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.
eyeFlow, Inc. Obtains Colombia Approval for its Pilot Clinical Study
On February 14, 2024, INVIMA, Colombia's regulatory agency, approved a pilot study by eyeFlow, Inc. at one research center in Barranquilla. This pilot clinical trial aims to recruit 60 subjects in Colombia and will last approximately 18 months.
i-Lumen Scientific, Inc. Obtains Colombia Approval for its i-Sight 2 Clinical Study
On January 17, 2024, Colombia's regulatory agency, INVIMA, approved i-Lumen Scientific, Inc.'s i-Sight 2 study at two research centers, one in Medellín and another in Cali. The i-Sight clinical trial seeks to recruit up to 75 subjects in Colombia and will last about 27 months.
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.
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.
Unveiling Inspirational Journeys: Exploring the Innovators in Medical Research and Clinical Trials
Embark on a captivating journey as Pedro Martinez-Clark's exceptional story unfolds, from his bicultural upbringing in Colombia to his groundbreaking research experiences at esteemed institutions like Harvard University and Mayo Clinic. Discover the driving forces behind his entrepreneurial spirit, which led to the establishment of our company, Amavita Heart and Vascular Health™ - a distinguished cardiovascular practice committed to delivering patient-centric care and pioneering treatments.
Cook Medical Treats First Patient in First-In-Human Clinical Trial for Venous Valve
Cook Medical announces the first patient treated in a clinical study to evaluate a new venous valve for treating chronic venous insufficiency. The patient was treated by Dr. Mauricio Alviar, vascular surgeon and principal investigator of Clinica de la Costa in Barranquilla, Colombia.
Greenlight Guru & bioaccess™ Collaborate for Faster LATAM Studies and Enhanced Patient Outcomes
Greenlight Guru and bioaccess™ share the same goal and mission: To enhance the quality of life by helping Medtech manufacturers get to market faster, with less risk. Greenlight Guru and bioaccess™ announce their cooperation agreement to bring medical device companies closer to Latin America and conduct early-stage clinical trials or sell their innovations.
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.
Spine Stabilization Technologies Taps bioaccess™ for PerQdisc™ Latin America Launch!
Spine Stabilization Technologies, LLC (SST), a Texas company developing a spine disc nucleus replacement technology designed to replace the physical space of the nucleus, has decided to engage bioaccess™ as its CRO in Colombia to expand its clinical research network of sites and augment the clinical data of its innovative and less invasive treatment: The PerQdisc™ Nucleus Replacement System.. bioaccess™ will help SST select at least two clinical research sites and obtain institutional review board (IRB)/ethics committee and regulatory approval at Colombia's regulatory agency (INVIMA).
Avantec Vascular Chooses bioaccess™ For A First-In-Human Clinical Study In Latin America
Avantec Vascular Corporation (https://www.avantecvascular.com/), a company in the San Francisco Bay Area dedicated to advancing vascular therapies through innovation, has chosen Latin America as the destination for the first-in-human study of an innovative vascular device. bioaccess™ will help Avantec Vascular with the selection of a principal investigator, the submission of its regulatory dossier for the ministry of health approvals, and other activities related to carrying out the study.
Welwaze, bioaccess™ Collaborate for Celbrea® Launch in Colombia
Welwaze Medical Inc., the manufacturer of the innovative Celbrea® medical device for the detection of early signs of breast disease, has decided to enter the Latin American market and through its master distributor in Latin America, has chosen bioaccess™ as its regulatory and market access consulting firm to aid it in entering the Colombian market.
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.
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.
