Hancock Jaffe Laboratories Selects LATAM Market Access 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 LATAM Market Access Inc. (“LATAM”), 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 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 LATAM Market Access Inc. Sign Cooperation Agreement for Cosmetic Regulatory Consulting in Colombia

BIORIUS SPRL ("BIORIUS"), a leading regulatory consulting company in Belgium, and LATAM Market Access Inc. ("LATAM") announce a cooperation agreement for Colombia. BIORIUS and LATAM will work together to help each other  clients with their regulatory needs in Colombia and Europe.

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Omron Healthcare Appoints LATAM Market Access Inc. as Market Access Consultants in Colombia for its Automated Blood Pressure Monitor Devices in Colombia

Omron Healthcare, Inc. ("Omron") has appointed LATAM Market Access Inc. ("LATAM") as its market access consultants in Colombia. LATAM 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 LATAM Market Access 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 LATAM Market Access Inc. ("LATAM") as its market access, regulatory consultant and legal representative in Colombia. LATAM 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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ClarVista Medical (acquired by Alcon) Gains Approval in Colombia to Commercialize its HARMONI® Modular IOL – a Novel Intraocular Lens (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. LATAM Market Access Inc. 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. 

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Breakthrough 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.

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

Medimaps Group has appointed LATAM Market Access Inc. as its regulatory consultant and legal representative in Colombia. LATAM Market Access Inc. will help Medimaps Group register its novel method for improving osteoporotic fracture risk assessment, TBS iNsight®, at Colombia's medical device regulatory agency, INVIMA. 

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SANUWAVE Appoints LATAM Market Access 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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Empresa extranjera obtiene aprobación CE Mark para comercializar un novedoso dispositivo médico gracias a su estudio clínico-científico en Colombia

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.

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Colombia's Keraderm and Interventional Concepts join forces for a first-in-human trial to validate a technology to remodel and reconstruct skin tissue

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.

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Keraderm e Interventional Concepts se alían para un estudio de investigación clínica en humanos que permitirá validar una novedosa tecnología para remodelación y reconstrucción de tejidos de piel

Keraderm, un novedoso producto para el cubrimiento de defectos de la piel basado en cultivos de queratinocitos y fibroblastos, desarrollado en Colombia por los doctores Rodrigo Soto, Jennifer Gaona, Juan Zambrano y Jorge Luis Gaviria, confía en Interventional Concepts para diseñar y administrar un estudio clínico en humanos, cuyos rigurosos resultados permitirán que el producto sea validado por el Invima, así como otras entidades regulatorias internacionales como requisito para su comercialización global.

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Colombian leading ophthalmologist and Interventional Concepts joined forces to develop an innovative medical device for cataract surgeries

Clínica Oftalmológica del Caribe (COFCA), located in Barranquilla, Colombia, has received funding from Colombia's Administrative Department of Science, Technology and Innovation (COLCIENCIAS) to develop an injection system of viscoelastic substances during cataract surgery invented and patented by Dr. Luis Escaf, its founder and medical director. Ophthalmology experts agree that the quality and number of corneal endothelial cells decrease after intraocular surgery, especially during cataract phacoemulsification. The good health of the eye's endothelium ensures that the cornea is transparent and healthy. If the cornea is not transparent after cataract surgery, the patient's vision is impaired, so specialists need to perform a corneal transplant or transplant corneal endothelium to the damaged eye. Dr. Luis Escaf's device prevents the damage to the eye during cataract surgery. The prototype is being developed by Interventional Concepts' bioengineering team in Miami, FL. The project will be led by Dr. Pedro Martinez-Clark, a Colombian-born physician with extensive medical device development track record in the US. 

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