Anesthetic… Now in a Nasal Spray

Written by on February 2, 2012 in Research & Technology - No comments
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For the millions of people who fear going to the dentist because they hate the pain caused by needles used to numb teeth for many procedures, help is finally in sight. St. Renatus, LLC, based out of Fort Collins, Colo., heard the plea from the masses and is in the process of clinically testing a drug that the company believes will enhance pain control in dentistry. St. Renatus has patented the world’s first, needle-free nasal mist dental anesthetic. It is administered through the nasal cavity and is suitable for use in operative procedures involving most of the upper teeth such as fillings, crowns, bridges and root canals. The benefits of this new technology include:

  • Reducing the anxiety and fear associated with dental injections.
  • Decreasing the risk of diseases associated with contaminated needles.
  • Lowering the number of patient complaints of lip swelling or the “fat lip” feeling after leaving the dentist.

The Industrial Research Center recently conducted a study to find initial consumer data for the nasal mist product. Results indicated that when patients were given the choice between a nasal mist anesthetic and a needle-injected anesthetic, 90 percent are very or somewhat likely to choose the new product, and 23 percent are very likely to switch to a dentist offering the nasal spray option. This same study also concluded that 96 percent of dentists surveyed expect to offer the new nasal mist anesthetic to their patients when it becomes available.

St. Renatus’ nasal mist has successfully undergone Phase I and Phase II clinical trials of the U.S. Food and Drug Administration (FDA) process. The Phase II trials’ initial results indicated 90 percent efficacy which is equal to needle injection results. With a completed favorable End of Phase II review with the FDA in March 2011, St. Renatus established readiness to proceed with conducting Phase III efficacy studies.

“We are very pleased with how the nasal mist has performed in trials thus far, and with the

outcome of our meetings with the FDA,” says Steve Merrick, chief executive officer for St. Renatus, LLC. “We believe it represents a significant step forward for both St. Renatus and the field of dentistry.”

In December 2011, St. Renatus announced it secured an additional investment of up to $3.5 million for completing FDA clinical trials for its innovative needle-free dental anesthetic product.

“This is a major step toward bringing this new technology to dentists and their patients,” says Merrick. “With this additional funding, we can proceed with all remaining clinical trials.”

The FDA has granted permission for the company to proceed with Phase III clinical studies that will conclude by late spring of 2012. St. Renatus is planning to submit the New Drug Application to the FDA by the summer of 2012 for review. Additional funding, when secured in 2012, will be used to prepare for U.S. commercialization in 2013 and for submitting additional registration in other countries.

For more information and continuous updates, please visit www.st-renatus.com or contact Jill Shoemaker, Vice President of Investor Relations, at (970) 282-0156 ext. 16 or by email at jshoemaker@st-renatus.com

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