Sedation

Sedana Medical submits market approval application for the drug Sedaconda

Friday, November 27, 2020 - 11:59am

STOCKHOLM, Nov. 27, 2020 /PRNewswire/ -- Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has submitted an application for approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care.

Key Points: 
  • STOCKHOLM, Nov. 27, 2020 /PRNewswire/ -- Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has submitted an application for approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care.
  • The application is the starting point of the review process of Sedaconda in 15 of the EU member states, including Norway.
  • If all goes well, Sedana Medical expects an approval in the second half of 2021.
  • The market approval application is based on the strong results in Sedana Medical's pivotal phase III study, SED-001.

Sedana Medical submits market approval application for the drug Sedaconda

Friday, November 27, 2020 - 11:57am

STOCKHOLM, Nov. 27, 2020 /PRNewswire/ -- Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has submitted an application for market approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care.

Key Points: 
  • STOCKHOLM, Nov. 27, 2020 /PRNewswire/ -- Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has submitted an application for market approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care.
  • The application is the starting point of the review process of Sedaconda in 15 of the EU member states, including Norway.
  • If all goes well, Sedana Medical expects an approval in the second half of 2021.
  • The market approval application is based on the strong results in Sedana Medical's pivotal phase III study, SED-001.

DGAP-News: PAION REPORTS POSITIVE REMIMAZOLAM TOPLINE DATA IN EU PHASE III TRIAL IN GENERAL ANESTHESIA

Thursday, November 19, 2020 - 10:07pm

- Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol

Key Points: 
  • - Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol
    - EU Phase III program completed; data to serve as basis for MAA submission in general anesthesia
    Aachen (Germany), 19 November 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces positive topline data from the pivotal remimazolam EU Phase III trial in general anesthesia.
  • Assuming approval in procedural sedation, PAION plans to submit an extension of the marketing authorization for remimazolam for general anesthesia.
  • In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
  • In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.

DGAP-News: PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST NINE MONTHS OF 2020

Wednesday, November 11, 2020 - 7:01am

In the U.S., the FDA (Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.

Key Points: 
  • In the U.S., the FDA (Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.
  • In October 2020, the Drug Enforcement Administration (DEA) designated BYFAVO(TM) as a Schedule IV medicine, which was a prerequisite for launch.
  • The overall evaluation of opportunities and risks has not changed significantly in the first nine months of 2020.
  • PAION confirms its financial outlook for the current fiscal year announced on 12 August 2020 with the publication of the half-year results for 2020.

Natick Family Dental Offers Nitrous & Sedation Dentistry to help Patients overcome "Dental Phobia"

Tuesday, October 20, 2020 - 3:05pm

NATICK, Mass., Oct. 20, 2020 /PRNewswire/ -- Natick Family Dental is pleased to introduce sedation dentistry into its practice.

Key Points: 
  • NATICK, Mass., Oct. 20, 2020 /PRNewswire/ -- Natick Family Dental is pleased to introduce sedation dentistry into its practice.
  • To significantly reduce, if not eliminate, the fear and anxiety associated with dental treatment, Natick Family Dental is now offering sedation dentistry.
  • "The option to receive sedation has changed the lives of many of our patients enabling them to overcome their dental fears and to have a positive clinical experience," says Dr. Rachana Vora, President of Natick Family Dental.
  • Natick Family Dental is a multi-specialty dental practice based in Natick, MA serving neighboring communities of Wellesley, Framingham, Wayland, Needham, Ashland, Sherborn, Dover, Holliston, and Southborough.

AnaConDa from Sedana Medical reviewed by NICE in UK

Wednesday, October 7, 2020 - 7:09am

"The report confirms AnaConDa and its technology as an innovation and supports it as an alternative to intravenous sedation.

Key Points: 
  • "The report confirms AnaConDa and its technology as an innovation and supports it as an alternative to intravenous sedation.
  • They are NICE advice, designed to support NHS and social care commissioners and staff who are considering using new medical devices, and other medical or diagnostic technologies.
  • Sedana Medical AB (publ) has developed and sells the medical device AnaConDa for the administration of volatile anaesthetics.
  • Through a combination of AnaConDa and the candidate drug IsoConDa (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated intensive care patients.

Dr. Bijal Patel Joins the Dental Staff at Elegant Smiles in Brookhaven, Georgia

Wednesday, September 9, 2020 - 2:00pm

Elegant Smiles is committed to delivering dentistry at its best, providing every patient with a pathway toward achieving functional and aesthetic smiles.

Key Points: 
  • Elegant Smiles is committed to delivering dentistry at its best, providing every patient with a pathway toward achieving functional and aesthetic smiles.
  • Dr. Bijal Patel is a welcome addition, and her dental knowledge and expertise are a great fit for this Atlanta area practice.
  • Elegant Smiles offers emergency dental care, same day appointments, in-house financing plans and sedation dentistry.
  • For more information about Dr. Bijal Patel or the services offered at Elegant Smiles, please visit http://www.dentalatl.com or call (404) 634-4224.

Leedy Dental Raises Awareness of Harm in Delaying Dental Care, Offers Sedation Dentistry to Calm Dental Anxiety in Abilene, TX

Monday, August 31, 2020 - 12:15pm

Whether to minimize physical discomfort or to limit dental anxiety, the doctors at Leedy Dental offer a variety of sedation dentistry treatments including nitrous oxide and oral sedation.

Key Points: 
  • Whether to minimize physical discomfort or to limit dental anxiety, the doctors at Leedy Dental offer a variety of sedation dentistry treatments including nitrous oxide and oral sedation.
  • Those in need of a routine dental cleaning or exam are welcome to receive sedation dentistry during their appointment at Leedy Dental.
  • Leedy Dental is a comprehensive dental practice located in Abilene, TX that specializes in full mouth rehabilitation and implant dentistry, as well as personalized dental care and cosmetic services.
  • To learn more about the life-changing services provided at Leedy Dental, visit http://www.leedydental.com or call the Abilene, TX practice at 325-268-0013.

In response to the COVID-19 pandemic, Dental Associates of Arlington is offering patients a variety of "touchless" digital options

Wednesday, August 12, 2020 - 3:01pm

Prior to check-in, all patients receive links (by email) to intake and screening forms to fill out electronically.

Key Points: 
  • Prior to check-in, all patients receive links (by email) to intake and screening forms to fill out electronically.
  • Upon arrival to our facility, patients must wear face masks for their own safety and that of others.
  • Dental Associates of Arlington is a multi-specialty dental practice that meets all of our patients needs under one roof from general, cosmetic, implant, and emergency procedures to sedation.
  • As the director of Dental Associates of Arlington, she has worked with patients of all ages and has been practicing dentistry for over 10 years.

DGAP-News: PAION AG REPORTS FINANCIAL RESULTS FOR THE FIRST HALF-YEAR 2020

Wednesday, August 12, 2020 - 7:01am

In the U.S., the FDA (U.S. Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.

Key Points: 
  • In the U.S., the FDA (U.S. Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.
  • In July 2020, after market approval of BYFAVOTM, PAION, Cosmo and Acacia agreed to assign the BYFAVOTM license agreement signed in 2016 between Cosmo and PAION to Acacia.
  • In Europe, PAION is seeking approval for remimazolam in procedural sedation and in general anesthesia.
  • Procedural sedation: PAION submitted a Marketing Authorization Application (MAA) for procedural sedation to the European Medicines Agency (EMA) in November 2019.