Navigation Links
St. Renatus, LLC, with Guidance from the U.S. Food and Drug Administration, Has Established Readiness to Proceed to Phase 3 Trials for a New Needle-Free Dental Anesthetic
Date:3/7/2011

FORT COLLINS, Colo., March 7, 2011 /PRNewswire/ -- St. Renatus, LLC, the northern Colorado start-up Company dedicated to bringing to market a needle-free dental anesthetic, announced today that the company had a favorable End of Phase 2 review with the U.S. Food and Drug Administration (FDA), and agreed that in the near future, the company will proceed with conducting Phase 3 efficacy studies to determine the exact parameters for their nasal mist dental anesthetic achieving dental anesthesia in the maxillary arch.

St. Renatus and the FDA discussed details for both Phase 3 Adult and Pediatric studies to be conducted in the near future. Final revised protocols will be forwarded to the FDA in the coming weeks.

The Phase 2 clinical trial results submitted to the FDA indicated that the nasal mist is comparable to that of a standard needle-injected dental anesthetic.

"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. We believe it represents a significant step forward for both St. Renatus and the field of Dentistry," said Steve Merrick, Chief Executive Officer for St. Renatus, LLC.

Initial consumer research for the nasal mist product found that if patients are given the choice between a nasal mist anesthetic and a needle-injected anesthetic, 90 percent of all patients 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.(1)

96% of dentists surveyed expect to offer the new nasal mist anesthetic to their patients.(1)

Phase 3 clinical studies required by the FDA are expected to be completed in the second half of 2011. A New Drug Application will likely be filed in the latter part of 2011.

ABOUT ST. RENATUSSt. Renatus, LLC was founded to commercialize and distribute a new needle-free dental anesthetic in the form of a nasal mist that is designed to achieve dental anesthesia in the maxillary arch. St. Renatus aims to create a better experience for dentists and qualifying patients by conducting clinical trials on an accurate and sophisticated method to anesthetize the upper teeth without the risk and pain of a needle. For more information, please visit www.st-renatus.com or call 970.282.0156.St. Renatus, LLC1000 Centre AvenueFort Collins, CO 80526Toll Free: 1.888.NUMB314 (1.888.686.2314)P: 970.282.0156F: 970.221.4365Info@St-Renatus.comInvestment information:Jill ShoemakerVice President of Investor Relations(970) 231-3243 jshoemaker@st-renatus.com P: 970.282.0156Investor_Relations@St-Renatus.comFor More Information Contact:Christine KozsuchBurgess CommunicationsPhone: 267.257.5866 Toll Free: 888 846 5759Email: ckozsuch@burgesscom.comReferences:

(1) Research conducted by Industrial Research Center, Glen Mills, PA. February, 2011.


'/>"/>

SOURCE St. Renatus, LLC
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. PDL BioPharma Provides First Quarter 2011 Revenue Guidance of $83 Million
2. Cyberonics Reports Strong Fiscal 2011 Third Quarter Results and Increases Guidance
3. Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results
4. Telik Announces Fourth Quarter and 2010 Year End Financial Results and 2011 Financial Guidance
5. NxStage® Reports Fourth Quarter and Full-Year 2010 Financial Results; Revenue Growth Exceeds Company Guidance
6. Masimo Reports Fourth Quarter and Full Year 2010 Financial Results; Provides 2011 Guidance
7. AssureRx Expands GeneSightRx® Pharmacogenetic Profile with Sixth Gene to Enhance Guidance of Psychiatric Drug Prescribing
8. Perrigo Reports Record Quarterly Revenue and Earnings and Raises Full Year Adjusted EPS Guidance
9. Lotus Pharmaceuticals Provides Inner Mongolia Land Price Guidance from Cha You Qian Qi Government
10. Lilly Reports Fourth-Quarter and Full-Year 2010 Results, Provides 2011 Financial Guidance
11. InstaCare Corp. Announces 2011 Genstrip Guidance Report Penned by William Walling, CFA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/17/2017)... Feb 17, 2017 Research and Markets has announced ... Report" report to their offering. ... The report provides separate comprehensive analytics for the US, ... , Asia-Pacific , and Rest of World. Annual estimates ... six-year historic analysis is provided for these markets. Market data and analytics ...
(Date:2/17/2017)... NEW YORK , Feb. 17, 2017   ... other side effects allegedly associated with use of the ... Philadelphia Court of Common Pleas, ... a mass tort program. According to a notice posted ... scheduled to convene a meeting on March 9, 2017 ...
(Date:2/17/2017)... , Feb. 17, 2017   FormFast , ... announced a new partnership with Engage , one ... United States . FormFast will serve as the ... Engage,s implementations with MEDITECH .  ... essential functionality to complement and enhance the electronic health ...
Breaking Medicine Technology:
(Date:2/18/2017)... ... February 18, 2017 , ... ProParagraph Fashion ... Film Studios ’ ProParagraph Fashion Volume 2 for all multi-line FCPX project needs. ... Users can pick and choose from hand-crafted trend-setting designs with smooth animations that ...
(Date:2/17/2017)... CA (PRWEB) , ... February 17, 2017 , ... ... focus on foundational and sustainable systems change designed to further positively impact the ... “The Board of Trustees has long considered it our duty to seriously consider ...
(Date:2/17/2017)... Palos Verdes, CA (PRWEB) , ... February 17, ... ... and emotional flow is Dr. Carol Francis' goals for each and ... Retreat Conference, Dr. Carol Francis will demonstrate five different brainwave tools which help ...
(Date:2/17/2017)... ... February 17, 2017 , ... Program will serve ... Health and the U.S. Soccer Foundation announced today that they have awarded nine ... for Success, the Foundation’s soccer mentoring program, teaches kids the fundamentals of soccer ...
(Date:2/17/2017)... ... 2017 , ... Cancer diagnostics workflow solution provider Inspirata, Inc., ... 22 in San Francisco. As part of the Tri-Conference expo, which is open ... as well as its new precision medicine platform, “Crosswalk Insight: Oncology™.” , Inspirata ...
Breaking Medicine News(10 mins):