Therma Bright Inc V.THRM

News

[thrmadmin]

Therma Bright Initiates Clinical Performance Study in Brazil for its AcuVid COVID-19 Rapid Saliva-Based Antigen Test Toronto, Ontario--(Newsfile Corp. March 18, 2021) - Therma Bright Inc. (TSXV: THRM) ("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. Brazil's increase in its COVID-19 infection rate in the past week set another record in terms of new cases and deaths - 12,818 new deaths and more than 464,000 new cases, according to Johns Hopkins University figures. This increase was greater than that seen in the United States, the only country in the world harder hit by the pandemic in absolute numbers. Because of this, recruitment in this clinical performance study will be completed much faster in Brazil because of the high positivity rate. The study will be conducted under the direction of Dr. Ricardo Fujiwara from the Federal University of Minas Gerais with the support of Safetest. Safetest Diagnsticos was founded in 2016 to bring high quality rapid tests to the market in Brazil and elsewhere. Its first product, the Leishmaniasis Rapid Test, was developed in partnership with the Federal University of Minas Gerais. Safetest has extensive expertise in the development and validation of antigen and antibody based diagnostic tests with a robust R&D pipeline of diagnostic kits that include tests for Hansens Disease, Brucellosis, HTLV and blood screening tests. The study aims to validate a minimum of 60 samples of the AcuVidTM Covid-19 Antigen Test with fresh saliva samples of patients. The samples will be confirmed with an approved PCR test. Rob Fia, CEO, commented, the tests will be performed on fresh saliva from patients upon admission to the testing facility. Considering the current positivity in Brazil, we are aiming to complete recruitment and complete the study in less than 2 weeks. The study result will supplement and strengthen the evidence of the clinical value of AcuVid saliva test, an accurate and highly specific, easy to use diagnostic tool to help our fight against this pandemic. Mr. Fia went on to say, recent lab results of our locked test showed 100% sensitivity and 100% specificity in most patients when tested within 7 days of onset of symptoms. This is the test that will be entering the performance study. Dr. Fujiwara commented, the AcuVID Covid-19 Antigen Test results will be compared to the respective PCR test results which will compare the performance of the tests and will also provide us with real-life data on the ease of use of the device. Therma Bright is not making any express or implied claims that its test product has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus. About Therma Bright Inc. Therma Bright is a progressive medical device technology company focused on providing consumers and medical professionals with quality medical devices that address their medical and healthcare needs. The Company's initial breakthrough proprietary technology delivers effective, non-invasive and pain-free skincare. Therma Bright received a Class II medical device status from the FDA for its platform technology that is indicated for the relief of the pain, itch, and inflammation of a variety of insect bites or stings. The Company received clearance for the above claims from the US FDA in 1997. Therma Bright Inc. trades on the TSXV: THRM, OTCMARKETS:THRBF, FRA:JNX. For more information visit: www.thermabright.com and www.coldsores.com For further information, please contact: Therma Bright Inc. Rob Fia, CEO [e-mail] Follow us on Twitter: FORWARD LOOKING STATEMENTS Certain statements in this news release constitute "forward-looking" statements. These statements relate to future events such as development and commercialization of a rapid COVID-19 viral assay and related instrumentation, regulatory applications and manufacturing scale up as described in the news release. All such statements involve substantial known and unknown risks, uncertainties and other factors which may cause the actual results to vary from those expressed or implied by such forward-looking statements. Forward-looking statements involve significant risks and uncertainties, they should not be read as guarantees of future performance or results, and they will not necessarily be accurate indications of whether or not such results will be achieved. Actual results could differ materially from those anticipated due to a number of factors and risks. Although the forward-looking statements contained in this news release are based upon what management of the Company believes are reasonable assumptions on the date of this news release, the Company cannot assure investors that actual results will be consistent with these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof and the Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required under applicable securities regulations. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. This press release is not an offer of the securities for sale in the United States. The securities have not been registered under the U.S. Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an exemption from registration. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful.

[boubouna]

Thank you..great news!!

[boubouna]

Does this testing negate the Greater Toronto testing? (Feb NR)...or are the two running parallel?

[forrest6748]

Interesting number changes. Major upgrade Mr. Fia went on to say, "Recent lab results of our locked test showed 100% sensitivity and 100% specificity in most patients when tested within 7 days of onset of symptoms. This is the test that will be entering the performance study."

[boubouna]

Those numbers alone in this NR were 'halt' worthy...this, in my opinion, was extremely worthy of EARTH SHATTERING news!! 

[Moemoney42]

Yeah so what.. they're "lab results" not field results... all tests out already show that kind of sensitivity and specificity 7 days out...!!

[Moemoney42]

And what about the GTA being the best place to test due to high viral loads.. now thats off the table.. these guys pitch and spin more than a country jig..!

[St0ckR0cker]

Can they not be doing both? They are supposed to hear back from REB by March 20? 

[spygate]

thats really the question isnt it? Did we enter in this arrangement for testing in Brazil,because we didnt get approval to proceed with the current local testing? or will it be done in parrallel? One will propel our SP and one will unfortunately send it the other way.

[Kaiser]

There is absolutely NO reason testing in Canada would be denied especially with 100% spec and 100% sens!  Therma already said they are expecting approval which should be granted this week from the REB.  There is no logical theory that would suggest thrm wasn't granted testing.  That fear mongering is not even worth entertaining.  Perhaps this testing site in a heavily

[mooseslayer]

I think it is in tandem and a good chance to test in an area that you can't swing a dead cat without hitting someone with Covid.

[Whydunnit]

Those are great numbers but the thing that bothers me is what does "most patients" mean?  If something is going to be 100% shouldn't it include all patients?  Did they exclude 10% of patients for whom it wasn't 100%?  That would make it sort of 100% but not really.  Also, it says they are lab results.  Shouldn't it say field results if patients were

[moonball32]

I agree with your assessment of the NR, you highlighted parts that should have been clearer, interpreting the NR on boards like this is not ideal. Those points are needed to fully understand where the company is and where it is going. Putting up a 2 week timeline is dangerous given recent failures to meet timelines. The 1 week timeline on the last promise is up today, mgmt needs to under promise

[hemi3tc]

The test only works on high viral loads. So test results that were low to mid viral loads that tested negative were excluded.

[Whydunnit]

I've heard that accuracy increases with viral load, and that only makes sense.  In the case of this test, is it that the test doesn't work or doesn't work as well with lower loads?  They're hoping to eventually use it for asymptomatic cases so presumably it must still work with lower viral loads, just not at a 100% level.  Maybe that's where the previously

[Whydunnit]

Another point I'd make is that in the real world, when they test someone they're not going to know beforehand what the viral load of the person is, but ideally they're going to want to find all infectious people.  It seems disingenuous to me to exclude lower viral loads from sensitivity numbers they way they've done in the press release.  IMO if they are going to exclude

[Smokey1958]

Actually they weren't excluded as news just not repeated in today's NR. This can be found in an earlier NR. Overall sensitivity has been as high as 86% ...above expectations for HC approval. For high viral loads the sensitivity is 100% per the previous NR. Have there been even more improvements ...hope so ....but not important. The 100% specificity of AcuVid is critical as there will be no

[Whydunnit]

Okay, thanks for that, that explains it better.  I thought I'd read something about higher viral loads returning 100% specificity but wasn't sure if it was something THRM put out.  The part you bolded is most important.

[nrv090909]

This stock price at christmas time will be $3-4, remember that. 42 cents is a gift to buy in at.