FDA OK's FoCo firm's needle-free dental anesthetic

If the fear of a giant needle piercing the roof of your mouth keeps you from the dentist, there's some relief in sight.

 

The FDA recently approved Kovanaze, the first needle-free dental anesthetic developed by Fort Collins-based bio-pharmaceutical company St. Renatus LLC.

 

Instead of a needle, Kovanaze is administered through a nasal spray and is effective on half the upper teeth in adults and children.

 

“For more than 100 years, the dental industry has delivered dental anesthesia using a needle injection," St. Renatus CEO Steve Merrick said. "This is the first time we've proven there is a needle-free method" that delivers the same effect.

 

U.S. dentists currently administer about 250 million injections each year; Kovanaze could be an option in 70 million to 80 million of those injections. "Realistically, if we target 10 percent of that I would consider it a success," Merrick said.

 

St. Renatus, founded by Dr. Mark Kollar, has been working on the nasal mist for a decade.

 

"It's very fulfilling for those of us who have been there since the beginning," Merrick said. "An idea Mark came up with went the distance."

The company plans to roll out Kovanaze at the annual meeting of the American Dental Association later this year in Denver and at a meeting in New York City attended by 15,000 doctors.

 

"We are hoping by the end of the year we will have reached over 25,000 dentists," he said. St. Renatus is also tapping into a distribution network that will field about 3,000 sales representatives to visit 150,000 dental offices. "We will have good coverage pretty quickly," Merrick said.

 

The startup graduated from the Innosphere in January 2014 and a few months later received a $5 million investment from Blue Ocean Holdings to help bring the product to market.

 

The nasal mist is effective as an anesthetic on the upper teeth and gums, according to St. Renatus. It allows patients to avoid a painful shot and the numb feeling in their lips and cheeks following a dental procedure, according to the company.

 

"We know about 50 percent of all people go to the dentist, and we believe fear, anxiety and pain represents some portion of that. Our goal is to make the dental experience more pleasant with a different type of product."