St. Renatus, LLC Announces FDA Approval of KOVANAZE™ Nasal Spray for Use in Dentistry

St. Renatus, LLC Announces FDA Approval of KOVANAZE™ Nasal Spray for Use in Dentistry

July 12, 2016 – St. Renatus LLC, a privately held company based in Fort Collins, Colorado, is pleased to announce it received U.S. Food and Drug Administration (FDA) approval on June 29, 2016 for its first product, a new dental anesthetic, KOVANAZE™ (tetracaine HCl and oxymetazoline HCl) Nasal Spray. This is the first product that allows for dental anesthesia to be administered through a nasal spray without using a needle.

“For more than 100 years, the dental industry has delivered dental anesthesia using a needle injection. Now, through the efforts of a dedicated team, we have developed a revolutionary needle-free method for delivering pulpal anesthesia,” said Steve Merrick, St. Renatus’ CEO.

Kovanaze is intended for use in dentistry as a topical anesthetic, delivered in the nasal cavity to achieve pulpal (tooth nerve) anesthesia for the restorative treatment of teeth. Like traditional dental injections, this product delivers a local dental anesthetic but without the needle.

Kovanaze is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more.

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