St. Renatus, LLC, a Fort Collins, Colorado start-up that aims to commercialize and distribute a new needle-free dental anesthetic, secured up to $3.5m from an angel investment group.
The company intends to use the funding to move forward with Phase 3 clinical trials on a new 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.
St. Renatus had a favorable End of Phase 2 review with the U.S. Food and Drug Administration (FDA), 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.
Led by CEO Steve Merrick, the company plans to secure additional funding in 2012 in order to prepare for United States commercialization in 2013 and for submitting additional registrations in other countries.