Nasal mist

St. Renatus's nasal mist is the world’s first dental anesthetic administered through the nasal cavity and suitable for use in hard tissue (i.e., tooth) procedures involving most of the upper teeth (e.g., fillings, crowns, bridges, root canals, etc.). The mist, unlike traditional shots used in numbing the teeth, is sprayed into the nasal cavity, anesthetizing only the upper teeth and not the patient’s lips and face.

The objectives behind the drug include:

• Creating a drug to reduce the risk of blood borne disease for the patient and dental office staff
• Reducing the fear and anxiety of patients needing dental procedures involving the upper teeth by eliminating the needle

The FDA approval process

St. Renatus’ nasal mist has undergone Phase 1 and Phase 2 clinical trials of the U.S. Food and Drug Administration (FDA) process at the University at Buffalo School of Dental Medicine. Initial results following the tests indicated the nasal mist to be safe and effective. The FDA Phase 2 trial initial results indicated more than 90-percent efficacy which is equal to or greater than injections.

Subject to the completion of the Phase 2 meeting with the FDA and its review of our Phase 3 protocol, St. Renatus anticipates initiating Phase 3 clinical studies, which will study efficacy and final formulation, in the first quarter of 2011. Phase 3 clinical studies and other preclinical testing required by the FDA are expected to be completed in the first quarter 2011. St. Renatus expects to submit the new drug application (NDA) to the FDA promptly after completion of Phase 3 studies.