St. Renatus trials

Jan. 9, 2012
Phase 3 trials to be conducted for new needle-free dental anesthetic.

FORT COLLINS, Colorado--St. Renatus, the northern Colorado start-up company founded to commercialize and distribute a new, needle-free dental anesthetic, has announced that the company has secured up to $3.5 million from an angel investment group to move forward with Phase 3 clinical trials.

Steve Merrick, chief executive officer for St. Renatus, said: "Thanks to this angel investment group we are able to take a major step forward in bringing this new technology to dentists and their patients. We appreciate their support and look forward to proceeding with all remaining clinical trials."

St. Renatus aims to create a better experience for dentists and qualifying patients by conducting clinical trials on an accurate and sophisticated method to anesthetize the upper teeth without the risk and pain of a needle. The new needle-free dental anesthetic, in the form of a nasal mist, is designed to achieve dental anesthesia in the maxillary arch.

Studies undertaken involving a nasal mist anesthetic

St. Renatus had a favorable end of Phase 2 review with the U.S. Food and Drug Administration with agreement that the company can proceed with conducting Phase 3 clinical studies. Phase 3 studies, required by the FDA, provide a basis for understanding the safety and efficacy of an investigative new drug in the general population. These studies will also help generate the data needed to complete the final labeling for professional use.

Phase 3 clinical studies are expected to be completed by late spring 2012. A new drug application to the FDA will likely be filed by the summer of 2012 for review.

Added Merrick, "In 2012, we plan to secure additional funding to prepare for United States commercialization in 2013 and for submitting additional registrations in other countries."

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