Next Safety, Inc. (NSI) is a privately held medical technology company located in Jefferson, NC. The Company’s mission is to create new devices that improve global health. NSI fulfills this mission through its development of pulmonary drug delivery devices and pulmonary respirators. Clinical research is focused on the pulmonary delivery of nicotine for nicotine replacement and smoking cessation. Next Safety is also developing products for the pulmonary delivery of insulin along with treatments for asthma and COPD. Next Safety’s platform for drug delivery is driven by a basic change in delivery physics that allows the delivery of drugs to the lungs that are either soluble or are suspended in water.
Next Safety believes that the global revenue stream generated by its pulmonary delivery platform will be large. For example, in 2006 over 46 million adults and children in the U.S. suffered from asthma or chronic obstructive pulmonary disease (COPD); the worldwide revenue generated from treating these conditions was $18.5 billion. The primary technologies that produced this revenue—nebulizers, metered-dose inhalers and dry powder inhalers—are expensive, inefficient, inconsistent, and difficult for people to use. Furthermore, it is widely understood that the lung deposition efficiency for nebulizers and metered-dosed inhalers is very poor. Only 10% to 30% of the droplets produced by nebulizers and inhalers are within the optimal diameter.
In contrast, independent third party tests confirmed more than 80% of manufactured albuterol droplets by the Next Safety pulmonary delivery platform are the optimal diameter for deposition in the tracheo-bronchial tree. The Company believes that the platform will provide far higher, safety, efficacy, and dose confidence than any other method for the delivery of drugs to treat asthma and COPD. Next Safety believes that the new drug delivery platform is expected to allow large-market but off-patent drugs, such as albuterol, to be sold as new and more effective proprietary medications.
Next Safety’s testing has particularly shown that its pulmonary devices deliver nicotine with a far greater efficacy than other nicotine replacement products. While previous nicotine replacement products, such as nicotine gum and patches (a $1.6 billion global market), have helped millions of smokers worldwide, they cannot equal the power of nicotine that is delivered through an actual smoked cigarette. The result is that most smokers succumb to the need for a ‘nicotine hit’ by smoking again.
The ultimate solution in nicotine replacement treatment would therefore be the rapid delivery of nicotine directly to the lungs and brain in the same manner as a cigarette, but without the 4,000 harmful chemicals that exist in tobacco particles.
Cigarette sales in 2006 exceeded $200 billion in developed countries where strong trends to eliminate smoking inside work establishments and all public areas are firmly entrenched. Moreover, Next Safety projects that the cost of nicotine delivered by its pulmonary devices will be between 5% to 10% of the price currently paid by smokers in the United States for an equivalent blood nicotine dose.