Resvent chooses bioaccess™ as regulatory and market access consultant to enter the Colombian sleep apnea medical device market
“We didn’t have much knowledge and expertise in the Latin American medical device market. We were looking for market access consultancies to help us enter the Colombian market with the resvent line of respiration healthcare products. We quickly found that bioaccess’ service capabilities are not present in the traditional regulatory consultancies that operate in Latin America. bioaccess helped us gather market intelligence, obtain regulatory market clearance at INVIMA, search, conduct due diligence, select, and quickly execute a distribution agreement with a reputable distribution business partner in Colombia. The best thing about bioaccess is its team of expert market access professionals who have in-depth knowledge of the Latin American medical device regulatory and commercial sector. The bioaccess team was professional, helpful, and delivered the results we were expecting on time. I would easily recommend bioaccess to foreign manufacturers of medical devices that are looking for guidance on how to succeed in Latin America.”
[Orlando, FL, October 27, 2019] — China-based Resvent has chosen bioaccess™ as its regulatory and market access partner to obtain marketing authorization at Colombia's INVIMA towards the commercialization of its sleep apnea iBreeze series of medical devices. bioaccess™ will also search and select a leading distributor for Resvent in Colombia.
Resvent aims to offer an easy to use series of continuous positive airway pressure (CPAP), automatic positive airway pressure (APAP), and bilevel positive airway pressure (BPAP) medical devices for the treatment of sleep apnea. The iBreeze series requires a minimum amount of fuss and set up, and their intuitive flat-screen user interface provides a fully interactive experience in a compact design.
Resvent's iBreeze series of sleep apnea medical devices include the Imatrix software that allows patients and physicians to use their smartphones and tablets to connect to the devices and obtain data and manage the device effectively.
Resvent's iBreeze series of sleep apnea medical devices also include an algorithm called Intelligence Pressure Release (IPR) that is used during inspiration and expiration to offer patients a more comfortable experience during ventilation therapy. Three IPR grades are available to meet the personalized requirement of each patient.
The iBreeze series of sleep apnea devices also include an intelligent humidifier designed with a plug and seal water tank. The intelligent humidifier will continuously monitor the water level, will stop heating, and will give a visible alert when the water level drops. This feature will avoid patient's discomfort caused by dry air and will delivery the maximum safety. The iBreeze series also includes an humidifier feature. During respiration treatment, water condensation in the breathing circuit
will affect the therapy and even threaten the safety of patients. To solve this problem, Resvent's intelligent humidifier can measure the temperature and humidity of the patient's room and will maintain the right humidification level so that there will be no condensation in the respiration hose or mask.
About bioaccess™
bioaccess™ —a Florida-based clinical research organization (CRO) with the mission to help innovative life science companies conduct clinical research and commercialize their innovations in Colombia— will design the Libella study and will provide support services (e.g., IRB submission, logistical support, project management, statistical analysis, and study monitoring; among others). More information at www.bioaccessla.com.
About Resvent
Resvent was founded in 2015 and is now one of the leading providers of medical devices and solutions in the respiration and ventilation sector. Resvent is headquartered in Shenzhen, China. The company has three main line of products: diagnosis and therapy of sleep and respiration, critical care ventilation, and cloud based intelligent information systems. Resvent has a local presence in global markets such as China, Europe, the U.S., Australia and other emerging countries. More information at www.resvent.com.
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