Confusion Assessment Method

Trevena Reports Fourth Quarter 2022 Results and Provides Business Update

Retrieved on: 
Thursday, March 30, 2023

CHESTERBROOK, Pa., March 30, 2023 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the fourth quarter ended December 31, 2022 and provided an overview of its recent operational highlights.

Key Points: 
  • As reference, in pooled data for the Company’s pivotal Phase 3 studies of OLINVYK, the GI complete response rate was 46.2% (0.35mg) and 39.7% (0.50mg).
  • Analysis of respiratory data from VOLITION is not yet available, and the Company expects to report these data mid-2023.
  • In the fourth quarter of 2022, the commercial team signed contracts with three new specialty distributors that focus primarily on ambulatory surgery centers (ASCs).
  • Cash and cash equivalents were $38.3 million as of December 31, 2022, which the Company believes will be sufficient to fund the Company’s operating expenses and capital expenditure requirements into the fourth quarter of 2023.

PhosAgro Earns Brazilian “Environmental Quality Label”

Retrieved on: 
Thursday, December 29, 2022

The Brazilian ABNT standard is harmonised for most criteria with the Russian Vitality Leaf standard.

Key Points: 
  • The Brazilian ABNT standard is harmonised for most criteria with the Russian Vitality Leaf standard.
  • The Brazilian standard establishes strict limits for arsenic and heavy metals that are identical to the Ecological Union standard.
  • I would like to congratulate PhosAgro, one of the biggest players in the Brazilian market, which has become the first Russian fertilizer producer to receive the Brazilian ‘Environmental Quality Label’,” said Brazil’s ambassador to Russia, Rodrigo de Lima Baena Soares.
  • Marking our products with the ABNT’s ‘Environmental Quality Label’ will give Brazilian producers the opportunity to make an informed choice in favour of environmentally preferable fertilizers whose quality is confirmed on a global scale,” said Mikhail Rybnikov, CEO of PhosAgro.

Ceribell Receives FDA Breakthrough Device Designation for Delirium Indication

Retrieved on: 
Thursday, September 8, 2022

SUNNYVALE, Calif., Sept. 8, 2022 /PRNewswire/ -- Ceribell, Inc. announced today that it has received Breakthrough Device Designation for its delirium indication from the United States Food and Drug Administration (FDA). A first-of-its-kind technology, the Ceribell® system utilizes machine learning to analyze electroencephalography (EEG) signals to detect delirium. The Ceribell point-of-care EEG system first received FDA 510(k) clearance in 2017 for indicating suspected seizure activity and is currently utilized in intensive care units (ICUs) and Emergency Rooms across the United States.  

Key Points: 
  • Breakthrough Device Designation recognizes Ceribell's point-of-care EEG as a first-of-its-kind technology for the detection of delirium.
  • SUNNYVALE, Calif., Sept. 8, 2022 /PRNewswire/ -- Ceribell, Inc. announced today that it has received Breakthrough Device Designation for its delirium indication from the United States Food and Drug Administration (FDA).
  • A first-of-its-kind technology, the Ceribell system utilizes machine learning to analyze EEG signals to detect delirium.
  • The Ceribell system's Breakthrough Device Designation was grounded in early clinical studies that have provided clear evidence that the system is likely to improve the current standard of care.

EyeControl Expands R&D Program with EyeControl-Pro for Delirium

Retrieved on: 
Monday, June 13, 2022

TEL AVIV, Israel, June 13, 2022 /PRNewswire/ -- EyeControl is developing the EyeControl-Pro, an AI-based, smart, screenless and wearable, eye-tracking communication solution for Delirium reduction. The company will display its new investigational device, EyeControl-Pro, at the American Delirium Society Conference (ADS), June 12-14, Indianapolis, IN. 

Key Points: 
  • The company will display its new investigational device, EyeControl-Pro, at the American Delirium Society Conference (ADS), June 12-14, Indianapolis, IN.
  • EyeControl-Pro is being designed to enable bi-directional remote connectivity and communication between the patient's headset, the medical team and family members.
  • EyeControl CEO Mr. Or Retzkin said, "Our intention is to effectively empower the up to 80% of ICU patientsexperiencing Delirium to communicate with their medical support team, family and friends, center and regain control of reality.
  • EyeControl-Pro, based on the same communication platform, is an investigational device being developed to treat those experiencing Delirium.

PhosAgro Certified for Compliance with the Vitality Leaf International Environmental Standard

Retrieved on: 
Wednesday, January 26, 2022

This is in line with the requirements set out in the Vitality Leaf standard.

Key Points: 
  • This is in line with the requirements set out in the Vitality Leaf standard.
  • Companies complete questionnaires with questions about compliance with environmental laws, the operation of their environmental management systems and energy conservation.
  • The fact that our production sites were the first to be certified for compliance with the Vitality Leaf environmental standard is clear confirmation of the unique eco-efficiency of PhosAgro's mineral fertilizers, as well as our commitment to sustainability, environmental conservation and the protection and restoration of soils.
  • In 2021, the environmental management system was certified at all of the Company's production sites, and its full compliance with the requirements of the ISO 14001 standard was affirmed.

PhosAgro Certified for Compliance with the Vitality Leaf International Environmental Standard

Retrieved on: 
Wednesday, January 26, 2022

This is in line with the requirements set out in the Vitality Leaf standard.

Key Points: 
  • This is in line with the requirements set out in the Vitality Leaf standard.
  • Companies complete questionnaires with questions about compliance with environmental laws, the operation of their environmental management systems and energy conservation.
  • The fact that our production sites were the first to be certified for compliance with the Vitality Leaf environmental standard is clear confirmation of the unique eco-efficiency of PhosAgro's mineral fertilizers, as well as our commitment to sustainability, environmental conservation and the protection and restoration of soils.
  • In 2021, the environmental management system was certified at all of the Company's production sites, and its full compliance with the requirements of the ISO 14001 standard was affirmed.