CONFIDANT Receives FDA Clearance for OTC product
RESEARCH TRIANGLE PARK, NC (November 20, 2007) -- CONFIDANT, a leading developer of mobile communication solutions for chronic disease management, has received FDA market clearance for Over-the-Counter sales of its chronic disease management product – CONFIDANT 2.5.
In May 2005, CONFIDANT became the first company to receive clearance from the U.S. Food and Drug Administration (FDA) for a mobile phone-based system to communicate with multiple home medical devices. This was followed by the October 2006 clearance which included significant user interface improvements and the ability to work with a broader group of home medical devices. With an initial focus on home diabetes management, the system is capable of collecting data from a range of popular glucose meters, weight scales and blood pressure devices.
With the OTC product, users can collect data from the same full range of off-the-shelf devices supported by CONFIDANT’s prescription product. Objective and motivational feedback is returned directly to the user’s cell phone within seconds and automatic reminders help the user keep on track with routine monitoring.
“The OTC clearance greatly improves consumer access to our solution. While we continue to offer our standard prescription-based product with enhanced patient-clinician communication and monitoring features, we now have an opportunity to sell directly to the consumer. We anticipate retail availability through pharmacy based chronic disease management programs and as a complement to their Medication Therapy Management programs. Broader distribution by healthcare plans and disease management organizations will increase throughout 2008.” said Bjorn Nordwall, president and chief executive officer for CONFIDANT.
CONFIDANT’s vision is to improve patient self-management while at the same time providing better data to both traditional and non-traditional caregivers. Whether a clinic- based physician, a case manager working for a disease management company or a local pharmacist, the caregiver can provide a higher quality of care with better data and improved patient interaction. Patient data can be accessed directly through the Confidant portal or by accessing Personal Health Record or Electronic Medical Record systems that are populated from the Confidant system.
Approximately 45 percent of Americans live with a chronic condition, and 20 percent live with two or more. The costs of chronic disease are crippling the healthcare system. The top 25 chronic illnesses account for 80 percent of healthcare spending. Lacking the tools to proactively manage chronic disease, the U.S. healthcare system is structured to predominantly treat symptoms and react to events instead of enabling education and proactive disease management.
About CONFIDANT
CONFIDANT is the leading provider of mobile phone-based solutions for improved management of chronic diseases. CONFIDANT’s solutions are built on a flexible technology platform that is being applied to a variety of chronic diseases. Initially targeting diabetes and obesity, applications for asthma and addiction management are currently under development.
CONFIDANT empowers patients to help themselves and informs caregivers to better help their patients, resulting in more effective care and reduced costs. CONFIDANT is based in North Carolina’s Research Triangle Park. For more information, please visit www.confidantinc.com.
MEDIA CONTACT
Kelly Hubbard
Largemouth Communications (for CONFIDANT)
(919) 341-7374
kelly@largemouthpr.com
CONFIDANT CONTACT
Thomas Wall
Vice President for Business Development and Marketing
(919) 806-4334
thomas.wall@confidantinc.com
