cliexa-Protocols, web-based disease management system is a member of cliexaTM family of products which is a data and algorithm hub. It provides decision support to physicians and other healthcare providers during the treatment process and optimizes treatment methods based on evidence-based knowledge and data.
cliexa-Protocols has started as a pilot program, developed and evolved in early 2014. It was recognized and initiated letter of intents by multiple healthcare provider firms as well as specialty pharma focusing on Hyponatremia and Hep C treatments.
In December 2013, CN4CE Inc. has submitted a 513(g) application for cliexa-Protocols. After reviewed by FDA, FDA confirmed that cliexa-Protocols Disease Management System is a medical device as defined in section 201(h) of the Act.
On May 10, 2016, cliexa-Protocols has received a confirmation from FDA for 513(g) application as cliexa-Protocols will not be enforced any regulatory requirements under applicable provisions of the Section 513(g) Act, including premarket notification, and its implementing regulations, in accordance with the Mobile Medical Applications Guidance.
Feb. 11, 2016 – Collaborative Network 4 Clinical Excellence, LLC (CN4CE) has just launched their first mobile chronic disease tracking application, cliexa-RA. cliexa-RA is available for iOS devices in the App Store. It tracks medications, symptoms and disease activity for Rheumatoid Arthritis. The Clinical Excellence Algorithms concept, cliexa™, is the healthcare technology product line for CN4CE which is built on published and recognized scientific quantitative models that translate chronic disease activity into a scoring model.
The Genesis of cliexa™ originated with the idea of applying mobile technology to help optimize chronic disease care. cliexaTM utilizes mobile applications to help patients more accurately track key disease activity indicators used by their physicians to make decisions about their care plan. While CN4CE focuses on Clinical Excellence Networks (CEN) and Disease Management Algorithms/Protocols, cliexa™ interfaces with end users, enabling patients to track daily chronic disease symptoms as well as medications.
cliexa™ is a powerful communication layer for end users to sync with physicians, clinics and other healthcare providers for disease activity tracking and reporting. It also integrates well with cliexa™ web protocols to update Disease Protocols, managed by Medical Directors (CEN) along with the physicians who are experts in their respective specialties.
CN4CE’s Lance Goudzwaard said, “It is hard to remember your RA symptoms and accurately communicate it to physicians during visits.” Dr. Robert Spencer has been integral in developing cliexa-RA, a tool which allows RA patients to calculate and follow their disease activity using an accepted disease activity measure called the DAS-28. Dr. Spencer stated that, “In today’s demanding medical environment physicians have limited time to gather relevant data, much less calculate an activity index. With an easily used technology application, patients can be instrumental in helping their doctors determine their disease activity, which, in turn, can lead to better informed treatment decisions.” With cliexa-RA we are offering a free mobile application to achieve this goal. CN4CE Co-Founder and the Scientific Director Dr. Esra Nutku-Bilir said, “cliexa-RA is one step forward in healthcare. The goal has been to design a tool to provide a service based on a need in healthcare… cliexa-RA is designed to gather real life data, which may provide a service tool for patients, physicians, health insurance companies, pharmaceutical companies, with an immense potential to reach out to every aspect of healthcare, today and in the future”.
Bahri Bilir MD FACP FAASLD, could not hide his excitement: “I found this app to be a very important step in realizing the vision of CN4CE, to provide tools to achieve best outcomes in complex chronic illnesses. The simplicity of this app, will allow patients with RA, without anybody’s help, utilize a well accepted and validated scientific tool, to continuously assess and monitor the activity of their illness. I believe that it will improve their adherence to the medications, when they are in remission. In the possibility of a flare, they will be able to see the warning signs, and reach out to their physicians earlier, before they develop deformities or costly ER visits and hospitalizations.”
CN4CE Co-Founder and CEO Mehmet Kazgan added, “Our ultimate vision is to adapt this modular system to other chronic diseases where certain data or clinical indices have been shown to have evidence-based utility in disease and treatment monitoring.”
CN4CE staff consists of executive healthcare professionals, physicians, scientists and technologists. CN4CE was founded originally in 2011 focusing on Dr. Bahri Bilir’s evidence based disease algorithms concept which has a patent pending status.