Flow-FX Selects Colombia for a First-In-Human Clinical Trial on its Flow-Screw Medical Device for Delivery of Intraosseous (IO) Antibiotics

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.

Colombia's Minister of Health and Social Protection —Juan Pablo Uribe— and bioaccess™ Meet to Discuss Transforming Colombia into the Best Destination for Clinical Trials in Latin America

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 Chooses bioaccess.™ to Expand its Ambulatory Services to 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.

Clinical TrialsJulio G. Martinez-ClarkMarch 22, 2019GCCT, GlobalCare Clinical TrialsComment

Mandala International and bioccess.™ Sign Cooperation Agreement for ANVISA, COFEPRIS, AND INVIMA Regulatory and Market Access Consulting Services in Brazil, Colombia, and Mexico

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 Chooses bioaccess.™ to Seek Licensing Data Collaboration Partners 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.

Market AccessJulio G. Martinez-ClarkFebruary 17, 2019IDx Technologies Inc., diabetic retinopathy, Artificial Intelligence, AIComment

LumiThera Chooses bioaccess.™ as its Regulatory and Market Access Consultant to Sell its Innovative Valeda™ Light Delivery System in Colombia

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.

Hernán Orjuela —a famous Colombian TV presenter— Interviews Julio G. Martinez-Clark, bioaccess.™, CEO

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 chooses bioaccess™ as its regulatory and market access consulting company to sell its innovative EZ Detect colorectal screening test 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.

Market AccessJulio G. Martinez-ClarkOctober 15, 2018Biomerica, EZ Detect colorectal screening testComment

IOPtima Selects bioaccess.™ as Market Access Consultant to Find Distributors in Latin America

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.

Market Access, ColombiaJulio G. Martinez-ClarkAugust 30, 2018distributor search, IOPTIMA, IOPTIMATEComment

London-based WEP Clinical Selects bioaccess.™ As Market Access Consultant to Enter the Colombian Market and Provide Patients Access to Life-Savings Drugs

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.

MMT Appoints bioaccess.™ as Market Access and Regulatory Consultants in Colombia for its AcquiCell® Medical Device

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 Selects bioaccess™ as CRO for its First-in-Human VenoValve® Study in Colombia

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 and bioaccess.™ Sign Cooperation Agreement for Cosmetic Regulatory Consulting in Colombia

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 Appoints bioaccess.™ as Market Access Consultants in Colombia for its Automated Blood Pressure Monitor Devices in Colombia

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.

Market AccessJulio G. Martinez-ClarkJuly 6, 2018Omron, BPM, automated blood pressure monitor, colombia, hypertensionComment

POM Medical Appoints bioaccess™ as Market Access and Regulatory Consultants in Colombia for its Panoramic Oxygen Mask – the Best Choice to Reduce Hypoxic Events

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.

bioaccess.™ Helps ClarVista Medical (acquired by Alcon) Gain Approval in Colombia to Commercialize its HARMONI® Modular IOL – a Novel IOL Used to Restore Vision after Cataract Surgery

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.

Market AccessJulio G. Martinez-ClarkFebruary 21, 2018ClarVista Medical, Colombia, medical device registration, invimaComment

CoapTech Considers Colombia For its First-In-Man Clinical Trial to Prove The Efficacy of its Enteral Nutrition Feeding Tube Placement Technology

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.

Medimaps Group Appoints bioaccess.™ as Regulatory Consultant and Legal Representative in Colombia for TBS iNsight® – a Novel Osteoporotic Fracture Assessment Diagnostic Tool

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.

Market AccessJulio G. Martinez-ClarkDecember 23, 2017Medimaps Group, TBS Insight ToolComment

SANUWAVE Appoints BIOACCESS™ as Territory Sales Manager and Partner to Access Clinical Trial Participation in Colombia; Revenue Expected Before Year End.

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.

ColombiaJulio G. Martinez-ClarkJune 21, 2017Sanuwave, Market Access Latin America, dermaPACEComment

Colombia becomes the most clinical trial-friendly country in Latin America; it now boasts the best study protocol approval times in the region: 30 days for medical devices and 60 days for drugs

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.

ColombiaJulio G. Martinez-ClarkApril 24, 2016Colombia, clinical trial, invima, approval time, processing timeComment

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