Company Product Description Indication Status
Saluda Medical Pty. Ltd., of Artarmon, Australia Evoke Evoked compound action potential (ECAP)-controlled, closed-loop spinal cord stimulation (SCS) system Measures the spinal cord's response to stimulation (via ECAPs) and adjusts on every pulse to optimize activation within the patient's therapeutic window for pain management The Lancet Neurology published 12-month results from the U.S. pivotal study in patients with chronic intractable back and leg pain; closed-loop demonstrated statistically superior overall back and leg pain relief (with no increase in pain medications) vs. control (open-loop SCS) with 83.1% (49/59) of closed-loop subjects achieving ≥50% pain relief (open-loop: 61.0% [36/59]), (p=0.0060); among subjects taking opioids at baseline, opioid use was reduced or eliminated in 55% (17/31) of closed-loop patients vs. 40% of open-loop patients (12/30); the closed-loop system maintained spinal cord activation within the therapeutic window 95.2% of the time vs. 47.9% of the time with open-loop
Sphingotec GmbH, of Hennigsdorf, Germany Bio-ADM (Bioactive Adrenomedullin) Endothelial function biomarker Predicts circulatory shock before blood pressure decline, e.g., in septic patients, and diagnosis of residual congestion in acute heart failure patients Data on 2,000 ICU patients, published in Critical Care, demonstrated that Bio-ADM not only identifies high-risk patients for septic shock at admission, but also identifies those in the general ICU patient population who require immediate life-saving therapeutic intervention; in an observational ancillary study to the FROG-ICU study, high blood levels of Bio-ADM at admission to the ICU were an early predictor of the requirement for organ support and treatment with ionotropes and vasopressors; elevated Bio-ADM blood levels were also significantly associated with a prolonged length of ICU stay and fatal outcomes within 28 days post-admission, whereas low levels of Bio-ADM at admission were associated with positive outcomes

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