Company Product Description Indication Status
Avacta Group plc, of Wetherby, U.K. Affidx SARS-CoV-2 antigen lateral flow test Rapid antigen test Detects SARS-CoV-2 viral antigens Reported positive data from a clinical validation study in Europe across a broad range of viral loads; the study tested 98 positive samples with viral loads confirmed by PCR (31 with cycle threshold <26; 65 with cycle threshold 26-30 and 2 with cycle threshold 30-31); the test identified 96/98 of these correctly as positive with a 20 minutes read time, resulting in a clinical sensitivity of 98.0%; out of a total of 102 negative samples tested with the lateral flow device, the test correctly identified 101 as negative, giving a clinical specificity of 99.0%
Co-Diagnostics Inc., of Salt Lake City Logix Smart COVID-19 test kit In vitro diagnostic test that uses Coprimer technology For the qualitative detection of RNA from SARS-CoV-2 Australian researchers demonstrated rapidly deployable mobile molecular diagnostics support for remote locations; when tested on clinical samples, the sensitivity and specificity of Co-Diagnostics's test showed complete concordance with the comparison assay; demonstrated an analytical sensitivity of 1,010 viral copies per milliliter, which they found to be comparable to other tests used across Western Australia; results were published in the Journal of Medical Microbiology
Limacorporate SpA, of Udine, Italy Smr stemless reverse shoulder system Prosthetic implant For total reverse shoulder arthroplasty First surgery was performed in the U.S. IDE study; the multicenter trial is evaluating the safety and effectiveness of the Smr stemless reverse shoulder system compared to the Smr reverse shoulder system; will enroll 200 patients with 2-year follow-up
Medtronic plc, of Dublin In.Pact AV Drug-coated balloon (DCB) For treatment of failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) undergoing dialysis The In.Pact AV Access study showed sustained and superior effectiveness through 2 years compared to standard percutaneous transluminal angioplasty (PTA) in ESRD patients with de novo or non-stented restenotic native arteriovenous fistulae in the upper extremity; target lesion primary patency through 24 months was 52.2% in the In.Pact AV DCB group vs. 36.2% in the PTA control group (log-rank p<0.001); access circuit primary patency through 24 months was 39.5% in the In.Pact AV DCB group vs. 25.4% in the PTA control group (log-rank p<0.001); freedom from all-cause mortality through 24 months was 82.4% in the In.Pact AV DCB study group vs. 82.8% in the PTA control group (log-rank p=0.829)
Phagenesis Ltd., of Manchester, U.K. Phagenyx system Neurostimulation device that using pharyngeal electrical stimulation (PES) Treatment of intubation-induced severe neurogenic post-extubation dysphagia in COVID-19 patients Published in Journal of Medical Case Reports the experience of a 71-year-old female patient with confirmed SARS-CoV-2 infection and severe neurogenic dysphagia following prolonged intubation in the ICU who was treated with PES using the Phagenyx system; patient demonstrated rapid improvement in saliva management with increased spontaneous swallowing and post-treatment diet advancement; patient was discharged from the ICU to a non-intensive medical department 5 days after final PES treatment session
Renalytix AI plc, of New York Kidneyintelx In vitro diagnostics platform for blood-based biomarkers that uses an artificial intelligence-enabled algorithm Identifies early-stage patients at high risk for kidney disease progression and failure Study found the Kidneyintelx test accurately predicted progression of diabetic kidney disease (DKD) in a multinational cohort from the CANagliflozin CardioVAScular Assessment Study (CANVAS) with early-stage DKD (stages I-III); participants identified by Kidneyintelx as high risk (15% of the study population) had more than an 8-fold higher rate of disease progression vs. those that scored low risk (42% of the population); the application of the guideline-recommended Kidney Disease: Improving Global Outcomes risk classification tool only provided a 2.5-fold gradient for DKD progression among study participants identified as high risk compared with those scored as low risk
Vivasure Medical Ltd., of Galway, Ireland Perqseal+ Fully absorbable, patch-based implant Sutureless closure of large-bore vessel punctures Enrolled first patient in Frontier V study

Notes

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