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:6/24/2016)... SAN FRANCISCO, Calif. , June 24, 2016 ... GBT ), a biopharmaceutical company developing novel therapeutics ... significant unmet needs, today announced the closing of ... shares of common stock, at the public offering ... shares in the offering were offered by GBT. ...
(Date:6/24/2016)... BEIJING , June 24, 2016 Dehaier ... or the "Company"), which develops, markets and sells medical ... China , signed a strategic cooperation agreement with ... as "Hongyuan Supply Chain") on June 20, 2016, to ... Under the strategic cooperation agreement, Dehaier will leverage Hongyuan ...
(Date:6/24/2016)... Belgium , June 24, 2016 /PRNewswire/ ... announced the appointment of Dr. Edward Futcher ... a Non-Executive Director, effective June 23, 2016.Dr. Futcher ... and Nominations and Governance Committees.  As a non-executive ... provide independent expertise and strategic counsel to VolitionRx ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery ... of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , ... for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey ...
(Date:6/25/2016)... Oklahoma (PRWEB) , ... June 25, 2016 , ... ... both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures ... Oklahoma City area —Johnson is one of the first doctors to perform the ...
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort ... holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain ... Disease (SCD) is a disorder of the red blood cells, which can cause episodes ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Comfort Keepers® ... American Cancer Society and the Road To Recovery® program to drive cancer patients to ... and other adults to ensure the highest quality of life and ongoing independence. ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... client, The Grove Investment Group (TGIG), has initiated cultivation and processing operations at ... Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of a complete ...
Breaking Medicine News(10 mins):