Therma Bright Inc (TSX-V:THRM, OTC:TBRIF) along with its partner Inretio Inc has highlighted the successful completion of a Good Laboratory Practice (GLP) study for its breakthrough PREVA mechanical thrombectomy device.
The study was conducted at the Shamir Medical Center's Research Unit and demonstrated that the device effectively removed blood clots, underscoring its potential to revolutionize the treatment of ischemic stroke.
"The PREVA device achieved overall removal of 100% of the clot in 100% of the cases during the GLP study," Raviv Vine, CEO of Inretio, said in a statement. "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."
The GLP study usually precedes the initiation of First-in-Human (FIH) studies that are requested by the various regulatory agencies, including the US Food and Drug Administration (FDA), Health Canada (HC), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA-Japan) and Israel's Ministry of Health.
“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 company added.
As things stand, thrombectomy procedures involve using stents that open inside the clot without aspiration, leading to potential fragmentation and secondary damage to the brain tissue which can result in new blockages downstream. Uniquely, the PREVA device mechanically removes 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.
Inretio expects to start clinical trials for the PREVA device in around four months and the results will be submitted to the Israeli Ministry of Health for Clinical Trial clearance in humans.
Therma Bright also said that Health Canada has requested a long-term stability study of the AcuVid Covid-19 Rapid Antigen Saliva Test to determine shelf life along with a post-production validation study to ensure that the test's sensitivity remains intact.
Therma Bright is a developer and partner in a wide range of leading-edge, proprietary diagnostic and medical device technologies that address some of the most important medical and healthcare challenges.
Contact the author at jon.hopkins@proactiveinvestors.com