Changing Healthcare Worldwide


Release issued 07/25/2012

PALM BEACH GARDENS, Fla. (July 25, 2012) ---Testagen™ TDS, a new and unique spray-on treatment for low testosterone levels in men, commonly referred to as Low T, is currently being prepared for clinical testing by its developer, Palm Beach Gardens, Florida-based Hormone Replacement Technologies (HRT Inc.). Researchers at the Langford Institute anticipate submitting stability and scale-up reproduce-ability findings to HRT for the FDA by later this year.

Approximately 13.8 million men in the United States suffer from low testosterone levels, which have been linked to common ailments ranging from hypertension to low sex drive. Testosterone Replacement Therapy (TRT) drug sales have increased dramatically over the past seven years, from approximately $552 million in 2006 to over $1.6 billion in 2011.Testagen™ TDS® is a patented treatment formulation technology that is expected to revolutionize topical testosterone application because it enables rapid, nearly complete absorption of controlled amounts of testosterone across intact skin. The system is based on a delivery vehicle which mimics physical chemistry of compounds that readily transmigrate the skin and provides faster absorption, lower concentrations left on the skin, and lower cost than current transdermal formulations. The formulation process produces an extremely stable dosespecific and drug-specific formula enabling rapid, safe and efficient transdermal drug delivery.

Testagen™ TDS® was developed through a proprietary system that measures and calculates the intermolecular attractive and repulsive forces of the drug. The patent features include the conceptual development and process for designing and formulating a unique, balanced transdermal system for a particular drug, in this case Testosterone, including stimulus of cellular activation energy. Because the resulting product is liquid, dosing can be adjusted for individual needs by modifying the number of sprays applied. The rapidly drying ethanol base is expected to greatly diminish or eliminate any danger of transferring testosterone to women or children, a significant health risk from existing gel therapies. It is expected that Testogen™ TDS will stand alone as the only product to meaningfully address the health risk of transference with a more convenient, flexible-dosing, easy-to-apply product.

HRT, Inc., a subsidiary of TransDermal Delivery Solutions Corporation (TDSC) was formed in January 2011 to develop and commercialize innovative spray-on transdermal remedies for men and women. HRT is backed by private investors and has recently completed a funding round to take it through its clinical trials and FDA approval submissions.