SANUWAVE Appoints Interventional Concepts 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.

André Mouton, V.P. International Sales and Relations of SANUWAVE, stated, "This decision to engage Interventional Concepts was made to increase our focus and visibility within South America. It is of the utmost importance that we partner with distributors that have influence and a good track record within the Colombian market. We also need speedy access to potential clinical trials to ensure we add value with our product offering as well as clinically proven outcome. These factors will lead to faster market entry and closer ties with identified Key Opinion Leaders (KOL's)," concluded André Mouton.

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.

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. 

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.

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.

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.  

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.

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.

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.

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. 

La Clínica Oftalmológica del Caribe se alía con Interventional Concepts para desarrollar novedoso sistema para cirugías de catarata

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.

Dr. Pedro Martinez-Clark presented our proposed Colombia Life Sciences Initiative to the Colombian Ambassador to the United States —Colombia will be Latin America's life sciences innovation star

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. 

Miami MedTech —Interventional Concepts' sister company— seals an strategic alliance agreement with Florida International University to foster medical device innovation

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.

Miami MedTech —empresa hermana de Interventional Concepts— firma alianza estratégica con Florida International University (FIU) para desarrollar innovaciones en salud de gran impacto socio-económico

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.

Annual ranking reveals that Colombia has the best hospitals and clinics in Latin America

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 Harvard-trained Colombian cardiologist— receives funding to develop and market an innovative medical device based on the revolutionary TransCaval Access technique

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.

Pedro Martinez-Clark, reconocido cardiólogo colombiano, recibe fondos millonarios para desarrollar y comercializar su innovador dispositivo médico basado en la ingeniosa técnica TransCaval Access

Pedro Martinez-Clark, reconocido cardiólogo colombiano graduado de Harvard, recibe fondos millonarios para desarrollar y comercializar dispositivos médicos basados en su ingeniosa técnica TransCaval Access (TCA).

In Battle Against Alzheimer’s, This May Be Ground Zero

The study, funded by Roche’s U.S. unit, Genentech, along with the U.S. National Institutes of Health and an arm of Banner Alzheimer’s Institute in Phoenix, is one the drug industry’s last big attempts to test a long-held theory: that a buildup of amyloid plaque in the brain is the main cause of Alzheimer’s. The hope is that Roche’s drug can block or slow the process of amyloid formation, or the chain of events that triggers it.