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

Hernan Orjuela entrevista a Julio G. Martinez-Clark (http://www.juliomartinezclark.com/biografia.html), CEO de bioaccess.™ (https://www.bioaccessla.com/), 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.

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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.

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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. 

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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.

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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. 

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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.

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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.

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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. 

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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. 

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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. 

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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.

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Breakthrough Gene Therapy Clinical Trial in Colombia Aims to Cure Alzheimer's Disease And Could Reverse 20 Years of Age on Patients

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.

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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. 

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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.

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Dr. Martinez-Clark's Miami MedTech Incubator Gains Traction

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.

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Life-saving artificial pancreas startup considers Colombia for its first-in-human trial

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. 

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Interventional Concepts and Immunotrex partner for a Phase 0 study to be conducted in Colombia on a novel anti-sepsis compound

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.

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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.

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Miami MedTech —Dr. Pedro Martinez-Clark's initiative to create a medical innovation ecosystem in South Florida— received the first Lifees Award at eMerge Americas 2016

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.  

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