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
'/>"/>

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

Page: 1 2

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:12/15/2014)... BOSTON , December 15, 2014 ... discovery and development company, is pleased to announce the ... United States relating to its GPCR-focused drug ... US significantly strengthens the global patent estate covering Heptares, ... The suite of patents recently granted by the ...
(Date:12/13/2014)... , Dec. 12, 2014  Radiologists can transmit ... images, to their referring physicians, electronic health records ... carefully selected technology.  That was ... Systems Corporation (ADS) at the recent Radiology Society ... transmitting of radiology reports in this manner also ...
(Date:12/13/2014)... and INDIANAPOLIS , Dec. 12, ... and Chip Ganassi Racing Teams (CGRT), today announced a multi-year ... the primary sponsor of the No. 83 Novo Nordisk Chip ... the Verizon IndyCar Series. Kimball, 29, from ... only licensed driver with diabetes in the history of INDYCAR ...
Breaking Medicine Technology:Heptares Extends Global Patent Protection for GPCR-Focused Drug Discovery Platform With Grant of Core Patents in the United States 2Advanced Data Systems Presents on Interface-Free EHR Communications at RSNA's 2014 Conference: Streamlining Communication of Reports and Images to Referring Physicians 2Advanced Data Systems Presents on Interface-Free EHR Communications at RSNA's 2014 Conference: Streamlining Communication of Reports and Images to Referring Physicians 3Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 2Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 3Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 4Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 5Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 6Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 7
... August 27 , - Oralair(R) Grasses 300IR Highly ... Allergen Challenge Chamber, Stallergenes S.A. announces the highly ... Challenge Chamber (ACC)., The study on Oralair(R) Grasses ... different treatment durations: 1 week, 1 month,2 and 4 ...
... INDIANAPOLIS, Aug. 26 Semafore Pharmaceuticals Inc.,announced data ... in Cancer in Washington, D.C., showing additional antiangiogenic,activity ... both VEGF and Bv8 signaling., PI3K is ... /mTOR pathway that,has been shown to play a ...
Cached Medicine Technology:Stallergenes: New Study VO 56 Highly Positive Results Conducted in an Allergen Challenge Chamber 2Stallergenes: New Study VO 56 Highly Positive Results Conducted in an Allergen Challenge Chamber 3SF1126, Semafore's PI3 Kinase Inhibitor, Found to Block Angiogenic Signaling From Both VEGF and Bv8 in Multiple Cell Lines 2SF1126, Semafore's PI3 Kinase Inhibitor, Found to Block Angiogenic Signaling From Both VEGF and Bv8 in Multiple Cell Lines 3
(Date:12/17/2014)... -- Expectant parents should leave prenatal picture-taking to medical ... Use of ultrasound imaging and heartbeat monitors to get ... agency warns. "Although there is a lack ... and heartbeat monitors, prudent use of these devices by ... FDA biomedical engineer, said in an agency news release. ...
(Date:12/17/2014)... HealthDay Reporter , TUESDAY, Dec. 16, ... America, and work commitment is a big reason why, new ... said Dr. Mathias Basner, an assistant professor of sleep and ... of Medicine. A time-use survey of nearly 125,000 Americans, ... main activity exchanged for sleep. Short sleepers -- those who ...
(Date:12/15/2014)... 15, 2014 South Florida’s leading urgent care ... can be a daze of hassle, hustle, and bustle that ... decking halls, to burns when making special meals and heartburn ... can happen at any time. To prevent this season of ... made a list of helpful and healthful holiday tips to ...
(Date:12/15/2014)... News) -- Expert pilots process visual information more efficiently ... better decisions during landings, a new study shows. ... pilots to master, and 36 percent of all airplane ... final approach and landing. Researchers monitored the brain ... pilots while they were at the controls of a ...
(Date:12/15/2014)... 15, 2014 At the leading, long-established ... AutismOne and Focus Autism will welcome ... research on the effects of toxins to children’s health, ... information. , Luminaries such as Dr. Lucija Tomljenovic ... with esteemed, credentialed colleagues of the United States to ...
Breaking Medicine News(10 mins):Health News:FDA Warns Against Fetal 'Keepsake' Videos 2Health News:Work Steals Valuable Sleep Time, Study Finds 2Health News:Work Steals Valuable Sleep Time, Study Finds 3Health News:MD Now Urgent Care Presents Healthy Holiday Tips 2Health News:MD Now Urgent Care Presents Healthy Holiday Tips 3Health News:Study Shows Why Expert Pilots Are Experts 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 3
... ... medical device industry expands its precision micro-machining facility, increases work force to three shifts ... ... Medical,s San Diego facility has completed a multi-million dollar expansion in order to integrate ...
... NEW YORK, Oct. 20 Philips is delivering on their ... the launch of Philips DirectLife, a new customized, interactive fitness ... eager to adopt a more active lifestyle. The DirectLife program ... the more than 60 percent of the global population who ...
... announced a donation of $211,306 from Eagle Golf, the Dallas-based ... Club at Castle Hills in Lewisville, Texas. From Sept. 1-Oct. ... a Swing at Cancer" to raise awareness and funds for the ... Eagle Golf and its patrons for supporting our work on behalf ...
... children are already anticipating Halloween "trick or treating," some parents ... door-to-door to receive free candy. , Parents of ... when their child is the recipient of food outside the ... allergy can stay safe without having to miss out on ...
... lie when it comes to showing signs of aging. Yet ... Studies have demonstrated that volume loss of soft tissue and ... loss of volume in the face over time can cause deep ... With the recent FDA approval of Scrulptra® Aesthetic, physicians now have ...
... 1. For Patients with Erectile Dysfunction, Treatment with ... and Erectile Function , ACP issues clinical practice ... inhibitor drugs used to treat patients with ED, ... the treatment of erectile dysfunction (ED). ACP strongly ...
Cached Medicine News:Health News:Johnson Matthey Expands San Diego Facility 2Health News:Philips Launches DirectLife, a New Personal Fitness Program to Help People Lead Healthier Lives 2Health News:Philips Launches DirectLife, a New Personal Fitness Program to Help People Lead Healthier Lives 3Health News:Philips Launches DirectLife, a New Personal Fitness Program to Help People Lead Healthier Lives 4Health News:LIVESTRONG(R) Receives $211,306 Donation from Eagle Golf 2Health News:Halloween Doesn't Have to Be Scary for Kids With Food Allergies 2Health News:Pumping Up the Volume in the Face to Reduce Signs of Aging 2Health News:Pumping Up the Volume in the Face to Reduce Signs of Aging 3Health News:Embargoed news from Annals of Internal Medicine 2Health News:Embargoed news from Annals of Internal Medicine 3
... the art in inverted microscopy from Zeiss. ... range of ICS objectives, with innovative condensers ... an unusual scope of sophisticated documentation and ... designed. And Axiovert 200 M, fully motorized, ...
... TS100 is an innovative and efficient ... tool complements any research facility. Improved ... Nikon offers the TS100 binocular and ... model comes with a photo port ...
... direct digital output. Three-chip color camera for ... array of high-quality color video cameras give ... you need for an efficient viewing experience. ... image of your specimen that can be ...
... Tech GT-Capture digital camera photomicrographic system can ... such as Olympus, Leica, Nikon, and Zeiss, ... transferring images over the Internet easy and ... a performance-proven Nikkor lens. The system records ...
Medicine Products: