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The Answer is Colombia for Medical Device Clinical Trials

Julio G. Martinez-Clark, President & CEO | December 14, 2016 | www.colombiaclinicaltrials.com

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Interventional Concepts (IC) is a Miami, FL-based clinical consulting firm helping innovative startup medical device companies successfully reach their clinical development goals. IC partners its clients with clinical research sites in Colombia for faster regulatory approval, significant cost savings and easier patient recruitment.

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Revenue modelThanks to IC's business development methods, US and European medical device startup clients will likely choose a CRO with operations in Colombia as their choice for site identification, study start-up, contract and budget management, project management, clinical monitoring, regulatory, logistics, etc.

Medical device startup learns about Colombia

CRO

Research site in Colombia

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About 40 current opportunities that IC is working for Colombia

● TransCaval Solutions: https://goo.gl/Z0Euq1● CellectGen: https://goo.gl/kiKRSC● PainQx: http://www.painqx.com/● Sunshine Nutritionals: http://www.sunshineislife.com/● Clinical Financial Group (on behalf of a sponsor for three trials):

http://www.clinicalfinancialgroup.com/● Micron Biomedical: http://micronbiomedical.com/● Soffio Medical: http://www.soffiomedical.com/● Panexcell (on behalf of client/sponsor): http://panexcell.com/● TransVerse Medical: http://transversemedical.com/● PhysioCue: http://physiocue.com/● CorMedix: http://www.cormedix.com/● RxGenesys: http://www.rxgenesysgroup.com/● Voyager Biomedical: http://voyagerbiomedical.yolasite.com/● Z Lens: http://www.zlensllc.com/● Spinal Singularity: http://www.spinalsingularity.com/● Innomed: http://innomed.com.cn/

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● Pepper Medical: http://www.peppermedical.com/● SunshineCare Partners: http://www.sunshinecarepartners.com/● Bridge Innovations: http://www.bridgeinnovations.com/● Urotech Surgical: http://www.urotechsurgical.com/● Greenlight Medicines: http://www.greenlightmedicines.com/● GruppoFarmaImpresa (three trials):

http://www.farmaimpresa.com/it/● N8 Medical: http://www.n8medical.com/● Micell Technologies: http://www.micell.com/● CHD Bioscience: https://chdbioscience.com/● PeptiGelDesign: http://www.peptigeldesign.com/● Above and Beyond: http://www.aboveandbeyondresearch.com/● Apellis Pharmaceuticals: http://www.apellis.com/● C-Level/CryoMedic: http://www.c-levelclone.com/Cad.html● Future Life: http://www.futurelife.us/● Ideal Medical: http://idealmedtech.com/● Etc.

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Current IC projects

● Floelle: https://goo.gl/rGaU1O (trial in Colombia)● ClarVista Medical: http://www.clarvistamedical.com/ (trial in Colombia)● Immunotrex Biologics: http://immunotrex.com/ (trial in Colombia)● Keraderm: http://www.keraderm.com.co/ (trial in Colombia)● Synexis: https://synexis.com/ (trial in US)

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The problem for startups "There are more than 6,500 medical device companies in the United States, mostly small and

medium-sized enterprises (SMEs). More than 80 percent of medical

device companies have fewer than 50 employees." —US Department of

Commerce

¹Medical Device Innovation Consortium 6

1. Development stage medical device startup companies struggle to find highly talented medical staff that will give them the focus and energy to complete —in a timely manner— quality and ethical clinical research at a very competitive cost.

2. The regulatory process to conduct a medical device early feasibility study in the US is very lengthy due to current FDA regulations.¹

3. The cost of conducting an early-stage clinical trial in the US is high.¹

This forces startups to look outside of the US (OUS) to conduct their foreign clinical trials (FCT) and to look for a country where they can find competent clinical research sites. Medical device startups have no well-defined, professional and structured processes to identify OUS sites; startups mostly rely on word-of-mouth to identify investigators and sites. The existing few medical device CRO's mostly ignore medical device startup companies (1-50 employees) and focus on the mature medical device companies (50+ employees), but with outdated (and not so efficient anymore) business development methods.

ConfidentialContent is the currency of modern marketers, including in B2B when it is ideally tailored to the different members of the buying team and stages of the buying cycle. Content

can take many forms including blog posts, webinars, infographics, marketing apps, and videos as well as

traditional forms such as events. And the quality of content is key. So high quality, creative content is critical.

—Harvard Business Review, Nov. 2014

The problem for CROs

¹Read more here and here. 7

1. Too many competing CROs with no differentiated value: Too many "me too" CROs marketing themselves as just another CRO.

2. Most CROs still use outdated, expensive (and not so effective anymore) business development methods (e.g., booths at industry events, magazine ads, etc.). They have not adopted modern (and very efficient) B2B social selling and digital marketing strategies.

3. Underutilized in-country resources: Not enough trials! ○ Colombia's INVIMA approved 32 trials in 2016 for 120 INVIMA-certified research

sites: 0.3 trials per site!

For a B2B company to thrive, it needs to make its online presence truly felt. In the past, events, conferences, magazines, and advertising could get companies in front of prospective buyers. While these tactics are still important, it is vital that they are supported by a digital business development strategy that includes digital marketing and social selling.¹

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The opportunityGlobal medical devices CRO market will grow 131.25% by

2018 ($7.4 billion)⁷

¹Association of Clinical Research Organizations (ACRO). ²Zion Research. ³MD+DI, GlobalData. ⁴Interventional Concepts data extracted from Colombia's INVIMA.⁵Health tourism sector: The Colombian case. ⁶America Economía Magazine, annual ranking. ⁷CRO medical device trial services include first-in-man, pilot/feasibility, pivotal and post-market studies. ⁸Ministry of Commerce, Industry and Tourism (MinCIT), letter from local clinical research industry associations to MinCIT. ⁹US Department of Commerce. ¹⁰MarketsandMarkets.

● Medical device companies are increasingly turning to CROs to outsource their trials³. There are over 6,500 medical device companies in the US.⁹

● The CRO services market has witnessed healthy growth during the last decade, and is expected to grow at a CAGR of 7.4% between 2016 and 2021 to reach USD 41.86 Billion by 2021.¹⁰

● The global medical devices CRO market is expected to grow at a compound annual growth rate (CAGR) of 12.5% over the period 2011-2018, with revenue growing from $3.2 billion in 2011 to $7.4 billion by 2018.³

● Fast regulatory approval: Colombia has one of the world's fastest national regulatory processes —30 days for medical devices.⁴

● Cost savings: Health services in Colombia cost 30%-40% less than in the US.⁵● Access to patients: Colombia has a population of almost 50 million with

universal healthcare access. ● Trial infrastructure: Colombia has 110 ICH/GCP government-certified clinical

research sites (with about 30 years of experience) and about 50% of the best hospitals and clinics in Latin America.⁶

● Strategic location: Same EST time zone and direct flights from any major US city.

● Initiative from Colombia's Ministry of Commerce, Industry and Tourism (MinCIT) to export sophisticated and added-value services, and from the local industry associations to make the country increasingly competitive for clinical trials.⁸

The projected 2020 market for outsourced clinical research is $40 billion. In 2015, CRO industry revenue was estimated at $25.6 billion; that amount is expected to reach $27.8 billion in 2016¹ and $59.42 billion by 2020 with 9.80% compound annual growth rate (CAGR)². The revenue estimates represent approximately one-third of drug development spending.¹ Approximately two-thirds of CRO business is funded by the pharmaceutical industry, 27 percent from biotech, and the rest by the medical device, foundation and government sectors.¹ 8

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9Source: 5 Tips For Successfully Outsourcing A Medical Device Clinical Trial, Med Device Online

"Ëveryone is demanding more clinical evidence from medical device and diagnostics companies these days. Regulators want to see more of it before granting market approval. Payers are requiring more of it to substantiate product value claims and approve reimbursement. Healthcare systems and physicians are asking for more of it when making purchasing decisions. Even patients are starting to request it.

"This pressure is forcing manufacturers to amass more clinical data on their products than ever before, and they are primarily responding by running more (and/or larger) clinical trials. This trend is manifesting itself even in situations when clinical evidence isn’t mandated, for instance when submitting certain 510(k) applications. Device makers increasingly are turning to clinical trials to differentiate their products from competitors and improve their odds of adoption in the marketplace.

"However, most device makers lack the internal resources and expertise to run a complete clinical trial operation in-house. This is especially true for small companies, which have little bandwidth, experience, and margin for error — for them, clinical success or failure can mean life or death for the company.

"As a result, we are witnessing a corresponding rise in the outsourcing of clinical services to contract research organizations (CROs). Medical device makers are turning to CROs for assistance with clinical operations management, investigator recruitment, clinical monitoring, data management, biostatistical analysis, health economic and outcomes strategy, quality assurance, regulatory approval, and other needs."

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The solution

Interventional Concepts (IC) —founded and clinically led by a Colombian-born, Harvard-trained physician and medical device entrepreneur— is the only company promoting Colombia's clinical research capabilities and attracting medical device startups to Colombia to conduct their clinical trials. IC combines network intelligence and social selling (using an effective proprietary website and social media-based lead generation method¹²³) to identify C-level executives from medical device startups that may be looking to conduct an OUS clinical trial.

IC uses social selling to connect online to go offline and uses AI-based leading-edge technology to increase the quality of relationships with potential clients. IC matches the planned trial with the ideal site in Colombia and facilitates the regulatory and logistics process of conducting the trial at the right site. Medical device startups now can quickly get their trials started by accessing Colombia's world-class clinical trial infrastructure at significant cost and time savings, and with easier patient recruitment.

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¹Julio G. Martinez-Clark (President & CEO) Social Selling Index (SSI) ranks in the top 1% of the medical device industry ²According to Salesforce website and social media are two of the best lead generation sources³22% of B2B Salespeople will be Replaced by Search Engines by 2020

LinkedIn research states that 78% of social sellers outsell in comparison to colleagues who don’t use social media.

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The State of Sales in 2016

According to LinkedIn's State of Sales in 2016 90% of top salespeople use social selling tools.

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Technology is essential in today’s competitive sales landscape. LinkedIn’s State of Sales in 2016 survey investigates the link between top performers and a variety of sales technologies and strategies—including, most notably, social selling tools.

According to the study, “90% of top salespeople use social selling tools,” and social selling tools and CRM were rated as the “most likely to deliver value.” Other sales intelligence software includes email tracking tools, productivity apps, and other intelligent software. Still, social selling adoption that “build relationships with prospects and customers by leveraging professional social networks” dominated the survey.

The numbers are in: the future of intelligent sales is decidedly social.

Artificial Intelligence-based social selling systems multiply the human capacity for professional relationships so B2B companies & professionals can connect deeper and sell faster. Read more.

ConfidentialJulio G. Martinez-Clark LinkedIn Social Selling Index

12Julio's LinkedIn profile: https://www.linkedin.com/in/juliomartinezclark●

ConfidentialJulio G. Martinez-Clark LinkedIn Social Selling Index (cont.)

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Appendix

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Why social selling?

"With social selling, salespeople use social media platforms to research, prospect, and network by sharing educational content

and answering questions. As a result, they’re able to build relationships until prospects are ready to buy."

—Harvard Business Review, Nov. 2016

Harvard Business Review reports 90% of decision makers never respond to cold outreach & CEB states 75% of buyers now use social media to be more informed on vendors. Gartner reports at least 61% of buyers are doing self-driven information research during the exploring phase of the buying process. Today's modern buyer has changed the game on us!

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16Over 25,000 advertising channels

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The team

Pedro Martinez-Clark, MD

Founder & Chief Medical Officer. Harvard-trained interventional

cardiologist. Founder and consultant for medical device startups. Extensive

experience in the development of innovative medical technologies.

Julio G. Martinez-Clark, MBA

Osvaldo R. Martinez-Clark

President & CEO. Extensive international business experience and

creator of new ventures. Past experience includes Alcatel-Lucent, Nortel and a real estate investment venture that he co-founded. BSc in

Electrical Engineering.

Business Development. 10+ years of business development experience

including medical innovation and the medical device startup industry. B.A.

degrees in International Relations and Political Science.

Jorge Franceschi, MSH, RDN, CCRC

Project Management. 15+ years of experience conducting clinical trials

for pharmaceuticals, devices, vaccines, and biotechnology. Roles

included operations, business development, finances, and market

intelligence.

17The advisory committee includes Dr. William O'Neill —one of the world's leading interventional cardiologists and innovators. Other team members include Monica C. Mora, VP of operations and responsible for client proposals, operational and administrative matters.

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Milestones

August 2010Founded by Pedro Martinez-Clark, M.D. Company focuses on consulting and medical device sales in Colombia

Julio Martinez-ClarkJoins as President & CEO. Company focuses on medical devices clinical trials in Colombia

Keraderm, ForSight VISION5, Mount SinaiTrials in Colombia

Strategic Alliance with ACRESStrategic alliance and co-development agreement to create ACRES-Colombia

Interventional Concepts and PROCOLOMBIA

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

First Sponsor (Mitralign)Roxwood, InterValve follow.

CeloNova, Kona,

MitraspanTrials in Colombia

AvingerTrial in Colombia

Government of ColombiaInterventional Concepts executes a licensing agreement for the use of the official Colombia (CO) country brand.

CenterWatch, Stanford BiodesignFront-page article about Interventional Concepts' work in Colombia and mention on Biodesign website

Bogota Site NetworkInterventional Concepts and the Government of Bogota will create the first site network in Latin America

Colombia Site Database

INVIMAInterventional Concepts moves INVIMA to issue clear rules for medical device trials

Creation of a national technology platform to expedite trial start-up

Joint promotional activities to internationally promote the country's clinical trial capabilities

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Draft Bill to Colombian CongressProposed new clinical research law

+40 leadsCurrently matching +40 trial opportunities with sites in Colombia

LAMS trial at UMH

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Why Interventional Concepts?Access to C-level decision makers as clientsLarge network of C-level industry contacts. +30 current clinical trial opportunities representing ~$5 million. Dr. Pedro Martinez-Clark —founder— has been involved in the medical device innovation startup community for over 10 years and has an extensive network of industry contacts

Licensing agreement with the Government of Colombia for the promotional use of the official CO country brand

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Strong name, good reputation, and brand awareness

CRITICAL MASS

Proprietary social selling business development methodEfficient research, website and social selling method to generate C-level industry leads and opportunities

Note: Proprietary business development method is easily scalable beyond medical devices to biotech, small pharma, and fast growing digital health IT (i.e. wearables, population health management platforms), among other segments.

...and no client concentration issues: over 6,500 medical device companies in the US potentially in need of CRO clinical trial services.¹ ¹US Department of Commerce

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Why now?Just as pharmaceutical outsourcing came in a wave nearly 20 years ago, the trend now is catching on among medical device firms.¹ Over the last five years, medical device companies have shifted their initial clinical trials to Europe due, in part, to easier access to CROs with device expertise and faster approval times, before seeking FDA approval.¹ Now, device companies are seeking the expertise of large CROs on both sides of the Atlantic to address their unique needs.¹ The medical device industry is maturing and will be looking for CRO partners to help them deal with regulators, payers and clients.¹Large CRO's such as Icon have launched medical device groups to catch the next wave of outsourcing.¹

Pedro Martinez-Clark, M.D. is the only high-achieving Ivy League Colombian in the global medical device innovation industry. The Colombian government identified innovation as one of the five drivers of future economic growth and social development;² it has also made it a goal to export 30% more services by 2018.³ Colombia is now considered a world-leader in entrepreneurship and innovation.⁴ Interventional Concepts is the only Colombia-focused CRO bringing early-stage clinical trials with innovative medical devices to Colombia.

20¹Neal McCarthy, managing director of investment banking firm Fairmount Partners. ²Colombia Reports. ³Ministtry of Commerce, Industry and Tourism. ⁴World Economic Forum