What is Sinus Infection?

According to the National Center for Health Statistics, 92 million Americans suffer from at least one of four common chronic respiratory diseases: sinus infection, allergies, bronchitis and asthma.

Sinus infection is the number one chronic ailment in the United States, affecting one in three Americans and costing sufferers as much as $1.3 billion on medical visits plus another $1.3 billion on medications that treat symptoms rather than the cause.

Chronic sinus infection is defined as the inflammation of the paranasal sinuses due to viral, bacterial or fungal infection. Chronic inflammation of the nasal lining, called rhinitis, may be caused by both allergic and non-allergic sources, whether dust, smog or inhaled mold and bacteria-related. When chronic inflammation persists, the small opening of the sinuses draining into the nose becomes obstructed and an infection can result. Chronic inflammation can also lead to polyps, which are growths in the nose that create a more significant obstruction, may destroy normal tissue, and eventually can lead to loss of smell and taste. Over 32 million Americans have been diagnosed with chronic nasal and sinus disorders. Sufferers experience symptoms such as congestion, stuffiness, postnasal drainage, facial pain and discolored nasal drainage for greater than three months in a single bout.

Until 1999, molds in the nose were considered to be innocuous and occasional. But in 1999, researchers discovered that 93% of patients presenting with chronic rhinosinusitis, and 100% of normal patients also displayed nasal molds. Further investigations worldwide, have shown that these molds triggered a chronic inflammatory reaction. These findings proved that while molds are found in all of our noses, the degree of disease they incite depends on a person’s individual sensitivity.

Total operating costs for 2003 was $4.9 million, reflecting to the great extent the Company’s transition from the research and development phase in its product cycle to normal operations. This level of spending also reflects expenditures associated with building its corporate management team, marketing, and infrastructure; professional fees and costs associated with legal, accounting, and regulatory compliance in the pharmaceutical industry; and research and development costs for product line extensions and new product development. Significant among these costs were: $852,000 for salaries and benefits (up from $72,000 in 2002), $1.9 million in professional fees and costs (up from $220,000 in 2002), $1.2 million for marketing and advertising (up from $119,000 in 2002), $251,000 for depreciation and patent amortization (up from $16,000 in 2002), $185,000 in R & D (compared to $39,000 in 2002), and $561,000 for other general and administrative costs (compared to $62,000 in 2002). Management believes that 2003 spending will benefit future periods, accelerate the development of brand equity, and advance the achievement of NDA status for its flagship nasal spray and other select products.