Company Product Description Indication Status
Avenu Medical Inc., of San Juan Capistrano, Calif. Ellipsys vascular access system Catheter device For the creation of fistulas for hemodialysis Study published in the Journal of Vascular and Interventional Radiology compared the Ellipsys vascular access system and the Wavelinq 4F system; the Ellipsys system had a technical success rate of 100% and only 27.7% of patients required secondary interventions following fistula creation; the Wavelinq system demonstrated similar outcomes, with a technical success rate of 97% and 26.5% of patients requiring secondary interventions; overall, 79.5% of Ellipsys patients and 58% of Wavelinq patients were able to successfully begin dialysis with their fistula; at 12 months, 82% of Ellipsys fistulas were still functional vs. 60% of Wavelinq fistulas
Axonics Modulation Technologies Inc., of Irvine, Calif. Axonics r-SNM system Implantable sacral neuromodulation (SNM) device Treatment of urinary and bowel dysfunction Reported full 2-year clinical results from its ARTISAN-SNM pivotal study; 88% of all implanted participants (n=129) were therapy responders at 2-years, defined as a ≥50% reduction in urgency incontinence episodes compared to their baseline; 80% of therapy responders had ≥75% reduction in their urinary urge incontinence (UUI) episodes; 37% of therapy responders were dry, having experienced a 100% reduction in their UUI episodes
Hyperfine Research Inc., of Guilford, Conn. Swoop Portable magnetic resonance imaging device Enables bedside visualization of internal structures Study published in the Journal of the American Medical Association Neurology demonstrates the feasibility of Hyperfine's Swoop system to obtain bedside neuroimaging for critically ill patients in the intensive care unit (ICU) settings; the study used Swoop on a series of 50 ICU patients, including patients with ischemic stroke, hemorrhagic stroke, subarachnoid hemorrhage, traumatic brain injury, brain tumor, and COVID-19 and altered mental status; abnormal neuroimaging findings were detected in 29 of 30 patients without COVID-19 (97%); 8 of 20 patients with COVID-19 (40%) demonstrated abnormalities; there were no adverse events or complications
Medifiber, of Hanam, South Korea Virus Buster face masks Uses copper ion-bonded material (CAZ) Deactivates SARS-CoV-2 Tests at Colorado State University demonstrated that the surface material of the Virus Buster face mask can eliminate more than 99.99% of the SARS-CoV-2 virus strain within 30 minutes; 99.57% of the virus was neutralized within 10 minutes, when compared to the control material, which lacked the antiviral component
Reshape Lifesciences Inc., San Clemente, Calif. Diabetes Bloc-Stim Neuromodulation (DBSN) device Uses vagus nerve neuromodulation Treatment of type 2 diabetes mellitus A preclinical investigation consisting of simultaneous electrical blockade and stimulation of individual vagal nerve branches was conducted in a type 2 diabetic porcine animal model; results showed a significant reduction of blood glucose; histopathology of organ systems effected by the neuromodulation demonstrated healthy tissue


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