Company Product Description Indication Status
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

Notes

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