Paraguay Leading Early Feasibility Study Trials in Latin America
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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PAVmed Announces Successful First-in-Human Implantations of its PortIO™ Intraosseous Infusion System
Julio G. Martinez-Clark Julio G. Martinez-Clark

PAVmed Announces Successful First-in-Human Implantations of its PortIO™ Intraosseous Infusion System

PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a diversified commercial-stage medical technology company, today announced that physicians at the Clinica Porto Azul in Barranquilla, Colombia successfully implanted the Company’s PortIO™ Intraosseous Infusion System in three patients—the first human implants of the device—as part of its IRB-approved first-in-human (FIH) clinical study of up to 40 patients. All patients have also undergone successful infusion of fluids consistent with the study protocol and the device’s intended use. No complications have occurred.

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Hancock Jaffe Principal Investigator Dr. Jorge Hernando Ulloa Presents VenoValve One Year First-In-Human Data at Charing Cross International Symposium
Julio G. Martinez-Clark Julio G. Martinez-Clark

Hancock Jaffe Principal Investigator Dr. Jorge Hernando Ulloa Presents VenoValve One Year First-In-Human Data at Charing Cross International Symposium

IRVINE, CA / April 23, 2021 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that Dr. Jorge Hernando Ulloa, the Principal Investigator for HJLI’s first-in-human VenoValve® study in Bogota, Colombia, presented one year data this past week at the Charing Cross International Symposium. The Charing Cross International Symposium is the longest-running vascular and endovascular global symposium in Europe and is attended by the world’s leading experts in vascular and endovascular medicine.

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ReGelTec Successfully Treats First Eleven Chronic Low Back Pain Patients with HYDRAFIL™ in Colombia
Julio G. Martinez-Clark Julio G. Martinez-Clark

ReGelTec Successfully Treats First Eleven Chronic Low Back Pain Patients with HYDRAFIL™ in Colombia

ReGelTec, Inc., a medical device company developing a percutaneous treatment for chronic low back pain, announced today that eleven patients with degenerative disc disease have been enrolled in the Company’s Early Feasibility Study in Barranquilla, Colombia. The procedures were proctored remotely via Zoom, and all eleven patients were successfully treated with HYDRAFIL™. This patented hydrogel is melted before injection into the nucleus of a degenerated disc via a 17-gauge needle.

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Breakthrough Gene Therapy Clinical Trial is the World's First That Aims to Reverse 20 Years of Aging in Humans
Julio G. Martinez-Clark Julio G. Martinez-Clark

Breakthrough Gene Therapy Clinical Trial is the World's First That Aims to Reverse 20 Years of Aging in Humans

MANHATTAN, Kan., Nov. 21, 2019 /PRNewswire/ -- Libella Gene Therapeutics, LLC ("Libella") announces an institutional review board (IRB)-approved pay-to-play clinical trial in Colombia (South America) using gene therapy that aims to treat and ultimately cure aging. This could lead to Libella offering the world's only treatment to cure and reverse aging by 20 years.

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