Other Potential Applications and Candidate Products
In addition to our patents and patent applications on our current products and the core technologies underlying our products, we have licensed worldwide exclusive rights to patents and pending patent applications that we believe will enable, with further research and development, the development of future candidate products and technologies that can address significant unmet medical needs. These potential future products and technologies include:
SMART® for Pharmaceutical Supply Chain Integrity
We believe that our SMART® technology can be further developed to create a system that would use vapor analysis of pharmaceutical products to reduce drug counterfeiting.
The composition of fraudulent drugs ranges from crude mixtures of glue, chalk, and sugar to nearly exact chemical replicas of complex pharmaceuticals. According to the Center for Medicine in the Public Interest, worldwide drug counterfeiting generated an estimated $75 billion in 2010. According to FDA, the number of fraudulent prescription drugs intercepted by customs officials nearly doubled between 2004 and 2005. And according to the Center for Medicine in the Public Interest, counterfeit sales are increasing at nearly twice the pace of legitimate pharmaceutical sales – estimated at 13% annually.
While we have not begun development of a system, our SMART® technology and intellectual property envisions using vapor analysis of special volatile markers to determine if batches of pharmaceutical product are legitimate or counterfeit.
SMART® System for Reduction of Drug Diversion
We believe that our existing SMART® technology and product candidates can be marketed for use in reducing drug diversion, the diversion of drugs from legal and medically necessary uses towards uses that are illegal and typically not medically authorized or necessary.
SMART® Therapeutic Drug Monitoring
We believe that the breath analysis technology that underlies our SMART® Medication Adherence Monitoring System can be further developed to create candidate products that would utilize vapor analysis of exhaled breath to correlate to drug levels in the blood.
Propofol Breath Sensor
Propofol (2,6-diisopropylphenol) is an intravenous general anesthetic agent that has become the most frequently administered intravenous agent used in anesthetic practice worldwide.
We hold U.S. and international patents with issued claims protecting the measurement and monitoring of the IV-infused anesthetic agent propofol in exhaled breath, and we have developed functional sensors which enable the measurement of propofol in exhaled breath.
While we have not begun development of a commercial version of the system, we believe our propofol technology can be used to monitor patient blood propofol concentration via exhaled breath to give anesthesiologists information useful in the management of patients undergoing anesthesia.
Assurance® Pharmacodynamic Anesthesia Administration
While we have not begun development of a system, we believe our Assurance Multi-Sense technology can be used to monitor the pharmacodynamic effects (the effects of drugs and the mechanism of their action in the human body) of drugs used during anesthesia and to guide the administration of the anesthetic agents.
Breath-Based Glucose Monitoring
We have exclusive license rights to patents relating to non-invasive monitoring of blood glucose concentration by measurement and correction of the glucose concentration measured in exhaled breath condensate, and are seeking funding and partnerships to develop and commercialize this early stage technology.
The SMART System has not been cleared by the FDA for any potential application.