Business
Therma Bright's Investment Partner Inretio Announces Successful Completion of GLP Study for PREVA(TM) Thrombectomy Device
Both Companies Anticipates Approval to Launch of Human Clinical Trials Tel Aviv, Israel and Toro...
About this update from Therma Bright Inc.
[{"type":"text","content":"Therma Bright's Investment Partner Inretio Announces Successful Completion of GLP Study for PREVA(TM) Thrombectomy DeviceBoth Companies Anticipates Approval to Launch of Human Clinical TrialsTel 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 ...