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.
Read MoreGreenlight 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.
Read MoreSpine 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).
Read MoreAvantec 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.
Read MoreN8 Medical, LLC (N8 Medical) –a clinical-stage medical device company focused on commercializing medical devices that incorporate a novel class of active compounds called ceragenins– has chosen Colombia and bioaccess™ as its contract research organization (CRO) to conduct a clinical trial of its CeraShield™ Endotracheal Tubes in mechanically ventilated COVID-19 patients. bioaccess™ will help N8 Medical with its institutional review board (IRB)/ethics committee approval and regulatory approval at Colombia's regulatory agency (INVIMA).
Read MoreNeoProgen, Inc. a Baltimore-based company led by Medtech entrepreneur Bill Niland, has chosen Colombia for its first-in-human clinical trial as it develops a cell therapy for patients following a heart attack. bioaccess™ will help NeoProgen select a research center and obtain institutional review board (IRB) approval to initiate its trial. The biotech company is developing a cell therapy that could help patients who have suffered a heart attack.
Read MoreLibella Gene Therapeutics, LLC announces an institutional review board (IRB)-approved pay-to-play clinical trial in Colombia (South America) using gene therapy to reverse aging in humans. Sierra Sciences, LLC, headed by Bill Andrews, Ph.D., has developed a gene therapy that aims to lengthen telomeres by introducing the enzyme telomerase into human cells. Sierra Sciences, LLC exclusively licensed the technology to Libella. Dr. Andrews led the research over 20 years ago that initially discovered human telomerase and then led the studies related to telomerase induction. Libella chose bioaccess™ as its CRO for this trial.
Read MorePAVmed Inc. (Nasdaq:PAVM), is a highly-differentiated, multi-product medical device company employing a unique and proven business model designed to advance products from concept to commercialization much more rapidly and with significantly less capital than the typical medical device company. PAVmed has selected bioaccess.™ as its contract research organization (CRO) for a first-in-human clinical trial of its PortIO medical device. The clinical trial will be led by Dr. Jorge Humberto Ulloa —a leading vascular surgeon who trained at the Walter Reed Army Medical Center Washington DC— and will be conducted at Cirulaser Andes (“Cirulaser”) in Bogota, Colombia — a specialized vascular center affiliated with Hospital Universitario de la Fundación Santa Fé de Bogotá ("FSFB").
Read MoreReGelTec, Inc., a Baltimore-based medical device startup company that is developing the next generation of minimally invasive spinal implants for lower back pain and degenerative disc disease, has chosen Colombia and bioaccess™ as its CRO to conduct the first-in-human clinical trial of its Hydrafil System. bioaccess™ will help ReGelTec with its institutional review board (IRB)/ethics committee approval and regulatory approval at Colombia's regulatory agency (INVIMA).
Read MoreEstablishment Labs Holdings Inc. (Nasdaq: ESTA) (the “Company”) —a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market— has chosen bioaccess™ for its Motiva breast implant post-market clinical trial in Colombia. bioaccess™ will help the Company obtain institutional review board (IRB)/ethics committee (EC) approval at Hospital Universitario San Ignacio in Bogota to initiate its clinical trial and will also provide assistance in obtaining regulatory approval at Colombia's regulatory agency; INVIMA.
Read MoreAdvanced Research for Health Improvement LLC (ARHI) —a leading clinical research site in Naples, FL that has specialized in conducting clinical trials in the area of heart failure, heart disease, Alzheimer’s disease, aging frailty, among others— has executed an memorandum of understanding (MOU) with bioaccess™ —the only contract research organization (CRO) that helps US medical device company operationalize early-stage/first-in-human clinical trials in Colombia—. The purpose of the MOU is to explore collaboration opportunities on clinical research projects in Latin America with a special emphasis in Colombia —the country with the most competitive medical device clinical trial environment in Latin America.
Read MoreFlow-FX, a Mokena, IL company poised to catalyze dramatic changes in orthopedic surgery with the ultimate goal of significantly improving patient outcomes, has selected Colombia and bioaccess™ as its contract research organization (CRO) for a first-in-human clinical study on its innovative Flow-Screw medical device for the delivery of intraosseous (IO) antibiotics. The study will be conducted at Clinical La Misericordia in Barranquilla, Colombia and will be led by Dr. Carlos Severini —chief of orthopedic surgery and trauma at Clinica La Misericordia and at Clinica Regional de la Policía Nacional, Mired IPS and university professor at Universidad Libre.
Read Morebioaccess™ and Caribbean Health Group (CHG) —a cluster of the eight leading healthcare institution in Barranquilla, Colombia— have announced a collaboration to bring clinical research trials to the city with the objective of creating the paving the way to make Barranquilla as the most attractive destination for clinical research in Latin America. The collaboration was announced on Friday, March 29, 2019 during a meeting in Miami, FL at PROCOLOMBIA's office in Miami, FL. Colombia's Minister of Health attended this meeting and openly supported the initiative to bring more clinical research trial projects to Barranquilla and the rest of Colombia.
Read MoreGlobalCare Clinical Trials, LLC (“GCCT") has executed an agreement with bioaccess.™ to expand its clinical trial ambulatory services to Colombia. Under this agreement, GCCT will leverage bioaccess.™ extensive presence in Colombia to expand its ambulatory service offering in Latin America in support of its global pharmaceutical clients that need GCCT to assist them with their clinical trial patient in-home needs in Colombia. Reduction in clinical trial subject recruitment time by over 50% and an increase in subject retention rate of over 95% are among the results that have spurred GCCT's rapid growth.
Read MoreHancock Jaffe Laboratories, Inc. (Nasdaq:HJLI) (Nasdaq:HJLIW), a company specializing in bioprosthetic medical devices to establish improved standards of care for treating cardiac and vascular diseases, has selected bioaccess.™ as its contract research organization (CRO) for a first-in-human clinical trial of its VenoValve® bioprosthetic medical device. The clinical trial will be conducted at Hospital Universitario de la Fundación Santa Fé de Bogotá ("FSFB") in Bogota, Colombia. FSFB owns a 205-bed university hospital in Bogota, and was the first hospital in Colombia to receive the distinguished Joint Commission International accreditation; FSFB also boasts an academic affiliation with John’s Hopkins Medical International in Baltimore, MD.
Read MoreCoapTech is an early-stage medical device company with a patent-pending, platform technology to disrupt the market for enteral nutrition feeding tubes. The CoapTech system will de-skill the procedure for feeding tube placement, offering a simpler, safer, and more affordable method. CoapTech has chosen Colombia to conduct its first-in-man clinical trial. CoapTech has chosen BIOACCESS™ as its CRO to explore conducting this trial in Colombia by helping it find a qualified site and investigator.
Read More"Miami-based consultancy bringing more U.S. startups' phase I trials to Colombia" -CenterWatch Weekly, April 6, 2015. This was the title of a recent front-page article that CenterWatch, the leading clinical research publication, has published profiling our work in Colombia.
Read More
