight: 46 g/mol Boiling point: 21 °C (70 °F) Gas density: 3.4 kg/m3 UN Number: UN1067 Description: Yellowish-brown liquid or reddish-brown gas with a pungent, acrid odor. Challenge organism: Geobacillus stearothermophilus

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Appendix F: Licensed Patents

Additional patents issued in 2012 and 2013: Canada – NO2 as a sterilant issued 9/11/12 U.S. – Sterilization device issued 3/13/12 EU -- Sterilization device issued 9/12/12 Hong Kong -- Sterilization device issued 1/18/13

TITLE INVENTORS US PATENTS OR APPLICATION NO./DATE

Sterilization system and device

Arnold; Doletski; Dunn; Raulli; Mueller; Benedek; Murville

U.S. Patent No.: 8,017, 074, issued 9/13/11. Foreign: PCT/US01/15093, filed 6/29/07

Sterilization system and device

Arnold; Doletski; Dunn; Raulli; Mueller; Benedek; Murville

U.S. Patent Appln. No.: 13/194,351, filed 7/29/11

Eniware has an exclusive global license for power independent uses

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You should direct all inquiries relating to the Company to: James Bernstein, M.D., CEO Eniware, LLC 2300 N Street NW, 5th Floor Washington, D.C., 20037 Tel: 202.288.4816 [email protected] www.EniwareSterile.com  The information contained herein is confidential and may not be reproduced in whole or in part without the express written consent of Eniware, LLC. The Company is represented by the law firm Pillsbury Winthrop Shaw Pittman, LLP.