FactsAll NR facts for your reading pleasure. A list of news releases that never happened as described, were delayed, or lead to no FDA approval as of today. Let's all take time to thank management for their efforts. I didn't even add in all my Venowave facts.
Dec 7th, 2020
Therma will procure up to 300 prototype tests from one of its suppliers to undertake initial testing with selected sites in Ontario.
Jan 18th, 2021 Therma is in discussions with selected sites in Ontario, the US and international locations to conduct prospective studies with the optimized test. The initial testing of the CoviSafe™ prototype will be for both symptomatic and asymptomatic patients. Therma has been working with Public Health Ontario, US partners, and international partners to identify sites for the prospective testing and evaluation of CoviSafe™. Testing is expected to start upon approval from one of the study locations. The initial prospective test will test a minimum of 100 CoviSafe™ prototype devices using fresh saliva from the study participants to gain feedback on how the test performs in a real-life setting. This information will be used to improve the CoviSafe™ prototype at which time the final CoviSafe™ design will be locked. The final locked CoviSafe™ design will be used for a minimum of a 300 person prospective study and the data obtained will be used for regulatory approval under the Interim Order with Health Canada and the EUA with FDA and to obtain the CE mark from Europe.
Feb 26th, 2021 ("Therma" or the "Company"), a progressive medical device technology company, is pleased to announce that it has entered into an agreement with a COVID-19 testing site located in the Greater Toronto Area to conduct a clinical study with the Company's AcuVid TM rapid antigen test for detecting SARS-CoV-2 virus in saliva.The testing site is located within the Greater Toronto Area that has one of the highest positivity rates in Ontario. The positivity rate around the testing center is currently at 19%. Due to the high positivity rate the Company expects to achieve the minimum number of positive samples required for regulatory approvals more quickly than other locations that were originally considered. Many of the original sites the Company was investigating for clinical trials have been experiencing lower positivity rates due to lockdowns across Canada which would have resulted in a greater expense to the Company along with longer testing periods to complete the clinical testing. The testing site will allow the Company to complete the clinical trial quickly followed by submission of the data to both the FDA and Health Canada.
March 11th, 2021
("Therma" or the "Company"), a progressive medical device technology company, is pleased to announce that it has submitted an application to an independent Research Ethics Board ("REB") for approval to conduct a clinical study with the Company's AcuVid TM rapid antigen test for detecting SARS CoV-2 virus in saliva. Approval is expected within a week, at which point Therma will submit a complete package, including the REB review, to Health Canada to conduct the clinical trial.
April 13th, 2021
("Therma" or the "Company"), a progressive medical device technology company, is pleased to announce that it has entered into an agreement with Safetest Diagnsticos("Safetest") of Brazil in partnership with the Federal University of Minas Gerais to conduct a clinical performance study of its AcuVidTM COVID-19 Rapid Saliva-based Antigen Test.
April 19th, 2021
pleased to announce that it has received CE approval certification from an EU competent authority of Belgium for its AcuVid™ COVID-19 Rapid Antigen Saliva Test, and has secured a conditional purchase order for 100,000 units through a new global distribution partner, McWilliams Collective
April 28th, 2021
Afero has entered into a memorandum of understanding (MOU) agreement with Therma Bright Inc. (TSXV: THRM), the "Company" or "Therma Bright"), developer of the AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies. The mutually beneficial partnership looks to bring Afero's innovation, security and tracking technology to Therma Bright's 15-minute COVID-19 rapid antigen screening solution. Upon completion, the proposed agreement will offer AcuVid™ COVID-19 Rapid Antigen Saliva Tests powered by Afero, with a goal to help communities safely and securely return to work and play using an embedded and encrypted technology for tracking and reporting AcuVID Tests for quality assurance, shipping, logistics, and point-of-care test results. It also paves the way for preparing the AcuVID COVID-19 Rapid Antigen Test for approval for at-home testing. The MOU was competed and signed on April 28, 2021. Both parties expect to complete a definitive agreement and begin work on or before June 1, 2021.
May 21st, 2021
AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce that it has secured a development and manufacturing partnership with K-One MediTech to bring the Acuvid™ COVID-19 Rapid Antigen Saliva Test Kit to the marketplace.
July 22nd, 2021
AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to provide an update on its AcuVid™ COVID-19 Rapid Antigen Saliva Test and awaits an official response from the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) review for its COVID-19 rapid antigen test application.
In addition to exceeding the minimum results for FDA-EUA review with the initial 63 tests from the Brazilian AcuVid™ Saliva / RT-PCR Test Clinical Study, which was publicly announced in June 2021, the Company continued to recruit individuals in the clinical study to secure additional real-life patient data on its AcuVid™ saliva test. In total, 264 individuals were enrolled in the study with duration of symptoms that ranged from one (1) day to more than 10
Nov12th, 2021
AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce that it will begin its U.S. clinical performance study with the receipt of Institutional Review Board's (IRB) conditional approval late yesterday, Thursday, November 11, 2021.