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How Medtech Companies are Unlocking the Potential of Latin America in Clinical Research
Julio G. Martinez-Clark Julio G. Martinez-Clark

How Medtech Companies are Unlocking the Potential of Latin America in Clinical Research

Medtech startups' challenges in the medical device industry in the US are multifaceted, ranging from regulatory hurdles to limited financial resources and prolonged subject recruitment timelines. US Medtech companies face professionalism, language barriers, fragmentation of resources, and lack of CRO corporate structures in Latin America. This impedes Latin American hospitals from having seamless communication and collaboration with American clinical trial clients, particularly in the medical device first-in-human clinical trial industry. These factors underscore the urgent need for a solution-driven approach to bridge the gap between innovation and execution in Latin America.

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3ive Labs Obtains Colombia Approval for its BIPASS-AKI 2 Study
Julio G. Martinez-Clark Julio G. Martinez-Clark

3ive Labs Obtains Colombia Approval for its BIPASS-AKI 2 Study

On November 15, 2023, INVIMA, Colombia's regulatory agency, approved the BIPASS-AKI-2 early feasibility study by 3ive Labs, LLC (aka “Roivios™), with its JuxtaFlow ® (RAD) renal assist device at two research centers, one in Barranquilla, and the other one in Bucaramanga. This early feasibility study aims to recruit up to 40 subjects in Colombia and will last approximately 30 months.

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Imperative Care Obtains Colombia Approval for its ADVANCE First-In-Human study
Julio G. Martinez-Clark Julio G. Martinez-Clark

Imperative Care Obtains Colombia Approval for its ADVANCE First-In-Human study

On September 28, 2023, INVIMA, the regulatory agency of Colombia, approved Imperative Care, Inc.'s ADVANCE first-in-human study, which will be conducted at one research center in Cartagena. The ADVANCE study aims to recruit up to 15 subjects from Colombia and will last for approximately five years.

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