XHALE SMART® | An Xhale, Inc. Company
A Significant Unmet Need
The SMART® system is a platform technology that has applicability across the entire pharmaceutical market, including clinical trials, managed care and disease management, and product life-cycle management.
The initial market focus for Xhale is pharmaceutical clinical trials, which presents a significant market opportunity in light of the money and time pharmaceutical companies spend developing new drugs, coupled with the poor performance of clinical trial participants in following the medication regimens of clinical trial protocols.
Approximately 16,000 clinical trials are currently being conducted worldwide. A pharmaceutical company spends on average $1.2 billion in order to obtain marketing approval from the FDA for a new medication. In addition, it takes an average of 10 to 15 years to obtain marketing approval from the FDA for a new medication.
According to an article published in The New England Journal of Medicine in 2005 (Lars Osterberg, M.D. and Terrence Blaschke, M.D., “Drug Therapy: Adherence to Medication”), average adherence rates among patients in clinical trials receiving treatment for chronic conditions are 43% to 78%. Non-adherence to study medications and unknown levels of adherence introduce risk and uncertainty into clinical research and drug development.
Non-adherence is one of the most important sources of variability in drug response and may result in failed studies and shelved drugs.