Easy Clinical Trials for

&BIOTECHMEDTECH

startups

1. Introduction

3. Clients 4. Regulatory

2. Colombia

We are a contract research organization (CRO) for medtech & biotech startups looking to conduct their clinical trials in Colombia. We provide operational support services to ensure a successful trial at a site in Colombia.

1. Introduction

We help innovative medtech & biotech startups operationalize their clinical trials in Colombia“

“What we doWho we areStudy and protocol design

Site selection

Regulatory submission

Logistics (import, storage, distribution, disposal, export)Trial set-up

Study project managementStudy monitoring

Safety monitoring

Patient recruitment

1.

We recognized that development stage startups struggle to find highly talented medical staff that will give them the focus and energy to complete, on a timely manner, quality and ethical clinical research at a very competitive cost.

We recognized that the country of Colombia, with a population of almost 50 million, has over 120 ICH /GCP-government-certified clinical research sites. These sites have been conducting trials for almost 30 years, have very little international exposure and are unknown to the medtech & biotech industry around the world. These are highly qualified sites that receive about 100 annual trials sponsored mainly by the local

1. Introduction

Our history

Why we do it

Interventional Concepts, Inc. was founded in 2010 by Pedro Martinez-Clark, M.D., an interventional cardiologist trained at Harvard University's Beth Israel Deaconess Medical Center, who later became Assistant Professor at the Miller School of Medicine at the University of Miami, where he worked side-by-side with the internationally renowned Dr. William O'Neill, who is part of our advisory board. Interventional Concepts, Inc.

OUR PURPOSEAND BEGINNING

Dr. Martinez-Clark was part of the University of Miami's International Medicine Institute where he acquired extensive experience in international clinical trials. Dr. Martinez-Clark currently serves as Chief Medical Officer for Interventional Concepts, Inc.

More information about Dr. Martinez-Clark: http://interventionalconcepts.net/pedro-martinez-clark

2.

Colombian subsidiaries of multinational pharmaceutical companies.

These sites are staffed by experienced and highly trained personnel and can be made available to your startup.

We bring value to the sponsor and to the site

1. Introduction

OUR VALUEPROPOSITION

Our value proposition for medtech & biotech clinical trial sponsors is built on the fact that most Colombian clinical research sites are not ready to deal directly with foreign sponsors. Clinical trials have been conducted in Colombia for about 30 years, and Colombia is one of the top trial destinations in Latin America —along with Mexico, Argentina, Brazil and Chile. However, sites in Colombia, for the most part, do not deal directly with foreign sponsors, much less with sponsors seeking to conduct early-stage medtech & biotech trials.

Sites in Colombia struggle to provide their clinical research services directly to a foreign sponsor since they are not seasoned enough in international business transactions and the English proficiency of their staff is not sufficient to satisfactorily match the sponsor's expectations.

Our value proposition for medtech & biotech sponsors is to become their agents to operationalize their trials in Colombia. The typical sponsor that we attract is a small development stage medtech & biotech startup typically backed with venture capital funds; these companies seek to conduct fast, cost effective and ethical clinical trials for their innovation. These sponsors, by nature, are very dynamic and require speed in regulatory approval, project management, product importation, patient screening, recruitment, etc.

When we manage the relationship between our sponsors and our affiliated research sites in Colombia, we ensure that sponsors are isolated against the realities of conducting trials at a research site in a developing country

(i.e. lack of international business/legal experience, poor command of English, inexperience with regulatory and importation processes, cultural differences, etc.).

When sites in Colombia become members of our network, they value the fact that we bring to them word-class clinical trials with medical innovations that otherwise they would have never received.

3.

Site identification, selection and budget preparation

Logistics management (importation, storage, distribution, disposal, export, reporting)Technovigilance and pharmacovigilancePatient recruitment campaignAdjudication of adverse eventsStudy monitoring

Trial set-up (pre-trial visit, clinical trial agreement, regulatory approval, site initiation visit)Study project management (payments to site, weekly follow-up meetings, budget and contract amendments, single point of contact, etc.)

Our services to a sponsor:

4.

High enrollment rate, competitive costs, highly motivated and bilingual investigators, and a fast and predictable national regulatory pathway —about 30 days for medical devices and 90 days for pharma.

2. Colombia

Why Colombia

CONDUCT YOUR CLINICAL TRIAL IN COLOMBIA one of the world's fastest growing emerging economies.

Colombia is a Latin-American leader in volume of clinical research and receives about 100 annual trials.

Great healthcare infrastructure and business environment. According to the annual ranking of América Economía magazine, Colombia has the best hospitals in Latin America and has the largest share (+40%) of the best hospitals in the region.

A 50-million population with universal health care coverage ensures a large patient pool of all ages.

Great geographical location: EST time zone, fast and direct airline connectivity from any major city.

Over 120 ICH/GCP-government-certified research sites with almost 30 years of experience and with the same quality and ethical standards that you would find in the U.S. and Europe.

Fast product importation (free trade agreement with the U.S. and the E.U.).

5.

"The combination of good healthcare (95% of Colombian citizens have health insurance), an already strong clinical trial industry, stringent regulations issued in 2008 that requires sites to be certified by INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) and a relatively quick and predictable approval process for launching a trial has made it a desirable clinical trial destination."

Ronald Rosenberg, CenterWatch Weekly, April 6, 2015

2. Colombia

6.

Mass Challenge Winner 2013. With a 5mm healthy skin

sample, it covers skin tissue loss of an area four times the size of a business card, 2014

Pacemaker, 1963Dr. Jorge Reynolds Pombo

Malaria Vaccine, 1986Dr. Manuel Patarroyo

First fully implantable,battery-powered artificial heart - the AbioCor, 1981David Lederman, Founder

of Abiomed, Inc.

COLOMBIA INNOVATIONS

Ultrachopper: invented and developed by Dr. Luis Escaf in Colombia and sold to Alcon in 2008.

WHO TRUSTSUS

3. Clients

Clients such as the University of Miami (DirectFlow Medical, NeuroTronik), Mitralign, InterValve, Avinger, CeloNova BioSciences, Syntheon Medical, MitraSpan, Kona Medical, among others, have trusted us with their clinical trials in Colombia.

7.

“I can only say good things about our

experience in Colombia” -Dr. John B. Simpson. CEO,

Avinger, Inc.

REGULATORY PROCESS

4. Schemes

PROTOCOL APPROVAL PROCESS

Studyprotocol

Applicationpackage

Local EC meetsevery 30 days

Approves

Approves Import permit

Studybegins

Request for aditionaldocuments

Sponsorallowed toship medicaldevices toColombia

MultipleDocuments

RegulatoryAgency - meetsevery 30 days

Patientrecruitmentbegins

Request for additional documents

Multiple Documents

4. Regulatory Process

Approx. 30 days for medical devices and 90

days for pharma

9.

4. Regulatory Process

Activity Days (approx.) Fee (USD, approx) Required Documents

3Import Permit

(Ministry of Industry and Commerce/VUCE office)

10 $0 Pro-forma invoiceINVIMA approval

4

1

2

Transportation from origin to Colombia 5

Based on size and weight

Commercial invoice

4.1

Nationalization of medical products(ordinary importation)

(Customs Broker and Colombian Customs Agency [DIAN])

4

~0% -30% of CIF value

(Cost, insurance,

and freight) depending on the type of medical

product.

Commercial invoiceProduct brochure

4.2

Nationalization of supporting medical equipment (temporary

importation)(Customs Broker and Colombian

Customs Agency [DIAN])

4

~16% of CIF value (Cost, insurance,

and freight) depending on the type of medical product.

Commercial invoice

Insurance policy

10.

Local EC 30

30 (medtech)90 (biotech)INVIMA Approval

$1,500

$850 (medtech)$1,700 (biotech

ProtocolInformed consentInvestigator's manualInsurance policy

MedtechBiotech

4. Regulatory Process

Notes:

Customs broker fees, document preparation fees, and Interventional Concepts, Inc. CRO professional fees (billable at an hourly rate) are not included in the above prices.

Sponsors will ship devices to our INVIMA-approved storage facility in Bogota, D.C., Colombia - not directly to the research site.

Unless it is absolutely necessary due to an emergency procedure or missing devices critical for a procedure, we do not recommend shipping anything by courier nor bringing devices as part of a traveller's personal luggage.

INVIMA keeps strict control of the importation (and returns if applicable) of devices that are approved for importation and may visit the site unannounced to check on the proper proof and paper trail of importation.

Contacts for all shipping, importation and logistics related questions:

Monica Mora, Vice President of Clinical Operations: mmora@interventionalconcepts.net

11.

Interventional Concepts, Inc. | 2520 Coral Way - Suite 2120 - Miami, FL 33145-3438 USA | www.interventionalconcepts.net

Easy Clinical Trials for

&BIOTECHMEDTECH

startups