Fluidx Medical Technology LLC

New Catheter-Delivered Embolic Shows Promise for Treating Life-Threatening Bleeding around the Brain SALT LAKE CITY, Jan. 10, 2023 /PRNewswire/ -- Fluidx Medical Technology, Inc., released information regarding the success of the IMPASS Embolic Device in in-vivo research related to middle meningeal artery (MMA) embolizations which can be used to treat chronic subdural hematomas (CSDH) on the surface of the brain.[i] CSDH is a common pathology encountered that can result in death and/or disability in patients. The typical treatment of CSDH involves drilling a hole in the skull and draining the blood. Minimally invasive catheter-based MMA embolization can be an alternative to surgical treatment. "We've been listening to clinicians and they need better tools to treat CSDH," says Danny Smith, VP of R&D for Fluidx. "We designed the IMPASS Embolization Device to work with standard embolization catheters and embolize small microvasculature in the MMA. Our results are encouraging and the IMPASS product could be a great solution to unmet patient needs." MMA embolization is a promising option to address CSDH and is particularly appealing for elderly patients and others who cannot undergo invasive surgical procedures. Hundreds of thousands of patients with CSDHs may benefit from this minimally invasive procedure. During this procedure, a small catheter is navigated into the MMA which is located within the dura mater which covers the brain, then an embolic material is delivered into the vessel to block arterial flow. The IMPASS Embolic Device is part of the portfolio of embolics currently under development by Fluidx. In the fall, Fluidx announced successful completion of a multi-center clinical trial with the GPX Embolic Device to treat a broad range of peripheral applications including tumor devascularization. Similar to the GPX Embolic Device, the IMPASS Embolic Device uses core Fluidx embolic technology but is designed specifically for neurovascular uses. The material is a low viscosity, aqueous-based solution that solidifies into a durable embolus upon delivery without polymerization or dimethyl-sulfoxide (DMSO) precipitation. [ii] The Fluidx embolic platform is expected to bring simple preparation and controllable material delivery to a range of applications. The IMPASS device is packaged in a ready-to-use syringe, can be prepped tableside by the clinician in about 30 seconds, and may be delivered through standard microcatheters (no complex mixing systems or special delivery catheters are necessary). About Fluidx Medical Technology: Fluidx Medical Technology is a Salt Lake City, Utah based company focused on developing GPX, IMPASS, and other embolic technologies with applications across peripheral vascular, interventional oncology, and neurovascular embolization. The GPX and IMPASS Embolic Devices are under development, described and shown for research, educational, and engineering use only, and do not have marketing clearance or approval in any market at this time. CONTACT: Russell Bjorklund, russell.bjorklund@fluidxmedical.com, (801) 209-1297 [i] Data on file. In-vivo results may not correlate to clinical outcomes [ii] Data on file. In-vivo results may not correlate to clinical outcomes View original content to download multimedia: SOURCE Fluidx Medical Technology

Fluidx Medical's GPX Embolic Material Yields Promising Results for Oncology Uses SALT LAKE CITY, Aug. 10, 2022 /PRNewswire/ -- Fluidx Medical disclosed study results examining extent of vessel filling using the GPX Embolic Device compared to microspheres, a common treatment for many types of tumors. Embolization is a procedure in which arterial or venous blood supply to an organ, malformation, aneurysm, bleed, tumor, and/or other abnormal area of issue is blocked. Metal coils, microsphere particles, and/or liquids are common embolics delivered through small 0.5mm – 1.5mm outer diameter 100 – 150cm long catheters. "GPX is demonstrating deep distal vessel penetration," said Ryan O'Hara, M.D., Interventional Oncologist, University of Utah. "The ability to fill the smallest tumor feeding vessels and reach distal vessel beds is very important in effective treatment of hypervascular tumors and in other therapeutic embolic procedures." Embolizing blood supply to tumors is a high-growth procedure to block blood supply to certain tumors. Transarterial chemoembolization (TACE) includes delivering chemotherapy with embolization. Tumor embolization may also be performed prior to resection. "GPX exhibited effective and thorough embolization throughout the renal cortical vasculature," according to a pathology assessment conducted by study pathologist James Stanley, DVM, MS, DACVP. "GPX filled the smallest arteries/arterioles of the distal cortex which was not observed with 40-micron microspheres." GPX and microspheres were studied in selected small branches of renal arteries. The GPX Embolic Device was found to fill vessels more completely and penetrate deeper into smaller vessel beds than the smallest microspheres commonly used for tumor treatments. "The extent of distal penetration of GPX, combined with its potential as a drug-loadable oncology solution, make this a unique technology with an exciting future in advancing cancer care," said Danny Smith, Vice President of R&D. About the GPX Embolic Device: The GPX Embolic Device is an innovative embolic designed for simple preparation and controllable material delivery. The device is packaged ready-to-use in a syringe, can be prepped tableside by the clinician in about 30 seconds, and may be delivered through standard microcatheters (no complex mixing systems or special delivery catheters are necessary). GPX technology is a low viscosity, aqueous-based solution in a syringe that solidifies into a durable embolus upon delivery without polymerization or dimethyl-sulfoxide (DMSO) precipitation. GPX is designed to be highly visible and to occlude blood vessels independent of a patient's coagulation situation.* About Fluidx Medical Technology: Fluidx Medical Technology is a Salt Lake City, Utah based company focused on developing the GPX Embolic Device and other embolic technologies with applications across peripheral vascular, interventional oncology, and neurovascular. The GPX Embolic Device is under development and does not have marketing clearance or approval in any market at this time. For investigational use (in New Zealand) only.

Novel Oncology Embolic Device financing supports prospective, clinical trials and market entry [01-December-2021] SALT LAKE CITY, Dec. 1, 2021 /PRNewswire/ -- Fluidx Medical Technology, a privately held medical device company founded to develop GPX, an innovative embolic material, and other technologies today announced the oversubscribed closing of the first tranche of its Series A financing round. The Series A was led by a large multinational strategic investor, and joined by its existing investor base as well as several new investors. The funding will be used to support prospective clinical trials, including the pivotal trial, as well as preparation for market entry. "GPX has been quite simple to prepare, deliver and control," said Dr. Andrew Holden, M.D., MBChB, FRANZCR, EBIR, ONZM, Director of Interventional Radiology, Auckland City Hospital, Auckland, New Zealand. "The material is very radiopaque during delivery and has demonstrated excellent distal penetration, particularly important in our tumor embolization cases." Embolic devices are widely used to stop blood flow for targeted treatment of hypervascular tumors, vessel malformations, internal bleeds, and other cancer-related uses. Challenges with embolic devices today can include complicated preparation processes, issues with visibility during device delivery, reliance on the body's coagulation situation, and lack of complete penetration of vessel beds and tumor feeding vessels. The GPX Embolic Device is an innovative embolic designed for simple preparation and quick material delivery. GPX technology is a low viscosity, aqueous-based solution in a syringe that solidifies into a durable embolus upon delivery without polymerization or dimethyl-sulfoxide (DMSO) precipitation. GPX is designed to occlude blood vessels independent of a patient's coagulation situation. Unlike competitive technologies that require special preparation materials and time, the GPX device is packaged ready-to-use in a syringe, requires less than 30 seconds of tableside preparation by the clinician, and may be delivered through standard catheters or small microcatheters (no complex mixing systems or special delivery catheters are necessary).* "The GPX team achieved a great deal with seed funding including first patient use of the device. We have been very pleased with the overwhelming investor support for our Series A raise," said Libble Ginster, CEO of Fluidx Medical Technology. "Our company's mission is to elevate patient care through innovation, and we look forward to bringing the GPX technology to the clinical community." Fluidx Medical Technology is a Salt Lake City, Utah based company focused on developing the GPX Embolic Device and other innovative medical technologies. The GPX Embolic Device is under development and does not have marketing clearance or approval in any market at this time. For investigational use (in New Zealand) only. *Fluidx Medical Technology data on file.