[Orlando, FL, October 14, 2018] — 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.
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.
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.
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.
La Clínica Oftalmológica del Caribe (COFCA) ha recibido fondos de Colciencias bajo la convocatoria Locomotora de la Innovación para Empresas para desarrollar un sistema de inyección de sustancias viscoelásticas durante la cirugía de catarata. La idea de este sistema de inyección surge como respuesta a los daños que sufre el ojo durante las cirugías intraoculares. Según especialistas en esta rama, la calidad y el número de células del endotelio corneal disminuye luego de una cirugía, en especial de la de catarata con técnica de facoemulsificación. Esto es crucial para la salud, pues el buen estado del endotelio garantiza que la córnea esté transparente y sana. Si la córnea no está transparente, la visión se compromete y el paciente no puede ver, por lo que hay que realizar un trasplante de córnea o un trasplante de endotelio corneal. El sistema ideado y patentado por el Dr. Luis Escaf —fundador y director médico de COFCA— evita los daños que sufre el ojo durante la cirugía de catarata. El prototipo del sistema está siendo desarrollado en el laboratorio de bioingeniería de Interventional Concepts en Miami, FL —una empresa dedicada al desarrollo de innovaciones en ciencias de salud. Ambas empresas, conscientes de la importancia de estar a la vanguardia de la investigación e innovación en ciencias de la vida, han unido esfuerzos para desarrollar este sistema como antesala a su comercialización global.
Colombia's vision by 2025 is to become one of the top three innovative countries in Latin America by promoting human capital for the knowledge economy, research and development (R&D) and innovation; and by raising awareness of science, technology and innovation in the Colombian society. The initiative seeks to attract foreign innovative life sciences startups to Colombia by offering them R&D funding and a generous 175% capital allocation tax deduction —among other incentives.
StartUp FIU —Florida International University (FIU)'s entrepreneurship program— and Miami MedTech Innovation Center (MMT) join forces to create the first medical innovation ecosystem to develop medical innovation projects in Miami and the rest of Latin America.
StartUp FIU —el programa de emprendimiento de Florida International University (FIU)— y Miami MedTech Innovation Center (MMT) unen fuerzas para crear el primer ecosistema de innovación médica para desarrollar proyectos de innovación en salud en Miami y América Latina.
Talent, innovation and service explain why Colombia leads the annual ranking of the best clinics and hospitals in Latin America. According to America Economía magazine's annual ranking of clinics and hospitals in Latin America, Colombia leads the region with 22 of the best institutions out of 43 in the list. Medellin's General Hospital leads the ranking as the best public health institution in Latin America.
Dr. Pedro Martinez-Clark, a renowned interventional cardiologist trained at Harvard, is developing an innovative medical device based on the revolutionary TransCaval Access (TCA) technique —co-developed with his research group in Cali, Colombia—, to treat patients with severely clogged arteries. The technique won the Best of the Best Abstract Award at The Society for Cardiovascular Angiography and Interventions (SCAI)'s 2014 meeting. Dr. Martinez-Clark obtained funding from private investors to develop and market his medical device to treat over 154,000 patients annually who can not be treated with conventional technical devices, thus creating a $ 2.2 billion market opportunity in 2020.