Therma Bright Inc. and its investment Inretio Inc. 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 strokes. 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).

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. 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 AcuVidTM 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.