An unnamed angel investment group is providing up to $3.5 million dollars to St. Renatus for Phase 3 clinical trials of its nasal mist dental anesthesia. St. Renatus announced in March 2011 that it had had a successful end-of-Phase 2 meeting with FDA regulators and planned to move ahead with Phase 3. The product, delivered to the nasal cavity, numbs only the upper teeth without affecting the lips or face.
St. Renatus CEO Steve Merrick 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.”
According to its website, the company originally planned to file an NDA for the product by mid-2011. Now it says that it expects to complete Phase 3 trials by late spring 2012, to submit an NDA by summer of 2012, and to commercialize the product in 2013. Merrick says that they are looking for additional funding to support commercialization and for registration in additional countries.
Read the St. Renatus press release.