News
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.
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 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 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.
Ambiance 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.
Adaptive 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.
NeuraMetrix, 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.
N8 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).
Hasten 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.
Emergo 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.
Human 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.
NeoProgen, 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.
Libella 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.
PAVmed 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").
ReGelTec, 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).
China-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.
Establishment 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.
Israel-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.
Advanced 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.
Flow-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.
bioaccess™ 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.
GlobalCare 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.
MANDALA International ("MANDALA"), a leading regulatory consulting company in France, and bioaccess.™ announce a cooperation agreement to work together to help each other's clients with their regulatory and market access needs in Brazil, Colombia, and Mexico —the top three medical device markets in Latin America. Under this cooperation agreement between MANDALA and bioaccess.™, now foreign manufacturers of medical technologies will be able to cost-effectively and timely obtain market clearance for their products, have a well thought out market access plan, and find reliable local distributors so that they can achieve meaningful sales and have long-term growth in Brazil, Colombia, and Mexico —the top three medical device markets in Latin America.
IDx Technologies Inc. has chosen bioaccess.™ as its market access consultant to search, find, and select high-volume ophthalmology centers in Latin America that can be its data-licensing collaboration partners for its breakthrough autonomous artificial intelligence (AI) system that detects diseases in medical images. By enabling diagnostic assessment in primary care settings, IDx aims to increase patient access to high-quality, affordable disease detection.
LumiThera, Inc. has chosen bioaccess.™ as its regulatory and market access partner to obtain marketing authorization and commercialize its innovative Valeda™ Light Delivery System in Colombia. Valeda™ is the first approved treatment for dry age-related macular degeneration using photobiomodulation (PBM). LumiThera is at the forefront of the development of PBM treatments for patients with age-related macular degeneration and other degenerative ocular diseases.
Hernan Orjuela entrevista a Julio G. Martinez-Clark, CEO de bioaccess.™, en su programa Entrevistas con Hernán. bioaccess.™ es una organización de investigación por contrato (CRO por sus siglas en inglés) basada en Orlando, FL que ayuda a empresas de tecnologías médicas a desarrollar y comercializar sus innovaciones en Colombia.
Hernán Orjuela interviews Julio G. Martinez-Clark, CEO, bioaccess.™, on its Entrevistas con Hernán TV show at RCN Internacional —the leading TV channel in Colombia.
Biomerica, Inc. (Nasdaq: BMRA) has chosen bioaccess.™ as its regulatory and market access partner to obtain marketing authorization and commercialize its innovative EZ Detect colorectal screening test in Colombia. The EZ Detect colorectal screening test is the simplest and most affordable way to help identify the early warning signs of colorectal cancer (CRC). Globally, colorectal cancer is the third most common type of cancer, making up about 10% of all cases.
IOPtima Ltd.—an innovative ophthalmology medical device company based in Israel— has selected bioaccess.™ as its market access and business development consultant to expand its market reach to Latin America. bioaccess.™ will assist IOPtima with searching and selecting distributors in Colombia, Chile, Mexico, and Peru.
WEP Clinical —a London-based drug sourcing, and distribution company— has selected bioaccess.™ as its market access, regulatory and business development consultant to enter the Colombian market for hard-to-find drugs. For hospitals or health management organizations (HMOs) that want to provide a life-saving and hard-to-find drug to their patients, WEP Clinical offers an efficient, end-to-end product distribution model. From the required regulatory filings, through to product handling and delivery, WEP Clinical is well positioned to support patient's needs.
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.