Safety and Toxicity

The TDS^® delivery system is composed of ingredients which, with one exception, have Generally Regarded as Safe (GRAS) status. TTI has had the safety of the only unclassified ingredient which is sold in the U.S. as a nutritional supplement, as well as the system itself independently tested for dermal toxicity. Individual applications of the system have also been evaluated at the Institute for In Vitro Sciences in Rockville, Maryland and in all instances, the ingredients, system and applications tested safe. In one instance, a TDS^® application was tested for dermal toxicity side-by-side with an FDA-approved system delivering the same active ingredient. The TDS^® product proved markedly less toxic
than its “safe and effective” competitor.

More than 500 patients have been exposed to the TDS^® system in clinical trials and there have been no documented reports of erythema (redness) or skin irritation of any kind in acute and chronic use scenarios.

Pre-clinical and Clinical Trials Completed

TTI, through its academic collaboration with the Royal London School of Medicine and
the William Harvey Institute, have completed 18 trials of 18 different molecules, including five human trials, two of which have been published in peer-reviewed publications in 2006. (See News Tab) The pre-clinical work set out to establish that the TDS^® technology was
able to deliver and accomplish blood levels with a diverse list of pharmaceutical actives.
A few of these have been successfully delivered with patch or gel technology, but most
are too large, of too large a dose or otherwise bio-chemically incompatible with across intact skin delivery.

As success was achieved in kinetics, the work shifted to documenting that the drugs
were bio-available as delivered and having their designed effect. The Department of Experimental Pathology at the William Harvey Institute maintains over 160 validated
models of various disease conditions and studies showed that delivering drugs with the
TDS^® process accomplished therapeutic outcomes comparable with oral and injected delivery and in some cases, less drug was required to achieve the outcome.

On-Going Clinical Work

 TTI has a number of projects in clinical studies, some under our academic collaboration and others underway with industry partners. TTI relies on the faculty of the School for
world-class expertise in Dermatology, Endocrinology, pain management, clinical research and other disciplines, and leading exponents in these diverse specialties enhance our
inter-disciplinary approach to clinical research. All clinical work is done under full ethics, regulatory compliance and EMEA oversight.