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 MoreWelwaze 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.
Read MoreAmbiance Ventures™ ("AV"), a Division of Nadkarni Media Group LLC, a Pennsylvania based advisory company specialized in managing corporate innovation and business development programs for life science companies; and bioaccess™- a Colombia and Florida based clinical research and regulatory services company, are pleased to announce a cooperation agreement for licensing innovative medical products, clinical trials regulatory processing, and marketing/distribution in Latin America.
Read MoreAdaptive Testing Technologies (ATT), a Chicago-based company; and bioccess™, an Orlando-based market access consulting firm dedicated to helping innovative Medtech companies succeed with their market expansion plans in Latin America, announced that they have entered into a partnership agreement to market and commercialize the CAT-MH™ –the only multi-dimensional clinically validated adaptive behavioral health measures in the world –in Latin America.
Read MoreNeuraMetrix, a San Francisco-based company with breakthrough medical technology to detect and monitor mental disorders and brain diseases through typing cadence; and bioaccess™, an Orlando-based contract research organization (CRO) and market access consulting firm dedicated to helping innovative Medtech companies succeed with their market expansion plans in Latin America, announced that they have entered into a partnership agreement to conduct clinical research and commercialize the brain health monitoring tool based on typing cadence in Latin America.
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 MoreHasten LLC, a company specialized in enabling and accelerating the entry of new innovative products, devices, solutions, and technologies in developing countries, has chosen bioaccess™ to obtain regulatory registration and market clearance for its clients, Palette Life Sciences, Germitec, and Bioderm at INVIMA in Colombia, and help guide Hasten's market access strategy in the country.
Read MoreEmergo by UL ("Emergo"), a global medical device and healthcare technology consultancy, and bioaccess™, a medical device contract research organization and market access consultancy focused in Latin America, have announced an agreement to help each other's clients with their clinical research, regulatory compliance and market access needs in Brazil, Colombia, Costa Rica, Mexico, and Peru — some of the most attractive medical device markets in Latin America.
Read MoreHuman Med AG, a progressive Germ manufacturer of progressive medical technology devices, has chosen bioaccess™ to obtain regulatory registration and market clearance for its body-jet® line of products at INVIMA in Colombia.
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 MoreChina-based Resvent has chosen bioaccess™ as its regulatory and market access partner to obtain marketing authorization at Colombia's INVIMA towards the commercialization of its sleep apnea iBreeze series of medical devices. bioaccess™ will also search and select a leading distributor for Resvent in Colombia.
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 MoreIsrael-based Sight Diagnostics has chosen bioaccess™ as its regulatory and market access partner to obtain marketing authorization towards the commercialization of its innovative point-of-care blood diagnostic device, OLO. The OLO device uses artificial intelligence (AI) to optically read small amounts of blood and provide complete blood count tests during a single doctor’s visit. In 2018, Sight Diagnostics received its CE mark and begun selling its OLO device in Europe and other countries.
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 More
