|Adaptive Biotechnologies Corp., of Seattle||T-Detect COVID||T-cell test||Detects past SARS-CoV-2 infection||T-Detect identified 97% (68/70) of past PCR-confirmed SARS-CoV-2 infections vs. 77% (54/70) with FDA emergency use authorized antibody testing at similar specificity approximately 2 months after PCR diagnosis; the T-cell response was greater in symptomatic vs. asymptomatic subjects, whereas there was no correlation between antibody levels and disease severity in recovered patients; preliminary results are available on medRxiv|
|Glympse Bio, of Cambridge, Mass.||Injectable mixture of synthetic sensors||Bioengineered, tunable sensors||Measure the activity of proteases associated with non-alcoholic steatohepatitis (NASH) via a urine test||Presented first-in-human data supporting the safety of Glympse Bio's Biosensors; in the open-label phase I trial, 3 cohorts of 6 subjects were sequentially administered increasing doses of the biosensors developed for NASH; the study provided clinical translational data to demonstrate safety in healthy volunteers, confirm urine signal detection and identify optimum time points for urine collection in future trials|
|Helio Health, of Irvine, Calif.||Helio Liver Test||Cell-free DNA methylation blood test||Detects hepatocellular carcinoma (HCC)||Presented positive data from validation study; results showed that the Helio Liver Test produced 88.7% (95% CI: 87.3-90.0%) sensitivity in early-stage (stages 1 and 2) HCC, while sensitivity for AFP alone was 57.5% (95% CI: 52.6-61.8%)|
|Inari Medical Inc., of Irvine, Calif.||Flowtriever||Clot aspiration and mechanical thrombectomy device||For intermediate- and high-risk pulmonary embolism (PE) patients||Reported follow-up results of the first 230 patients enrolled in its FLASH study; at 30 days, only one death was reported, vs. the PERT Consortium Quality Database 30-day mortality rate of 25.9% and 6.1% for high- and intermediate-risk PE patients; the FLASH Registry showed a readmission rate of 6.7% vs. the nearly 25% readmission rate shown in the PERT Database; efficacy data were also compelling, showing normalization or near normalization in a battery of hemodynamic variables like pulmonary artery pressure, RV/LV ratio, and heart rate, as well as dyspnea (shortness of breath) metrics|
|Pq Bypass Inc., of Milpitas, Calif.||Detour system||Femoral-popliteal bypass device||Treatment of long, complex lesions in the superficial femoral artery||Reported long-term safety and effectiveness results from 24-month follow-up data from the DETOUR1 clinical study, including a 79% primary patency, with 82% of patients maintaining freedom from major adverse events at 2 years post-procedure|
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