Both Companies Anticipates Approval to Launch of Human Clinical Trials
Tel Aviv, Israel and Toronto, Ontario--(Newsfile Corp. - June 7, 2023) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer and partner in a wide-range of leading-edge, proprietary diagnostic and medical device technologies, and its investment Inretio Inc., an innovative Israeli medical device company , has announced the successful completion of a Good Laboratory Practice (GLP) study for its breakthrough PREVA™ mechanical thrombectomy device. This significant milestone brings the device one step closer to human clinical trials and eventual market availability, marking a major advancement in the treatment of ischemic stroke.
The GLP study, conducted at the Shamir Medical Center's Research Unit, demonstrated the PREVA™ device's ability to effectively remove blood clots, confirming its potential to revolutionize the treatment of ischemic stroke. GLP studies are essential for this class of medical device and usually precede the initiation of First-in-Human (FIH) studies that are requested by the various regulatory agencies, including Israel's Ministry of Health, U.S. Food and Drug Administration (U.S. FDA), Health Canada (HC), European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA-Japan).
"The PREVA™ device achieved overall removal of 100% of the clot in 100% of the cases during the GPL study," shared Raviv Vine, CEO of Inretio. "We are thrilled with the results we've seen in the GLP study. Our team has worked tirelessly to develop a device that could make a meaningful difference in the treatment of ischemic stroke, and we believe these results move us one step closer to achieving that goal."
Current thrombectomy procedures are based on stents that open inside the clot without aspiration, leading to potential fragmentation and secondary damage to the brain tissue. This can result in new blockages downstream, causing significant impact on the patient's quality of life. The PREVA™ device is uniquely designed to mechanically remove blood clots from the brain, using a distal basket to 'ensnare' the clot, protecting the brain from any sub-clots breaking off during the procedure. This leads to more successful revascularization of the brain, preventing further damage and complications, and potentially improving patient outcomes.
"We wish to congratulate Raviv and his talented team on the success of the GLP study," shared Rob Fia, CEO of Therma Bright. "We're equally excited that the results will help Inretio move forward in securing regulatory approval for human trials with the PREVA™ thrombectomy device."
Inretio anticipates starting clinical trials for the PREVA™ device in approximately four months. The results from these studies will be submitted to the Israeli Ministry of Health for Clinical Trial clearance in humans, marking a significant milestone towards the device's commercialization.
In other news, Health Canada has requested a long-term stability study of the AcuVid™ Covid-19 Rapid Antigen Saliva Test to determine shelf life, as well as a comprehensive post-production validation study by a third (3rd) party independent lab to further ensure that the test's sensitivity remains intact. Both studies are complex and will require manufacturing of additional test lots and the identification and hiring of a reputable third (3rd) party, highly specialized lab partner to conduct these studies.
The Company is currently evaluating the best option and approach to ensure that all additional investments in Covid-19 diagnostic testing are sound and viable.
About Inretio
Inretio was born out of the need for improving stroke care and reducing thrombectomy complications. The company aims to reduce the burden of stroke and patient suffering by leading in the neurovascular field, and providing physicians with simple, yet innovative solutions1.
About Therma Bright Inc.
Therma Bright is a developer and partner in a wide range of leading edge, proprietary diagnostic and medical device technologies focused on providing consumers and medical professionals with quality, innovative solutions that address some of today's most important medical and healthcare challenges. Therma Bright Inc. trades on the (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX). Visit: www.thermabright.com.
Therma Bright Inc.
Rob Fia, CEO
rfia@thermabright.com
FORWARD-LOOKING STATEMENTS
Certain statements in this news release constitute "forward-looking" statements. These statements relate to future events such as the commercialization of PREVA™ and related technology 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 such results will be achieved. Actual results could differ materially from those anticipated due to several 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 because 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.
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