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. Under this collaboration, bioaccess.™ will give first right of refusal for all clinical research opportunities with innovative medical technologies that bioaccess.™ brings to health institutions throughout Colombia and will assist CHG to increase the competitiveness and quality of the research infrastructure of its member institutions. 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.
EOFlow Co., Ltd., an emerging medical device manufacturer with offices in Seoul, South Korea and San Jose, California, is on a mission to offer the best, the safest, the most reliable, and the most economical ways to manage diabetes disease. EOFlow's device integrates a continuous glucose sensor and an insulin pump in one small wearable module and autonomously controls insulin infusion to ensure that the patient’s blood glucose level stays within the normal range most of the time with little input from the patient. EOFlow has selected bioaccess.™ as its contract research organization (CRO) for the first-in-human (FIH) clinical trial of its EOPancreas medical device. The clinical trial will be conducted at CIMEDICAL in Barranquilla, Colombia — a top-performing clinical research center known for its ability to recruit patients and for the quality of the data it gathers from its research activities.
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.
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").
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.
Millenlum Medical Technologies, Inc. ("MMT"), a company specializing in manufacturing and distributing medical devices in liposuction, body shaping, adipose tissue collection and transfer, and autologous cell processing, has selected bioaccess.™ as its market access, regulatory consultant and legal representative in Colombia. bioaccess.™ will help MMT conduct market research, build a distribution network, and obtain marketing authorization for its novel AcquiCell® equipment at Colombia's medical device regulatory agency, INVIMA.
Hancock 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.
BIORIUS SPRL ("BIORIUS"), a leading regulatory consulting company in Belgium, and bioaccess.™ , the leading CRO and regulatory consulting company in Colombia, announce a cooperation agreement for Colombia. BIORIUS and bioaccess.™ will work together to help each other clients with their regulatory needs in Colombia and Europe.
Omron Healthcare, Inc. ("Omron") has appointed bioaccess.™ as its market access consultants in Colombia. bioaccess.™ will help Omron formulate a strategy and implementation plan in Colombia so that more hypertensive patients have access to Omron's automated home blood pressure (BPM) monitors in Colombia.
POM Medical, LLC ("POM") has appointed bioaccess.™ as its market access, regulatory consultant and legal representative in Colombia. bioaccess.™ will help POM conduct market research, build a distribution network, and obtain marketing authorization for its novel Panoramic Oxygen Mask at Colombia's medical device regulatory agency, INVIMA.
ClarVista Medical, Inc. ("ClarVista"), a privately-held ophthalmic device company —acquired by Alcon in 2017— developer of the HARMONI Modular IOL System, a novel intraocular lens (IOL) used to restore vision after cataract surgery, obtained regulatory approval at Colombia's INVIMA to commercialize its HARMONI Modular IOL. bioaccess.™ led the registration process and became ClarVista's legal representative in Colombia.
CoapTech 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.
Libella Gene Therapeutics, LLC ("Libella") announces a clinical trial in Colombia (South America) using gene therapy to treat and ultimately cure Alzheimer's disease. This trial could lead to Libella offering the world's most expensive treatment in excess of $5 million to cure Alzheimer's disease and reverse about 20 years of age on patients. Libella has chosen bioaccess.™ as its CRO for this trial.
Medimaps Group has appointed bioaccess.™ as its regulatory consultant and legal representative in Colombia. bioaccess.™ will help Medimaps Group register its novel method for improving osteoporotic fracture risk assessment, TBS iNsight®, at Colombia's medical device regulatory agency, INVIMA. Medimaps Group – developers of the TBS iNsight® diagnostic tool – and bioaccess.™ signed a service agreement to have Medimaps Group's TBS iNsight® product registered for sales in the Colombian territory.
SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company has appointed Interventional Concepts, Inc. to act as Territory Sales Manager for sourcing and screening of potential distributors and access to clinical trials participation for SANUWAVE's products in Colombia.
MMT is the first comprehensive healthcare incubator in South Florida that is dedicated to medical device innovation and works to develop products that will make a real impact on people’s lives. The incubator wouldn’t have been possible without Dr. Pedro Martinez-Clark, a renowned Harvard-trained interventional cardiologist who goes above and beyond the call of duty. Dr. Martinez-Clark became involved in medical innovation during his fellowship in Boston and pursued his passion after relocating to South Florida.
An Asheville doctor-and-son team have an idea they say could save at least 100,000 lives a year. Leon and Jeremy DeJournett have patented an artificial pancreas, a system that uses a form of artificial intelligence to ensure patients’ glucose levels don’t get too high or low. Their company is called Ideal Medical Technologies and is considering conducting its first-in-human trial in Colombia.
Immunotrex Biologics —a Boston-based biotech startup company developing a novel anti-sepsis compound capable of blocking the multiple pathophysiologic processes involved in sepsis— has selected Interventional Concepts —a leading US-based contract research organization for innovative life science startup companies— to design a Phase 0 human study to understand the effects of the compound in the human system and how the human body processes it. Immunotrex intends to conduct this study at a clinical research center in Colombia. Interventional Concepts, through an strategic alliance with JSS Research, will design the study, will select the center and principal investigator in Colombia, and will facilitate the regulatory approval process, among other activities necessary to make the study a success in Colombia.
Interventional Concepts and the Alliance for Clinical Research Excellence and Safety (ACRES) partner in efforts to more firmly connect Colombia with the larger world of biomedical research, increasing opportunities for both Colombia and the clinical research enterprise.
Colombia's National Institute of Food and Drug Monitoring (INVIMA), announced that it has reduced from 4.5 months (135 days) to 2 months (60 days) the processing time for the evaluation and approval of a clinical research human study protocol involving an investigational drug. INVIMA announced this change on its website on April 12, 2016, and also stated that it would achieve this time reduction by improving the efficiency of internal processes without compromising the quality of the evaluation of the study protocol.
The Lifees are a way of honoring those companies that are helping to transform South Florida into a life sciences epicenter. The Miami MedTech initiative —co-founded by Dr. Pedro Martinez-Clark and Max Mendez— is Interventional Concepts' product development initiative in Miami that allows local (and Latin American) innovators to fulfill their dreams of bringing new medical technologies with global impact to market.
Mitralign, Inc., un fabricante de soluciones innovadoras para la reparación de la valvula mitral y tricúspide por medio de catéter, ha anunciado que su Sistema de Anuloplastia Percutánea Mitralign (MPAS, por sus siglas en inglés) ha recibido la aprobación CE Mark para su uso en el tratamiento de regurgitación mitral funcional. Esta aprobación ofrece una novedosa alternativa de tratamiento para pacientes con síntomas de regurgitación mitral funcional. La aprobación le permitirá a Mitralign comercializar su sistema MPAS en la Unión Europea. El estudio clínico en humanos para validar la seguridad y eficacia del MPAS fue conducido a través de Interventional Concepts en el centro de investigación cardiovascular de una clínica líder en Cali, Valle.
Interventional Concepts y Health Quality Services & Products (HQSP) se alían para que las instituciones de salud de Bogotá se beneficien de la gran demanda de la industria de la innovación médica mundial por servicios de investigación clínica en Colombia.
Keraderm, an innovative product to heal skin defects based on cultures of keratinocytes and fibroblasts, developed in Colombia by Dr. Rodrigo Soto, Jennifer Gaona and Juan Zambrano, has joined forces with Interventional Concepts to design and manage a clinical study in humans. The study results will allow the product to be approved for commercialization by Colombia's Invima and other international regulatory bodies as a requirement for global expansion.